Ausper Biopharma Co., Ltd.

A total of 122 participants, including 30 CHB patients, have received administration of AHB-137 Enrollment of CHB patients in the 150mg and 300mg cohorts has been completed in China Six CHB patients have completed 4-week dosing in the study in the US and New Zealand Chronic tox studies in monkeys have completed the in-life phase and histopathological evaluation. SAN FRANCISCO, Feb. 14, 2024 /PRNewswire/ -- AusperBio Therapeutics, Inc. and Ausper Biopharma Co., Ltd. (Together AusperBio), a clinical-stage biotechnology company dedicated to advancing oligonucleotide therapies, with a primary focus on achieving a functional cure for chronic hepatitis B (CHB) infection, today announced significant updates on the clinical development of its leading molecule, AHB-137, an unconjugated antisense oligonucleotide (ASO) targeting all HBV RNA. AHB-137, empowered by AusperBio's proprietary Med-OligoTM ASO technology platform, holds the potential as a backbone in the quest for a functional cure for CHB. This novel dual-mechanism ASO has been evaluated in two Phase 1a/1b clinical trials in parallel, one in China and another outside China. To date, 122 participants, including 30 CHB patients, have received either single or multiple doses of AHB-137. In China (chinadrugtrials.org.cn #CTR20232098; clinicaltrials.gov #NCT06115993), enrollment of CHB patients in the 150mg and 300mg cohorts has been completed. The study outside China (clinicaltrials.gov #NCT05717686) is also rapidly progressing in dosing of CHB patients, with 6 participants having completed 4-week dosing in the US and New Zealand. "The rapid progress of AHB-137's clinical development across multiple regions is truly remarkable. This milestone signifies another crucial turning point for AusperBio, and I am extremely proud of our team's consistent and outstanding execution in advancing innovative therapies toward a functional cure for CHB," said Dr. Guofeng Cheng, AusperBio CEO and co-founder. "This achievement owes gratitude to our study principal investigators, participants, clinical CROs, and many others who have gone above and beyond to accelerate the clinical development of AHB-137." "What we have accomplished for AHB-137 in less than a year since the first dosing in human is incredibly exciting. We are very encouraged by the initial efficacy data observed in CHB patients. Importantly, having this large safety dataset in such a short timeframe instills greater confidence for the continued development of AHB-137." Commented Dr. Chris Yang, co-founder and CSO. "Following the successful completion of the 26-week chronic tox studies in monkeys and mice, we are poised to swiftly progress AHB-137 into Phase II clinical studies. We eagerly look forward to presenting the results of our clinical studies at the upcoming international conferences." About Chronic Hepatitis B Chronic Hepatitis B (CHB) infection is a liver disease estimated to affect nearly 290 million people worldwide and is a leading cause of major liver diseases such as liver cirrhosis and hepatocellular carcinoma. Although current treatment options can suppress HBV replication, achieving a cure is rare. Therefore, the discovery of a cure for CHB with finite treatment is a serious and urgent medical need. About AusperBio. AusperBio is a clinical-stage biopharmaceutical company with operations in the USA and China, dedicated to advancing oligonucleotide and targeted delivery technologies for transformative therapies, with an initial focus on curing chronic hepatitis B infection. The company has developed a proprietary Med-OligoTM ASO platform which has been shown to substantially enhance the current ASO therapeutics, through novel insights into ASO design. Combining with efficient targeted delivery conjugation technologies, the modular Med-OligosTM Platform empowers ASO therapeutics to treat a broad range of diseases, including viral infections, metabolic conditions, genetic disorders, and immune diseases. For further information, please contact: Media Contact Email: [email protected] Investor Relations Contact: Tel: 650-888-1756 (US) Email: [email protected] SOURCE AusperBio Therapeutics Inc.

