L-HBsAg

SOUTH SAN FRANCISCO, Calif., Dec. 14, 2022 (GLOBE NEWSWIRE) -- Aligos Therapeutics, Inc. (Nasdaq: ALGS), a clinical stage biopharmaceutical company focused on developing novel therapeutics to address unmet medical needs in viral and liver diseases, reported today that dosing with ALG-125755, a small interfering RNA (siRNA) targeting the production of hepatitis B surface antigen (HBsAg), was initiated in subjects with chronic hepatitis B (CHB) in Study ALG-125755-501 (NCT05561530). “siRNA drugs targeting HBsAg production have generally been well tolerated and have consistently lowered HBsAg levels, demonstrating the potential to become a cornerstone therapy to achieve functional cure in CHB,” said Lawrence Blatt, Ph.D., MBA, CEO and Chairman of the Board at Aligos. “The team has made excellent progress over the past two months advancing ALG-125755 through the single ascending dose (SAD) portion of the study in healthy volunteers, where doses up to 100 mg have been evaluated. This has enabled us to advance into CHB subjects ahead of schedule. We plan to evaluate additional CHB cohorts receiving single or multiple doses of ALG-125755 throughout the coming year to identify a dose regimen to advance into combination studies. Additionally, we plan to share available study data in healthy volunteers and CHB subjects at scientific conferences throughout 2023.” About Aligos Aligos Therapeutics, Inc. is a 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 discovery and 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 team has in liver disease, particularly viral hepatitis, to rapidly advance its pipeline of potentially best-in-class molecules.

CONCORD, Mass.--(BUSINESS WIRE)-- ClearB Therapeutics, Inc., a company developing CLB-3000, a therapeutic vaccine designed to drive functional cure in patients chronically infected with Hepatitis B, announced today that two abstracts were accepted for poster presentation at the American Association for the Study of Liver Diseases (AASLD), The Liver Meeting, to be held in Washington, DC, USA, November 4 – 8, 2022. “We are excited to continue to make the Hepatitis B community aware of our progress for the therapeutic vaccine candidate CLB-3000, toward first in human trials and our confidence in this novel and differentiated approach” said Aileen Rubio, PhD., CEO for the company. Chronic infection with Hepatitis B (CHB) remains a significant global disease infecting hundreds of millions of people, where functional cure remains elusive and combination therapies are likely needed. We believe that re-education of patients’ immune systems to break tolerance of their chronic HBV infections through administration of ClearB’s therapeutic vaccine could become an important component of combination treatment regimens.” Abstract Number / Poster Number: 36528 / SAT1193 Abstract Title : Evaluation of the Hepatitis B therapeutic vaccine candidate CLB-3000 (CLB-405 + CLB-505 with Alhydrogel): a 9- or 15-week toxicity study in New Zealand White (NZW) rabbits with a 4-week recovery period Date: Friday, 4 November 2022 Time: 12:00 pm EDT Presenter Name: Aileen Rubio, ClearB Therapeutics Abstract Number / Poster Number: 37190 / SAT1215 Abstract Title : Immunogenicity following intramuscular vaccination with increasing dose levels of recombinant Hepatitis B surface antigen (HBsAg) variants CLB-405 and CLB-505 with or without Alhydrogel in New Zealand White (NZW) rabbits Date: Friday, 4 November 2022 Time: 12:00 pm EDT Presenter Name: Aileen Rubio, ClearB Therapeutics For more information regarding AASLD 2022 please visit The Liver Meeting | AASLD About ClearB Therapeutics ClearB Therapeutics was co-founded in 2017 by Morningside Ventures in collaboration with Professor Stephen Locarnini and the Victoria Infectious Diseases Reference Laboratory in Melbourne, Australia. ClearB is working to develop therapeutic vaccines designed to drive functional cure of Hepatitis B. The work is grounded in proprietary insights derived from studying rare-event infection resolution in patients who suffer from chronic Hepatitis B. For more information, please visit . About Morningside Ventures: Morningside was founded in 1986 by the Chan family, to make private equity and venture capital investments in North America, Europe, and Asia Pacific. In the life sciences, Morningside specializes in early-stage (pre-clinical through human proof-of-concept) investments in biopharmaceutical products. They partner with academic founders and entrepreneurs to build world-class companies that want to markedly improve the current state of medicine today and ultimately, the lives of patients. Morningside's focus is to invest in excellent biomedical research, where a significant body of knowledge has been gathered and there is a plausible path forward in clinical development. Their mission is to contribute to making a meaningful, positive impact on the prevention or treatment of human disease, and believe that so long as this is achieved, commercial success will follow.

