Ascletis Pharma Inc announces the approval for ASC22 to conduct clinical trials in chronic hepatitis B patients in China from China’s National Medical Products Administration. ASC22 is a first-in-class, subcutaneously administered PD-L1 antibody approved for such clinical trials in HBV patients on a global basis.
As T cell exhaustion in HBV infections is an important factor in immune tolerance, blocking the PD-1/PD-L1 pathway could be an effective immunotherapy approach to improve specific T cell function and lead to an effective clinical cure for chronic hepatitis B. There are 257 million people worldwide, including 86 million people in China, infected by HBV.
In addition to ASC22, Ascletis has three other drug product or candidates in its pipeline for curing chronic hepatitis B, being Pegasys®, a marketed drug product, and two in-house discovered pre-IND or IND-ready drug candidates.
“We are excited about the approval of ASC22 to conduct clinical trials in chronic hepatitis B patients,” said Dr. Jinzi J. Wu, Founder, Chairman and CEO of Ascletis. “As a first-in-class immunotherapy with the potential to clinically cure chronic hepatitis B, ASC22 can serve as a cornerstone in various treatment regimens, including combinations with our in-house developed drug candidates and potentially with drug candidates from other industrial leaders.”
ASC22, also known as KN035, is a PD-L1 single domain antibody Fc fusion and has the advantages of subcutaneous injection and good stability at room temperature. These would be of great value to improve patients’ compliance and quality of life and to help realize the goal of long-term management of chronic diseases such as chronic hepatitis B. Ascletis and Suzhou Alphamab Co., Ltd. announced on January 14, 2019 the strategic collaboration and licensing agreement for anti-PD-L1 to treat Hepatitis B and other viral diseases.
Ascletis is an innovative R&D driven biotech with two commercial products and listed on Hong Kong Stock Exchange (Ascletis, 1672.HK). Ascletis is committed to developing and commercializing innovative drugs with the focus on liver diseases for unmet medical needs in China and Globally. Led by a management team with deep expertise and a proven track record, Ascletis has developed into a fully integrated platform covering the entire value chain from discovery and development to manufacturing and commercialization. Ascletis’ pipeline is focused primarily on three therapeutic areas: 1. HCV: one commercial stage product, one near commercial stage drug and two R&D stage drug candidates. Ganovo® (Danoprevir) is the first direct-acting anti-viral agent for hepatitis C, developed by a domestic firm in China. 2. HBV: one commercial stage product and three R&D stage drug candidates. Pegasys® (Peginterferon alfa-2a) is a leading markted pegylated interferon for hepatitis B&C partnered with Roche. 3. NASH (Non-Alcoholic SteatoHepatitis): three R&D stage drug candidates against three different targets for combination treatments.