SAN FRANCISCO, Jan. 3, 2024 /PRNewswire/ -- AusperBio Therapeutics, Inc. and Ausper Biopharma Co., Ltd. (Together AusperBio), a clinical-stage biotechnology company committed to advancing oligonucleotide therapies, with a primary focus on achieving a functional cure for chronic hepatitis B (CHB) infection, today announced that Dr. Will Wei has joined the company as Head of CMC, SVP. "We are excited to welcome Dr. Wei to AusperBio's leadership team at this pivotal time for the company," said Dr. Guofeng Cheng, chief executive officer. "Will's depth and breadth of experience in end-to-end CMC operations, strategic insight will be instrumental in executing our plans, propelling our pipeline, and navigating the dynamic landscape of drug development." Bringing over two decades of outstanding leadership in the biotech and pharmaceutical industry, Dr. Wei has excelled across critical domains in drug development. Previously held key leadership roles at global pharmaceutical companies such as GSK as a Director of CMC, and Roche as a Senior Director of CMC, Dr. Wei spearheaded teams responsible for process development, clinical supply chain management, and successful regulatory submissions for both China and Global markets. "Joining AusperBio is both an honor and an exciting opportunity. I am inspired by AusperBio's mission, and extremely impressed by the clinical data and the forging-ahead development speed of AHB-137 program," said Dr. Wei. "I'm excited to lead and collaborate with the outstanding team, building upon the Company's robust scientific foundation, to advance HBV cure and beyond and make a meaningful impact on patient care." Dr. Wei earned his Ph.D. in the Department of Organic Chemistry at the University of Lausanne in Switzerland and completed his postdoctoral training at The Scripps Research Institute. About AusperBio. AusperBio is a clinical-stage biopharmaceutical company with operations in the USA and China, dedicated to advancing oligonucleotide and targeted delivery technologies for transformative therapies, with initial focus on curing chronic hepatitis B. The company has developed a proprietary Med-Oligo™ ASO platform with novel insights into ASO design and optimization to substantially enhance the current ASO therapeutics. Combining with efficient targeted delivery conjugation technologies, the modular Med-Oligos™ Platform empowers ASO therapeutics to treat broad viral infections, metabolic conditions, genetic disorders, and immune diseases. Media Contact Email: [email protected] Investor Contact Tel: 650-888-1756 (US) Email: [email protected] SOURCE AusperBio Therapeutics Inc.

AHB-137 is cleared for initiation of a clinical trial in CHB patients in the US AHB-137 is an unconjugated antisense oligonucleotide (ASO) aimed for functional cure of CHB SAN FRANCISCO, Aug. 25, 2023 /PRNewswire/ -- AusperBio Therapeutics, Inc. and Ausper Biopharma Co., Ltd. (Together AusperBio), a clinical-stage biotech company committed to advancing antiviral therapies and vaccines, with a primary focus on achieving a functional cure for chronic hepatitis B (CHB) infection, today announced the U.S. Food and Drug Administration (FDA) has granted clearance for the Investigational New Drug (IND) application for a clinical trial on AHB-137. The clinical trial in the US is part of a multiregional, randomized, double-blinded, placebo-controlled study, intended to assess the safety, tolerability, pharmacokinetics, and initial efficacy of AHB-137 in CHB patients (clinicaltrials.gov # NCT05717686). Continue Reading "The FDA's clearance of our IND application to initiate clinical evaluation of AHB-137 in CHB patients in the United States brings us one step closer to introducing a potential functional cure for people living with HBV." said AusperBio CEO and Co-founder Dr. Guofeng Cheng, "This milestone is a pivotal juncture for AusperBio, underscoring our consistent and outstanding execution in driving innovative therapies towards a functional cure for CHB." This milestone is a pivotal juncture for AusperBio. Tweet this "We are committed to expediting patient access to innovative treatments." Dr. Cheng Yong Yang, CSO and Co-founder of AusperBio highlighted. "Our focus now is on working closely with key opinion leaders to initiate the CHB patient study in the US." About Chronic Hepatitis B Chronic Hepatitis B (CHB) infection is a liver disease estimated to affect nearly 290 million people worldwide and can cause other chronic complications such as cirrhosis and hepatocellular carcinoma. Although current treatment options can suppress HBV replication, achieving a cure is rare. Therefore, the discovery of a cure for CHB remains an urgent need. About AusperBio. AusperBio is a clinical-stage biopharmaceutical company with operations in the USA and China, dedicated to the development of innovative therapeutics for curing chronic hepatitis B. The company has developed a proprietary Med-Oligo™ ASO technology platform, substantially enhancing the potency of targeted therapies, not only for liver diseases, but also with the potential for expansion beyond the liver. AusperBio's strategy is to combine its leading oligonucleotide therapies with other medications including therapeutic antibodies and mRNA vaccines to address a broad range of unmet medical needs. Media Contact Email: [email protected] Investor Contact Tel: 650-888-1756 (US) Email: [email protected] SOURCE AusperBio Therapeutics Inc.