Press Releases

SOUTH SAN FRANCISCO, Calif. October 8, 2020 – Aligos Therapeutics, Inc. (Aligos), a clinical stage biopharmaceutical company focused on developing novel therapeutics to address unmet medical needs in viral and liver diseases, today announced that the company is presenting an e-poster at the virtual Therapeutics for COVID-19 meeting held by the International Society for Influenza and other Respiratory Virus Diseases-Antiviral Group (ISIRV-AVG), taking place October 6 – 8 from noon to 4 p.m. GMT.

The e-poster highlights Aligos’ recently developed assay to identify protease inhibitor candidates potentially suitable for use as coronavirus therapeutics. Presentation information is as follows:

E-Poster Title: Evaluation of SARS-CoV-2 3C-like protease inhibitors using self-assembled monolayer desorption ionization mass spectrometry

E-Poster number: AAVGV0025

Presenter: Jerome Deval, Ph.D., Senior Director, Head of Biochemistry
Date/time: The e-poster will is available for the duration of the conference.

About Aligos

Aligos Therapeutics, Inc., is a privately held, clinical stage biopharmaceutical company that was founded in 2018 with the mission to become a world leader in the treatment of viral infections and liver diseases. Aligos is focused on the development of targeted antiviral therapies for chronic hepatitis B (CHB) and coronaviruses as well as leveraging its expertise in liver diseases to create targeted therapeutics for nonalcoholic steatohepatitis (NASH). Aligos’ strategy is to harness the deep expertise and decades of drug development experience its workforce has in liver disease, particularly viral hepatitis, to rapidly advance its pipeline of potentially best-in-class molecules.

Please visit www.aligos.com for more information.

Media Contact

Amy Jobe, Ph.D.
LifeSci Communications
+1 315 879 8192
ajobe@lifescicomms.com

Investor Contact

Corey Davis, Ph.D.
LifeSci Advisors
+1 212 915 2577
cdavis@lifesciadvisors.com

 Second drug candidate from Aligos’ CHB portfolio cleared to start first-in-human clinical trial

SOUTH SAN FRANCISCO, Calif. September 28, 2020 – Aligos Therapeutics, Inc. (Aligos), a clinical stage biopharmaceutical company focused on developing novel therapeutics to address unmet medical needs in viral and liver diseases, today announced that the Company has received approval for a clinical trial application (CTA) for a first-in-human Phase 1a/b proof-of-concept clinical trial. Aligos may now commence study ALG-000184-201 (NCT04536337) to evaluate ALG-000184, a small molecule class II capsid assembly modulator (CAM) that targets hepatitis B virus (HBV) capsid assembly as well as the establishment of covalently closed circular DNA (cccDNA). ALG-000184 is the second of Aligos’ chronic hepatitis B (CHB) drug candidates cleared to begin clinical trials.

“In collaboration with Emory University, we have utilized our small molecule chemistry expertise to identify multiple promising CAMs including ALG-000184, which has been optimized for potency as well as other pharmacokinetic properties,” said Lawrence Blatt, Ph.D., MBA, Chief Executive Officer of Aligos. “We look forward to determining how these properties translate in the clinic towards development of novel therapies for patients with chronic hepatitis B.”

ALG-000184-201 is a multipart Phase 1a/1b umbrella trial that will evaluate the safety, pharmacokinetics and antiviral activity of up to 28 days of once-daily doses of orally administered ALG-000184 in healthy volunteers (1a) and patients with CHB (1b).

Aligos’ CAM program is one of four classes of compounds in its CHB development portfolio, which also includes STOPS ™ (S-antigen Transport-inhibiting Oligonucleotide Polymers) molecules, antisense oligonucleotide (ASO), and small interfering RNA (siRNA) drug candidates.

About Chronic Hepatitis B (CHB)

CHB is a major cause of chronic liver disease that affects over 290 million people worldwide. Serious complications of CHB include cirrhosis and liver cancer, which are associated with significant mortality. Approximately 900,000 people died from CHB-related causes in 2015 alone and the mortality rate associated with HBV-related liver cancer continues to increase. Although current standard of care for patients with CHB is effective in suppressing HBV, it is associated with very low rates of functional cure, which is the goal for future CHB treatments.

About Aligos

Aligos Therapeutics, Inc., is a privately held, clinical stage biopharmaceutical company that was founded in 2018 with the mission to become a world leader in the treatment of viral infections and liver diseases. Aligos is focused on the development of targeted antiviral therapies for chronic hepatitis B (CHB) and coronaviruses as well as leveraging its expertise in liver diseases to create targeted therapeutics for nonalcoholic steatohepatitis (NASH). Aligos’ strategy is to harness the deep expertise and decades of drug development experience its workforce has in liver disease, particularly viral hepatitis, to rapidly advance its pipeline of potentially best-in-class molecules.

Please visit www.aligos.com for more information.

Media Contact

Amy Jobe, Ph.D.
LifeSci Communications
+1 315 879 8192
ajobe@lifescicomms.com

Investor Contact

Corey Davis, Ph.D.
LifeSci Advisors
+1 212 915 2577
cdavis@lifesciadvisors.com

SOUTH SAN FRANCISCO, Calif., August 27, 2020 – Aligos Therapeutics, Inc. (Aligos), a private biopharmaceutical  company focused on developing novel therapeutics to address unmet medical needs in viral and liver diseases, including  chronic hepatitis B (CHB), COVID-19 and therapeutics for NASH, will present four abstracts highlighting nonclinical data for drug candidates in the company’s CHB portfolio at the European Association for the Study of the Liver (EASL) Digital International Liver Congress™ 2020.

“Taken together, our findings show promising progress across our chronic hepatitis B portfolio, both individually and in pairwise combinations,” said Lawrence Blatt, Ph.D., MBA, chief executive officer of Aligos. “As our lead candidates advance in the clinic, we are gratified to see that our approach of designing purpose-built drug candidates targeting clinically validated mechanisms of action have shown promising activity in our nonclinical studies to date.”

The presentations provide new information for many of the company’s classes of drug candidates designed for use in combination therapy to develop high rates of functional cure in CHB. Of note, an abstract related to Aligos’ STOPS™ program, entitled “Structural requirements for ’S-antigen transport-inhibiting oligonucleotide polymer inhibition of hepatitis B surface antigen secretion,” was selected for inclusion in the meeting’s ‘Best of ILC’ category, which highlights the most noteworthy contributions to the meeting’s scientific program. The titles of each abstract, the class(es) of candidates highlighted and the findings are as follows:

S-antigen Transport-inhibiting Oligonucleotide PolymerS (STOPS™)

Title: Structural requirements for S-antigen Transport-inhibiting Oligonucleotide Polymer inhibition of hepatitis B surface antigen secretion

Summary: Aligos’ proprietary STOPS candidates were evaluated for S-antigen (or HBsAg) reduction and cytotoxicity in cell culture to optimize activity relative to structurally similar nucleic acid polymers (NAPs). Upon varying sequence, length, and chemical modifications of STOPS, it was found that STOPS’ activity is dependent on length, with the highest potency observed at over 34 nucleotides. Sequence was critical for STOPS activity: when the AC dinucleotide repeat was changed to AG, the antiviral activity was completely lost. However, activity was retained when the base identities were maintained, such as with a CA repeat. Site-specific incorporation of backbone chemistries such as a stereospecific phosphorothioate bond also improved potency.

Note: This abstract will be available publicly after the meeting as part of EASL’s ‘Best of ILC’ summary slide deck.

Capsid Assembly Modulators (CAMs)

Title: ALG-000184, a prodrug of capsid assembly modulator ALG-001075, demonstrates best-in-class preclinical characteristics for the treatment of chronic hepatitis B

Summary:  ALG-001075 was found to be a potent inhibitor of HBV DNA production in HepG2.117 cells with EC₅₀/EC₉₀ values of 0.63/3.17 nM (n = 12), respectively. This level of potency exceeds that of all other known reported CAMs that have entered clinical development, efficiently blocking both HBV genome encapsidation and de novo cccDNA formation. ALG-000184, a prodrug of ALG-001075, showed improved pharmacokinetic properties, including improved aqueous solubility, stability and oral absorption across species with efficient conversion to ALG-001075 in vivo.

Antisense oligonucleotides (ASOs)

Title: Best in class hepatitis B virus anti-sense oligonucleotides: Next generation bridged nucleic acid chemistries significantly improve the therapeutic index by reducing hepatotoxicity and increasing in vivo efficacy in a mouse model

Summary: Although locked nucleic acid (LNA)-modified ASOs can cause liver toxicity, applying bridged nucleic acid and nucleobase gap modifications to LNA ASOs showed improved efficacy and reduced liver toxicity in a mouse model of hepatitis B virus (HBV) infection, suggesting that Aligos’ anti-HBV ASO candidates have potential to be best in class compounds.

STOPS in combination with other agents

Title: Combination drug interactions of hepatitis B virus (HBV) S-antigen Transport-inhibiting Oligonucleotide Polymers in vitro

Summary: STOPS in combination with nucleos(t)ides, core assembly modulators (CAMs), and HBV-specific antisense oligonucleotides (ASOs) were evaluated for inhibition of HBV replication and HBsAg release in HBV-producing hepatic cells. When tested in pairwise combinations with the other HBV inhibitors, STOPS demonstrated synergy or additivity. Overall, the activity of STOPS warrants further study as a component of a combination therapy in CHB. 

About Chronic Hepatitis B (CHB)

CHB is a major cause of chronic liver disease that the World Health Organization estimates affects ~257 million people worldwide, more people than hepatitis C virus (HCV) and HIV infection combined. Serious complications of CHB include cirrhosis and liver cancer, which are associated with significant mortality.  Approximately 900,000 people died from CHB-related causes in 2015 alone and the mortality rate has been rising for decades. Although current standard of care for patients with CHB is effective in suppressing HBV, it is associated with very low rates of functional cure, which is the main goal of CHB treatment.

About Aligos

Aligos Therapeutics, Inc., is a privately held, clinical stage biopharmaceutical company that was founded in 2018 with the mission to become a world leader in the treatment of viral infections and liver diseases. Aligos is focused on the development of targeted antiviral therapies for chronic hepatitis B (CHB) and coronaviruses as well as leveraging its expertise in liver diseases to create targeted therapeutics for nonalcoholic steatohepatitis (NASH). Aligos’ strategy is to harness the deep expertise and decades of drug development experience its workforce has in liver disease, particularly viral hepatitis, to rapidly advance its pipeline of potentially best-in-class molecules.

Please visit www.aligos.com for more information.

 

Media Contact
Amy Jobe, Ph.D.
LifeSci Communications
+1 315 879 8192
ajobe@lifescicomms.com

Investor Contact
Corey Davis, Ph.D.
LifeSci Advisors
+1 212 915 2577
cdavis@lifesciadvisors.com

SOUTH SAN FRANCISCO, Calif., August 26, 2020 – Aligos Therapeutics, Inc. (Aligos), a private biopharmaceutical company focused on developing novel therapeutics to address unmet medical needs in viral and liver diseases, including chronic hepatitis B (CHB), COVID-19 and therapeutics for nonalcoholic steatohepatitis (NASH), will present nonclinical data related to the company’s thyroid hormone receptor-beta (THR-B) therapeutic program for NASH on August 27 at the European Association for the Study of the Liver (EASL) Digital International Liver Congress™ 2020.

The data, summarized in an abstract titled “Molecular, cellular, and pharmacological characterization of beta-selective partial agonists of human thyroid hormone receptor for the treatment of nonalcoholic steatohepatitis,” will be presented as part of a poster session. Data details a novel series of B- selective THR partial agonists targeting NASH by reducing harmful levels of liver fat without causing the side effects associated with non-selective THR agonists, which can activate the THR-alpha (A) isoform in the heart.

“Following profiling in a panel of in vitro assays, our team assessed the THR activation of several small molecule THR-B agonists in hepatic cells. Promising compounds were then evaluated for efficacy in rats fed with a high fat diet,” said Jerome Deval, Ph.D., senior director of biochemistry at Aligos and lead author of the study. “In contrast to currently known THR-B agonists, the compounds tested show potential for cholesterol reduction in vivo without detectable activation of THR-A.”

In vitro, Aligos’ compounds activated THR-B with an EC₅₀ of approximately 40-60 nM, with a maximum effective amplitude (E_max) of approximately 25-50% relative to the natural thyroid hormone T3. At much higher concentrations (up to 10 µM), the same compounds did not significantly activate THR-A. Further, reporter assays in hepatic (HEK293T) cells demonstrated an E_max value of approximately 55% relative to T3 with no measurable THR-A activation. Aligos’ compounds yielded a >90-fold THR-B/THR-A selectivity index, relative to indices of 1- to 3.4-fold among three existing THR-B agonists. In a diet-induced obese (DIO) rat efficacy model, single doses of B-selective THR partial agonists induced cholesterol reduction, albeit at lower levels compared with full THR agonists.

“Current NASH treatments lack selectivity, supporting our conclusion that there is significant value in pursuing improved candidates as part of Aligos’ portfolio in highly prevalent liver diseases,” said Lawrence Blatt, Ph.D., MBA, chief executive officer of Aligos. “We believe that these compounds warrant further study.”

 About Aligos

Aligos Therapeutics, Inc. is a privately held biopharmaceutical company that was founded in 2018 with the mission to become a world leader in the treatment of viral infections and liver diseases. Aligos is focused on the development of targeted antiviral therapies for chronic hepatitis B (CHB) and COVID-19 as well as leveraging its expertise in liver diseases to create targeted therapeutics for NASH. Aligos’ strategy is to harness the deep expertise and decades of drug development experience its workforce has in liver disease, particularly viral hepatitis, to rapidly advance its pipeline of best-in-class molecules.

Please visit www.aligos.com for more information.

 

Aligos Media Contact
Amy Jobe, Ph.D.
LifeSci Communications
+1 315 879 8192
ajobe@lifescicomms.com

Aligos Investor Contact
Corey Davis, Ph.D.
LifeSci Advisors
+1 212 915 2577
cdavis@lifesciadvisors.com

Second drug candidate from Aligos’ CHB portfolio advances towards clinical trial

 SOUTH SAN FRANCISCO, Calif. August 24, 2020 – Aligos Therapeutics, Inc. (Aligos), a clinical stage biopharmaceutical company focused on developing novel therapeutics to address unmet medical needs in viral and liver diseases, today announced that it has submitted a clinical trial application (CTA) to the New Zealand Medicines and Medical Devices Safety Authority for a first-in-human Phase 1a/b proof-of-concept trial (ALG-000184-201). The trial is evaluating ALG-000184, a small molecule class II capsid assembly modulator (CAM) that targets hepatitis B virus (HBV) capsid assembly as well as the regulation and transcription of covalently closed circular DNA (cccDNA).

“This is a significant achievement for Aligos Therapeutics,” said Lawrence Blatt, Ph.D., MBA, Chief Executive Officer of Aligos. “Starting with novel CAM compounds discovered in Dr. Raymond Schinazi’s laboratory at Emory University, our teams have collaborated over the last 2 years to further improve upon the CAM technology. This work culminated in the discovery of ALG-000184, which has optimized pharmacokinetic properties and sub-nanomolar potency. ALG-000184 appears to be the most potent class II CAM drug candidate known to have entered clinical development to date and we are excited to see how its enhanced properties translate in clinical trials.”

ALG-000184-201 is a multipart Phase 1a/1b umbrella trial that will evaluate the safety, pharmacokinetics and antiviral activity of up to 28 days of once-daily doses of orally administered ALG-000184 in healthy volunteers and patients with chronic hepatitis B (CHB). “We aim to follow our Phase 1 STOPS^TM candidate into the clinic with ALG-000184 and conduct concurrent Phase 1 trials with each of these drug candidates before moving them into combination trials,” noted Matthew McClure, M.D., Chief Medical Officer of Aligos. “We believe that by advancing a purpose-built combination of therapeutics with additive or synergistic antiviral activity, we may be able to significantly improve upon the low rates of functional cure seen with current standard of care medications.”

Aligos’ CAM program is one of four classes of compounds in its CHB development portfolio, which also includes STOPS (S-antigen Transport-inhibiting Oligonucleotide Polymers), antisense oligonucleotide (ASO), and small interfering RNA (siRNA) drug candidates.

 About Chronic Hepatitis B (CHB)

CHB is a major cause of chronic liver disease that the World Health Organization estimates affects ~257 million people worldwide, more people than hepatitis C virus (HCV) and HIV infection combined. Serious complications of CHB include cirrhosis and liver cancer, which are associated with significant mortality.  Approximately 900,000 people died from CHB-related causes in 2015 alone and the mortality rate has been rising for decades. Although current standard of care for patients with CHB is effective in suppressing HBV, it is associated with very low rates of functional cure, which is the main goal of CHB treatment.

About Aligos

Aligos Therapeutics, Inc., is a privately held, clinical stage biopharmaceutical company that was founded in 2018 with the mission to become a world leader in the treatment of viral infections and liver diseases. Aligos is focused on the development of targeted antiviral therapies for chronic hepatitis B (CHB) and coronaviruses as well as leveraging its expertise in liver diseases to create targeted therapeutics for nonalcoholic steatohepatitis (NASH). Aligos’ strategy is to harness the deep expertise and decades of drug development experience its workforce has in liver disease, particularly viral hepatitis, to rapidly advance its pipeline of potentially best-in-class molecules.

Please visit www.aligos.com for more information.

 

Media Contact
Amy Jobe, Ph.D.
LifeSci Communications
+1 315 879 8192
ajobe@lifescicomms.com

Investor Contact
Corey Davis, Ph.D.
LifeSci Advisors
+1 212 915 2577
cdavis@lifesciadvisors.com

First Aligos drug candidate to commence clinical trials

First-in-human trial marks ~2.5-year path from company formation to entry into the clinic

SOUTH SAN FRANCISCO, Calif. August 18, 2020 – Aligos Therapeutics, Inc. (Aligos), a private clinical stage biopharmaceutical company focused on developing novel therapeutics to address unmet medical needs in viral and liver diseases, including chronic hepatitis B (CHB) and coronaviruses and therapeutics for nonalcoholic steatohepatitis (NASH), today announced that it has dosed its first subject in a first-in-human Phase 1a/b trial. This trial will evaluate ALG-010133, a proprietary oligonucleotide S-antigen transport-inhibiting oligonucleotide polymer (STOPS^TM) molecule that functions to decrease viral S-antigen (or HBsAg) levels, an essential step for enabling functional cure in CHB.

“This marks an important milestone for the company, as ALG-010133 is Aligos’ first asset to enter into clinical trials since the company’s launch in 2018,” said Lawrence Blatt, Ph.D., MBA, Chief Executive Officer of Aligos. “Our team has spent the last two years discovering and optimizing STOPS molecules, which ultimately led to the identification and advancement of ALG-010133.  We believe that this drug candidate has the potential to significantly suppress HBsAg levels in patients with CHB and are excited to initiate this important proof of concept trial.”

ALG-010133-101 (NCT04485663) is a multi-part umbrella trial that will evaluate the safety, pharmacokinetics and antiviral activity of up to 12 weekly doses of subcutaneously administered ALG-010133 in healthy volunteers and virologically suppressed patients with CHB.  Initially, Aligos is conducting the trial at a single clinical pharmacology unit in Auckland, New Zealand, and, once dosing in CHB patients starts, at multiple investigational sites across the Asia-Pacific region and Europe.  Aligos expects to report topline CHB results for certain trial cohorts beginning in the second half of 2021.

Aligos’ STOPS program is one of several programs in its CHB portfolio that target different clinically validated mechanisms of action.  The portfolio also includes capsid assembly modulator (CAM), antisense oligonucleotide (ASO), and small interfering RNA (siRNA) drug candidates.  All of these drug candidates have properties that indicate that they could be used in combinations to develop potentially best-in-class treatment regimens that may achieve higher rates of functional cure than current standard of care. For each of these drug candidates, Aligos plans to initially establish proof of concept as monotherapy in Phase 1 umbrella trials before evaluating them in combination in subsequent trials.

 “Approved treatments, such as nucleos(t)ide analogs, result in low rates of functional cure and require lifelong therapy for the approximately 290 million people living with CHB around the world,” noted Matthew McClure, M.D., Chief Medical Officer. “A key part of our mission at Aligos is to improve this rate by advancing multiple drug candidates, each of which interrupts distinct steps in the viral life cycle, that will act additively or synergistically when combined.  This trial is a first step in our effort to achieve that mission.”

 About Aligos

Aligos Therapeutics, Inc., is a privately held, clinical stage biopharmaceutical company that was founded in 2018 with the mission to become a world leader in the treatment of viral infections and liver diseases. Aligos is focused on the development of targeted antiviral therapies for chronic hepatitis B (CHB) and coronaviruses as well as leveraging its expertise in liver diseases to create targeted therapeutics for nonalcoholic steatohepatitis (NASH). Aligos’ strategy is to harness the deep expertise and decades of drug development experience its workforce has in liver disease, particularly viral hepatitis, to rapidly advance its pipeline of potentially best-in-class molecules.

Please visit www.aligos.com for more information.

 

Media Contact
Amy Jobe, Ph.D.
LifeSci Communications
+1 315 879 8192
ajobe@lifescicomms.com

Investor Contact
Corey Davis, Ph.D.
LifeSci Advisors
+1 212 915 2577
cdavis@lifesciadvisors.com

SOUTH SAN FRANCISCO, Calif. and LEUVEN, Belgium, July 01, 2020 (GLOBE NEWSWIRE) — Aligos Therapeutics, Inc. (Aligos), a private biotechnology company focused on the development of targeted antiviral therapies directed against chronic hepatitis B (CHB), COVID-19 and therapeutics for NASH, today announced that they have entered into a collaboration and license agreement with KU Leuven, in particular its Centre for Drug Design and Discovery (CD3), a drug discovery unit and investment mechanism of KU Leuven, and the Rega Institute for Medical Research, to develop a coronavirus protease inhibitor as a potential therapeutic candidate to address the COVID-19 pandemic.

Principal investigator Johan Neyts, Ph.D., professor of virology, and his scientific staff at the Rega Institute, together with the CD3 team, have focused for many years on discovering novel antiviral strategies against a number of virus families. In this collaboration, Johan Neyts’ research group and CD3 will join forces with Aligos, whose team has extensive experience in antiviral drug discovery, development and viral protease inhibitor chemistry. Their combined objective is to develop a therapeutic candidate designed to target the SARS-CoV-2 infection as well as other coronavirus infections.

“The Rega Institute together with CD3 was a natural and complementary fit for this collaborative effort, with their longstanding track record of developing effective antiviral products against a number of viruses,” said Aligos President Leonid Beigelman, Ph.D. “The teams agreed on the specific coronavirus protease as a promising therapeutic target, which is essential in the viral life cycle and conserved among viruses in the coronavirus family, meaning that a candidate that inhibits this target may also serve as a therapeutic in potential future coronavirus epidemics.”

“Besides the urgent need for treatment options to fight the current SARS-CoV-2 virus,” said Professor Neyts, “it is clear that there is also an important need for preparedness for the next coronavirus outbreak. A pan-coronavirus antiviral is the best and only approach to be able to respond quickly to any new emerging coronavirus in the future and avoid large outbreaks that may lead to epidemics or a pandemic.”

“We are delighted to enter into this collaboration aiming to deliver a new drug against SARS-CoV-2 and other coronaviruses,” said Patrick Chaltin, Managing Director of CD3. “The SARS-CoV-2 crisis demands the implementation of a strong integrated approach combining and leveraging world leading academic virology expertise and our early drug discovery capabilities with an exceptionally strong and committed biotech partner like Aligos.”

About Aligos

Aligos Therapeutics, Inc. is a privately held biotechnology company that was founded in 2018 with the mission to become a world leader in the treatment of viral infections and liver diseases. Aligos is focused on the development of targeted antiviral therapies for chronic hepatitis B (CHB) and COVID-19 as well as leveraging its expertise in liver diseases to create targeted therapeutics for NASH. Aligos’ strategy is to harness the deep expertise and decades of drug development experience its workforce has in liver disease, particularly viral hepatitis, to rapidly advance its pipeline of best-in-class molecules.

Please visit www.aligos.com for more information.

About the Centre for Drug Design and Discovery – KU Leuven

The Centre for Drug Design and Discovery (CD3) is a drug discovery platform and investment fund with a focus on the discovery and development of innovative medicines mainly starting from innovative academic research. By providing the necessary drug discovery expertise and financial resources, CD3 ensures that biomedical research carried out by universities and small biotech companies is collaboratively translated into promising new medicines. Subsequently, such new potential medicines can then be further developed by pharma or biotech industry or can form the basis for the establishment of new biotechs. CD3 was set up in 2006 by KU Leuven Research & Development and the European Investment Fund (EIF) and launched a 60 million euro fund in 2016.

