Angel Pharmaceuticals Gains CDE Approval for Mupadolimab Phase I/Ib Study

China-based Angel Pharmaceuticals Ltd has announced that it has received approval from the Center for Drug Evaluation (CDE) to initiate a Phase I/Ib clinical study in China for its mupadolimab (formerly CPI-006) in advanced solid tumors. Angel Pharma owns the rights to mupadolimab in Greater China.

Drug Overview and Mechanism
Mupadolimab is a humanized monoclonal antibody directed against CD73, acquired by Angel from US-headquartered Corvus Pharmaceuticals Inc. (NASDAQ: CRVS). Unlike other anti-CD73 antibodies and small-molecule drugs in development, mupadolimab is designed to react with a region of the molecule that stimulates B cells and blocks the production of immunosuppressive adenosine. Its unique mechanism involves activating B cells to generate immune responses to tumor antigens and viruses.

Clinical Development and Global Trials
Outside China, mupadolimab has been studied in combination with pembrolizumab in a Phase I/Ib trial in patients with advanced head and neck cancers and in patients with non-small cell lung cancer (NSCLC) that have failed chemotherapy and anti-PD(L)1 therapy. The initiation of the Phase I/Ib study in China marks a significant step in the global development of this innovative therapy.

Future Outlook
The approval from the CDE underscores Angel Pharmaceuticals’ commitment to advancing innovative treatments for advanced solid tumors. With its unique mechanism of action and ongoing global trials, mupadolimab has the potential to address significant unmet needs in oncology.-Fineline Info & Tech

Insight, China's Pharmaceutical Industry