On October 12, Gerry Pharmaceuticals announced that it will orally report the results of the ASC22 (envolimab) chronic hepatitis B phase IIa study at the 2021 American Association for the Study of Liver Disease Annual Meeting. The American Association for the Study of Liver Diseases Annual Conference is currently one of the most authoritative hepatology conferences in the world. This conference will be held from November 12, 2021 to November 15, 2021.
ASC22 (Envolimab) is a subcutaneously injected PD-L1 monoclonal antibody. Blocking the PD-1 /PD-L1 pathway can restore the function of HBV-specific T cells, thereby achieving a functional cure for chronic hepatitis B.
ASC22 Phase IIa clinical trial is a single-dose escalation study, using three subcutaneous doses (0.3, 1.0 and 2.5 mg/kg, each dose injects 3 patients), and conduct A 12-week follow-up was conducted to explore the safety and preliminary efficacy of ASC22 in patients with chronic hepatitis B who have been treated with nucleoside (acid) analogs.
Research data show that after a single administration of ASC22 (0.3, 1.0, 2.5 mg/kg), the patients were followed up for 12 weeks, and patients with hepatitis B surface antigen (HBsAg) showed a dose-dependent downward trend. Among the 3 patients in the 2.5 mg/kg ASC22 dose group, one patient had the highest HBsAg drop of 1.2 log10 IU/mL during the 12-week follow-up period.
security,The three dose groups of ASC22 all showed good safety and tolerability, and the adverse reactions during the study period were all grade 1.
Envolimab (KN035) is a recombinant humanized PD-L1 single-domain antibody Fc fusion protein, independently developed by , Corning Jerry, and the idea of Di Medicine Developed and expected to become the world's first PD-L1 antibody to be administered by subcutaneous injection. Compared with other similar drugs on the market, KN035 has significant differentiation advantages in terms of safety, convenience, and compliance, and can effectively improve the quality of life of patients. Its marketing application for the treatment of advanced solid tumors is currently in the "review and approval" stage.
In January 2019, Gerry and Corning Jereh reached a partnership to obtain an exclusive license agreement for the development of envolimab for the treatment of hepatitis B and other viral diseases in Greater China.
.