Please visit www.cd3.eu for more information.

About Rega Institute

The Rega Institute for Medical Research is a biomedical research institute of KU Leuven that comprises the Laboratory of Virology and Chemotherapy, which specializes particularly in antiviral research. Medications discovered at the Rega Institute are successfully being used for the treatment of, for example, HIV, hepatitis B and infections caused by herpes viruses and several other drug candidates are in development against human rhinovirus, dengue and other (viral) diseases.

Please visit www.kuleuven.be/rega for more information.

Aligos Media Contact
Amy Jobe, Ph.D.
LifeSci Communications
+1 315 879 8192
ajobe@lifescicomms.com

Aligos Investor Contact
Corey Davis, Ph.D.
LifeSci Advisors
+1 212 915 2577
cdavis@lifesciadvisors.com

KU Leuven Contact
Dr. Patrick Chaltin
Managing Director CD3
+32 477 61 08 54
patrick.chaltin@kuleuven.be

SOUTH SAN FRANCISCO, Calif., ATLANTA, June 23, 2020 – Aligos Therapeutics, Inc. (Aligos), a private biotechnology company focused on the development of antiviral therapies targeting chronic hepatitis B (CHB) and COVID-19 as well as therapeutics for NASH, announced an expansion to their existing license agreement with Emory University (Emory) to include additional technology developed at Emory related to Aligos’ capsid assembly modulator (CAM) program in CHB. Aligos and Emory have also entered into a collaboration agreement to futher advance this technology.

The license expansion builds upon the parties’ existing agreement whereby Aligos acquired from Emory an exclusive license to technology with respect to a novel class of non-nucleoside class-II CAMs. Professor Raymond F. Schinazi, director of the Laboratory of Biochemical Pharmacology at Emory, and colleagues have developed a series of potent, novel CAMs, small molecules that disrupt viral capsid assembly. Aligos is advancing its CAM program as part of a CHB portfolio designed to produce a combination therapy delivering a high rate of functional cure. Each program in the portfolio targets clinically validated mechanisms in the replication cycle of the hepatitis B virus.

“We are pleased to continue our collaboration with Emory by adding a wider range of potential drug candidates to our CAM discovery and development programs,” said Aligos CEO Lawrence Blatt, Ph.D., MBA. “Building upon the foundation established in 2018, we plan to further explore the technology Dr. Schinazi and his group at Emory have developed in an effort to create a best-in-class combination therapy for the treatment of chronic Hepatitis B.”

Raymond F. Schinazi, Ph.D., D.Sc., FAASLD (Pediatrics) at Emory, added, “We are pleased to collaborate with a very experienced group of scientists at Aligos towards an HBV cure. Together we have optimized our compounds providing potency in the picomolar range with a favorable preclinical safety profile. Clearly a fixed dose combination will not only prevent or reduce the likelihood of drug resistance, but will also provide a powerful blow to the virus capsid, which is essential for virus replication and persistence.”

SOUTH SAN FRANCISCO, Calif. June 18, 2020 – Aligos Therapeutics, Inc. (Aligos), a private biotechnology company focused on the development of targeted antiviral therapies directed against chronic hepatitis B (CHB) and COVID-19 and therapeutics for NASH, today announced that it has submitted its first clinical trial application for a first-in-human Phase 1a/b study evaluating ALG-010133.  ALG-010133 is a proprietary oligonucleotide S-antigen transport inhibiting oligonucleotide polymer (STOPS^TM) which is thought to act as an aptamer that interacts with specific proteins to decrease viral HBsAg levels, which is essential for enabling functional cure in CHB.

“We are excited to announce the achievement of this important developmental milestone for ALG-010133” said Lawrence Blatt, Ph.D., MBA, Chief Executive Officer of Aligos. “With worldwide disease prevalence in the hundreds of millions, chronic Hepatitis B patients are at significant risk of progression to liver fibrosis, cirrhosis, end stage liver disease, and hepatocellular carcinoma.  Currently available therapies are given for life and rarely result in a sustained functional cure.  Our goal is to develop a therapeutic regimen that can lead to high rates of functional cure for patients living with chronic Hepatitis B. ”

Aligos’ STOPS program is the first of three classes of compounds in its CHB development portfolio, which also includes a capsid assembly modulator (CAM) and antisense oligonucleotide (ASO).  Initially, Aligos plans to evaluate these in separate Phase 1 studies and then combine them in subsequent studies.

SOUTH SAN FRANCISCO, Calif. June 3, 2020 – Aligos Therapeutics, Inc. (Aligos), a private biotechnology company focused on the development of targeted, antiviral therapies including chronic hepatitis B (CHB) and COVID-19 as well as therapeutics for NASH, today announced the appointment of Lesley Ann Calhoun, as chief financial officer. Ms. Calhoun will serve as a member of the Aligos leadership team and will report to Aligos’ chief executive officer, Lawrence Blatt, Ph.D., MBA.

Ms. Calhoun is an experienced finance executive with 17 years in the biopharma industry as well as an earlier career in U.S. and multinational technology companies and public accounting. She brings broad experience in both public and pre-IPO companies and in driving financial vision, direction, guidance and compliance to support and advise on operations for companies. She has had a successful career in transforming companies from private, pre-IPO stages to publicly traded business driven, commercial operating companies.

“With Ms. Calhoun’s significant financial and business operations experience, we are pleased to welcome her to the team as we move our lead chronic hepatitis B candidates toward clinical development,” said Dr. Blatt. “She has led numerous companies through major periods of growth and finance planning activities, and I look forward to partnering with Lesley on executing our initiatives with a clear goal of developing a functional cure for patients with chronic hepatitis B.”

Prior to joining the Aligos team, Ms. Calhoun most recently served as senior vice president of finance & administration and chief accounting officer at Global Blood Therapeutics, where she was responsible for the finance, accounting and administrative functions aimed at supporting the companies’ transition from clinical stage to a publicly traded, commercial environment and was part of the company’s successful regulatory approval and commercial launch of Oxbryta® for the treatment of sickle cell disease. Previously, Ms. Calhoun served as vice president of finance at Hyperion Therapeutics Inc., a commercial stage biopharmaceutical company focused on orphan diseases. During her time there, she was instrumental in building the company’s finance infrastructure, which led to the successful commercialization of RAVICTI® for the treatment of urea cycle disorders. Prior to her time at Hyperion, she served as senior director of finance/corporate controller at Theravance, Inc., where she supported the company’s CFO and was responsible for all corporate and regulatory accounting reporting, serving as a key player in the company’s financial vision and direction.

Ms. Calhoun has also held roles of increasing financial responsibility at Cell Genesys, Inc., Snap Appliances, Inc., Inktomi Corporation and Silicon Graphics, Inc. and was a member of the audit practice of Deloitte &Touche LLP.

Ms. Calhoun stated, “I am honored to join the Aligos team sitting parallel to veteran experts with years of drug research and development experience, and I look forward to joining them in driving Aligos’ future financial, strategic and operational capabilities. With a diversified asset portfolio in chronic hepatitis B backed by elite management and scientific teams, the company is well positioned to advance toward the clinic.”

Ms. Calhoun received her Bachelor of Science in Business Administration from San Francisco State University and is a Certified Public Accountant (inactive).

SOUTH SAN FRANCISCO, Calif. June 2, 2020 – Aligos Therapeutics, Inc., a private biotechnology company focused on the development of targeted, antiviral therapies including chronic hepatitis B (CHB) and COVID-19 as well as therapeutics for NASH, today announced that Lawrence Blatt, Ph.D., MBA , Chief Executive Officer of Aligos, will present at the Jefferies Virtual Healthcare Conference on Thursday, June 4, 2020 at 1:30 p.m. Eastern Time.

Jefferies Virtual Healthcare Conference

Date:                  Thursday, June 4^th, 2020

Time:                 1:30 pm Eastern Time

Webcast:           http://wsw.com/webcast/jeff126/alig/

About Jefferies Virtual Healthcare Conference

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SOUTH SAN FRANCISCO, Calif. April 15, 2020 – Aligos Therapeutics, Inc., a preclinical stage biotechnology company focused on the development of targeted therapies for hepatologic diseases and viral infections, including chronic hepatitis B (CHB), nonalcoholic steatohepatitis (NASH) and hepatocellular carcinoma (HCC), announces the expansion of an existing license agreement with Luxna Biotech Inc., Ltd. pursuant to Luxna’s innovative modified nucleic acid technology.

The amended agreement, expanded relative to an initial agreement with Luxna in December 2018, grants Aligos exclusive rights to use Luxna’s technology to target the genomes of certain families of respiratory viruses, including Coronaviridae, which includes SARS-CoV-2, the virus causing COVID-19.

“Luxna’s nucleotide stabilization technology already serves as an indispensable component for the Aligos’ antisense oligonucleotide clinical candidates targeting chronic hepatitis B, and we are now moving ahead with efforts to utilize this technology to target viruses that have the potential to cause pandemic infections,” said Aligos CEO Dr. Lawrence Blatt, Ph.D., MBA. “Our team, with decades of experience in anti-viral drug development and oligonucleotide chemistry, is well equipped to explore the potential benefits of the same technology to knock down viral transcripts in respiratory viruses like SARS-CoV-2. In light of the current pandemic and its estimated impact in the coming months, it is our responsibility as a healthcare company to investigate all possible paths to mitigate a global health issue like this one.”

SOUTH SAN FRANCISCO, Calif. January 10, 2020 – Aligos Therapeutics, Inc., a preclinical stage biotechnology company focused on the development of targeted therapies for hepatologic diseases and viral infections, including chronic hepatitis B (CHB), nonalcoholic steatohepatitis (NASH) and hepatocellular carcinoma (HCC), today announced the closing of an oversubscribed $125M Series B equity financing round led by Wellington Management Company and a global investment management firm. In addition to Wellington and the global investment management firm, new participants to this round include funds managed by Janus Henderson Investor, Boxer Capital of Tavistock Group, Cormorant Asset Management, Pivotal bioVenture Partners and Logos Capital.

Aligos had previously closed a $100M Series A financing in 2018 with the support of Vivo Capital, Versant Ventures, Novo Holdings, Roche Venture Fund and an undisclosed healthcare fund. All of these aforementioned investors participated in the Series B round.

“We are grateful for the confidence and commitment from our new and existing investors,” said Lawrence Blatt, Ph.D., MBA, CEO of Aligos. “This round of funding provides Aligos with the capital needed to move our portfolio of products aimed at treatment of chronic hepatitis B into clinical development.”

SOUTH SAN FRANCISCO, Calif. January 7, 2020 – Aligos Therapeutics, a pre-clinical stage biotechnology company focused on the development of targeted therapies for hepatologic diseases and viral infections, including chronic hepatitis B (CHB), nonalcoholic steatohepatitis (NASH), and hepatocellular carcinoma (HCC), today announced that CEO Lawrence Blatt, Ph.D., MBA, will present at the 38th Annual J.P. Morgan Healthcare Conference on Tuesday, January 14, 2020 at 11:30 a.m. PT at the Westin St. Francis (room Elizabethan C) in San Francisco, CA.

A webcast of the presentation will be available within 24 hours of the presentation and will remain available for 30 days at the following link: https://jpmorgan.metameetings.net/events/hc20/sessions/30482-aligos-therapeutics/webcast

Oral Presentation on Combination Therapy Targeting CHB

SOUTH SAN FRANCISCO, Calif. December 10, 2019 – Aligos Therapeutics, a pre-clinical stage biotechnology company focused on the development of targeted therapies for hepatologic diseases and viral infections, including chronic hepatitis B (CHB), nonalcoholic steatohepatitis (NASH), and hepatocellular carcinoma (HCC), today announced that chief executive officer Larry Blatt will deliver an invited oral presentation at HEP DART 2019 held on December 8 – 12, in Kauai, Hawaii.

Titled “Combination approaches towards a functional cure for chronic hepatitis B,” today’s presentation will detail Aligos’ overarching approach in developing multiple candidates to target clinically validated mechanisms for inhibiting the hepatitis B virus (HBV) life cycle, which comprise capsid assembly modulators (CAMs), S-antigen transport-inhibiting oligonucleotide polymers (STOPSTM) and antisense oligonucleotides (ASOs).

“One key marker of functional cure in CHB is durable hepatitis B surface antigen (HBsAg or S-antigen) loss following treatment, which is currently lacking in the CHB therapeutic space,” said Aligos chief executive officer Lawrence Blatt, Ph.D., MBA. “Considering that a triple combination therapy is likely required to achieve high rates of functional cure, we have targeted essential components of the HBV life cycle, which include S-antigen secretion, genome replication and maintenance and viral transcription and translation. Aligos is developing a combination therapy including CAMs, STOPs and ASOs, each targeting one or more clinically validated pathways necessary for viral replication.”

Blatt continued, “We see an outstanding need in CHB for treatment regimens that are optimized for delivery, target engagement and safety. Our CAM candidate, ALG-000184, has picomolar potency and excellent oral pharmacokinetic properties, our STOP candidate, ALG-010133, can be delivered via subcutaneous administration and demonstrates the most potent in vitro anti-S-antigen activity to date. Our two-trigger ASO candidates target two conserved transcripts in HBV, providing an increased resistance barrier and better viral genotype coverage. These drug candidates are poised to deliver a best-in-class combination regimen resulting in high rates of functional cure for CHB.”

SOUTH SAN FRANCISCO, Calif. November 25, 2019 – Aligos Therapeutics, Inc. (Aligos), a biotechnology company focused on the development of targeted therapies for hepatologic diseases and viral infections, including chronic hepatitis B (CHB), nonalcoholic steatohepatitis (NASH), and hepatocellular carcinoma (HCC), today announced the appointment of Kathleen Sereda Glaub to the company’s board of directors. With over 30 years of experience in corporate development and strategy, financing and company-building for life science and technology companies, Ms. Glaub has a successful track record of financings, partnerships and company sales. She currently serves as executive chair of the board of directors at CuraSen Therapeutics, which she also co-founded, and as board director of Escient Pharmaceuticals and IO Biotech. Past board affiliations include Afferent Pharmaceuticals and Codexis, Inc. Previously, Ms. Glaub was the CEO of Afferent Pharmaceuticals, where she advanced gefapixant for chronic cough to Phase 3 readiness, raised $80 million in additional private funding and led the 2016 sale of the company to Merck for $1.25 billion.

“We are honored to add Ms. Glaub’s trusted perspective to our board of directors at this critical stage of Aligos’ development, as we lay the groundwork toward the clinic in chronic hepatitis B and other liver diseases,” commented Aligos CEO Lawrence Blatt, Ph.D., MBA. “We are very proud of the team we’ve assembled at Aligos – particularly as we pursue a functional cure for highly prevalent chronic hepatitis B. With her extensive experience, we welcome Ms. Glaub to the board.”

“Aligos presents a wonderful opportunity in the form of a differentiated and diversified asset portfolio assembled by a seasoned management team. It will be a pleasure to support the company as it progresses to the clinic to aid patient populations in need of effective therapeutics in liver disease.”

Prior to Afferent, Ms. Glaub served as president of Plexxikon, Inc., for 12 years, where she led business and financing strategies, negotiated several multimillion-dollar partnerships and led the sale of the company to Daiichi Sankyo for nearly $1 billion in 2011. She also was instrumental in Plexxikon’s advancement of multiple novel molecules to the clinic, including advancement of Zelboraf®, a targeted treatment for melanoma, along with its companion diagnostic to market approval in 2011.

She also previously held positions as senior vice president and chief financial officer of Cell Genesys, treasurer of Genentech and various finance and treasury roles within Intel Corporation. Ms. Glaub received her BA from the University of California, Berkeley, and her MBA from Northwestern University.

SOUTH SAN FRANCISCO, Calif., November 11, 2019 – Aligos Therapeutics, Inc. (Aligos), a pre-clinical stage biotechnology company focused on the development of targeted therapies for hepatologic diseases and viral infections, including chronic hepatitis B (CHB), nonalcoholic steatohepatitis (NASH), and hepatocellular carcinoma (HCC), highlighted promising preclinical performance of the company’s thyroid hormone receptor beta (THR-b) agonist for NASH today atThe Liver Meeting®, hosted annually by the American Association for the Study of Liver Disease (AASLD).

Aligos’ poster presentation, titled “Preclinical development of ALG-055009 as a Potent and Selective Thyroid Hormone Receptor Beta Agonist for the Treatment of NASH”, highlighted key preclinical data for the company’s lead NASH candidate ALG-055009, a thyroid hormone receptor-β (THR-β) agonist. NASH, which presents with liver inflammation and fibrosiscaused by liver fat build-up, currently has no approved drug treatment. However, THR-β agonists have shown the potential to reduce liver fat and inflammation, restore liver function and possibly reverse fibrosis in NASH patients¹.

In a diet-induced obese murine model, ALG-055009 reduced cholesterol in a pronounced and sustained fashion after a single dose and demonstrated excellent bioavailability when administered orally. Correspondingin vitro studies demonstrated potent, selective behavior with favorable pharmacokinetic profiles. Combined, these data indicate potential for safe, effective once-daily oral dosing in humans.

“This particular candidate distinguished itself among several in-house compound that we screened for THR-β agonism and continues to exceed expectations through a battery of tests in vitro and in vivo,” said Jerome Deval, Ph.D., Director of Biochemistry at Aligos, who delivered the presentation. “ALG-055009 demonstrated a rare combination of high potency and selectivity, the latter of which is critical for precluding cardiac toxicity.”

Aligos CEO Lawrence Blatt, Ph.D., MBA, added, “We are pleased to show that ALG-055009, representing the second generation of the THR-β agonist class, is on track to potentially outperform the current top clinical-stage players in the field. We expect to advance ALG-055009 into Phase 1 trials after completion of toxicology studies.”

Poster presentations demonstrate early preclinical successes of strategically designed, complementary therapies aimed at effecting a functional cure in chronic hepatitis B

 SOUTH SAN FRANCISCO, Calif. November 8, 2019 – Aligos Therapeutics, Inc. (Aligos), a pre-clinical stage biotechnology company focused on the development of targeted therapies for hepatologic diseases and viral infections, including chronic hepatitis B (CHB), nonalcoholic steatohepatitis (NASH), and hepatocellular carcinoma (HCC), delivered presentations detailing promising pre-clinical studies todayatThe Liver Meeting®, hosted annually by the American Association for the Study of Liver Disease (AASLD). The three poster presentations demonstrated promising early results from Aligos’ multi-pronged pipeline of candidates to address CHB, the most common chronic viral infection worldwide.

“Current standards of CHB care fall short of a functional cure for most patients,” explained Leo Beigelman, Ph.D., president of Aligos. “Aligos’ approach is to strategically develop potentially best-in-class drug candidates that target key clinically validated mechanisms of the hepatitis B virus (HBV) life cycle.”

Two presentations demonstrated strong pre-clinical activity for Aligos’ capsid assembly modulator (CAM) candidates—ALG-001075and ALG-001024—that trigger HBV core proteins to assemble empty, nonviable viral capsids while also inhibiting formation and maintenance of HBV’s covalently closed circular DNA (or cccDNA). In vitroHBV DNA replication studies with the two Aligos CAM compounds demonstrate potent in hibitory activity with EC₅₀ values of 0.54 nM and 2.07 nM for ALG-001075 and ALG-001024, respectively, making these molecules among the most potent CAMs identified to date. In murine studies, both candidates have demonstrated a high degree of efficacy consistent with the potential for once-daily dosing in humans, and warrant further development as potentially best-in-class CAMs. Aligos is developing CAM molecules in collaboration with the laboratory of Raymond Schinazi, Ph.D., D.Sc., FAASLD (Pediatrics) under a license agreement with Emory University.

A third presentation addressed Aligos’ development of proprietary oligonucleotides that inhibit the production of HBsAg (or S-antigen) by a novel mechanism targeting host proteins. HBsAgis a viral encoded protein that suppresses the immune system. Designated S-Antigen Transport-Inhibiting Oligonucleotide Polymers, or STOPs, this class of oligonucleotides is designed to address a barrier to a functional CHB cure: the standard of care targets viral DNA replication but fails to address S-antigen reduction. Preclinical profiling experiments studying the release of HBsAg from HBV-infected cells have shown potent anti-S-antigen activity for Aligos’ ALG-010093, with an EC₅₀ value of 2.5 nM. Mechanism of action studies have demonstrated that STOPs act potentially by affecting protein trafficking from the infected cell, thereby warranting further study.

“We are pleased to be presenting the first publication of the Aligos portfolio at the annual AASLD meeting,” commented Lawrence Blatt, Ph.D., MBA, CEO of Aligos. “We believe we are building a portfolio of compounds that target key aspects of the HBV life cycle that are designed to work in concert and have the potential to benefit patients living with chronic hepatitis B. We have built a team of highly accomplished virologists, oligonucleotide and medicinal chemists, toxicologists, and clinical scientists who are directing their collective talent towards building a functional cure for chronic hepatitis B.”

Posters to highlight recent advances for the company’s development-stage products for HBV and NASH

SOUTH SAN FRANCISCO, Calif. October 29, 2019 – Aligos Therapeutics, Inc. (Aligos), a pre-clinical stage biotechnology company focused on the development of targeted therapies for hepatologic diseases and viral infections, including chronic hepatitis B (CHB), nonalcoholic steatohepatitis (NASH), and hepatocellular carcinoma (HCC), today announced the upcoming presentation of four abstracts at The Liver Meeting® hosted annually by the American Association for the Study of Liver Disease (AASLD). The 2019 meeting will be held in Boston on November 8-12.

Experts from Aligos’ team of scientists will present posters detailing recent advances in the company’s products in development to address CHB and NASH. Poster presentation details include the following:

Poster session I

Date/Time: Friday, November 8, 12:30 p.m. – 1:30p.m. ET

Location: John B. Hynes Memorial Convention Center

• Poster Title: S-Antigen Transport-inhibiting Oligonucleotide Polymers (STOPs) can Effectively Inhibit Hepatitis B Surface Antigen (HBsAg) Secretion from Hepatitis B Virus (HBV) Cell Lines

Poster number: 689

Presenter: Jin Hong (Director, Oligonucleotide Biology) 

• Poster Title: Preclinical Assessment of a Novel Capsid Assembly Modulator, ALG-001075, Demonstrates Best-in-Class In Vitro Potency and In Vivo Antiviral Efficacy

Poster number: 699

Presenter: Yannick Debing (Senior Scientist)

• Poster Title: Preclinical Assessment of Potency and Efficacy of a Novel Class-II Capsid Assembly Modulator ALG-001024

Poster number: 703

Presenter: Andreas Jekle (Director, Virology)

Poster session IV

Date/Time: Monday, November 11, 12:30 p.m. – 1:30 p.m. ET

Location: John B. Hynes Memorial Convention Center

• Poster Title: Preclinical development of ALG-009 as a Potent and Selective Thyroid Hormone Receptor Beta Agonist for the Treatment of NASH

Poster number: 2149

Presenter: Jerome Deval (Director, Biochemistry)

South San Francisco, California, October 14, 2019 – Aligos Therapeutics, Inc.(Aligos), a pre-clinical stage biotechnology company focused on the development of targeted therapies for hepatologic diseases and viral infections, including chronic hepatitis B(CHB), nonalcoholic steatohepatitis(NASH), and hepatocellular carcinoma(HCC),today announced the appointment of Matthew W. McClure, M.D., as executive vice president (EVP) and chief medical officer(CMO).

Dr. McClure has more than20 years of clinical and drug development experience with significant expertise in the design, execution and interpretation of Phase 1-3 clinical trials across a range of therapeutic areas, particularly in chronic viral hepatitis and NASH.

“I am very pleased to welcome Dr. McClure to Aligos Therapeutics,” said Lawrence Blatt, Ph.D., MBA, chief executive officer of Aligos. “With his broad experience in the development of drugs in chronic viral hepatitis and NASH, we are confident he will add substantial expertise to our team as we look forward to advancing what we believe to be a robust and potentially transformative pipeline. This is an exciting time for Aligosas we prepare to advance best-in-class compounds for the potential treatment of chronic hepatitis B and NASH into the clinic in 2020.”