Single ascending doses to be evaluated in healthy volunteers in Q4 2022 Single ascending doses to be evaluated in subjects with chronic hepatitis B beginning in Q1 2023 SOUTH SAN FRANCISCO, Calif., Oct. 14, 2022 (GLOBE NEWSWIRE) -- Aligos Therapeutics, Inc. (Nasdaq: ALGS), a clinical stage biopharmaceutical company focused on developing novel therapeutics to address unmet medical needs in viral and liver diseases, reported today that dosing with ALG-125755, an siRNA targeting the production of hepatitis B surface antigen (HBsAg), was initiated in healthy volunteers in Study ALG-125755-501 (NCT05561530). “Emerging data continue to indicate that siRNA drugs targeting HBsAg production have the potential to become a cornerstone therapy to achieve functional cure in chronic hepatitis B,” said Lawrence Blatt, Ph.D., MBA, CEO and Chairman of the Board at Aligos. “Drugs in this class have generally been well tolerated and have consistently lowered HBsAg levels with more convenient dosing frequencies compared to other injectable HBsAg lowering agents. This, coupled with the longer duration of action observed in nonclinical studies for ALG-125755 compared to other siRNAs, suggests that ALG-125755 has the potential to be administered less frequently than other drugs in this class.” “This is an important first step in the clinical evaluation of the safety, pharmacokinetics, and antiviral activity of ALG-125755,” said Matthew W. McClure, M.D., Chief Medical Officer of Aligos. “We plan to evaluate single ascending doses across multiple cohorts of healthy volunteers in Q4 2022. Following that, beginning in Q1 2023, we then plan to evaluate single ascending doses across multiple cohorts of subjects with chronic hepatitis B. If the safety, pharmacokinetics, and pharmacodynamics of ALG-125755 in Phase 1 are favorable, we then plan to combine this drug with other mechanisms of action in Phase 2, where we hope to achieve high rates of functional cure.” About Aligos Aligos Therapeutics, Inc. is a 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 discovery and 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 team has in liver disease, particularly viral hepatitis, to rapidly advance its pipeline of potentially best-in-class molecules. Forward-Looking Statement This press release contains forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995. Any statements in this press release that are not historical facts may be considered “forward-looking statements,” including without limitation statements regarding, siRNA drugs targeting HBsAg production having the potential to become a cornerstone therapy in the effort to achieve functional cure in chronic hepatitis B; ALG-125755 having the potential to be administered less frequently than other drugs in this class; and our plans (i) to evaluate single ascending doses across multiple cohorts of healthy volunteers in Q4 2022, (ii) to evaluate single ascending doses across multiple cohorts of subjects with chronic hepatitis B beginning in Q1 2023 and (iii) to combine this drug with other mechanisms of action in Phase 2 if the safety, pharmacokinetics, and pharmacodynamics of ALG-125755 in Phase 1 are favorable. Forward-looking statements are typically, but not always, identified by the use of words such as “may,” “will,” “would,” “believe,” “intend,” “plan,” “anticipate,” “estimate,” “expect,” and other similar terminology indicating future results. Such forward looking statements are subject to substantial risks and uncertainties that could cause our development programs, future results, performance, or achievements to differ materially from those anticipated in the forward-looking statements. Such risks and uncertainties include without limitation risks and uncertainties inherent in the drug development process, including Aligos’s clinical-stage of development, the process of designing and conducting clinical trials, the regulatory approval processes, the timing of regulatory filings, the challenges associated with manufacturing drug products, Aligos’s ability to successfully establish, protect and defend its intellectual property, other matters that could affect the sufficiency of Aligos’s capital resources to fund operations, reliance on third parties for manufacturing and development efforts, changes in the competitive landscape and the effects on our business of the worldwide COVID-19 pandemic and the ongoing conflict between Russia and Ukraine. For a further description of the risks and uncertainties that could cause actual results to differ from those anticipated in these forward-looking statements, as well as risks relating to the business of Aligos in general, see Aligos’s Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on August 4, 2022 and its future periodic reports to be filed or submitted with the Securities and Exchange Commission. Except as required by law, Aligos undertakes no obligation to update any forward-looking statements to reflect new information, events or circumstances, or to reflect the occurrence of unanticipated events. Media ContactAmy Jobe, Ph.D.LifeSci Communications+1 315 879 8192ajobe@lifescicomms.com Investor ContactCorey Davis, Ph.D.LifeSci Advisors+1 212 915 2577cdavis@lifesciadvisors.com