L-HBsAg

DURHAM, N.C. and BEIJING, May 13, 2024 /PRNewswire/ -- Brii Biosciences Limited ("Brii Bio" or the "Company", stock code: 2137.HK), a biotechnology company developing therapies to improve patient health and choice across diseases with high unmet need, today announced that the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) granted Breakthrough Therapy Designations for BRII-877 (tobevibart), an investigational broadly neutralizing monoclonal antibody targeting hepatitis B virus (HBV) and BRII-835 (elebsiran), an investigational HBV-targeting small interfering ribonucleic acid (siRNA). This represents another milestone in the Company's pursuit of a functional cure for HBV, following the Breakthrough Therapy Designation granted for BRII-179, a recombinant protein-based HBV immunotherapeutic, in November 2023. The Breakthrough Therapy Designation for BRII-877 (tobevibart) was supported by Phase 1 and 2 studies conducted by Vir Biotechnology ("Vir", Nasdaq: VIR) and Brii Bio. As of September 2023, more than 350 people living with HBV have received treatment of BRII-877 (tobevibart). Data has shown BRII-877 (tobevibart) to be well-tolerated and to have resulted in marked decreases in HBsAg levels suggesting the potential for BRII-877 (tobevibart) to be an important part of a treatment regimen for people living with chronic HBV infection and chronic hepatitis D virus (HDV) infection. The Breakthrough Therapy Designation for BRII-835 (elebsiran) was supported by Phase 1 and 2 studies conducted by Brii Bio and its partner Vir. As of September 2023, more than 570 people living with HBV have participated in clinical studies where BRII-835 (elebsiran) has been shown to be well-tolerated and has demonstrated direct antiviral activity against HBV in participants with chronic HBV and HDV infection. "Receiving Breakthrough Therapy Designations for BRII-877 and BRII-835 as well as the earlier Breakthrough Therapy Designation for BRII-179 further supports our long-held scientific rationales in the development of functional cure combination regimens for patients with chronic HBV infection," said Dr. Qing Zhu, Head of China R&D, Brii Bio. "Brii Bio and our partner Vir Biotechnology have conducted numerous clinical trials over the past five years, from which we have gained comprehensive clinical safety and efficacy data as well as critical insight towards our late-stage development plan and achieving potentially higher rates of HBV functional cure in broader patient populations." Having three breakthrough therapeutic modalities puts the Company in a unique position to address the broader populations of HBV infections including co-infection with HDV. As part of Brii Bio's approach to developing a functional cure for HBV, the Company and its partner Vir are progressing plans to initiate multiple combination studies in 2024 to further optimize the curative regimens that will inform the Company's registration strategy to bring the best regimens to HBV patients. About Hepatitis B Hepatitis B viral infection (HBV) is one of the world's most significant infectious disease threats with more than 254 million people infected globally.1 Chronic HBV infection is the leading cause of liver disease and an estimated 820,000 people die of complications from chronic HBV each year.1 HBV is of exceptional concern in China, where 87 million people are infected.2 About Hepatitis D Hepatitis D is a liver inflammation caused by the hepatitis D virus (HDV), which relies on hepatitis B virus (HBV) for replication. This infection can only occur in the presence of HBV. The combination of HDV-HBV co-infection is considered the most severe form of chronic viral hepatitis, leading to a quicker progression towards hepatocellular carcinoma and liver-related death. Globally, nearly 5% of individuals with chronic HBV infection are affected by HDV. HDV infection can occur through either simultaneous infection with both hepatitis B and D (co-infection) or acquiring hepatitis D after already having hepatitis B (super-infection).3 About BRII-877 (Tobevibart) BRII-877 (tobevibart) is an investigational subcutaneously administered neutralizing monoclonal antibody designed to block entry of HBV and HDV into hepatocytes and also to reduce the level of virions and subviral particles in the blood. BRII-877 (tobevibart), which incorporates Xencor's Xtend™ and other Fc technologies, has been engineered to potentially function as a T-cell vaccine against HBV and HDV, as well as to have an extended half-life. Brii Bio licensed exclusive rights to develop and commercialize BRII-877 (tobevibart) for the greater China territory from Vir Biotechnology, Inc. ("Vir") in 2022. About BRII-835 (Elebsiran) BRII-835 (elebsiran) is an investigational subcutaneously administered HBV-targeting siRNA that has the potential to stimulate an effective immune response and has direct antiviral activity against HBV and HDV. It is the first siRNA in the clinic to include Enhanced Stabilization Chemistry Plus (ESC+) technology to enhance stability and minimize off-target activity, which potentially can result in an increased therapeutic index. Brii Bio licensed exclusive rights to develop and commercialize BRII-835 (elebsiran) for the greater China territory from Vir Biotechnology, Inc. ("Vir") in 2020. About BRII-179 BRII-179 is a novel recombinant protein-based HBV immunotherapeutic candidate that expresses the Pre-S1, Pre-S2, and S HBV surface antigens, and is designed to induce enhanced and broad B-cell and T-cell immunity. Brii Bio licensed BRII-179 from VBI Vaccines, Inc. ("VBI") in December 2018 and has extended the exclusive license to global rights since July 2023. About Brii Bio Brii Biosciences Limited ("Brii Bio", stock code: 2137.HK) is a biotechnology company developing therapies to address major public health challenges where patients experience high unmet medical needs, limited choice and significant social stigmas. With a focus on infectious and central nervous system diseases, the Company is advancing a broad pipeline of unique therapeutic candidates with lead programs against hepatitis B viral infection (HBV). The Company is led by a visionary and experienced leadership team and has operations in key biotech hubs, including Raleigh-Durham, the San Francisco Bay Area, Beijing and Shanghai. For more information, visit . [1] World Health Organization. (April 2024). Global hepatitis report 2024: action for access in low- and middle-income countries. World Health Organization. Retrieved from [2] World Health Organization. Hepatitis. World Health Organization. Retrieved from . [3] World Health Organization. (July 2023). Hepatitis D. World Health Organization. Retrieved from SOURCE Brii Biosciences Limited

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.