“I am delighted to help Aligos achieve its vision of discovering and developing effective therapies for diseases where significant unmet needs remain,” said Dr.McClure.“In particular, I am confident that with the combination of innovative compounds being advanced and the highly experienced team at Aligos, we may find a potentially curative treatment regimen for chronic hepatitis B infection in the coming years.”

Dr. McClure’s drug development career began in academia at the Duke Clinical Research Institute during his medical training. Following his work as an attending physician, he transitioned to the biotechnology industry, where he has held roles of increasing responsibility and seniority, culminating in his most recent position as chief medical officer at Second Genome. Prior to Second Genome, Dr. McClure played an important role in the clinical development of Esbriet® (pirfenidone)during his time at InterMune, Inc., which was acquired by Roche in 2014, and andexanet alfa during his time at Portola Pharmaceuticals, Inc.,as well as a critical role as the lead clinician in the development of lumicitabine during his time at AliosBioPharma, Inc., which was acquired by Johnson and Johnson in 2014. After Alios’ acquisition and while at Janssen, a pharmaceutical company of Johnson & Johnson, Dr. McClure continued to play an important role in the lumicitabine program.

Dr. McClure received his degree in medicine from Duke University and graduated (summa cum laude) with a Bachelor of Science in biochemistry and cell biology from the University of California, San Diego.

 Second drug candidate from Aligos’ CHB portfolio cleared to start first-in-human clinical trial

SOUTH SAN FRANCISCO, Calif. September 28, 2020 – Aligos Therapeutics, Inc. (Aligos), a clinical stage biopharmaceutical company focused on developing novel therapeutics to address unmet medical needs in viral and liver diseases, today announced that the Company has received approval for a clinical trial application (CTA) for a first-in-human Phase 1a/b proof-of-concept clinical trial. Aligos may now commence study ALG-000184-201 (NCT04536337) to evaluate ALG-000184, a small molecule class II capsid assembly modulator (CAM) that targets hepatitis B virus (HBV) capsid assembly as well as the establishment of covalently closed circular DNA (cccDNA). ALG-000184 is the second of Aligos’ chronic hepatitis B (CHB) drug candidates cleared to begin clinical trials.

“In collaboration with Emory University, we have utilized our small molecule chemistry expertise to identify multiple promising CAMs including ALG-000184, which has been optimized for potency as well as other pharmacokinetic properties,” said Lawrence Blatt, Ph.D., MBA, Chief Executive Officer of Aligos. “We look forward to determining how these properties translate in the clinic towards development of novel therapies for patients with chronic hepatitis B.”

ALG-000184-201 is a multipart Phase 1a/1b umbrella trial that will evaluate the safety, pharmacokinetics and antiviral activity of up to 28 days of once-daily doses of orally administered ALG-000184 in healthy volunteers (1a) and patients with CHB (1b).

Aligos’ CAM program is one of four classes of compounds in its CHB development portfolio, which also includes STOPS ™ (S-antigen Transport-inhibiting Oligonucleotide Polymers) molecules, antisense oligonucleotide (ASO), and small interfering RNA (siRNA) drug candidates.

About Chronic Hepatitis B (CHB)

CHB is a major cause of chronic liver disease that affects over 290 million people worldwide. Serious complications of CHB include cirrhosis and liver cancer, which are associated with significant mortality. Approximately 900,000 people died from CHB-related causes in 2015 alone and the mortality rate associated with HBV-related liver cancer continues to increase. Although current standard of care for patients with CHB is effective in suppressing HBV, it is associated with very low rates of functional cure, which is the goal for future CHB treatments.

About Aligos

Aligos Therapeutics, Inc., is a privately held, clinical stage biopharmaceutical company that was founded in 2018 with the mission to become a world leader in the treatment of viral infections and liver diseases. Aligos is focused on the development of targeted antiviral therapies for chronic hepatitis B (CHB) and coronaviruses as well as leveraging its expertise in liver diseases to create targeted therapeutics for nonalcoholic steatohepatitis (NASH). Aligos’ strategy is to harness the deep expertise and decades of drug development experience its workforce has in liver disease, particularly viral hepatitis, to rapidly advance its pipeline of potentially best-in-class molecules.

Please visit www.aligos.com for more information.

Media Contact

Amy Jobe, Ph.D.
LifeSci Communications
+1 315 879 8192
ajobe@lifescicomms.com

Investor Contact

Corey Davis, Ph.D.
LifeSci Advisors
+1 212 915 2577
cdavis@lifesciadvisors.com

SOUTH SAN FRANCISCO, Calif., August 27, 2020 – Aligos Therapeutics, Inc. (Aligos), a private biopharmaceutical  company focused on developing novel therapeutics to address unmet medical needs in viral and liver diseases, including  chronic hepatitis B (CHB), COVID-19 and therapeutics for NASH, will present four abstracts highlighting nonclinical data for drug candidates in the company’s CHB portfolio at the European Association for the Study of the Liver (EASL) Digital International Liver Congress™ 2020.

“Taken together, our findings show promising progress across our chronic hepatitis B portfolio, both individually and in pairwise combinations,” said Lawrence Blatt, Ph.D., MBA, chief executive officer of Aligos. “As our lead candidates advance in the clinic, we are gratified to see that our approach of designing purpose-built drug candidates targeting clinically validated mechanisms of action have shown promising activity in our nonclinical studies to date.”

The presentations provide new information for many of the company’s classes of drug candidates designed for use in combination therapy to develop high rates of functional cure in CHB. Of note, an abstract related to Aligos’ STOPS™ program, entitled “Structural requirements for ’S-antigen transport-inhibiting oligonucleotide polymer inhibition of hepatitis B surface antigen secretion,” was selected for inclusion in the meeting’s ‘Best of ILC’ category, which highlights the most noteworthy contributions to the meeting’s scientific program. The titles of each abstract, the class(es) of candidates highlighted and the findings are as follows:

S-antigen Transport-inhibiting Oligonucleotide PolymerS (STOPS™)

Title: Structural requirements for S-antigen Transport-inhibiting Oligonucleotide Polymer inhibition of hepatitis B surface antigen secretion

Summary: Aligos’ proprietary STOPS candidates were evaluated for S-antigen (or HBsAg) reduction and cytotoxicity in cell culture to optimize activity relative to structurally similar nucleic acid polymers (NAPs). Upon varying sequence, length, and chemical modifications of STOPS, it was found that STOPS’ activity is dependent on length, with the highest potency observed at over 34 nucleotides. Sequence was critical for STOPS activity: when the AC dinucleotide repeat was changed to AG, the antiviral activity was completely lost. However, activity was retained when the base identities were maintained, such as with a CA repeat. Site-specific incorporation of backbone chemistries such as a stereospecific phosphorothioate bond also improved potency.

Note: This abstract will be available publicly after the meeting as part of EASL’s ‘Best of ILC’ summary slide deck.

Capsid Assembly Modulators (CAMs)

Title: ALG-000184, a prodrug of capsid assembly modulator ALG-001075, demonstrates best-in-class preclinical characteristics for the treatment of chronic hepatitis B

Summary:  ALG-001075 was found to be a potent inhibitor of HBV DNA production in HepG2.117 cells with EC₅₀/EC₉₀ values of 0.63/3.17 nM (n = 12), respectively. This level of potency exceeds that of all other known reported CAMs that have entered clinical development, efficiently blocking both HBV genome encapsidation and de novo cccDNA formation. ALG-000184, a prodrug of ALG-001075, showed improved pharmacokinetic properties, including improved aqueous solubility, stability and oral absorption across species with efficient conversion to ALG-001075 in vivo.

Antisense oligonucleotides (ASOs)

Title: Best in class hepatitis B virus anti-sense oligonucleotides: Next generation bridged nucleic acid chemistries significantly improve the therapeutic index by reducing hepatotoxicity and increasing in vivo efficacy in a mouse model

Summary: Although locked nucleic acid (LNA)-modified ASOs can cause liver toxicity, applying bridged nucleic acid and nucleobase gap modifications to LNA ASOs showed improved efficacy and reduced liver toxicity in a mouse model of hepatitis B virus (HBV) infection, suggesting that Aligos’ anti-HBV ASO candidates have potential to be best in class compounds.

STOPS in combination with other agents

Title: Combination drug interactions of hepatitis B virus (HBV) S-antigen Transport-inhibiting Oligonucleotide Polymers in vitro

Summary: STOPS in combination with nucleos(t)ides, core assembly modulators (CAMs), and HBV-specific antisense oligonucleotides (ASOs) were evaluated for inhibition of HBV replication and HBsAg release in HBV-producing hepatic cells. When tested in pairwise combinations with the other HBV inhibitors, STOPS demonstrated synergy or additivity. Overall, the activity of STOPS warrants further study as a component of a combination therapy in CHB. 

About Chronic Hepatitis B (CHB)

CHB is a major cause of chronic liver disease that the World Health Organization estimates affects ~257 million people worldwide, more people than hepatitis C virus (HCV) and HIV infection combined. Serious complications of CHB include cirrhosis and liver cancer, which are associated with significant mortality.  Approximately 900,000 people died from CHB-related causes in 2015 alone and the mortality rate has been rising for decades. Although current standard of care for patients with CHB is effective in suppressing HBV, it is associated with very low rates of functional cure, which is the main goal of CHB treatment.

About Aligos

Aligos Therapeutics, Inc., is a privately held, clinical stage biopharmaceutical company that was founded in 2018 with the mission to become a world leader in the treatment of viral infections and liver diseases. Aligos is focused on the development of targeted antiviral therapies for chronic hepatitis B (CHB) and coronaviruses as well as leveraging its expertise in liver diseases to create targeted therapeutics for nonalcoholic steatohepatitis (NASH). Aligos’ strategy is to harness the deep expertise and decades of drug development experience its workforce has in liver disease, particularly viral hepatitis, to rapidly advance its pipeline of potentially best-in-class molecules.

Please visit www.aligos.com for more information.

 

Media Contact
Amy Jobe, Ph.D.
LifeSci Communications
+1 315 879 8192
ajobe@lifescicomms.com

Investor Contact
Corey Davis, Ph.D.
LifeSci Advisors
+1 212 915 2577
cdavis@lifesciadvisors.com

SOUTH SAN FRANCISCO, Calif., August 26, 2020 – Aligos Therapeutics, Inc. (Aligos), a private biopharmaceutical company focused on developing novel therapeutics to address unmet medical needs in viral and liver diseases, including chronic hepatitis B (CHB), COVID-19 and therapeutics for nonalcoholic steatohepatitis (NASH), will present nonclinical data related to the company’s thyroid hormone receptor-beta (THR-B) therapeutic program for NASH on August 27 at the European Association for the Study of the Liver (EASL) Digital International Liver Congress™ 2020.

The data, summarized in an abstract titled “Molecular, cellular, and pharmacological characterization of beta-selective partial agonists of human thyroid hormone receptor for the treatment of nonalcoholic steatohepatitis,” will be presented as part of a poster session. Data details a novel series of B- selective THR partial agonists targeting NASH by reducing harmful levels of liver fat without causing the side effects associated with non-selective THR agonists, which can activate the THR-alpha (A) isoform in the heart.

“Following profiling in a panel of in vitro assays, our team assessed the THR activation of several small molecule THR-B agonists in hepatic cells. Promising compounds were then evaluated for efficacy in rats fed with a high fat diet,” said Jerome Deval, Ph.D., senior director of biochemistry at Aligos and lead author of the study. “In contrast to currently known THR-B agonists, the compounds tested show potential for cholesterol reduction in vivo without detectable activation of THR-A.”

In vitro, Aligos’ compounds activated THR-B with an EC₅₀ of approximately 40-60 nM, with a maximum effective amplitude (E_max) of approximately 25-50% relative to the natural thyroid hormone T3. At much higher concentrations (up to 10 µM), the same compounds did not significantly activate THR-A. Further, reporter assays in hepatic (HEK293T) cells demonstrated an E_max value of approximately 55% relative to T3 with no measurable THR-A activation. Aligos’ compounds yielded a >90-fold THR-B/THR-A selectivity index, relative to indices of 1- to 3.4-fold among three existing THR-B agonists. In a diet-induced obese (DIO) rat efficacy model, single doses of B-selective THR partial agonists induced cholesterol reduction, albeit at lower levels compared with full THR agonists.

“Current NASH treatments lack selectivity, supporting our conclusion that there is significant value in pursuing improved candidates as part of Aligos’ portfolio in highly prevalent liver diseases,” said Lawrence Blatt, Ph.D., MBA, chief executive officer of Aligos. “We believe that these compounds warrant further study.”

 About Aligos

Aligos Therapeutics, Inc. is a privately held biopharmaceutical company that was founded in 2018 with the mission to become a world leader in the treatment of viral infections and liver diseases. Aligos is focused on the development of targeted antiviral therapies for chronic hepatitis B (CHB) and COVID-19 as well as leveraging its expertise in liver diseases to create targeted therapeutics for NASH. Aligos’ strategy is to harness the deep expertise and decades of drug development experience its workforce has in liver disease, particularly viral hepatitis, to rapidly advance its pipeline of best-in-class molecules.

Please visit www.aligos.com for more information.

 

Aligos Media Contact
Amy Jobe, Ph.D.
LifeSci Communications
+1 315 879 8192
ajobe@lifescicomms.com

Aligos Investor Contact
Corey Davis, Ph.D.
LifeSci Advisors
+1 212 915 2577
cdavis@lifesciadvisors.com

Second drug candidate from Aligos’ CHB portfolio advances towards clinical trial

 SOUTH SAN FRANCISCO, Calif. August 24, 2020 – Aligos Therapeutics, Inc. (Aligos), a clinical stage biopharmaceutical company focused on developing novel therapeutics to address unmet medical needs in viral and liver diseases, today announced that it has submitted a clinical trial application (CTA) to the New Zealand Medicines and Medical Devices Safety Authority for a first-in-human Phase 1a/b proof-of-concept trial (ALG-000184-201). The trial is evaluating ALG-000184, a small molecule class II capsid assembly modulator (CAM) that targets hepatitis B virus (HBV) capsid assembly as well as the regulation and transcription of covalently closed circular DNA (cccDNA).

“This is a significant achievement for Aligos Therapeutics,” said Lawrence Blatt, Ph.D., MBA, Chief Executive Officer of Aligos. “Starting with novel CAM compounds discovered in Dr. Raymond Schinazi’s laboratory at Emory University, our teams have collaborated over the last 2 years to further improve upon the CAM technology. This work culminated in the discovery of ALG-000184, which has optimized pharmacokinetic properties and sub-nanomolar potency. ALG-000184 appears to be the most potent class II CAM drug candidate known to have entered clinical development to date and we are excited to see how its enhanced properties translate in clinical trials.”

ALG-000184-201 is a multipart Phase 1a/1b umbrella trial that will evaluate the safety, pharmacokinetics and antiviral activity of up to 28 days of once-daily doses of orally administered ALG-000184 in healthy volunteers and patients with chronic hepatitis B (CHB). “We aim to follow our Phase 1 STOPS^TM candidate into the clinic with ALG-000184 and conduct concurrent Phase 1 trials with each of these drug candidates before moving them into combination trials,” noted Matthew McClure, M.D., Chief Medical Officer of Aligos. “We believe that by advancing a purpose-built combination of therapeutics with additive or synergistic antiviral activity, we may be able to significantly improve upon the low rates of functional cure seen with current standard of care medications.”

Aligos’ CAM program is one of four classes of compounds in its CHB development portfolio, which also includes STOPS (S-antigen Transport-inhibiting Oligonucleotide Polymers), antisense oligonucleotide (ASO), and small interfering RNA (siRNA) drug candidates.

 About Chronic Hepatitis B (CHB)

CHB is a major cause of chronic liver disease that the World Health Organization estimates affects ~257 million people worldwide, more people than hepatitis C virus (HCV) and HIV infection combined. Serious complications of CHB include cirrhosis and liver cancer, which are associated with significant mortality.  Approximately 900,000 people died from CHB-related causes in 2015 alone and the mortality rate has been rising for decades. Although current standard of care for patients with CHB is effective in suppressing HBV, it is associated with very low rates of functional cure, which is the main goal of CHB treatment.

About Aligos

Aligos Therapeutics, Inc., is a privately held, clinical stage biopharmaceutical company that was founded in 2018 with the mission to become a world leader in the treatment of viral infections and liver diseases. Aligos is focused on the development of targeted antiviral therapies for chronic hepatitis B (CHB) and coronaviruses as well as leveraging its expertise in liver diseases to create targeted therapeutics for nonalcoholic steatohepatitis (NASH). Aligos’ strategy is to harness the deep expertise and decades of drug development experience its workforce has in liver disease, particularly viral hepatitis, to rapidly advance its pipeline of potentially best-in-class molecules.

Please visit www.aligos.com for more information.

 

Media Contact
Amy Jobe, Ph.D.
LifeSci Communications
+1 315 879 8192
ajobe@lifescicomms.com

Investor Contact
Corey Davis, Ph.D.
LifeSci Advisors
+1 212 915 2577
cdavis@lifesciadvisors.com

First Aligos drug candidate to commence clinical trials

First-in-human trial marks ~2.5-year path from company formation to entry into the clinic

SOUTH SAN FRANCISCO, Calif. August 18, 2020 – Aligos Therapeutics, Inc. (Aligos), a private clinical stage biopharmaceutical company focused on developing novel therapeutics to address unmet medical needs in viral and liver diseases, including chronic hepatitis B (CHB) and coronaviruses and therapeutics for nonalcoholic steatohepatitis (NASH), today announced that it has dosed its first subject in a first-in-human Phase 1a/b trial. This trial will evaluate ALG-010133, a proprietary oligonucleotide S-antigen transport-inhibiting oligonucleotide polymer (STOPS^TM) molecule that functions to decrease viral S-antigen (or HBsAg) levels, an essential step for enabling functional cure in CHB.

“This marks an important milestone for the company, as ALG-010133 is Aligos’ first asset to enter into clinical trials since the company’s launch in 2018,” said Lawrence Blatt, Ph.D., MBA, Chief Executive Officer of Aligos. “Our team has spent the last two years discovering and optimizing STOPS molecules, which ultimately led to the identification and advancement of ALG-010133.  We believe that this drug candidate has the potential to significantly suppress HBsAg levels in patients with CHB and are excited to initiate this important proof of concept trial.”

ALG-010133-101 (NCT04485663) is a multi-part umbrella trial that will evaluate the safety, pharmacokinetics and antiviral activity of up to 12 weekly doses of subcutaneously administered ALG-010133 in healthy volunteers and virologically suppressed patients with CHB.  Initially, Aligos is conducting the trial at a single clinical pharmacology unit in Auckland, New Zealand, and, once dosing in CHB patients starts, at multiple investigational sites across the Asia-Pacific region and Europe.  Aligos expects to report topline CHB results for certain trial cohorts beginning in the second half of 2021.

Aligos’ STOPS program is one of several programs in its CHB portfolio that target different clinically validated mechanisms of action.  The portfolio also includes capsid assembly modulator (CAM), antisense oligonucleotide (ASO), and small interfering RNA (siRNA) drug candidates.  All of these drug candidates have properties that indicate that they could be used in combinations to develop potentially best-in-class treatment regimens that may achieve higher rates of functional cure than current standard of care. For each of these drug candidates, Aligos plans to initially establish proof of concept as monotherapy in Phase 1 umbrella trials before evaluating them in combination in subsequent trials.

 “Approved treatments, such as nucleos(t)ide analogs, result in low rates of functional cure and require lifelong therapy for the approximately 290 million people living with CHB around the world,” noted Matthew McClure, M.D., Chief Medical Officer. “A key part of our mission at Aligos is to improve this rate by advancing multiple drug candidates, each of which interrupts distinct steps in the viral life cycle, that will act additively or synergistically when combined.  This trial is a first step in our effort to achieve that mission.”

 About Aligos

Aligos Therapeutics, Inc., is a privately held, clinical stage biopharmaceutical company that was founded in 2018 with the mission to become a world leader in the treatment of viral infections and liver diseases. Aligos is focused on the development of targeted antiviral therapies for chronic hepatitis B (CHB) and coronaviruses as well as leveraging its expertise in liver diseases to create targeted therapeutics for nonalcoholic steatohepatitis (NASH). Aligos’ strategy is to harness the deep expertise and decades of drug development experience its workforce has in liver disease, particularly viral hepatitis, to rapidly advance its pipeline of potentially best-in-class molecules.

Please visit www.aligos.com for more information.

 

Media Contact
Amy Jobe, Ph.D.
LifeSci Communications
+1 315 879 8192
ajobe@lifescicomms.com

Investor Contact
Corey Davis, Ph.D.
LifeSci Advisors
+1 212 915 2577
cdavis@lifesciadvisors.com

SOUTH SAN FRANCISCO, Calif. and LEUVEN, Belgium, July 01, 2020 (GLOBE NEWSWIRE) — Aligos Therapeutics, Inc. (Aligos), a private biotechnology company focused on the development of targeted antiviral therapies directed against chronic hepatitis B (CHB), COVID-19 and therapeutics for NASH, today announced that they have entered into a collaboration and license agreement with KU Leuven, in particular its Centre for Drug Design and Discovery (CD3), a drug discovery unit and investment mechanism of KU Leuven, and the Rega Institute for Medical Research, to develop a coronavirus protease inhibitor as a potential therapeutic candidate to address the COVID-19 pandemic.

Principal investigator Johan Neyts, Ph.D., professor of virology, and his scientific staff at the Rega Institute, together with the CD3 team, have focused for many years on discovering novel antiviral strategies against a number of virus families. In this collaboration, Johan Neyts’ research group and CD3 will join forces with Aligos, whose team has extensive experience in antiviral drug discovery, development and viral protease inhibitor chemistry. Their combined objective is to develop a therapeutic candidate designed to target the SARS-CoV-2 infection as well as other coronavirus infections.

“The Rega Institute together with CD3 was a natural and complementary fit for this collaborative effort, with their longstanding track record of developing effective antiviral products against a number of viruses,” said Aligos President Leonid Beigelman, Ph.D. “The teams agreed on the specific coronavirus protease as a promising therapeutic target, which is essential in the viral life cycle and conserved among viruses in the coronavirus family, meaning that a candidate that inhibits this target may also serve as a therapeutic in potential future coronavirus epidemics.”

“Besides the urgent need for treatment options to fight the current SARS-CoV-2 virus,” said Professor Neyts, “it is clear that there is also an important need for preparedness for the next coronavirus outbreak. A pan-coronavirus antiviral is the best and only approach to be able to respond quickly to any new emerging coronavirus in the future and avoid large outbreaks that may lead to epidemics or a pandemic.”

“We are delighted to enter into this collaboration aiming to deliver a new drug against SARS-CoV-2 and other coronaviruses,” said Patrick Chaltin, Managing Director of CD3. “The SARS-CoV-2 crisis demands the implementation of a strong integrated approach combining and leveraging world leading academic virology expertise and our early drug discovery capabilities with an exceptionally strong and committed biotech partner like Aligos.”

About Aligos

Aligos Therapeutics, Inc. is a privately held biotechnology company that was founded in 2018 with the mission to become a world leader in the treatment of viral infections and liver diseases. Aligos is focused on the development of targeted antiviral therapies for chronic hepatitis B (CHB) and COVID-19 as well as leveraging its expertise in liver diseases to create targeted therapeutics for NASH. Aligos’ strategy is to harness the deep expertise and decades of drug development experience its workforce has in liver disease, particularly viral hepatitis, to rapidly advance its pipeline of best-in-class molecules.

Please visit www.aligos.com for more information.

About the Centre for Drug Design and Discovery – KU Leuven

The Centre for Drug Design and Discovery (CD3) is a drug discovery platform and investment fund with a focus on the discovery and development of innovative medicines mainly starting from innovative academic research. By providing the necessary drug discovery expertise and financial resources, CD3 ensures that biomedical research carried out by universities and small biotech companies is collaboratively translated into promising new medicines. Subsequently, such new potential medicines can then be further developed by pharma or biotech industry or can form the basis for the establishment of new biotechs. CD3 was set up in 2006 by KU Leuven Research & Development and the European Investment Fund (EIF) and launched a 60 million euro fund in 2016.

Please visit www.cd3.eu for more information.

About Rega Institute

The Rega Institute for Medical Research is a biomedical research institute of KU Leuven that comprises the Laboratory of Virology and Chemotherapy, which specializes particularly in antiviral research. Medications discovered at the Rega Institute are successfully being used for the treatment of, for example, HIV, hepatitis B and infections caused by herpes viruses and several other drug candidates are in development against human rhinovirus, dengue and other (viral) diseases.

