HANGZHOU and SHAOXING, China, Nov. 9, 2023 /PRNewswire/ — Ascletis Pharma Inc. (HKEX: 1672, "Ascletis") today announces that Dr. Jinzi J. Wu, Founder, Chairman and CEO of Ascletis was invited to attend and have a presentation at the 10th International Workshop on HBV Cure 2023 held at Boston, United States.
Dr. Wu was invited to participate in Session 3: Clinical Immunology and Immunotherapy Updates, with a presentation titled "Efficacy and Safety of Targeting PD-L1 with Monoclonal Antibodies".
Ascletis recently announced positive interim data from the Phase IIb expansion cohort of subcutaneously administered PD-L1 antibody ASC22 (Envafolimab) for functional cure of CHB. The interim analysis included 25 patients who completed 24-week treatment (19 patients in ASC22 cohort and 6 patients in placebo cohort). Topline results indicated that in ASC22 cohort, 4 patients (4/19, 21.1%) achieved HBsAg loss at the end of 24-week treatment. In contrast, there were no patients (0/6, 0%) achieving HBsAg loss at the end of 24-week treatment in the placebo cohort. ASC22 was generally safe and well tolerated. Most of ASC22 drug related adverse effects were Grade 1 or 2.
Representatives from companies including Roche, GSK, Gilead, Immunocore, VIR, Arbutus, Aligos and experts from National Institutes of Health, University of Oxford, Massachusetts General Hospital, Johns Hopkins University, Lyon I University, University of Hong Kong, Toronto Centre for Liver Disease, Emory University Center for AIDS Research, Harvard Medical School, Northwestern University, University of Milan also joined the meeting. Ascletis is the only Chinese biotech company which presented at the meeting.
CHB remains to be a significantly unmet medical need globally, with approximately 86 million people in China and 1.59 million people in the U.S. infected with hepatitis B virus (HBV) .
"It’s a great honor to be invited to the 10th International Workshop on HBV Cure 2023 and share our latest progress in developing the immune checkpoint inhibitor for functional cure of CHB with the global industry. ASC22 is the most advanced clinical-stage immunotherapy in the world for CHB functional cure, i.e. HBsAg loss, through blocking PD-1/PD-L1 pathway. The number of patients with HBsAg ≤100 IU/mL is huge, which accounts for approximately 15%-22% of the total patient population . We will continue to accelerate the clinical study of ASC22 and benefit CHB patients." said Dr. Jinzi J. Wu, Founder, Chairman and CEO of Ascletis.
Lim J K, Nguyen M H, Kim W R, et al. Prevalence of Chronic Hepatitis B Virus Infection in the United States [J]. The American journal of gastroenterology 2020, 115(9): 1429-38.
Xie, Y., Li, M., Ou, X. et al. HBeAg-positive patients with HBsAg < 100 IU/mL and negative HBV RNA have lower risk of virological relapse after nucleos(t)ide analogues cessation. J Gastroenterol 56, 856–867 (2021).
Coffin, Carla S et al. "Clinical Outcomes and Quantitative HBV Surface Antigen Levels in Diverse Chronic Hepatitis B Patients in Canada: A Retrospective Real-World Study of CHB in Canada (REVEAL-CANADA)." Viruses vol. 14,12 2668. 29 Nov. 2022
About The International Workshop on HBV Cure
Since 2014, the International Workshop on HBV Cure has been a scientific platform acting as a catalyst to accelerate the progress for achieving a cure. Around the globe, more than 250 million people live with hepatitis B (HBV). The purpose of the workshop is to inform the participants about the developments in the work to find a cure for HBV. The meeting is highly interactive with input from experts out of the arena of basic, translational, and clinical HBV research. The 10th International Workshop on HBV Cure 2023 took place as a live workshop on 8 November 2023 in Boston, United States.
Ascletis is an innovative R&D driven biotech listed on the Hong Kong Stock Exchange (1672.HK), covering the entire value chain from discovery and development to manufacturing and commercialization. Led by a management team with deep expertise and a proven track record, Ascletis focuses on three therapeutic areas with unmet medical needs from a global perspective: viral diseases, non-alcoholic steatohepatitis (NASH) and oncology. Through excellent execution, Ascletis rapidly advances its drug pipeline with an aim of leading in global competition. To date, Ascletis has multiple drug candidates in its R&D pipeline. The most advanced drug candidates include ASC22 (CHB functional cure), ASC40 (acne), ASC40 (recurrent glioblastoma), ASC40 (NASH), ASC41 (NASH) and ASC61 (advanced solid tumors).
For more information, please visit www.ascletis.com.