Please visit www.kuleuven.be/rega for more information.

Aligos Media Contact
Amy Jobe, Ph.D.
LifeSci Communications
+1 315 879 8192
ajobe@lifescicomms.com

Aligos Investor Contact
Corey Davis, Ph.D.
LifeSci Advisors
+1 212 915 2577
cdavis@lifesciadvisors.com

KU Leuven Contact
Dr. Patrick Chaltin
Managing Director CD3
+32 477 61 08 54
patrick.chaltin@kuleuven.be

SOUTH SAN FRANCISCO, Calif., ATLANTA, June 23, 2020 – Aligos Therapeutics, Inc. (Aligos), a private biotechnology company focused on the development of antiviral therapies targeting chronic hepatitis B (CHB) and COVID-19 as well as therapeutics for NASH, announced an expansion to their existing license agreement with Emory University (Emory) to include additional technology developed at Emory related to Aligos’ capsid assembly modulator (CAM) program in CHB. Aligos and Emory have also entered into a collaboration agreement to futher advance this technology.

The license expansion builds upon the parties’ existing agreement whereby Aligos acquired from Emory an exclusive license to technology with respect to a novel class of non-nucleoside class-II CAMs. Professor Raymond F. Schinazi, director of the Laboratory of Biochemical Pharmacology at Emory, and colleagues have developed a series of potent, novel CAMs, small molecules that disrupt viral capsid assembly. Aligos is advancing its CAM program as part of a CHB portfolio designed to produce a combination therapy delivering a high rate of functional cure. Each program in the portfolio targets clinically validated mechanisms in the replication cycle of the hepatitis B virus.

“We are pleased to continue our collaboration with Emory by adding a wider range of potential drug candidates to our CAM discovery and development programs,” said Aligos CEO Lawrence Blatt, Ph.D., MBA. “Building upon the foundation established in 2018, we plan to further explore the technology Dr. Schinazi and his group at Emory have developed in an effort to create a best-in-class combination therapy for the treatment of chronic Hepatitis B.”

Raymond F. Schinazi, Ph.D., D.Sc., FAASLD (Pediatrics) at Emory, added, “We are pleased to collaborate with a very experienced group of scientists at Aligos towards an HBV cure. Together we have optimized our compounds providing potency in the picomolar range with a favorable preclinical safety profile. Clearly a fixed dose combination will not only prevent or reduce the likelihood of drug resistance, but will also provide a powerful blow to the virus capsid, which is essential for virus replication and persistence.”

SOUTH SAN FRANCISCO, Calif. June 18, 2020 – Aligos Therapeutics, Inc. (Aligos), a private biotechnology company focused on the development of targeted antiviral therapies directed against chronic hepatitis B (CHB) and COVID-19 and therapeutics for NASH, today announced that it has submitted its first clinical trial application for a first-in-human Phase 1a/b study evaluating ALG-010133.  ALG-010133 is a proprietary oligonucleotide S-antigen transport inhibiting oligonucleotide polymer (STOPS^TM) which is thought to act as an aptamer that interacts with specific proteins to decrease viral HBsAg levels, which is essential for enabling functional cure in CHB.

“We are excited to announce the achievement of this important developmental milestone for ALG-010133” said Lawrence Blatt, Ph.D., MBA, Chief Executive Officer of Aligos. “With worldwide disease prevalence in the hundreds of millions, chronic Hepatitis B patients are at significant risk of progression to liver fibrosis, cirrhosis, end stage liver disease, and hepatocellular carcinoma.  Currently available therapies are given for life and rarely result in a sustained functional cure.  Our goal is to develop a therapeutic regimen that can lead to high rates of functional cure for patients living with chronic Hepatitis B. ”

Aligos’ STOPS program is the first of three classes of compounds in its CHB development portfolio, which also includes a capsid assembly modulator (CAM) and antisense oligonucleotide (ASO).  Initially, Aligos plans to evaluate these in separate Phase 1 studies and then combine them in subsequent studies.

SOUTH SAN FRANCISCO, Calif. June 3, 2020 – Aligos Therapeutics, Inc. (Aligos), a private biotechnology company focused on the development of targeted, antiviral therapies including chronic hepatitis B (CHB) and COVID-19 as well as therapeutics for NASH, today announced the appointment of Lesley Ann Calhoun, as chief financial officer. Ms. Calhoun will serve as a member of the Aligos leadership team and will report to Aligos’ chief executive officer, Lawrence Blatt, Ph.D., MBA.

Ms. Calhoun is an experienced finance executive with 17 years in the biopharma industry as well as an earlier career in U.S. and multinational technology companies and public accounting. She brings broad experience in both public and pre-IPO companies and in driving financial vision, direction, guidance and compliance to support and advise on operations for companies. She has had a successful career in transforming companies from private, pre-IPO stages to publicly traded business driven, commercial operating companies.

“With Ms. Calhoun’s significant financial and business operations experience, we are pleased to welcome her to the team as we move our lead chronic hepatitis B candidates toward clinical development,” said Dr. Blatt. “She has led numerous companies through major periods of growth and finance planning activities, and I look forward to partnering with Lesley on executing our initiatives with a clear goal of developing a functional cure for patients with chronic hepatitis B.”

Prior to joining the Aligos team, Ms. Calhoun most recently served as senior vice president of finance & administration and chief accounting officer at Global Blood Therapeutics, where she was responsible for the finance, accounting and administrative functions aimed at supporting the companies’ transition from clinical stage to a publicly traded, commercial environment and was part of the company’s successful regulatory approval and commercial launch of Oxbryta® for the treatment of sickle cell disease. Previously, Ms. Calhoun served as vice president of finance at Hyperion Therapeutics Inc., a commercial stage biopharmaceutical company focused on orphan diseases. During her time there, she was instrumental in building the company’s finance infrastructure, which led to the successful commercialization of RAVICTI® for the treatment of urea cycle disorders. Prior to her time at Hyperion, she served as senior director of finance/corporate controller at Theravance, Inc., where she supported the company’s CFO and was responsible for all corporate and regulatory accounting reporting, serving as a key player in the company’s financial vision and direction.

Ms. Calhoun has also held roles of increasing financial responsibility at Cell Genesys, Inc., Snap Appliances, Inc., Inktomi Corporation and Silicon Graphics, Inc. and was a member of the audit practice of Deloitte &Touche LLP.

Ms. Calhoun stated, “I am honored to join the Aligos team sitting parallel to veteran experts with years of drug research and development experience, and I look forward to joining them in driving Aligos’ future financial, strategic and operational capabilities. With a diversified asset portfolio in chronic hepatitis B backed by elite management and scientific teams, the company is well positioned to advance toward the clinic.”

Ms. Calhoun received her Bachelor of Science in Business Administration from San Francisco State University and is a Certified Public Accountant (inactive).

SOUTH SAN FRANCISCO, Calif. June 2, 2020 – Aligos Therapeutics, Inc., a private biotechnology company focused on the development of targeted, antiviral therapies including chronic hepatitis B (CHB) and COVID-19 as well as therapeutics for NASH, today announced that Lawrence Blatt, Ph.D., MBA , Chief Executive Officer of Aligos, will present at the Jefferies Virtual Healthcare Conference on Thursday, June 4, 2020 at 1:30 p.m. Eastern Time.

Jefferies Virtual Healthcare Conference

Date:                  Thursday, June 4^th, 2020

Time:                 1:30 pm Eastern Time

Webcast:           http://wsw.com/webcast/jeff126/alig/

About Jefferies Virtual Healthcare Conference

The format will include video & audio company presentations, interactive panels, and 1×1 meetings conducted via organized conference calls.  This virtual gathering of over 400 public & private healthcare companies and 2,500 leading executives, institutional investors, private equity investors & VCs will address near- and long-term investment opportunities and discuss the current mechanisms driving healthcare in the U.S. and internationally.

For further information, please visit: www.Jefferies.com/Conferences

SOUTH SAN FRANCISCO, Calif. April 15, 2020 – Aligos Therapeutics, Inc., a preclinical stage biotechnology company focused on the development of targeted therapies for hepatologic diseases and viral infections, including chronic hepatitis B (CHB), nonalcoholic steatohepatitis (NASH) and hepatocellular carcinoma (HCC), announces the expansion of an existing license agreement with Luxna Biotech Inc., Ltd. pursuant to Luxna’s innovative modified nucleic acid technology.

The amended agreement, expanded relative to an initial agreement with Luxna in December 2018, grants Aligos exclusive rights to use Luxna’s technology to target the genomes of certain families of respiratory viruses, including Coronaviridae, which includes SARS-CoV-2, the virus causing COVID-19.

“Luxna’s nucleotide stabilization technology already serves as an indispensable component for the Aligos’ antisense oligonucleotide clinical candidates targeting chronic hepatitis B, and we are now moving ahead with efforts to utilize this technology to target viruses that have the potential to cause pandemic infections,” said Aligos CEO Dr. Lawrence Blatt, Ph.D., MBA. “Our team, with decades of experience in anti-viral drug development and oligonucleotide chemistry, is well equipped to explore the potential benefits of the same technology to knock down viral transcripts in respiratory viruses like SARS-CoV-2. In light of the current pandemic and its estimated impact in the coming months, it is our responsibility as a healthcare company to investigate all possible paths to mitigate a global health issue like this one.”

SOUTH SAN FRANCISCO, Calif. January 10, 2020 – Aligos Therapeutics, Inc., a preclinical stage biotechnology company focused on the development of targeted therapies for hepatologic diseases and viral infections, including chronic hepatitis B (CHB), nonalcoholic steatohepatitis (NASH) and hepatocellular carcinoma (HCC), today announced the closing of an oversubscribed $125M Series B equity financing round led by Wellington Management Company and a global investment management firm. In addition to Wellington and the global investment management firm, new participants to this round include funds managed by Janus Henderson Investor, Boxer Capital of Tavistock Group, Cormorant Asset Management, Pivotal bioVenture Partners and Logos Capital.

Aligos had previously closed a $100M Series A financing in 2018 with the support of Vivo Capital, Versant Ventures, Novo Holdings, Roche Venture Fund and an undisclosed healthcare fund. All of these aforementioned investors participated in the Series B round.

“We are grateful for the confidence and commitment from our new and existing investors,” said Lawrence Blatt, Ph.D., MBA, CEO of Aligos. “This round of funding provides Aligos with the capital needed to move our portfolio of products aimed at treatment of chronic hepatitis B into clinical development.”

SOUTH SAN FRANCISCO, Calif. January 7, 2020 – Aligos Therapeutics, a pre-clinical stage biotechnology company focused on the development of targeted therapies for hepatologic diseases and viral infections, including chronic hepatitis B (CHB), nonalcoholic steatohepatitis (NASH), and hepatocellular carcinoma (HCC), today announced that CEO Lawrence Blatt, Ph.D., MBA, will present at the 38th Annual J.P. Morgan Healthcare Conference on Tuesday, January 14, 2020 at 11:30 a.m. PT at the Westin St. Francis (room Elizabethan C) in San Francisco, CA.

A webcast of the presentation will be available within 24 hours of the presentation and will remain available for 30 days at the following link: https://jpmorgan.metameetings.net/events/hc20/sessions/30482-aligos-therapeutics/webcast

Oral Presentation on Combination Therapy Targeting CHB

SOUTH SAN FRANCISCO, Calif. December 10, 2019 – Aligos Therapeutics, a pre-clinical stage biotechnology company focused on the development of targeted therapies for hepatologic diseases and viral infections, including chronic hepatitis B (CHB), nonalcoholic steatohepatitis (NASH), and hepatocellular carcinoma (HCC), today announced that chief executive officer Larry Blatt will deliver an invited oral presentation at HEP DART 2019 held on December 8 – 12, in Kauai, Hawaii.

Titled “Combination approaches towards a functional cure for chronic hepatitis B,” today’s presentation will detail Aligos’ overarching approach in developing multiple candidates to target clinically validated mechanisms for inhibiting the hepatitis B virus (HBV) life cycle, which comprise capsid assembly modulators (CAMs), S-antigen transport-inhibiting oligonucleotide polymers (STOPSTM) and antisense oligonucleotides (ASOs).

“One key marker of functional cure in CHB is durable hepatitis B surface antigen (HBsAg or S-antigen) loss following treatment, which is currently lacking in the CHB therapeutic space,” said Aligos chief executive officer Lawrence Blatt, Ph.D., MBA. “Considering that a triple combination therapy is likely required to achieve high rates of functional cure, we have targeted essential components of the HBV life cycle, which include S-antigen secretion, genome replication and maintenance and viral transcription and translation. Aligos is developing a combination therapy including CAMs, STOPs and ASOs, each targeting one or more clinically validated pathways necessary for viral replication.”

Blatt continued, “We see an outstanding need in CHB for treatment regimens that are optimized for delivery, target engagement and safety. Our CAM candidate, ALG-000184, has picomolar potency and excellent oral pharmacokinetic properties, our STOP candidate, ALG-010133, can be delivered via subcutaneous administration and demonstrates the most potent in vitro anti-S-antigen activity to date. Our two-trigger ASO candidates target two conserved transcripts in HBV, providing an increased resistance barrier and better viral genotype coverage. These drug candidates are poised to deliver a best-in-class combination regimen resulting in high rates of functional cure for CHB.”

SOUTH SAN FRANCISCO, Calif. November 25, 2019 – Aligos Therapeutics, Inc. (Aligos), a biotechnology company focused on the development of targeted therapies for hepatologic diseases and viral infections, including chronic hepatitis B (CHB), nonalcoholic steatohepatitis (NASH), and hepatocellular carcinoma (HCC), today announced the appointment of Kathleen Sereda Glaub to the company’s board of directors. With over 30 years of experience in corporate development and strategy, financing and company-building for life science and technology companies, Ms. Glaub has a successful track record of financings, partnerships and company sales. She currently serves as executive chair of the board of directors at CuraSen Therapeutics, which she also co-founded, and as board director of Escient Pharmaceuticals and IO Biotech. Past board affiliations include Afferent Pharmaceuticals and Codexis, Inc. Previously, Ms. Glaub was the CEO of Afferent Pharmaceuticals, where she advanced gefapixant for chronic cough to Phase 3 readiness, raised $80 million in additional private funding and led the 2016 sale of the company to Merck for $1.25 billion.

“We are honored to add Ms. Glaub’s trusted perspective to our board of directors at this critical stage of Aligos’ development, as we lay the groundwork toward the clinic in chronic hepatitis B and other liver diseases,” commented Aligos CEO Lawrence Blatt, Ph.D., MBA. “We are very proud of the team we’ve assembled at Aligos – particularly as we pursue a functional cure for highly prevalent chronic hepatitis B. With her extensive experience, we welcome Ms. Glaub to the board.”

“Aligos presents a wonderful opportunity in the form of a differentiated and diversified asset portfolio assembled by a seasoned management team. It will be a pleasure to support the company as it progresses to the clinic to aid patient populations in need of effective therapeutics in liver disease.”

Prior to Afferent, Ms. Glaub served as president of Plexxikon, Inc., for 12 years, where she led business and financing strategies, negotiated several multimillion-dollar partnerships and led the sale of the company to Daiichi Sankyo for nearly $1 billion in 2011. She also was instrumental in Plexxikon’s advancement of multiple novel molecules to the clinic, including advancement of Zelboraf®, a targeted treatment for melanoma, along with its companion diagnostic to market approval in 2011.

She also previously held positions as senior vice president and chief financial officer of Cell Genesys, treasurer of Genentech and various finance and treasury roles within Intel Corporation. Ms. Glaub received her BA from the University of California, Berkeley, and her MBA from Northwestern University.

SOUTH SAN FRANCISCO, Calif., November 11, 2019 – Aligos Therapeutics, Inc. (Aligos), a pre-clinical stage biotechnology company focused on the development of targeted therapies for hepatologic diseases and viral infections, including chronic hepatitis B (CHB), nonalcoholic steatohepatitis (NASH), and hepatocellular carcinoma (HCC), highlighted promising preclinical performance of the company’s thyroid hormone receptor beta (THR-b) agonist for NASH today atThe Liver Meeting®, hosted annually by the American Association for the Study of Liver Disease (AASLD).

Aligos’ poster presentation, titled “Preclinical development of ALG-055009 as a Potent and Selective Thyroid Hormone Receptor Beta Agonist for the Treatment of NASH”, highlighted key preclinical data for the company’s lead NASH candidate ALG-055009, a thyroid hormone receptor-β (THR-β) agonist. NASH, which presents with liver inflammation and fibrosiscaused by liver fat build-up, currently has no approved drug treatment. However, THR-β agonists have shown the potential to reduce liver fat and inflammation, restore liver function and possibly reverse fibrosis in NASH patients¹.

In a diet-induced obese murine model, ALG-055009 reduced cholesterol in a pronounced and sustained fashion after a single dose and demonstrated excellent bioavailability when administered orally. Correspondingin vitro studies demonstrated potent, selective behavior with favorable pharmacokinetic profiles. Combined, these data indicate potential for safe, effective once-daily oral dosing in humans.

“This particular candidate distinguished itself among several in-house compound that we screened for THR-β agonism and continues to exceed expectations through a battery of tests in vitro and in vivo,” said Jerome Deval, Ph.D., Director of Biochemistry at Aligos, who delivered the presentation. “ALG-055009 demonstrated a rare combination of high potency and selectivity, the latter of which is critical for precluding cardiac toxicity.”

Aligos CEO Lawrence Blatt, Ph.D., MBA, added, “We are pleased to show that ALG-055009, representing the second generation of the THR-β agonist class, is on track to potentially outperform the current top clinical-stage players in the field. We expect to advance ALG-055009 into Phase 1 trials after completion of toxicology studies.”

Poster presentations demonstrate early preclinical successes of strategically designed, complementary therapies aimed at effecting a functional cure in chronic hepatitis B

 SOUTH SAN FRANCISCO, Calif. November 8, 2019 – Aligos Therapeutics, Inc. (Aligos), a pre-clinical stage biotechnology company focused on the development of targeted therapies for hepatologic diseases and viral infections, including chronic hepatitis B (CHB), nonalcoholic steatohepatitis (NASH), and hepatocellular carcinoma (HCC), delivered presentations detailing promising pre-clinical studies todayatThe Liver Meeting®, hosted annually by the American Association for the Study of Liver Disease (AASLD). The three poster presentations demonstrated promising early results from Aligos’ multi-pronged pipeline of candidates to address CHB, the most common chronic viral infection worldwide.

“Current standards of CHB care fall short of a functional cure for most patients,” explained Leo Beigelman, Ph.D., president of Aligos. “Aligos’ approach is to strategically develop potentially best-in-class drug candidates that target key clinically validated mechanisms of the hepatitis B virus (HBV) life cycle.”

Two presentations demonstrated strong pre-clinical activity for Aligos’ capsid assembly modulator (CAM) candidates—ALG-001075and ALG-001024—that trigger HBV core proteins to assemble empty, nonviable viral capsids while also inhibiting formation and maintenance of HBV’s covalently closed circular DNA (or cccDNA). In vitroHBV DNA replication studies with the two Aligos CAM compounds demonstrate potent in hibitory activity with EC₅₀ values of 0.54 nM and 2.07 nM for ALG-001075 and ALG-001024, respectively, making these molecules among the most potent CAMs identified to date. In murine studies, both candidates have demonstrated a high degree of efficacy consistent with the potential for once-daily dosing in humans, and warrant further development as potentially best-in-class CAMs. Aligos is developing CAM molecules in collaboration with the laboratory of Raymond Schinazi, Ph.D., D.Sc., FAASLD (Pediatrics) under a license agreement with Emory University.

A third presentation addressed Aligos’ development of proprietary oligonucleotides that inhibit the production of HBsAg (or S-antigen) by a novel mechanism targeting host proteins. HBsAgis a viral encoded protein that suppresses the immune system. Designated S-Antigen Transport-Inhibiting Oligonucleotide Polymers, or STOPs, this class of oligonucleotides is designed to address a barrier to a functional CHB cure: the standard of care targets viral DNA replication but fails to address S-antigen reduction. Preclinical profiling experiments studying the release of HBsAg from HBV-infected cells have shown potent anti-S-antigen activity for Aligos’ ALG-010093, with an EC₅₀ value of 2.5 nM. Mechanism of action studies have demonstrated that STOPs act potentially by affecting protein trafficking from the infected cell, thereby warranting further study.

“We are pleased to be presenting the first publication of the Aligos portfolio at the annual AASLD meeting,” commented Lawrence Blatt, Ph.D., MBA, CEO of Aligos. “We believe we are building a portfolio of compounds that target key aspects of the HBV life cycle that are designed to work in concert and have the potential to benefit patients living with chronic hepatitis B. We have built a team of highly accomplished virologists, oligonucleotide and medicinal chemists, toxicologists, and clinical scientists who are directing their collective talent towards building a functional cure for chronic hepatitis B.”

Posters to highlight recent advances for the company’s development-stage products for HBV and NASH

SOUTH SAN FRANCISCO, Calif. October 29, 2019 – Aligos Therapeutics, Inc. (Aligos), a pre-clinical stage biotechnology company focused on the development of targeted therapies for hepatologic diseases and viral infections, including chronic hepatitis B (CHB), nonalcoholic steatohepatitis (NASH), and hepatocellular carcinoma (HCC), today announced the upcoming presentation of four abstracts at The Liver Meeting® hosted annually by the American Association for the Study of Liver Disease (AASLD). The 2019 meeting will be held in Boston on November 8-12.

Experts from Aligos’ team of scientists will present posters detailing recent advances in the company’s products in development to address CHB and NASH. Poster presentation details include the following:

Poster session I

Date/Time: Friday, November 8, 12:30 p.m. – 1:30p.m. ET

Location: John B. Hynes Memorial Convention Center

• Poster Title: S-Antigen Transport-inhibiting Oligonucleotide Polymers (STOPs) can Effectively Inhibit Hepatitis B Surface Antigen (HBsAg) Secretion from Hepatitis B Virus (HBV) Cell Lines

Poster number: 689

Presenter: Jin Hong (Director, Oligonucleotide Biology) 

• Poster Title: Preclinical Assessment of a Novel Capsid Assembly Modulator, ALG-001075, Demonstrates Best-in-Class In Vitro Potency and In Vivo Antiviral Efficacy

Poster number: 699

Presenter: Yannick Debing (Senior Scientist)

• Poster Title: Preclinical Assessment of Potency and Efficacy of a Novel Class-II Capsid Assembly Modulator ALG-001024

Poster number: 703

Presenter: Andreas Jekle (Director, Virology)

Poster session IV

Date/Time: Monday, November 11, 12:30 p.m. – 1:30 p.m. ET

Location: John B. Hynes Memorial Convention Center

• Poster Title: Preclinical development of ALG-009 as a Potent and Selective Thyroid Hormone Receptor Beta Agonist for the Treatment of NASH

Poster number: 2149

Presenter: Jerome Deval (Director, Biochemistry)

South San Francisco, California, October 14, 2019 – Aligos Therapeutics, Inc.(Aligos), a pre-clinical stage biotechnology company focused on the development of targeted therapies for hepatologic diseases and viral infections, including chronic hepatitis B(CHB), nonalcoholic steatohepatitis(NASH), and hepatocellular carcinoma(HCC),today announced the appointment of Matthew W. McClure, M.D., as executive vice president (EVP) and chief medical officer(CMO).

Dr. McClure has more than20 years of clinical and drug development experience with significant expertise in the design, execution and interpretation of Phase 1-3 clinical trials across a range of therapeutic areas, particularly in chronic viral hepatitis and NASH.

“I am very pleased to welcome Dr. McClure to Aligos Therapeutics,” said Lawrence Blatt, Ph.D., MBA, chief executive officer of Aligos. “With his broad experience in the development of drugs in chronic viral hepatitis and NASH, we are confident he will add substantial expertise to our team as we look forward to advancing what we believe to be a robust and potentially transformative pipeline. This is an exciting time for Aligosas we prepare to advance best-in-class compounds for the potential treatment of chronic hepatitis B and NASH into the clinic in 2020.”

“I am delighted to help Aligos achieve its vision of discovering and developing effective therapies for diseases where significant unmet needs remain,” said Dr.McClure.“In particular, I am confident that with the combination of innovative compounds being advanced and the highly experienced team at Aligos, we may find a potentially curative treatment regimen for chronic hepatitis B infection in the coming years.”

Dr. McClure’s drug development career began in academia at the Duke Clinical Research Institute during his medical training. Following his work as an attending physician, he transitioned to the biotechnology industry, where he has held roles of increasing responsibility and seniority, culminating in his most recent position as chief medical officer at Second Genome. Prior to Second Genome, Dr. McClure played an important role in the clinical development of Esbriet® (pirfenidone)during his time at InterMune, Inc., which was acquired by Roche in 2014, and andexanet alfa during his time at Portola Pharmaceuticals, Inc.,as well as a critical role as the lead clinician in the development of lumicitabine during his time at AliosBioPharma, Inc., which was acquired by Johnson and Johnson in 2014. After Alios’ acquisition and while at Janssen, a pharmaceutical company of Johnson & Johnson, Dr. McClure continued to play an important role in the lumicitabine program.

Dr. McClure received his degree in medicine from Duke University and graduated (summa cum laude) with a Bachelor of Science in biochemistry and cell biology from the University of California, San Diego.

 Second drug candidate from Aligos’ CHB portfolio cleared to start first-in-human clinical trial

SOUTH SAN FRANCISCO, Calif. September 28, 2020 – Aligos Therapeutics, Inc. (Aligos), a clinical stage biopharmaceutical company focused on developing novel therapeutics to address unmet medical needs in viral and liver diseases, today announced that the Company has received approval for a clinical trial application (CTA) for a first-in-human Phase 1a/b proof-of-concept clinical trial. Aligos may now commence study ALG-000184-201 (NCT04536337) to evaluate ALG-000184, a small molecule class II capsid assembly modulator (CAM) that targets hepatitis B virus (HBV) capsid assembly as well as the establishment of covalently closed circular DNA (cccDNA). ALG-000184 is the second of Aligos’ chronic hepatitis B (CHB) drug candidates cleared to begin clinical trials.

“In collaboration with Emory University, we have utilized our small molecule chemistry expertise to identify multiple promising CAMs including ALG-000184, which has been optimized for potency as well as other pharmacokinetic properties,” said Lawrence Blatt, Ph.D., MBA, Chief Executive Officer of Aligos. “We look forward to determining how these properties translate in the clinic towards development of novel therapies for patients with chronic hepatitis B.”

ALG-000184-201 is a multipart Phase 1a/1b umbrella trial that will evaluate the safety, pharmacokinetics and antiviral activity of up to 28 days of once-daily doses of orally administered ALG-000184 in healthy volunteers (1a) and patients with CHB (1b).

Aligos’ CAM program is one of four classes of compounds in its CHB development portfolio, which also includes STOPS ™ (S-antigen Transport-inhibiting Oligonucleotide Polymers) molecules, antisense oligonucleotide (ASO), and small interfering RNA (siRNA) drug candidates.

About Chronic Hepatitis B (CHB)

CHB is a major cause of chronic liver disease that affects over 290 million people worldwide. Serious complications of CHB include cirrhosis and liver cancer, which are associated with significant mortality. Approximately 900,000 people died from CHB-related causes in 2015 alone and the mortality rate associated with HBV-related liver cancer continues to increase. Although current standard of care for patients with CHB is effective in suppressing HBV, it is associated with very low rates of functional cure, which is the goal for future CHB treatments.

About Aligos

Aligos Therapeutics, Inc., is a privately held, clinical stage biopharmaceutical company that was founded in 2018 with the mission to become a world leader in the treatment of viral infections and liver diseases. Aligos is focused on the development of targeted antiviral therapies for chronic hepatitis B (CHB) and coronaviruses as well as leveraging its expertise in liver diseases to create targeted therapeutics for nonalcoholic steatohepatitis (NASH). Aligos’ strategy is to harness the deep expertise and decades of drug development experience its workforce has in liver disease, particularly viral hepatitis, to rapidly advance its pipeline of potentially best-in-class molecules.

Please visit www.aligos.com for more information.

Media Contact

Amy Jobe, Ph.D.
LifeSci Communications
+1 315 879 8192
ajobe@lifescicomms.com

Investor Contact

Corey Davis, Ph.D.
LifeSci Advisors
+1 212 915 2577
cdavis@lifesciadvisors.com

SOUTH SAN FRANCISCO, Calif., August 27, 2020 – Aligos Therapeutics, Inc. (Aligos), a private biopharmaceutical  company focused on developing novel therapeutics to address unmet medical needs in viral and liver diseases, including  chronic hepatitis B (CHB), COVID-19 and therapeutics for NASH, will present four abstracts highlighting nonclinical data for drug candidates in the company’s CHB portfolio at the European Association for the Study of the Liver (EASL) Digital International Liver Congress™ 2020.

“Taken together, our findings show promising progress across our chronic hepatitis B portfolio, both individually and in pairwise combinations,” said Lawrence Blatt, Ph.D., MBA, chief executive officer of Aligos. “As our lead candidates advance in the clinic, we are gratified to see that our approach of designing purpose-built drug candidates targeting clinically validated mechanisms of action have shown promising activity in our nonclinical studies to date.”

The presentations provide new information for many of the company’s classes of drug candidates designed for use in combination therapy to develop high rates of functional cure in CHB. Of note, an abstract related to Aligos’ STOPS™ program, entitled “Structural requirements for ’S-antigen transport-inhibiting oligonucleotide polymer inhibition of hepatitis B surface antigen secretion,” was selected for inclusion in the meeting’s ‘Best of ILC’ category, which highlights the most noteworthy contributions to the meeting’s scientific program. The titles of each abstract, the class(es) of candidates highlighted and the findings are as follows:

S-antigen Transport-inhibiting Oligonucleotide PolymerS (STOPS™)

Title: Structural requirements for S-antigen Transport-inhibiting Oligonucleotide Polymer inhibition of hepatitis B surface antigen secretion

Summary: Aligos’ proprietary STOPS candidates were evaluated for S-antigen (or HBsAg) reduction and cytotoxicity in cell culture to optimize activity relative to structurally similar nucleic acid polymers (NAPs). Upon varying sequence, length, and chemical modifications of STOPS, it was found that STOPS’ activity is dependent on length, with the highest potency observed at over 34 nucleotides. Sequence was critical for STOPS activity: when the AC dinucleotide repeat was changed to AG, the antiviral activity was completely lost. However, activity was retained when the base identities were maintained, such as with a CA repeat. Site-specific incorporation of backbone chemistries such as a stereospecific phosphorothioate bond also improved potency.

Note: This abstract will be available publicly after the meeting as part of EASL’s ‘Best of ILC’ summary slide deck.

Capsid Assembly Modulators (CAMs)

Title: ALG-000184, a prodrug of capsid assembly modulator ALG-001075, demonstrates best-in-class preclinical characteristics for the treatment of chronic hepatitis B

Summary:  ALG-001075 was found to be a potent inhibitor of HBV DNA production in HepG2.117 cells with EC₅₀/EC₉₀ values of 0.63/3.17 nM (n = 12), respectively. This level of potency exceeds that of all other known reported CAMs that have entered clinical development, efficiently blocking both HBV genome encapsidation and de novo cccDNA formation. ALG-000184, a prodrug of ALG-001075, showed improved pharmacokinetic properties, including improved aqueous solubility, stability and oral absorption across species with efficient conversion to ALG-001075 in vivo.

Antisense oligonucleotides (ASOs)

Title: Best in class hepatitis B virus anti-sense oligonucleotides: Next generation bridged nucleic acid chemistries significantly improve the therapeutic index by reducing hepatotoxicity and increasing in vivo efficacy in a mouse model

Summary: Although locked nucleic acid (LNA)-modified ASOs can cause liver toxicity, applying bridged nucleic acid and nucleobase gap modifications to LNA ASOs showed improved efficacy and reduced liver toxicity in a mouse model of hepatitis B virus (HBV) infection, suggesting that Aligos’ anti-HBV ASO candidates have potential to be best in class compounds.

STOPS in combination with other agents

Title: Combination drug interactions of hepatitis B virus (HBV) S-antigen Transport-inhibiting Oligonucleotide Polymers in vitro

Summary: STOPS in combination with nucleos(t)ides, core assembly modulators (CAMs), and HBV-specific antisense oligonucleotides (ASOs) were evaluated for inhibition of HBV replication and HBsAg release in HBV-producing hepatic cells. When tested in pairwise combinations with the other HBV inhibitors, STOPS demonstrated synergy or additivity. Overall, the activity of STOPS warrants further study as a component of a combination therapy in CHB. 

About Chronic Hepatitis B (CHB)

CHB is a major cause of chronic liver disease that the World Health Organization estimates affects ~257 million people worldwide, more people than hepatitis C virus (HCV) and HIV infection combined. Serious complications of CHB include cirrhosis and liver cancer, which are associated with significant mortality.  Approximately 900,000 people died from CHB-related causes in 2015 alone and the mortality rate has been rising for decades. Although current standard of care for patients with CHB is effective in suppressing HBV, it is associated with very low rates of functional cure, which is the main goal of CHB treatment.

About Aligos

Aligos Therapeutics, Inc., is a privately held, clinical stage biopharmaceutical company that was founded in 2018 with the mission to become a world leader in the treatment of viral infections and liver diseases. Aligos is focused on the development of targeted antiviral therapies for chronic hepatitis B (CHB) and coronaviruses as well as leveraging its expertise in liver diseases to create targeted therapeutics for nonalcoholic steatohepatitis (NASH). Aligos’ strategy is to harness the deep expertise and decades of drug development experience its workforce has in liver disease, particularly viral hepatitis, to rapidly advance its pipeline of potentially best-in-class molecules.

Please visit www.aligos.com for more information.

 

Media Contact
Amy Jobe, Ph.D.
LifeSci Communications
+1 315 879 8192
ajobe@lifescicomms.com

Investor Contact
Corey Davis, Ph.D.
LifeSci Advisors
+1 212 915 2577
cdavis@lifesciadvisors.com

SOUTH SAN FRANCISCO, Calif., August 26, 2020 – Aligos Therapeutics, Inc. (Aligos), a private biopharmaceutical company focused on developing novel therapeutics to address unmet medical needs in viral and liver diseases, including chronic hepatitis B (CHB), COVID-19 and therapeutics for nonalcoholic steatohepatitis (NASH), will present nonclinical data related to the company’s thyroid hormone receptor-beta (THR-B) therapeutic program for NASH on August 27 at the European Association for the Study of the Liver (EASL) Digital International Liver Congress™ 2020.

The data, summarized in an abstract titled “Molecular, cellular, and pharmacological characterization of beta-selective partial agonists of human thyroid hormone receptor for the treatment of nonalcoholic steatohepatitis,” will be presented as part of a poster session. Data details a novel series of B- selective THR partial agonists targeting NASH by reducing harmful levels of liver fat without causing the side effects associated with non-selective THR agonists, which can activate the THR-alpha (A) isoform in the heart.

“Following profiling in a panel of in vitro assays, our team assessed the THR activation of several small molecule THR-B agonists in hepatic cells. Promising compounds were then evaluated for efficacy in rats fed with a high fat diet,” said Jerome Deval, Ph.D., senior director of biochemistry at Aligos and lead author of the study. “In contrast to currently known THR-B agonists, the compounds tested show potential for cholesterol reduction in vivo without detectable activation of THR-A.”

In vitro, Aligos’ compounds activated THR-B with an EC₅₀ of approximately 40-60 nM, with a maximum effective amplitude (E_max) of approximately 25-50% relative to the natural thyroid hormone T3. At much higher concentrations (up to 10 µM), the same compounds did not significantly activate THR-A. Further, reporter assays in hepatic (HEK293T) cells demonstrated an E_max value of approximately 55% relative to T3 with no measurable THR-A activation. Aligos’ compounds yielded a >90-fold THR-B/THR-A selectivity index, relative to indices of 1- to 3.4-fold among three existing THR-B agonists. In a diet-induced obese (DIO) rat efficacy model, single doses of B-selective THR partial agonists induced cholesterol reduction, albeit at lower levels compared with full THR agonists.

“Current NASH treatments lack selectivity, supporting our conclusion that there is significant value in pursuing improved candidates as part of Aligos’ portfolio in highly prevalent liver diseases,” said Lawrence Blatt, Ph.D., MBA, chief executive officer of Aligos. “We believe that these compounds warrant further study.”

 About Aligos

Aligos Therapeutics, Inc. is a privately held biopharmaceutical company that was founded in 2018 with the mission to become a world leader in the treatment of viral infections and liver diseases. Aligos is focused on the development of targeted antiviral therapies for chronic hepatitis B (CHB) and COVID-19 as well as leveraging its expertise in liver diseases to create targeted therapeutics for NASH. Aligos’ strategy is to harness the deep expertise and decades of drug development experience its workforce has in liver disease, particularly viral hepatitis, to rapidly advance its pipeline of best-in-class molecules.

Please visit www.aligos.com for more information.

 

Aligos Media Contact
Amy Jobe, Ph.D.
LifeSci Communications
+1 315 879 8192
ajobe@lifescicomms.com

Aligos Investor Contact
Corey Davis, Ph.D.
LifeSci Advisors
+1 212 915 2577
cdavis@lifesciadvisors.com

Second drug candidate from Aligos’ CHB portfolio advances towards clinical trial

 SOUTH SAN FRANCISCO, Calif. August 24, 2020 – Aligos Therapeutics, Inc. (Aligos), a clinical stage biopharmaceutical company focused on developing novel therapeutics to address unmet medical needs in viral and liver diseases, today announced that it has submitted a clinical trial application (CTA) to the New Zealand Medicines and Medical Devices Safety Authority for a first-in-human Phase 1a/b proof-of-concept trial (ALG-000184-201). The trial is evaluating ALG-000184, a small molecule class II capsid assembly modulator (CAM) that targets hepatitis B virus (HBV) capsid assembly as well as the regulation and transcription of covalently closed circular DNA (cccDNA).

“This is a significant achievement for Aligos Therapeutics,” said Lawrence Blatt, Ph.D., MBA, Chief Executive Officer of Aligos. “Starting with novel CAM compounds discovered in Dr. Raymond Schinazi’s laboratory at Emory University, our teams have collaborated over the last 2 years to further improve upon the CAM technology. This work culminated in the discovery of ALG-000184, which has optimized pharmacokinetic properties and sub-nanomolar potency. ALG-000184 appears to be the most potent class II CAM drug candidate known to have entered clinical development to date and we are excited to see how its enhanced properties translate in clinical trials.”

ALG-000184-201 is a multipart Phase 1a/1b umbrella trial that will evaluate the safety, pharmacokinetics and antiviral activity of up to 28 days of once-daily doses of orally administered ALG-000184 in healthy volunteers and patients with chronic hepatitis B (CHB). “We aim to follow our Phase 1 STOPS^TM candidate into the clinic with ALG-000184 and conduct concurrent Phase 1 trials with each of these drug candidates before moving them into combination trials,” noted Matthew McClure, M.D., Chief Medical Officer of Aligos. “We believe that by advancing a purpose-built combination of therapeutics with additive or synergistic antiviral activity, we may be able to significantly improve upon the low rates of functional cure seen with current standard of care medications.”

Aligos’ CAM program is one of four classes of compounds in its CHB development portfolio, which also includes STOPS (S-antigen Transport-inhibiting Oligonucleotide Polymers), antisense oligonucleotide (ASO), and small interfering RNA (siRNA) drug candidates.

 About Chronic Hepatitis B (CHB)

CHB is a major cause of chronic liver disease that the World Health Organization estimates affects ~257 million people worldwide, more people than hepatitis C virus (HCV) and HIV infection combined. Serious complications of CHB include cirrhosis and liver cancer, which are associated with significant mortality.  Approximately 900,000 people died from CHB-related causes in 2015 alone and the mortality rate has been rising for decades. Although current standard of care for patients with CHB is effective in suppressing HBV, it is associated with very low rates of functional cure, which is the main goal of CHB treatment.

About Aligos

Aligos Therapeutics, Inc., is a privately held, clinical stage biopharmaceutical company that was founded in 2018 with the mission to become a world leader in the treatment of viral infections and liver diseases. Aligos is focused on the development of targeted antiviral therapies for chronic hepatitis B (CHB) and coronaviruses as well as leveraging its expertise in liver diseases to create targeted therapeutics for nonalcoholic steatohepatitis (NASH). Aligos’ strategy is to harness the deep expertise and decades of drug development experience its workforce has in liver disease, particularly viral hepatitis, to rapidly advance its pipeline of potentially best-in-class molecules.

Please visit www.aligos.com for more information.

 

Media Contact
Amy Jobe, Ph.D.
LifeSci Communications
+1 315 879 8192
ajobe@lifescicomms.com

Investor Contact
Corey Davis, Ph.D.
LifeSci Advisors
+1 212 915 2577
cdavis@lifesciadvisors.com

First Aligos drug candidate to commence clinical trials

First-in-human trial marks ~2.5-year path from company formation to entry into the clinic

SOUTH SAN FRANCISCO, Calif. August 18, 2020 – Aligos Therapeutics, Inc. (Aligos), a private clinical stage biopharmaceutical company focused on developing novel therapeutics to address unmet medical needs in viral and liver diseases, including chronic hepatitis B (CHB) and coronaviruses and therapeutics for nonalcoholic steatohepatitis (NASH), today announced that it has dosed its first subject in a first-in-human Phase 1a/b trial. This trial will evaluate ALG-010133, a proprietary oligonucleotide S-antigen transport-inhibiting oligonucleotide polymer (STOPS^TM) molecule that functions to decrease viral S-antigen (or HBsAg) levels, an essential step for enabling functional cure in CHB.

“This marks an important milestone for the company, as ALG-010133 is Aligos’ first asset to enter into clinical trials since the company’s launch in 2018,” said Lawrence Blatt, Ph.D., MBA, Chief Executive Officer of Aligos. “Our team has spent the last two years discovering and optimizing STOPS molecules, which ultimately led to the identification and advancement of ALG-010133.  We believe that this drug candidate has the potential to significantly suppress HBsAg levels in patients with CHB and are excited to initiate this important proof of concept trial.”

ALG-010133-101 (NCT04485663) is a multi-part umbrella trial that will evaluate the safety, pharmacokinetics and antiviral activity of up to 12 weekly doses of subcutaneously administered ALG-010133 in healthy volunteers and virologically suppressed patients with CHB.  Initially, Aligos is conducting the trial at a single clinical pharmacology unit in Auckland, New Zealand, and, once dosing in CHB patients starts, at multiple investigational sites across the Asia-Pacific region and Europe.  Aligos expects to report topline CHB results for certain trial cohorts beginning in the second half of 2021.

Aligos’ STOPS program is one of several programs in its CHB portfolio that target different clinically validated mechanisms of action.  The portfolio also includes capsid assembly modulator (CAM), antisense oligonucleotide (ASO), and small interfering RNA (siRNA) drug candidates.  All of these drug candidates have properties that indicate that they could be used in combinations to develop potentially best-in-class treatment regimens that may achieve higher rates of functional cure than current standard of care. For each of these drug candidates, Aligos plans to initially establish proof of concept as monotherapy in Phase 1 umbrella trials before evaluating them in combination in subsequent trials.

 “Approved treatments, such as nucleos(t)ide analogs, result in low rates of functional cure and require lifelong therapy for the approximately 290 million people living with CHB around the world,” noted Matthew McClure, M.D., Chief Medical Officer. “A key part of our mission at Aligos is to improve this rate by advancing multiple drug candidates, each of which interrupts distinct steps in the viral life cycle, that will act additively or synergistically when combined.  This trial is a first step in our effort to achieve that mission.”

 About Aligos

Aligos Therapeutics, Inc., is a privately held, clinical stage biopharmaceutical company that was founded in 2018 with the mission to become a world leader in the treatment of viral infections and liver diseases. Aligos is focused on the development of targeted antiviral therapies for chronic hepatitis B (CHB) and coronaviruses as well as leveraging its expertise in liver diseases to create targeted therapeutics for nonalcoholic steatohepatitis (NASH). Aligos’ strategy is to harness the deep expertise and decades of drug development experience its workforce has in liver disease, particularly viral hepatitis, to rapidly advance its pipeline of potentially best-in-class molecules.

Please visit www.aligos.com for more information.

 

Media Contact
Amy Jobe, Ph.D.
LifeSci Communications
+1 315 879 8192
ajobe@lifescicomms.com

Investor Contact
Corey Davis, Ph.D.
LifeSci Advisors
+1 212 915 2577
cdavis@lifesciadvisors.com

SOUTH SAN FRANCISCO, Calif. and LEUVEN, Belgium, July 01, 2020 (GLOBE NEWSWIRE) — Aligos Therapeutics, Inc. (Aligos), a private biotechnology company focused on the development of targeted antiviral therapies directed against chronic hepatitis B (CHB), COVID-19 and therapeutics for NASH, today announced that they have entered into a collaboration and license agreement with KU Leuven, in particular its Centre for Drug Design and Discovery (CD3), a drug discovery unit and investment mechanism of KU Leuven, and the Rega Institute for Medical Research, to develop a coronavirus protease inhibitor as a potential therapeutic candidate to address the COVID-19 pandemic.

Principal investigator Johan Neyts, Ph.D., professor of virology, and his scientific staff at the Rega Institute, together with the CD3 team, have focused for many years on discovering novel antiviral strategies against a number of virus families. In this collaboration, Johan Neyts’ research group and CD3 will join forces with Aligos, whose team has extensive experience in antiviral drug discovery, development and viral protease inhibitor chemistry. Their combined objective is to develop a therapeutic candidate designed to target the SARS-CoV-2 infection as well as other coronavirus infections.

“The Rega Institute together with CD3 was a natural and complementary fit for this collaborative effort, with their longstanding track record of developing effective antiviral products against a number of viruses,” said Aligos President Leonid Beigelman, Ph.D. “The teams agreed on the specific coronavirus protease as a promising therapeutic target, which is essential in the viral life cycle and conserved among viruses in the coronavirus family, meaning that a candidate that inhibits this target may also serve as a therapeutic in potential future coronavirus epidemics.”

“Besides the urgent need for treatment options to fight the current SARS-CoV-2 virus,” said Professor Neyts, “it is clear that there is also an important need for preparedness for the next coronavirus outbreak. A pan-coronavirus antiviral is the best and only approach to be able to respond quickly to any new emerging coronavirus in the future and avoid large outbreaks that may lead to epidemics or a pandemic.”

“We are delighted to enter into this collaboration aiming to deliver a new drug against SARS-CoV-2 and other coronaviruses,” said Patrick Chaltin, Managing Director of CD3. “The SARS-CoV-2 crisis demands the implementation of a strong integrated approach combining and leveraging world leading academic virology expertise and our early drug discovery capabilities with an exceptionally strong and committed biotech partner like Aligos.”

About Aligos

Aligos Therapeutics, Inc. is a privately held biotechnology company that was founded in 2018 with the mission to become a world leader in the treatment of viral infections and liver diseases. Aligos is focused on the development of targeted antiviral therapies for chronic hepatitis B (CHB) and COVID-19 as well as leveraging its expertise in liver diseases to create targeted therapeutics for NASH. Aligos’ strategy is to harness the deep expertise and decades of drug development experience its workforce has in liver disease, particularly viral hepatitis, to rapidly advance its pipeline of best-in-class molecules.

Please visit www.aligos.com for more information.

About the Centre for Drug Design and Discovery – KU Leuven

The Centre for Drug Design and Discovery (CD3) is a drug discovery platform and investment fund with a focus on the discovery and development of innovative medicines mainly starting from innovative academic research. By providing the necessary drug discovery expertise and financial resources, CD3 ensures that biomedical research carried out by universities and small biotech companies is collaboratively translated into promising new medicines. Subsequently, such new potential medicines can then be further developed by pharma or biotech industry or can form the basis for the establishment of new biotechs. CD3 was set up in 2006 by KU Leuven Research & Development and the European Investment Fund (EIF) and launched a 60 million euro fund in 2016.

Please visit www.cd3.eu for more information.

About Rega Institute

The Rega Institute for Medical Research is a biomedical research institute of KU Leuven that comprises the Laboratory of Virology and Chemotherapy, which specializes particularly in antiviral research. Medications discovered at the Rega Institute are successfully being used for the treatment of, for example, HIV, hepatitis B and infections caused by herpes viruses and several other drug candidates are in development against human rhinovirus, dengue and other (viral) diseases.

Please visit www.kuleuven.be/rega for more information.

Aligos Media Contact
Amy Jobe, Ph.D.
LifeSci Communications
+1 315 879 8192
ajobe@lifescicomms.com

Aligos Investor Contact
Corey Davis, Ph.D.
LifeSci Advisors
+1 212 915 2577
cdavis@lifesciadvisors.com

KU Leuven Contact
Dr. Patrick Chaltin
Managing Director CD3
+32 477 61 08 54
patrick.chaltin@kuleuven.be

SOUTH SAN FRANCISCO, Calif., ATLANTA, June 23, 2020 – Aligos Therapeutics, Inc. (Aligos), a private biotechnology company focused on the development of antiviral therapies targeting chronic hepatitis B (CHB) and COVID-19 as well as therapeutics for NASH, announced an expansion to their existing license agreement with Emory University (Emory) to include additional technology developed at Emory related to Aligos’ capsid assembly modulator (CAM) program in CHB. Aligos and Emory have also entered into a collaboration agreement to futher advance this technology.

The license expansion builds upon the parties’ existing agreement whereby Aligos acquired from Emory an exclusive license to technology with respect to a novel class of non-nucleoside class-II CAMs. Professor Raymond F. Schinazi, director of the Laboratory of Biochemical Pharmacology at Emory, and colleagues have developed a series of potent, novel CAMs, small molecules that disrupt viral capsid assembly. Aligos is advancing its CAM program as part of a CHB portfolio designed to produce a combination therapy delivering a high rate of functional cure. Each program in the portfolio targets clinically validated mechanisms in the replication cycle of the hepatitis B virus.

“We are pleased to continue our collaboration with Emory by adding a wider range of potential drug candidates to our CAM discovery and development programs,” said Aligos CEO Lawrence Blatt, Ph.D., MBA. “Building upon the foundation established in 2018, we plan to further explore the technology Dr. Schinazi and his group at Emory have developed in an effort to create a best-in-class combination therapy for the treatment of chronic Hepatitis B.”

Raymond F. Schinazi, Ph.D., D.Sc., FAASLD (Pediatrics) at Emory, added, “We are pleased to collaborate with a very experienced group of scientists at Aligos towards an HBV cure. Together we have optimized our compounds providing potency in the picomolar range with a favorable preclinical safety profile. Clearly a fixed dose combination will not only prevent or reduce the likelihood of drug resistance, but will also provide a powerful blow to the virus capsid, which is essential for virus replication and persistence.”

SOUTH SAN FRANCISCO, Calif. June 18, 2020 – Aligos Therapeutics, Inc. (Aligos), a private biotechnology company focused on the development of targeted antiviral therapies directed against chronic hepatitis B (CHB) and COVID-19 and therapeutics for NASH, today announced that it has submitted its first clinical trial application for a first-in-human Phase 1a/b study evaluating ALG-010133.  ALG-010133 is a proprietary oligonucleotide S-antigen transport inhibiting oligonucleotide polymer (STOPS^TM) which is thought to act as an aptamer that interacts with specific proteins to decrease viral HBsAg levels, which is essential for enabling functional cure in CHB.

“We are excited to announce the achievement of this important developmental milestone for ALG-010133” said Lawrence Blatt, Ph.D., MBA, Chief Executive Officer of Aligos. “With worldwide disease prevalence in the hundreds of millions, chronic Hepatitis B patients are at significant risk of progression to liver fibrosis, cirrhosis, end stage liver disease, and hepatocellular carcinoma.  Currently available therapies are given for life and rarely result in a sustained functional cure.  Our goal is to develop a therapeutic regimen that can lead to high rates of functional cure for patients living with chronic Hepatitis B. ”

Aligos’ STOPS program is the first of three classes of compounds in its CHB development portfolio, which also includes a capsid assembly modulator (CAM) and antisense oligonucleotide (ASO).  Initially, Aligos plans to evaluate these in separate Phase 1 studies and then combine them in subsequent studies.

SOUTH SAN FRANCISCO, Calif. June 3, 2020 – Aligos Therapeutics, Inc. (Aligos), a private biotechnology company focused on the development of targeted, antiviral therapies including chronic hepatitis B (CHB) and COVID-19 as well as therapeutics for NASH, today announced the appointment of Lesley Ann Calhoun, as chief financial officer. Ms. Calhoun will serve as a member of the Aligos leadership team and will report to Aligos’ chief executive officer, Lawrence Blatt, Ph.D., MBA.

Ms. Calhoun is an experienced finance executive with 17 years in the biopharma industry as well as an earlier career in U.S. and multinational technology companies and public accounting. She brings broad experience in both public and pre-IPO companies and in driving financial vision, direction, guidance and compliance to support and advise on operations for companies. She has had a successful career in transforming companies from private, pre-IPO stages to publicly traded business driven, commercial operating companies.

“With Ms. Calhoun’s significant financial and business operations experience, we are pleased to welcome her to the team as we move our lead chronic hepatitis B candidates toward clinical development,” said Dr. Blatt. “She has led numerous companies through major periods of growth and finance planning activities, and I look forward to partnering with Lesley on executing our initiatives with a clear goal of developing a functional cure for patients with chronic hepatitis B.”

Prior to joining the Aligos team, Ms. Calhoun most recently served as senior vice president of finance & administration and chief accounting officer at Global Blood Therapeutics, where she was responsible for the finance, accounting and administrative functions aimed at supporting the companies’ transition from clinical stage to a publicly traded, commercial environment and was part of the company’s successful regulatory approval and commercial launch of Oxbryta® for the treatment of sickle cell disease. Previously, Ms. Calhoun served as vice president of finance at Hyperion Therapeutics Inc., a commercial stage biopharmaceutical company focused on orphan diseases. During her time there, she was instrumental in building the company’s finance infrastructure, which led to the successful commercialization of RAVICTI® for the treatment of urea cycle disorders. Prior to her time at Hyperion, she served as senior director of finance/corporate controller at Theravance, Inc., where she supported the company’s CFO and was responsible for all corporate and regulatory accounting reporting, serving as a key player in the company’s financial vision and direction.

Ms. Calhoun has also held roles of increasing financial responsibility at Cell Genesys, Inc., Snap Appliances, Inc., Inktomi Corporation and Silicon Graphics, Inc. and was a member of the audit practice of Deloitte &Touche LLP.

Ms. Calhoun stated, “I am honored to join the Aligos team sitting parallel to veteran experts with years of drug research and development experience, and I look forward to joining them in driving Aligos’ future financial, strategic and operational capabilities. With a diversified asset portfolio in chronic hepatitis B backed by elite management and scientific teams, the company is well positioned to advance toward the clinic.”

Ms. Calhoun received her Bachelor of Science in Business Administration from San Francisco State University and is a Certified Public Accountant (inactive).

SOUTH SAN FRANCISCO, Calif. June 2, 2020 – Aligos Therapeutics, Inc., a private biotechnology company focused on the development of targeted, antiviral therapies including chronic hepatitis B (CHB) and COVID-19 as well as therapeutics for NASH, today announced that Lawrence Blatt, Ph.D., MBA , Chief Executive Officer of Aligos, will present at the Jefferies Virtual Healthcare Conference on Thursday, June 4, 2020 at 1:30 p.m. Eastern Time.

Jefferies Virtual Healthcare Conference

Date:                  Thursday, June 4^th, 2020

Time:                 1:30 pm Eastern Time

Webcast:           http://wsw.com/webcast/jeff126/alig/

About Jefferies Virtual Healthcare Conference

The format will include video & audio company presentations, interactive panels, and 1×1 meetings conducted via organized conference calls.  This virtual gathering of over 400 public & private healthcare companies and 2,500 leading executives, institutional investors, private equity investors & VCs will address near- and long-term investment opportunities and discuss the current mechanisms driving healthcare in the U.S. and internationally.

For further information, please visit: www.Jefferies.com/Conferences

SOUTH SAN FRANCISCO, Calif. April 15, 2020 – Aligos Therapeutics, Inc., a preclinical stage biotechnology company focused on the development of targeted therapies for hepatologic diseases and viral infections, including chronic hepatitis B (CHB), nonalcoholic steatohepatitis (NASH) and hepatocellular carcinoma (HCC), announces the expansion of an existing license agreement with Luxna Biotech Inc., Ltd. pursuant to Luxna’s innovative modified nucleic acid technology.

The amended agreement, expanded relative to an initial agreement with Luxna in December 2018, grants Aligos exclusive rights to use Luxna’s technology to target the genomes of certain families of respiratory viruses, including Coronaviridae, which includes SARS-CoV-2, the virus causing COVID-19.

“Luxna’s nucleotide stabilization technology already serves as an indispensable component for the Aligos’ antisense oligonucleotide clinical candidates targeting chronic hepatitis B, and we are now moving ahead with efforts to utilize this technology to target viruses that have the potential to cause pandemic infections,” said Aligos CEO Dr. Lawrence Blatt, Ph.D., MBA. “Our team, with decades of experience in anti-viral drug development and oligonucleotide chemistry, is well equipped to explore the potential benefits of the same technology to knock down viral transcripts in respiratory viruses like SARS-CoV-2. In light of the current pandemic and its estimated impact in the coming months, it is our responsibility as a healthcare company to investigate all possible paths to mitigate a global health issue like this one.”

SOUTH SAN FRANCISCO, Calif. January 10, 2020 – Aligos Therapeutics, Inc., a preclinical stage biotechnology company focused on the development of targeted therapies for hepatologic diseases and viral infections, including chronic hepatitis B (CHB), nonalcoholic steatohepatitis (NASH) and hepatocellular carcinoma (HCC), today announced the closing of an oversubscribed $125M Series B equity financing round led by Wellington Management Company and a global investment management firm. In addition to Wellington and the global investment management firm, new participants to this round include funds managed by Janus Henderson Investor, Boxer Capital of Tavistock Group, Cormorant Asset Management, Pivotal bioVenture Partners and Logos Capital.

Aligos had previously closed a $100M Series A financing in 2018 with the support of Vivo Capital, Versant Ventures, Novo Holdings, Roche Venture Fund and an undisclosed healthcare fund. All of these aforementioned investors participated in the Series B round.

“We are grateful for the confidence and commitment from our new and existing investors,” said Lawrence Blatt, Ph.D., MBA, CEO of Aligos. “This round of funding provides Aligos with the capital needed to move our portfolio of products aimed at treatment of chronic hepatitis B into clinical development.”

SOUTH SAN FRANCISCO, Calif. January 7, 2020 – Aligos Therapeutics, a pre-clinical stage biotechnology company focused on the development of targeted therapies for hepatologic diseases and viral infections, including chronic hepatitis B (CHB), nonalcoholic steatohepatitis (NASH), and hepatocellular carcinoma (HCC), today announced that CEO Lawrence Blatt, Ph.D., MBA, will present at the 38th Annual J.P. Morgan Healthcare Conference on Tuesday, January 14, 2020 at 11:30 a.m. PT at the Westin St. Francis (room Elizabethan C) in San Francisco, CA.

A webcast of the presentation will be available within 24 hours of the presentation and will remain available for 30 days at the following link: https://jpmorgan.metameetings.net/events/hc20/sessions/30482-aligos-therapeutics/webcast

Oral Presentation on Combination Therapy Targeting CHB

SOUTH SAN FRANCISCO, Calif. December 10, 2019 – Aligos Therapeutics, a pre-clinical stage biotechnology company focused on the development of targeted therapies for hepatologic diseases and viral infections, including chronic hepatitis B (CHB), nonalcoholic steatohepatitis (NASH), and hepatocellular carcinoma (HCC), today announced that chief executive officer Larry Blatt will deliver an invited oral presentation at HEP DART 2019 held on December 8 – 12, in Kauai, Hawaii.

Titled “Combination approaches towards a functional cure for chronic hepatitis B,” today’s presentation will detail Aligos’ overarching approach in developing multiple candidates to target clinically validated mechanisms for inhibiting the hepatitis B virus (HBV) life cycle, which comprise capsid assembly modulators (CAMs), S-antigen transport-inhibiting oligonucleotide polymers (STOPSTM) and antisense oligonucleotides (ASOs).

“One key marker of functional cure in CHB is durable hepatitis B surface antigen (HBsAg or S-antigen) loss following treatment, which is currently lacking in the CHB therapeutic space,” said Aligos chief executive officer Lawrence Blatt, Ph.D., MBA. “Considering that a triple combination therapy is likely required to achieve high rates of functional cure, we have targeted essential components of the HBV life cycle, which include S-antigen secretion, genome replication and maintenance and viral transcription and translation. Aligos is developing a combination therapy including CAMs, STOPs and ASOs, each targeting one or more clinically validated pathways necessary for viral replication.”

Blatt continued, “We see an outstanding need in CHB for treatment regimens that are optimized for delivery, target engagement and safety. Our CAM candidate, ALG-000184, has picomolar potency and excellent oral pharmacokinetic properties, our STOP candidate, ALG-010133, can be delivered via subcutaneous administration and demonstrates the most potent in vitro anti-S-antigen activity to date. Our two-trigger ASO candidates target two conserved transcripts in HBV, providing an increased resistance barrier and better viral genotype coverage. These drug candidates are poised to deliver a best-in-class combination regimen resulting in high rates of functional cure for CHB.”

SOUTH SAN FRANCISCO, Calif. November 25, 2019 – Aligos Therapeutics, Inc. (Aligos), a biotechnology company focused on the development of targeted therapies for hepatologic diseases and viral infections, including chronic hepatitis B (CHB), nonalcoholic steatohepatitis (NASH), and hepatocellular carcinoma (HCC), today announced the appointment of Kathleen Sereda Glaub to the company’s board of directors. With over 30 years of experience in corporate development and strategy, financing and company-building for life science and technology companies, Ms. Glaub has a successful track record of financings, partnerships and company sales. She currently serves as executive chair of the board of directors at CuraSen Therapeutics, which she also co-founded, and as board director of Escient Pharmaceuticals and IO Biotech. Past board affiliations include Afferent Pharmaceuticals and Codexis, Inc. Previously, Ms. Glaub was the CEO of Afferent Pharmaceuticals, where she advanced gefapixant for chronic cough to Phase 3 readiness, raised $80 million in additional private funding and led the 2016 sale of the company to Merck for $1.25 billion.

“We are honored to add Ms. Glaub’s trusted perspective to our board of directors at this critical stage of Aligos’ development, as we lay the groundwork toward the clinic in chronic hepatitis B and other liver diseases,” commented Aligos CEO Lawrence Blatt, Ph.D., MBA. “We are very proud of the team we’ve assembled at Aligos – particularly as we pursue a functional cure for highly prevalent chronic hepatitis B. With her extensive experience, we welcome Ms. Glaub to the board.”

“Aligos presents a wonderful opportunity in the form of a differentiated and diversified asset portfolio assembled by a seasoned management team. It will be a pleasure to support the company as it progresses to the clinic to aid patient populations in need of effective therapeutics in liver disease.”

Prior to Afferent, Ms. Glaub served as president of Plexxikon, Inc., for 12 years, where she led business and financing strategies, negotiated several multimillion-dollar partnerships and led the sale of the company to Daiichi Sankyo for nearly $1 billion in 2011. She also was instrumental in Plexxikon’s advancement of multiple novel molecules to the clinic, including advancement of Zelboraf®, a targeted treatment for melanoma, along with its companion diagnostic to market approval in 2011.

She also previously held positions as senior vice president and chief financial officer of Cell Genesys, treasurer of Genentech and various finance and treasury roles within Intel Corporation. Ms. Glaub received her BA from the University of California, Berkeley, and her MBA from Northwestern University.

SOUTH SAN FRANCISCO, Calif., November 11, 2019 – Aligos Therapeutics, Inc. (Aligos), a pre-clinical stage biotechnology company focused on the development of targeted therapies for hepatologic diseases and viral infections, including chronic hepatitis B (CHB), nonalcoholic steatohepatitis (NASH), and hepatocellular carcinoma (HCC), highlighted promising preclinical performance of the company’s thyroid hormone receptor beta (THR-b) agonist for NASH today atThe Liver Meeting®, hosted annually by the American Association for the Study of Liver Disease (AASLD).

Aligos’ poster presentation, titled “Preclinical development of ALG-055009 as a Potent and Selective Thyroid Hormone Receptor Beta Agonist for the Treatment of NASH”, highlighted key preclinical data for the company’s lead NASH candidate ALG-055009, a thyroid hormone receptor-β (THR-β) agonist. NASH, which presents with liver inflammation and fibrosiscaused by liver fat build-up, currently has no approved drug treatment. However, THR-β agonists have shown the potential to reduce liver fat and inflammation, restore liver function and possibly reverse fibrosis in NASH patients¹.

In a diet-induced obese murine model, ALG-055009 reduced cholesterol in a pronounced and sustained fashion after a single dose and demonstrated excellent bioavailability when administered orally. Correspondingin vitro studies demonstrated potent, selective behavior with favorable pharmacokinetic profiles. Combined, these data indicate potential for safe, effective once-daily oral dosing in humans.

“This particular candidate distinguished itself among several in-house compound that we screened for THR-β agonism and continues to exceed expectations through a battery of tests in vitro and in vivo,” said Jerome Deval, Ph.D., Director of Biochemistry at Aligos, who delivered the presentation. “ALG-055009 demonstrated a rare combination of high potency and selectivity, the latter of which is critical for precluding cardiac toxicity.”

Aligos CEO Lawrence Blatt, Ph.D., MBA, added, “We are pleased to show that ALG-055009, representing the second generation of the THR-β agonist class, is on track to potentially outperform the current top clinical-stage players in the field. We expect to advance ALG-055009 into Phase 1 trials after completion of toxicology studies.”

Poster presentations demonstrate early preclinical successes of strategically designed, complementary therapies aimed at effecting a functional cure in chronic hepatitis B

 SOUTH SAN FRANCISCO, Calif. November 8, 2019 – Aligos Therapeutics, Inc. (Aligos), a pre-clinical stage biotechnology company focused on the development of targeted therapies for hepatologic diseases and viral infections, including chronic hepatitis B (CHB), nonalcoholic steatohepatitis (NASH), and hepatocellular carcinoma (HCC), delivered presentations detailing promising pre-clinical studies todayatThe Liver Meeting®, hosted annually by the American Association for the Study of Liver Disease (AASLD). The three poster presentations demonstrated promising early results from Aligos’ multi-pronged pipeline of candidates to address CHB, the most common chronic viral infection worldwide.

“Current standards of CHB care fall short of a functional cure for most patients,” explained Leo Beigelman, Ph.D., president of Aligos. “Aligos’ approach is to strategically develop potentially best-in-class drug candidates that target key clinically validated mechanisms of the hepatitis B virus (HBV) life cycle.”

Two presentations demonstrated strong pre-clinical activity for Aligos’ capsid assembly modulator (CAM) candidates—ALG-001075and ALG-001024—that trigger HBV core proteins to assemble empty, nonviable viral capsids while also inhibiting formation and maintenance of HBV’s covalently closed circular DNA (or cccDNA). In vitroHBV DNA replication studies with the two Aligos CAM compounds demonstrate potent in hibitory activity with EC₅₀ values of 0.54 nM and 2.07 nM for ALG-001075 and ALG-001024, respectively, making these molecules among the most potent CAMs identified to date. In murine studies, both candidates have demonstrated a high degree of efficacy consistent with the potential for once-daily dosing in humans, and warrant further development as potentially best-in-class CAMs. Aligos is developing CAM molecules in collaboration with the laboratory of Raymond Schinazi, Ph.D., D.Sc., FAASLD (Pediatrics) under a license agreement with Emory University.

A third presentation addressed Aligos’ development of proprietary oligonucleotides that inhibit the production of HBsAg (or S-antigen) by a novel mechanism targeting host proteins. HBsAgis a viral encoded protein that suppresses the immune system. Designated S-Antigen Transport-Inhibiting Oligonucleotide Polymers, or STOPs, this class of oligonucleotides is designed to address a barrier to a functional CHB cure: the standard of care targets viral DNA replication but fails to address S-antigen reduction. Preclinical profiling experiments studying the release of HBsAg from HBV-infected cells have shown potent anti-S-antigen activity for Aligos’ ALG-010093, with an EC₅₀ value of 2.5 nM. Mechanism of action studies have demonstrated that STOPs act potentially by affecting protein trafficking from the infected cell, thereby warranting further study.

“We are pleased to be presenting the first publication of the Aligos portfolio at the annual AASLD meeting,” commented Lawrence Blatt, Ph.D., MBA, CEO of Aligos. “We believe we are building a portfolio of compounds that target key aspects of the HBV life cycle that are designed to work in concert and have the potential to benefit patients living with chronic hepatitis B. We have built a team of highly accomplished virologists, oligonucleotide and medicinal chemists, toxicologists, and clinical scientists who are directing their collective talent towards building a functional cure for chronic hepatitis B.”

Posters to highlight recent advances for the company’s development-stage products for HBV and NASH

SOUTH SAN FRANCISCO, Calif. October 29, 2019 – Aligos Therapeutics, Inc. (Aligos), a pre-clinical stage biotechnology company focused on the development of targeted therapies for hepatologic diseases and viral infections, including chronic hepatitis B (CHB), nonalcoholic steatohepatitis (NASH), and hepatocellular carcinoma (HCC), today announced the upcoming presentation of four abstracts at The Liver Meeting® hosted annually by the American Association for the Study of Liver Disease (AASLD). The 2019 meeting will be held in Boston on November 8-12.

Experts from Aligos’ team of scientists will present posters detailing recent advances in the company’s products in development to address CHB and NASH. Poster presentation details include the following:

Poster session I

Date/Time: Friday, November 8, 12:30 p.m. – 1:30p.m. ET

Location: John B. Hynes Memorial Convention Center

• Poster Title: S-Antigen Transport-inhibiting Oligonucleotide Polymers (STOPs) can Effectively Inhibit Hepatitis B Surface Antigen (HBsAg) Secretion from Hepatitis B Virus (HBV) Cell Lines

Poster number: 689

Presenter: Jin Hong (Director, Oligonucleotide Biology) 

• Poster Title: Preclinical Assessment of a Novel Capsid Assembly Modulator, ALG-001075, Demonstrates Best-in-Class In Vitro Potency and In Vivo Antiviral Efficacy

Poster number: 699

Presenter: Yannick Debing (Senior Scientist)

• Poster Title: Preclinical Assessment of Potency and Efficacy of a Novel Class-II Capsid Assembly Modulator ALG-001024

Poster number: 703

Presenter: Andreas Jekle (Director, Virology)

Poster session IV

Date/Time: Monday, November 11, 12:30 p.m. – 1:30 p.m. ET

Location: John B. Hynes Memorial Convention Center

• Poster Title: Preclinical development of ALG-009 as a Potent and Selective Thyroid Hormone Receptor Beta Agonist for the Treatment of NASH

Poster number: 2149

Presenter: Jerome Deval (Director, Biochemistry)

South San Francisco, California, October 14, 2019 – Aligos Therapeutics, Inc.(Aligos), a pre-clinical stage biotechnology company focused on the development of targeted therapies for hepatologic diseases and viral infections, including chronic hepatitis B(CHB), nonalcoholic steatohepatitis(NASH), and hepatocellular carcinoma(HCC),today announced the appointment of Matthew W. McClure, M.D., as executive vice president (EVP) and chief medical officer(CMO).

Dr. McClure has more than20 years of clinical and drug development experience with significant expertise in the design, execution and interpretation of Phase 1-3 clinical trials across a range of therapeutic areas, particularly in chronic viral hepatitis and NASH.

“I am very pleased to welcome Dr. McClure to Aligos Therapeutics,” said Lawrence Blatt, Ph.D., MBA, chief executive officer of Aligos. “With his broad experience in the development of drugs in chronic viral hepatitis and NASH, we are confident he will add substantial expertise to our team as we look forward to advancing what we believe to be a robust and potentially transformative pipeline. This is an exciting time for Aligosas we prepare to advance best-in-class compounds for the potential treatment of chronic hepatitis B and NASH into the clinic in 2020.”

“I am delighted to help Aligos achieve its vision of discovering and developing effective therapies for diseases where significant unmet needs remain,” said Dr.McClure.“In particular, I am confident that with the combination of innovative compounds being advanced and the highly experienced team at Aligos, we may find a potentially curative treatment regimen for chronic hepatitis B infection in the coming years.”

Dr. McClure’s drug development career began in academia at the Duke Clinical Research Institute during his medical training. Following his work as an attending physician, he transitioned to the biotechnology industry, where he has held roles of increasing responsibility and seniority, culminating in his most recent position as chief medical officer at Second Genome. Prior to Second Genome, Dr. McClure played an important role in the clinical development of Esbriet® (pirfenidone)during his time at InterMune, Inc., which was acquired by Roche in 2014, and andexanet alfa during his time at Portola Pharmaceuticals, Inc.,as well as a critical role as the lead clinician in the development of lumicitabine during his time at AliosBioPharma, Inc., which was acquired by Johnson and Johnson in 2014. After Alios’ acquisition and while at Janssen, a pharmaceutical company of Johnson & Johnson, Dr. McClure continued to play an important role in the lumicitabine program.

Dr. McClure received his degree in medicine from Duke University and graduated (summa cum laude) with a Bachelor of Science in biochemistry and cell biology from the University of California, San Diego.

 Second drug candidate from Aligos’ CHB portfolio cleared to start first-in-human clinical trial

SOUTH SAN FRANCISCO, Calif. September 28, 2020 – Aligos Therapeutics, Inc. (Aligos), a clinical stage biopharmaceutical company focused on developing novel therapeutics to address unmet medical needs in viral and liver diseases, today announced that the Company has received approval for a clinical trial application (CTA) for a first-in-human Phase 1a/b proof-of-concept clinical trial. Aligos may now commence study ALG-000184-201 (NCT04536337) to evaluate ALG-000184, a small molecule class II capsid assembly modulator (CAM) that targets hepatitis B virus (HBV) capsid assembly as well as the establishment of covalently closed circular DNA (cccDNA). ALG-000184 is the second of Aligos’ chronic hepatitis B (CHB) drug candidates cleared to begin clinical trials.

“In collaboration with Emory University, we have utilized our small molecule chemistry expertise to identify multiple promising CAMs including ALG-000184, which has been optimized for potency as well as other pharmacokinetic properties,” said Lawrence Blatt, Ph.D., MBA, Chief Executive Officer of Aligos. “We look forward to determining how these properties translate in the clinic towards development of novel therapies for patients with chronic hepatitis B.”

ALG-000184-201 is a multipart Phase 1a/1b umbrella trial that will evaluate the safety, pharmacokinetics and antiviral activity of up to 28 days of once-daily doses of orally administered ALG-000184 in healthy volunteers (1a) and patients with CHB (1b).

Aligos’ CAM program is one of four classes of compounds in its CHB development portfolio, which also includes STOPS ™ (S-antigen Transport-inhibiting Oligonucleotide Polymers) molecules, antisense oligonucleotide (ASO), and small interfering RNA (siRNA) drug candidates.

About Chronic Hepatitis B (CHB)

CHB is a major cause of chronic liver disease that affects over 290 million people worldwide. Serious complications of CHB include cirrhosis and liver cancer, which are associated with significant mortality. Approximately 900,000 people died from CHB-related causes in 2015 alone and the mortality rate associated with HBV-related liver cancer continues to increase. Although current standard of care for patients with CHB is effective in suppressing HBV, it is associated with very low rates of functional cure, which is the goal for future CHB treatments.

About Aligos

Aligos Therapeutics, Inc., is a privately held, clinical stage biopharmaceutical company that was founded in 2018 with the mission to become a world leader in the treatment of viral infections and liver diseases. Aligos is focused on the development of targeted antiviral therapies for chronic hepatitis B (CHB) and coronaviruses as well as leveraging its expertise in liver diseases to create targeted therapeutics for nonalcoholic steatohepatitis (NASH). Aligos’ strategy is to harness the deep expertise and decades of drug development experience its workforce has in liver disease, particularly viral hepatitis, to rapidly advance its pipeline of potentially best-in-class molecules.

Please visit www.aligos.com for more information.

Media Contact

Amy Jobe, Ph.D.
LifeSci Communications
+1 315 879 8192
ajobe@lifescicomms.com

Investor Contact

Corey Davis, Ph.D.
LifeSci Advisors
+1 212 915 2577
cdavis@lifesciadvisors.com

SOUTH SAN FRANCISCO, Calif., August 27, 2020 – Aligos Therapeutics, Inc. (Aligos), a private biopharmaceutical  company focused on developing novel therapeutics to address unmet medical needs in viral and liver diseases, including  chronic hepatitis B (CHB), COVID-19 and therapeutics for NASH, will present four abstracts highlighting nonclinical data for drug candidates in the company’s CHB portfolio at the European Association for the Study of the Liver (EASL) Digital International Liver Congress™ 2020.

“Taken together, our findings show promising progress across our chronic hepatitis B portfolio, both individually and in pairwise combinations,” said Lawrence Blatt, Ph.D., MBA, chief executive officer of Aligos. “As our lead candidates advance in the clinic, we are gratified to see that our approach of designing purpose-built drug candidates targeting clinically validated mechanisms of action have shown promising activity in our nonclinical studies to date.”

The presentations provide new information for many of the company’s classes of drug candidates designed for use in combination therapy to develop high rates of functional cure in CHB. Of note, an abstract related to Aligos’ STOPS™ program, entitled “Structural requirements for ’S-antigen transport-inhibiting oligonucleotide polymer inhibition of hepatitis B surface antigen secretion,” was selected for inclusion in the meeting’s ‘Best of ILC’ category, which highlights the most noteworthy contributions to the meeting’s scientific program. The titles of each abstract, the class(es) of candidates highlighted and the findings are as follows:

S-antigen Transport-inhibiting Oligonucleotide PolymerS (STOPS™)

Title: Structural requirements for S-antigen Transport-inhibiting Oligonucleotide Polymer inhibition of hepatitis B surface antigen secretion

Summary: Aligos’ proprietary STOPS candidates were evaluated for S-antigen (or HBsAg) reduction and cytotoxicity in cell culture to optimize activity relative to structurally similar nucleic acid polymers (NAPs). Upon varying sequence, length, and chemical modifications of STOPS, it was found that STOPS’ activity is dependent on length, with the highest potency observed at over 34 nucleotides. Sequence was critical for STOPS activity: when the AC dinucleotide repeat was changed to AG, the antiviral activity was completely lost. However, activity was retained when the base identities were maintained, such as with a CA repeat. Site-specific incorporation of backbone chemistries such as a stereospecific phosphorothioate bond also improved potency.

Note: This abstract will be available publicly after the meeting as part of EASL’s ‘Best of ILC’ summary slide deck.

Capsid Assembly Modulators (CAMs)

Title: ALG-000184, a prodrug of capsid assembly modulator ALG-001075, demonstrates best-in-class preclinical characteristics for the treatment of chronic hepatitis B

Summary:  ALG-001075 was found to be a potent inhibitor of HBV DNA production in HepG2.117 cells with EC₅₀/EC₉₀ values of 0.63/3.17 nM (n = 12), respectively. This level of potency exceeds that of all other known reported CAMs that have entered clinical development, efficiently blocking both HBV genome encapsidation and de novo cccDNA formation. ALG-000184, a prodrug of ALG-001075, showed improved pharmacokinetic properties, including improved aqueous solubility, stability and oral absorption across species with efficient conversion to ALG-001075 in vivo.

Antisense oligonucleotides (ASOs)

Title: Best in class hepatitis B virus anti-sense oligonucleotides: Next generation bridged nucleic acid chemistries significantly improve the therapeutic index by reducing hepatotoxicity and increasing in vivo efficacy in a mouse model

Summary: Although locked nucleic acid (LNA)-modified ASOs can cause liver toxicity, applying bridged nucleic acid and nucleobase gap modifications to LNA ASOs showed improved efficacy and reduced liver toxicity in a mouse model of hepatitis B virus (HBV) infection, suggesting that Aligos’ anti-HBV ASO candidates have potential to be best in class compounds.

STOPS in combination with other agents

Title: Combination drug interactions of hepatitis B virus (HBV) S-antigen Transport-inhibiting Oligonucleotide Polymers in vitro

Summary: STOPS in combination with nucleos(t)ides, core assembly modulators (CAMs), and HBV-specific antisense oligonucleotides (ASOs) were evaluated for inhibition of HBV replication and HBsAg release in HBV-producing hepatic cells. When tested in pairwise combinations with the other HBV inhibitors, STOPS demonstrated synergy or additivity. Overall, the activity of STOPS warrants further study as a component of a combination therapy in CHB. 

About Chronic Hepatitis B (CHB)

CHB is a major cause of chronic liver disease that the World Health Organization estimates affects ~257 million people worldwide, more people than hepatitis C virus (HCV) and HIV infection combined. Serious complications of CHB include cirrhosis and liver cancer, which are associated with significant mortality.  Approximately 900,000 people died from CHB-related causes in 2015 alone and the mortality rate has been rising for decades. Although current standard of care for patients with CHB is effective in suppressing HBV, it is associated with very low rates of functional cure, which is the main goal of CHB treatment.

About Aligos

Aligos Therapeutics, Inc., is a privately held, clinical stage biopharmaceutical company that was founded in 2018 with the mission to become a world leader in the treatment of viral infections and liver diseases. Aligos is focused on the development of targeted antiviral therapies for chronic hepatitis B (CHB) and coronaviruses as well as leveraging its expertise in liver diseases to create targeted therapeutics for nonalcoholic steatohepatitis (NASH). Aligos’ strategy is to harness the deep expertise and decades of drug development experience its workforce has in liver disease, particularly viral hepatitis, to rapidly advance its pipeline of potentially best-in-class molecules.

Please visit www.aligos.com for more information.

 

Media Contact
Amy Jobe, Ph.D.
LifeSci Communications
+1 315 879 8192
ajobe@lifescicomms.com

Investor Contact
Corey Davis, Ph.D.
LifeSci Advisors
+1 212 915 2577
cdavis@lifesciadvisors.com

SOUTH SAN FRANCISCO, Calif., August 26, 2020 – Aligos Therapeutics, Inc. (Aligos), a private biopharmaceutical company focused on developing novel therapeutics to address unmet medical needs in viral and liver diseases, including chronic hepatitis B (CHB), COVID-19 and therapeutics for nonalcoholic steatohepatitis (NASH), will present nonclinical data related to the company’s thyroid hormone receptor-beta (THR-B) therapeutic program for NASH on August 27 at the European Association for the Study of the Liver (EASL) Digital International Liver Congress™ 2020.

The data, summarized in an abstract titled “Molecular, cellular, and pharmacological characterization of beta-selective partial agonists of human thyroid hormone receptor for the treatment of nonalcoholic steatohepatitis,” will be presented as part of a poster session. Data details a novel series of B- selective THR partial agonists targeting NASH by reducing harmful levels of liver fat without causing the side effects associated with non-selective THR agonists, which can activate the THR-alpha (A) isoform in the heart.

“Following profiling in a panel of in vitro assays, our team assessed the THR activation of several small molecule THR-B agonists in hepatic cells. Promising compounds were then evaluated for efficacy in rats fed with a high fat diet,” said Jerome Deval, Ph.D., senior director of biochemistry at Aligos and lead author of the study. “In contrast to currently known THR-B agonists, the compounds tested show potential for cholesterol reduction in vivo without detectable activation of THR-A.”

In vitro, Aligos’ compounds activated THR-B with an EC₅₀ of approximately 40-60 nM, with a maximum effective amplitude (E_max) of approximately 25-50% relative to the natural thyroid hormone T3. At much higher concentrations (up to 10 µM), the same compounds did not significantly activate THR-A. Further, reporter assays in hepatic (HEK293T) cells demonstrated an E_max value of approximately 55% relative to T3 with no measurable THR-A activation. Aligos’ compounds yielded a >90-fold THR-B/THR-A selectivity index, relative to indices of 1- to 3.4-fold among three existing THR-B agonists. In a diet-induced obese (DIO) rat efficacy model, single doses of B-selective THR partial agonists induced cholesterol reduction, albeit at lower levels compared with full THR agonists.

“Current NASH treatments lack selectivity, supporting our conclusion that there is significant value in pursuing improved candidates as part of Aligos’ portfolio in highly prevalent liver diseases,” said Lawrence Blatt, Ph.D., MBA, chief executive officer of Aligos. “We believe that these compounds warrant further study.”

 About Aligos

Aligos Therapeutics, Inc. is a privately held biopharmaceutical company that was founded in 2018 with the mission to become a world leader in the treatment of viral infections and liver diseases. Aligos is focused on the development of targeted antiviral therapies for chronic hepatitis B (CHB) and COVID-19 as well as leveraging its expertise in liver diseases to create targeted therapeutics for NASH. Aligos’ strategy is to harness the deep expertise and decades of drug development experience its workforce has in liver disease, particularly viral hepatitis, to rapidly advance its pipeline of best-in-class molecules.

Please visit www.aligos.com for more information.

 

Aligos Media Contact
Amy Jobe, Ph.D.
LifeSci Communications
+1 315 879 8192
ajobe@lifescicomms.com

Aligos Investor Contact
Corey Davis, Ph.D.
LifeSci Advisors
+1 212 915 2577
cdavis@lifesciadvisors.com

Second drug candidate from Aligos’ CHB portfolio advances towards clinical trial

 SOUTH SAN FRANCISCO, Calif. August 24, 2020 – Aligos Therapeutics, Inc. (Aligos), a clinical stage biopharmaceutical company focused on developing novel therapeutics to address unmet medical needs in viral and liver diseases, today announced that it has submitted a clinical trial application (CTA) to the New Zealand Medicines and Medical Devices Safety Authority for a first-in-human Phase 1a/b proof-of-concept trial (ALG-000184-201). The trial is evaluating ALG-000184, a small molecule class II capsid assembly modulator (CAM) that targets hepatitis B virus (HBV) capsid assembly as well as the regulation and transcription of covalently closed circular DNA (cccDNA).

“This is a significant achievement for Aligos Therapeutics,” said Lawrence Blatt, Ph.D., MBA, Chief Executive Officer of Aligos. “Starting with novel CAM compounds discovered in Dr. Raymond Schinazi’s laboratory at Emory University, our teams have collaborated over the last 2 years to further improve upon the CAM technology. This work culminated in the discovery of ALG-000184, which has optimized pharmacokinetic properties and sub-nanomolar potency. ALG-000184 appears to be the most potent class II CAM drug candidate known to have entered clinical development to date and we are excited to see how its enhanced properties translate in clinical trials.”

ALG-000184-201 is a multipart Phase 1a/1b umbrella trial that will evaluate the safety, pharmacokinetics and antiviral activity of up to 28 days of once-daily doses of orally administered ALG-000184 in healthy volunteers and patients with chronic hepatitis B (CHB). “We aim to follow our Phase 1 STOPS^TM candidate into the clinic with ALG-000184 and conduct concurrent Phase 1 trials with each of these drug candidates before moving them into combination trials,” noted Matthew McClure, M.D., Chief Medical Officer of Aligos. “We believe that by advancing a purpose-built combination of therapeutics with additive or synergistic antiviral activity, we may be able to significantly improve upon the low rates of functional cure seen with current standard of care medications.”

Aligos’ CAM program is one of four classes of compounds in its CHB development portfolio, which also includes STOPS (S-antigen Transport-inhibiting Oligonucleotide Polymers), antisense oligonucleotide (ASO), and small interfering RNA (siRNA) drug candidates.

 About Chronic Hepatitis B (CHB)

CHB is a major cause of chronic liver disease that the World Health Organization estimates affects ~257 million people worldwide, more people than hepatitis C virus (HCV) and HIV infection combined. Serious complications of CHB include cirrhosis and liver cancer, which are associated with significant mortality.  Approximately 900,000 people died from CHB-related causes in 2015 alone and the mortality rate has been rising for decades. Although current standard of care for patients with CHB is effective in suppressing HBV, it is associated with very low rates of functional cure, which is the main goal of CHB treatment.

About Aligos

Aligos Therapeutics, Inc., is a privately held, clinical stage biopharmaceutical company that was founded in 2018 with the mission to become a world leader in the treatment of viral infections and liver diseases. Aligos is focused on the development of targeted antiviral therapies for chronic hepatitis B (CHB) and coronaviruses as well as leveraging its expertise in liver diseases to create targeted therapeutics for nonalcoholic steatohepatitis (NASH). Aligos’ strategy is to harness the deep expertise and decades of drug development experience its workforce has in liver disease, particularly viral hepatitis, to rapidly advance its pipeline of potentially best-in-class molecules.

Please visit www.aligos.com for more information.

 

Media Contact
Amy Jobe, Ph.D.
LifeSci Communications
+1 315 879 8192
ajobe@lifescicomms.com

Investor Contact
Corey Davis, Ph.D.
LifeSci Advisors
+1 212 915 2577
cdavis@lifesciadvisors.com

First Aligos drug candidate to commence clinical trials

First-in-human trial marks ~2.5-year path from company formation to entry into the clinic

SOUTH SAN FRANCISCO, Calif. August 18, 2020 – Aligos Therapeutics, Inc. (Aligos), a private clinical stage biopharmaceutical company focused on developing novel therapeutics to address unmet medical needs in viral and liver diseases, including chronic hepatitis B (CHB) and coronaviruses and therapeutics for nonalcoholic steatohepatitis (NASH), today announced that it has dosed its first subject in a first-in-human Phase 1a/b trial. This trial will evaluate ALG-010133, a proprietary oligonucleotide S-antigen transport-inhibiting oligonucleotide polymer (STOPS^TM) molecule that functions to decrease viral S-antigen (or HBsAg) levels, an essential step for enabling functional cure in CHB.

“This marks an important milestone for the company, as ALG-010133 is Aligos’ first asset to enter into clinical trials since the company’s launch in 2018,” said Lawrence Blatt, Ph.D., MBA, Chief Executive Officer of Aligos. “Our team has spent the last two years discovering and optimizing STOPS molecules, which ultimately led to the identification and advancement of ALG-010133.  We believe that this drug candidate has the potential to significantly suppress HBsAg levels in patients with CHB and are excited to initiate this important proof of concept trial.”

ALG-010133-101 (NCT04485663) is a multi-part umbrella trial that will evaluate the safety, pharmacokinetics and antiviral activity of up to 12 weekly doses of subcutaneously administered ALG-010133 in healthy volunteers and virologically suppressed patients with CHB.  Initially, Aligos is conducting the trial at a single clinical pharmacology unit in Auckland, New Zealand, and, once dosing in CHB patients starts, at multiple investigational sites across the Asia-Pacific region and Europe.  Aligos expects to report topline CHB results for certain trial cohorts beginning in the second half of 2021.

Aligos’ STOPS program is one of several programs in its CHB portfolio that target different clinically validated mechanisms of action.  The portfolio also includes capsid assembly modulator (CAM), antisense oligonucleotide (ASO), and small interfering RNA (siRNA) drug candidates.  All of these drug candidates have properties that indicate that they could be used in combinations to develop potentially best-in-class treatment regimens that may achieve higher rates of functional cure than current standard of care. For each of these drug candidates, Aligos plans to initially establish proof of concept as monotherapy in Phase 1 umbrella trials before evaluating them in combination in subsequent trials.

 “Approved treatments, such as nucleos(t)ide analogs, result in low rates of functional cure and require lifelong therapy for the approximately 290 million people living with CHB around the world,” noted Matthew McClure, M.D., Chief Medical Officer. “A key part of our mission at Aligos is to improve this rate by advancing multiple drug candidates, each of which interrupts distinct steps in the viral life cycle, that will act additively or synergistically when combined.  This trial is a first step in our effort to achieve that mission.”

 About Aligos

Aligos Therapeutics, Inc., is a privately held, clinical stage biopharmaceutical company that was founded in 2018 with the mission to become a world leader in the treatment of viral infections and liver diseases. Aligos is focused on the development of targeted antiviral therapies for chronic hepatitis B (CHB) and coronaviruses as well as leveraging its expertise in liver diseases to create targeted therapeutics for nonalcoholic steatohepatitis (NASH). Aligos’ strategy is to harness the deep expertise and decades of drug development experience its workforce has in liver disease, particularly viral hepatitis, to rapidly advance its pipeline of potentially best-in-class molecules.

Please visit www.aligos.com for more information.

 

Media Contact
Amy Jobe, Ph.D.
LifeSci Communications
+1 315 879 8192
ajobe@lifescicomms.com

Investor Contact
Corey Davis, Ph.D.
LifeSci Advisors
+1 212 915 2577
cdavis@lifesciadvisors.com

SOUTH SAN FRANCISCO, Calif. and LEUVEN, Belgium, July 01, 2020 (GLOBE NEWSWIRE) — Aligos Therapeutics, Inc. (Aligos), a private biotechnology company focused on the development of targeted antiviral therapies directed against chronic hepatitis B (CHB), COVID-19 and therapeutics for NASH, today announced that they have entered into a collaboration and license agreement with KU Leuven, in particular its Centre for Drug Design and Discovery (CD3), a drug discovery unit and investment mechanism of KU Leuven, and the Rega Institute for Medical Research, to develop a coronavirus protease inhibitor as a potential therapeutic candidate to address the COVID-19 pandemic.

Principal investigator Johan Neyts, Ph.D., professor of virology, and his scientific staff at the Rega Institute, together with the CD3 team, have focused for many years on discovering novel antiviral strategies against a number of virus families. In this collaboration, Johan Neyts’ research group and CD3 will join forces with Aligos, whose team has extensive experience in antiviral drug discovery, development and viral protease inhibitor chemistry. Their combined objective is to develop a therapeutic candidate designed to target the SARS-CoV-2 infection as well as other coronavirus infections.

“The Rega Institute together with CD3 was a natural and complementary fit for this collaborative effort, with their longstanding track record of developing effective antiviral products against a number of viruses,” said Aligos President Leonid Beigelman, Ph.D. “The teams agreed on the specific coronavirus protease as a promising therapeutic target, which is essential in the viral life cycle and conserved among viruses in the coronavirus family, meaning that a candidate that inhibits this target may also serve as a therapeutic in potential future coronavirus epidemics.”

“Besides the urgent need for treatment options to fight the current SARS-CoV-2 virus,” said Professor Neyts, “it is clear that there is also an important need for preparedness for the next coronavirus outbreak. A pan-coronavirus antiviral is the best and only approach to be able to respond quickly to any new emerging coronavirus in the future and avoid large outbreaks that may lead to epidemics or a pandemic.”

“We are delighted to enter into this collaboration aiming to deliver a new drug against SARS-CoV-2 and other coronaviruses,” said Patrick Chaltin, Managing Director of CD3. “The SARS-CoV-2 crisis demands the implementation of a strong integrated approach combining and leveraging world leading academic virology expertise and our early drug discovery capabilities with an exceptionally strong and committed biotech partner like Aligos.”

About Aligos

Aligos Therapeutics, Inc. is a privately held biotechnology company that was founded in 2018 with the mission to become a world leader in the treatment of viral infections and liver diseases. Aligos is focused on the development of targeted antiviral therapies for chronic hepatitis B (CHB) and COVID-19 as well as leveraging its expertise in liver diseases to create targeted therapeutics for NASH. Aligos’ strategy is to harness the deep expertise and decades of drug development experience its workforce has in liver disease, particularly viral hepatitis, to rapidly advance its pipeline of best-in-class molecules.

Please visit www.aligos.com for more information.

About the Centre for Drug Design and Discovery – KU Leuven

The Centre for Drug Design and Discovery (CD3) is a drug discovery platform and investment fund with a focus on the discovery and development of innovative medicines mainly starting from innovative academic research. By providing the necessary drug discovery expertise and financial resources, CD3 ensures that biomedical research carried out by universities and small biotech companies is collaboratively translated into promising new medicines. Subsequently, such new potential medicines can then be further developed by pharma or biotech industry or can form the basis for the establishment of new biotechs. CD3 was set up in 2006 by KU Leuven Research & Development and the European Investment Fund (EIF) and launched a 60 million euro fund in 2016.

Please visit www.cd3.eu for more information.

About Rega Institute

The Rega Institute for Medical Research is a biomedical research institute of KU Leuven that comprises the Laboratory of Virology and Chemotherapy, which specializes particularly in antiviral research. Medications discovered at the Rega Institute are successfully being used for the treatment of, for example, HIV, hepatitis B and infections caused by herpes viruses and several other drug candidates are in development against human rhinovirus, dengue and other (viral) diseases.

Please visit www.kuleuven.be/rega for more information.

Aligos Media Contact
Amy Jobe, Ph.D.
LifeSci Communications
+1 315 879 8192
ajobe@lifescicomms.com

Aligos Investor Contact
Corey Davis, Ph.D.
LifeSci Advisors
+1 212 915 2577
cdavis@lifesciadvisors.com

KU Leuven Contact
Dr. Patrick Chaltin
Managing Director CD3
+32 477 61 08 54
patrick.chaltin@kuleuven.be

SOUTH SAN FRANCISCO, Calif., ATLANTA, June 23, 2020 – Aligos Therapeutics, Inc. (Aligos), a private biotechnology company focused on the development of antiviral therapies targeting chronic hepatitis B (CHB) and COVID-19 as well as therapeutics for NASH, announced an expansion to their existing license agreement with Emory University (Emory) to include additional technology developed at Emory related to Aligos’ capsid assembly modulator (CAM) program in CHB. Aligos and Emory have also entered into a collaboration agreement to futher advance this technology.

The license expansion builds upon the parties’ existing agreement whereby Aligos acquired from Emory an exclusive license to technology with respect to a novel class of non-nucleoside class-II CAMs. Professor Raymond F. Schinazi, director of the Laboratory of Biochemical Pharmacology at Emory, and colleagues have developed a series of potent, novel CAMs, small molecules that disrupt viral capsid assembly. Aligos is advancing its CAM program as part of a CHB portfolio designed to produce a combination therapy delivering a high rate of functional cure. Each program in the portfolio targets clinically validated mechanisms in the replication cycle of the hepatitis B virus.

“We are pleased to continue our collaboration with Emory by adding a wider range of potential drug candidates to our CAM discovery and development programs,” said Aligos CEO Lawrence Blatt, Ph.D., MBA. “Building upon the foundation established in 2018, we plan to further explore the technology Dr. Schinazi and his group at Emory have developed in an effort to create a best-in-class combination therapy for the treatment of chronic Hepatitis B.”

Raymond F. Schinazi, Ph.D., D.Sc., FAASLD (Pediatrics) at Emory, added, “We are pleased to collaborate with a very experienced group of scientists at Aligos towards an HBV cure. Together we have optimized our compounds providing potency in the picomolar range with a favorable preclinical safety profile. Clearly a fixed dose combination will not only prevent or reduce the likelihood of drug resistance, but will also provide a powerful blow to the virus capsid, which is essential for virus replication and persistence.”

SOUTH SAN FRANCISCO, Calif. June 18, 2020 – Aligos Therapeutics, Inc. (Aligos), a private biotechnology company focused on the development of targeted antiviral therapies directed against chronic hepatitis B (CHB) and COVID-19 and therapeutics for NASH, today announced that it has submitted its first clinical trial application for a first-in-human Phase 1a/b study evaluating ALG-010133.  ALG-010133 is a proprietary oligonucleotide S-antigen transport inhibiting oligonucleotide polymer (STOPS^TM) which is thought to act as an aptamer that interacts with specific proteins to decrease viral HBsAg levels, which is essential for enabling functional cure in CHB.

“We are excited to announce the achievement of this important developmental milestone for ALG-010133” said Lawrence Blatt, Ph.D., MBA, Chief Executive Officer of Aligos. “With worldwide disease prevalence in the hundreds of millions, chronic Hepatitis B patients are at significant risk of progression to liver fibrosis, cirrhosis, end stage liver disease, and hepatocellular carcinoma.  Currently available therapies are given for life and rarely result in a sustained functional cure.  Our goal is to develop a therapeutic regimen that can lead to high rates of functional cure for patients living with chronic Hepatitis B. ”

Aligos’ STOPS program is the first of three classes of compounds in its CHB development portfolio, which also includes a capsid assembly modulator (CAM) and antisense oligonucleotide (ASO).  Initially, Aligos plans to evaluate these in separate Phase 1 studies and then combine them in subsequent studies.

SOUTH SAN FRANCISCO, Calif. June 3, 2020 – Aligos Therapeutics, Inc. (Aligos), a private biotechnology company focused on the development of targeted, antiviral therapies including chronic hepatitis B (CHB) and COVID-19 as well as therapeutics for NASH, today announced the appointment of Lesley Ann Calhoun, as chief financial officer. Ms. Calhoun will serve as a member of the Aligos leadership team and will report to Aligos’ chief executive officer, Lawrence Blatt, Ph.D., MBA.

Ms. Calhoun is an experienced finance executive with 17 years in the biopharma industry as well as an earlier career in U.S. and multinational technology companies and public accounting. She brings broad experience in both public and pre-IPO companies and in driving financial vision, direction, guidance and compliance to support and advise on operations for companies. She has had a successful career in transforming companies from private, pre-IPO stages to publicly traded business driven, commercial operating companies.

“With Ms. Calhoun’s significant financial and business operations experience, we are pleased to welcome her to the team as we move our lead chronic hepatitis B candidates toward clinical development,” said Dr. Blatt. “She has led numerous companies through major periods of growth and finance planning activities, and I look forward to partnering with Lesley on executing our initiatives with a clear goal of developing a functional cure for patients with chronic hepatitis B.”

Prior to joining the Aligos team, Ms. Calhoun most recently served as senior vice president of finance & administration and chief accounting officer at Global Blood Therapeutics, where she was responsible for the finance, accounting and administrative functions aimed at supporting the companies’ transition from clinical stage to a publicly traded, commercial environment and was part of the company’s successful regulatory approval and commercial launch of Oxbryta® for the treatment of sickle cell disease. Previously, Ms. Calhoun served as vice president of finance at Hyperion Therapeutics Inc., a commercial stage biopharmaceutical company focused on orphan diseases. During her time there, she was instrumental in building the company’s finance infrastructure, which led to the successful commercialization of RAVICTI® for the treatment of urea cycle disorders. Prior to her time at Hyperion, she served as senior director of finance/corporate controller at Theravance, Inc., where she supported the company’s CFO and was responsible for all corporate and regulatory accounting reporting, serving as a key player in the company’s financial vision and direction.

Ms. Calhoun has also held roles of increasing financial responsibility at Cell Genesys, Inc., Snap Appliances, Inc., Inktomi Corporation and Silicon Graphics, Inc. and was a member of the audit practice of Deloitte &Touche LLP.

Ms. Calhoun stated, “I am honored to join the Aligos team sitting parallel to veteran experts with years of drug research and development experience, and I look forward to joining them in driving Aligos’ future financial, strategic and operational capabilities. With a diversified asset portfolio in chronic hepatitis B backed by elite management and scientific teams, the company is well positioned to advance toward the clinic.”

Ms. Calhoun received her Bachelor of Science in Business Administration from San Francisco State University and is a Certified Public Accountant (inactive).

SOUTH SAN FRANCISCO, Calif. June 2, 2020 – Aligos Therapeutics, Inc., a private biotechnology company focused on the development of targeted, antiviral therapies including chronic hepatitis B (CHB) and COVID-19 as well as therapeutics for NASH, today announced that Lawrence Blatt, Ph.D., MBA , Chief Executive Officer of Aligos, will present at the Jefferies Virtual Healthcare Conference on Thursday, June 4, 2020 at 1:30 p.m. Eastern Time.

Jefferies Virtual Healthcare Conference

Date:                  Thursday, June 4^th, 2020

Time:                 1:30 pm Eastern Time

Webcast:           http://wsw.com/webcast/jeff126/alig/

About Jefferies Virtual Healthcare Conference

The format will include video & audio company presentations, interactive panels, and 1×1 meetings conducted via organized conference calls.  This virtual gathering of over 400 public & private healthcare companies and 2,500 leading executives, institutional investors, private equity investors & VCs will address near- and long-term investment opportunities and discuss the current mechanisms driving healthcare in the U.S. and internationally.

For further information, please visit: www.Jefferies.com/Conferences

SOUTH SAN FRANCISCO, Calif. April 15, 2020 – Aligos Therapeutics, Inc., a preclinical stage biotechnology company focused on the development of targeted therapies for hepatologic diseases and viral infections, including chronic hepatitis B (CHB), nonalcoholic steatohepatitis (NASH) and hepatocellular carcinoma (HCC), announces the expansion of an existing license agreement with Luxna Biotech Inc., Ltd. pursuant to Luxna’s innovative modified nucleic acid technology.

The amended agreement, expanded relative to an initial agreement with Luxna in December 2018, grants Aligos exclusive rights to use Luxna’s technology to target the genomes of certain families of respiratory viruses, including Coronaviridae, which includes SARS-CoV-2, the virus causing COVID-19.

“Luxna’s nucleotide stabilization technology already serves as an indispensable component for the Aligos’ antisense oligonucleotide clinical candidates targeting chronic hepatitis B, and we are now moving ahead with efforts to utilize this technology to target viruses that have the potential to cause pandemic infections,” said Aligos CEO Dr. Lawrence Blatt, Ph.D., MBA. “Our team, with decades of experience in anti-viral drug development and oligonucleotide chemistry, is well equipped to explore the potential benefits of the same technology to knock down viral transcripts in respiratory viruses like SARS-CoV-2. In light of the current pandemic and its estimated impact in the coming months, it is our responsibility as a healthcare company to investigate all possible paths to mitigate a global health issue like this one.”

SOUTH SAN FRANCISCO, Calif. January 10, 2020 – Aligos Therapeutics, Inc., a preclinical stage biotechnology company focused on the development of targeted therapies for hepatologic diseases and viral infections, including chronic hepatitis B (CHB), nonalcoholic steatohepatitis (NASH) and hepatocellular carcinoma (HCC), today announced the closing of an oversubscribed $125M Series B equity financing round led by Wellington Management Company and a global investment management firm. In addition to Wellington and the global investment management firm, new participants to this round include funds managed by Janus Henderson Investor, Boxer Capital of Tavistock Group, Cormorant Asset Management, Pivotal bioVenture Partners and Logos Capital.

Aligos had previously closed a $100M Series A financing in 2018 with the support of Vivo Capital, Versant Ventures, Novo Holdings, Roche Venture Fund and an undisclosed healthcare fund. All of these aforementioned investors participated in the Series B round.

“We are grateful for the confidence and commitment from our new and existing investors,” said Lawrence Blatt, Ph.D., MBA, CEO of Aligos. “This round of funding provides Aligos with the capital needed to move our portfolio of products aimed at treatment of chronic hepatitis B into clinical development.”

SOUTH SAN FRANCISCO, Calif. January 7, 2020 – Aligos Therapeutics, a pre-clinical stage biotechnology company focused on the development of targeted therapies for hepatologic diseases and viral infections, including chronic hepatitis B (CHB), nonalcoholic steatohepatitis (NASH), and hepatocellular carcinoma (HCC), today announced that CEO Lawrence Blatt, Ph.D., MBA, will present at the 38th Annual J.P. Morgan Healthcare Conference on Tuesday, January 14, 2020 at 11:30 a.m. PT at the Westin St. Francis (room Elizabethan C) in San Francisco, CA.

A webcast of the presentation will be available within 24 hours of the presentation and will remain available for 30 days at the following link: https://jpmorgan.metameetings.net/events/hc20/sessions/30482-aligos-therapeutics/webcast

Oral Presentation on Combination Therapy Targeting CHB

SOUTH SAN FRANCISCO, Calif. December 10, 2019 – Aligos Therapeutics, a pre-clinical stage biotechnology company focused on the development of targeted therapies for hepatologic diseases and viral infections, including chronic hepatitis B (CHB), nonalcoholic steatohepatitis (NASH), and hepatocellular carcinoma (HCC), today announced that chief executive officer Larry Blatt will deliver an invited oral presentation at HEP DART 2019 held on December 8 – 12, in Kauai, Hawaii.

Titled “Combination approaches towards a functional cure for chronic hepatitis B,” today’s presentation will detail Aligos’ overarching approach in developing multiple candidates to target clinically validated mechanisms for inhibiting the hepatitis B virus (HBV) life cycle, which comprise capsid assembly modulators (CAMs), S-antigen transport-inhibiting oligonucleotide polymers (STOPSTM) and antisense oligonucleotides (ASOs).

“One key marker of functional cure in CHB is durable hepatitis B surface antigen (HBsAg or S-antigen) loss following treatment, which is currently lacking in the CHB therapeutic space,” said Aligos chief executive officer Lawrence Blatt, Ph.D., MBA. “Considering that a triple combination therapy is likely required to achieve high rates of functional cure, we have targeted essential components of the HBV life cycle, which include S-antigen secretion, genome replication and maintenance and viral transcription and translation. Aligos is developing a combination therapy including CAMs, STOPs and ASOs, each targeting one or more clinically validated pathways necessary for viral replication.”

Blatt continued, “We see an outstanding need in CHB for treatment regimens that are optimized for delivery, target engagement and safety. Our CAM candidate, ALG-000184, has picomolar potency and excellent oral pharmacokinetic properties, our STOP candidate, ALG-010133, can be delivered via subcutaneous administration and demonstrates the most potent in vitro anti-S-antigen activity to date. Our two-trigger ASO candidates target two conserved transcripts in HBV, providing an increased resistance barrier and better viral genotype coverage. These drug candidates are poised to deliver a best-in-class combination regimen resulting in high rates of functional cure for CHB.”

SOUTH SAN FRANCISCO, Calif. November 25, 2019 – Aligos Therapeutics, Inc. (Aligos), a biotechnology company focused on the development of targeted therapies for hepatologic diseases and viral infections, including chronic hepatitis B (CHB), nonalcoholic steatohepatitis (NASH), and hepatocellular carcinoma (HCC), today announced the appointment of Kathleen Sereda Glaub to the company’s board of directors. With over 30 years of experience in corporate development and strategy, financing and company-building for life science and technology companies, Ms. Glaub has a successful track record of financings, partnerships and company sales. She currently serves as executive chair of the board of directors at CuraSen Therapeutics, which she also co-founded, and as board director of Escient Pharmaceuticals and IO Biotech. Past board affiliations include Afferent Pharmaceuticals and Codexis, Inc. Previously, Ms. Glaub was the CEO of Afferent Pharmaceuticals, where she advanced gefapixant for chronic cough to Phase 3 readiness, raised $80 million in additional private funding and led the 2016 sale of the company to Merck for $1.25 billion.

“We are honored to add Ms. Glaub’s trusted perspective to our board of directors at this critical stage of Aligos’ development, as we lay the groundwork toward the clinic in chronic hepatitis B and other liver diseases,” commented Aligos CEO Lawrence Blatt, Ph.D., MBA. “We are very proud of the team we’ve assembled at Aligos – particularly as we pursue a functional cure for highly prevalent chronic hepatitis B. With her extensive experience, we welcome Ms. Glaub to the board.”

“Aligos presents a wonderful opportunity in the form of a differentiated and diversified asset portfolio assembled by a seasoned management team. It will be a pleasure to support the company as it progresses to the clinic to aid patient populations in need of effective therapeutics in liver disease.”

Prior to Afferent, Ms. Glaub served as president of Plexxikon, Inc., for 12 years, where she led business and financing strategies, negotiated several multimillion-dollar partnerships and led the sale of the company to Daiichi Sankyo for nearly $1 billion in 2011. She also was instrumental in Plexxikon’s advancement of multiple novel molecules to the clinic, including advancement of Zelboraf®, a targeted treatment for melanoma, along with its companion diagnostic to market approval in 2011.

She also previously held positions as senior vice president and chief financial officer of Cell Genesys, treasurer of Genentech and various finance and treasury roles within Intel Corporation. Ms. Glaub received her BA from the University of California, Berkeley, and her MBA from Northwestern University.

SOUTH SAN FRANCISCO, Calif., November 11, 2019 – Aligos Therapeutics, Inc. (Aligos), a pre-clinical stage biotechnology company focused on the development of targeted therapies for hepatologic diseases and viral infections, including chronic hepatitis B (CHB), nonalcoholic steatohepatitis (NASH), and hepatocellular carcinoma (HCC), highlighted promising preclinical performance of the company’s thyroid hormone receptor beta (THR-b) agonist for NASH today atThe Liver Meeting®, hosted annually by the American Association for the Study of Liver Disease (AASLD).

Aligos’ poster presentation, titled “Preclinical development of ALG-055009 as a Potent and Selective Thyroid Hormone Receptor Beta Agonist for the Treatment of NASH”, highlighted key preclinical data for the company’s lead NASH candidate ALG-055009, a thyroid hormone receptor-β (THR-β) agonist. NASH, which presents with liver inflammation and fibrosiscaused by liver fat build-up, currently has no approved drug treatment. However, THR-β agonists have shown the potential to reduce liver fat and inflammation, restore liver function and possibly reverse fibrosis in NASH patients¹.

In a diet-induced obese murine model, ALG-055009 reduced cholesterol in a pronounced and sustained fashion after a single dose and demonstrated excellent bioavailability when administered orally. Correspondingin vitro studies demonstrated potent, selective behavior with favorable pharmacokinetic profiles. Combined, these data indicate potential for safe, effective once-daily oral dosing in humans.

“This particular candidate distinguished itself among several in-house compound that we screened for THR-β agonism and continues to exceed expectations through a battery of tests in vitro and in vivo,” said Jerome Deval, Ph.D., Director of Biochemistry at Aligos, who delivered the presentation. “ALG-055009 demonstrated a rare combination of high potency and selectivity, the latter of which is critical for precluding cardiac toxicity.”

Aligos CEO Lawrence Blatt, Ph.D., MBA, added, “We are pleased to show that ALG-055009, representing the second generation of the THR-β agonist class, is on track to potentially outperform the current top clinical-stage players in the field. We expect to advance ALG-055009 into Phase 1 trials after completion of toxicology studies.”

Poster presentations demonstrate early preclinical successes of strategically designed, complementary therapies aimed at effecting a functional cure in chronic hepatitis B

 SOUTH SAN FRANCISCO, Calif. November 8, 2019 – Aligos Therapeutics, Inc. (Aligos), a pre-clinical stage biotechnology company focused on the development of targeted therapies for hepatologic diseases and viral infections, including chronic hepatitis B (CHB), nonalcoholic steatohepatitis (NASH), and hepatocellular carcinoma (HCC), delivered presentations detailing promising pre-clinical studies todayatThe Liver Meeting®, hosted annually by the American Association for the Study of Liver Disease (AASLD). The three poster presentations demonstrated promising early results from Aligos’ multi-pronged pipeline of candidates to address CHB, the most common chronic viral infection worldwide.

“Current standards of CHB care fall short of a functional cure for most patients,” explained Leo Beigelman, Ph.D., president of Aligos. “Aligos’ approach is to strategically develop potentially best-in-class drug candidates that target key clinically validated mechanisms of the hepatitis B virus (HBV) life cycle.”

Two presentations demonstrated strong pre-clinical activity for Aligos’ capsid assembly modulator (CAM) candidates—ALG-001075and ALG-001024—that trigger HBV core proteins to assemble empty, nonviable viral capsids while also inhibiting formation and maintenance of HBV’s covalently closed circular DNA (or cccDNA). In vitroHBV DNA replication studies with the two Aligos CAM compounds demonstrate potent in hibitory activity with EC₅₀ values of 0.54 nM and 2.07 nM for ALG-001075 and ALG-001024, respectively, making these molecules among the most potent CAMs identified to date. In murine studies, both candidates have demonstrated a high degree of efficacy consistent with the potential for once-daily dosing in humans, and warrant further development as potentially best-in-class CAMs. Aligos is developing CAM molecules in collaboration with the laboratory of Raymond Schinazi, Ph.D., D.Sc., FAASLD (Pediatrics) under a license agreement with Emory University.

A third presentation addressed Aligos’ development of proprietary oligonucleotides that inhibit the production of HBsAg (or S-antigen) by a novel mechanism targeting host proteins. HBsAgis a viral encoded protein that suppresses the immune system. Designated S-Antigen Transport-Inhibiting Oligonucleotide Polymers, or STOPs, this class of oligonucleotides is designed to address a barrier to a functional CHB cure: the standard of care targets viral DNA replication but fails to address S-antigen reduction. Preclinical profiling experiments studying the release of HBsAg from HBV-infected cells have shown potent anti-S-antigen activity for Aligos’ ALG-010093, with an EC₅₀ value of 2.5 nM. Mechanism of action studies have demonstrated that STOPs act potentially by affecting protein trafficking from the infected cell, thereby warranting further study.

“We are pleased to be presenting the first publication of the Aligos portfolio at the annual AASLD meeting,” commented Lawrence Blatt, Ph.D., MBA, CEO of Aligos. “We believe we are building a portfolio of compounds that target key aspects of the HBV life cycle that are designed to work in concert and have the potential to benefit patients living with chronic hepatitis B. We have built a team of highly accomplished virologists, oligonucleotide and medicinal chemists, toxicologists, and clinical scientists who are directing their collective talent towards building a functional cure for chronic hepatitis B.”

Posters to highlight recent advances for the company’s development-stage products for HBV and NASH

SOUTH SAN FRANCISCO, Calif. October 29, 2019 – Aligos Therapeutics, Inc. (Aligos), a pre-clinical stage biotechnology company focused on the development of targeted therapies for hepatologic diseases and viral infections, including chronic hepatitis B (CHB), nonalcoholic steatohepatitis (NASH), and hepatocellular carcinoma (HCC), today announced the upcoming presentation of four abstracts at The Liver Meeting® hosted annually by the American Association for the Study of Liver Disease (AASLD). The 2019 meeting will be held in Boston on November 8-12.

Experts from Aligos’ team of scientists will present posters detailing recent advances in the company’s products in development to address CHB and NASH. Poster presentation details include the following:

Poster session I

Date/Time: Friday, November 8, 12:30 p.m. – 1:30p.m. ET

Location: John B. Hynes Memorial Convention Center

• Poster Title: S-Antigen Transport-inhibiting Oligonucleotide Polymers (STOPs) can Effectively Inhibit Hepatitis B Surface Antigen (HBsAg) Secretion from Hepatitis B Virus (HBV) Cell Lines

Poster number: 689

Presenter: Jin Hong (Director, Oligonucleotide Biology) 

• Poster Title: Preclinical Assessment of a Novel Capsid Assembly Modulator, ALG-001075, Demonstrates Best-in-Class In Vitro Potency and In Vivo Antiviral Efficacy

Poster number: 699

Presenter: Yannick Debing (Senior Scientist)

• Poster Title: Preclinical Assessment of Potency and Efficacy of a Novel Class-II Capsid Assembly Modulator ALG-001024

Poster number: 703

Presenter: Andreas Jekle (Director, Virology)

Poster session IV

Date/Time: Monday, November 11, 12:30 p.m. – 1:30 p.m. ET

Location: John B. Hynes Memorial Convention Center

• Poster Title: Preclinical development of ALG-009 as a Potent and Selective Thyroid Hormone Receptor Beta Agonist for the Treatment of NASH

Poster number: 2149

Presenter: Jerome Deval (Director, Biochemistry)

South San Francisco, California, October 14, 2019 – Aligos Therapeutics, Inc.(Aligos), a pre-clinical stage biotechnology company focused on the development of targeted therapies for hepatologic diseases and viral infections, including chronic hepatitis B(CHB), nonalcoholic steatohepatitis(NASH), and hepatocellular carcinoma(HCC),today announced the appointment of Matthew W. McClure, M.D., as executive vice president (EVP) and chief medical officer(CMO).

Dr. McClure has more than20 years of clinical and drug development experience with significant expertise in the design, execution and interpretation of Phase 1-3 clinical trials across a range of therapeutic areas, particularly in chronic viral hepatitis and NASH.

“I am very pleased to welcome Dr. McClure to Aligos Therapeutics,” said Lawrence Blatt, Ph.D., MBA, chief executive officer of Aligos. “With his broad experience in the development of drugs in chronic viral hepatitis and NASH, we are confident he will add substantial expertise to our team as we look forward to advancing what we believe to be a robust and potentially transformative pipeline. This is an exciting time for Aligosas we prepare to advance best-in-class compounds for the potential treatment of chronic hepatitis B and NASH into the clinic in 2020.”

“I am delighted to help Aligos achieve its vision of discovering and developing effective therapies for diseases where significant unmet needs remain,” said Dr.McClure.“In particular, I am confident that with the combination of innovative compounds being advanced and the highly experienced team at Aligos, we may find a potentially curative treatment regimen for chronic hepatitis B infection in the coming years.”

Dr. McClure’s drug development career began in academia at the Duke Clinical Research Institute during his medical training. Following his work as an attending physician, he transitioned to the biotechnology industry, where he has held roles of increasing responsibility and seniority, culminating in his most recent position as chief medical officer at Second Genome. Prior to Second Genome, Dr. McClure played an important role in the clinical development of Esbriet® (pirfenidone)during his time at InterMune, Inc., which was acquired by Roche in 2014, and andexanet alfa during his time at Portola Pharmaceuticals, Inc.,as well as a critical role as the lead clinician in the development of lumicitabine during his time at AliosBioPharma, Inc., which was acquired by Johnson and Johnson in 2014. After Alios’ acquisition and while at Janssen, a pharmaceutical company of Johnson & Johnson, Dr. McClure continued to play an important role in the lumicitabine program.

Dr. McClure received his degree in medicine from Duke University and graduated (summa cum laude) with a Bachelor of Science in biochemistry and cell biology from the University of California, San Diego.