Approval of an investigational new drug (IND) application for mupadolimab has been granted by the Center for Drug Evaluation (CDE) to initiate a phase 1/1b clinical trial in China.
Angel Pharma, a clinical stage biopharmaceutical company owns the rights to mupadolimab in Greater China.
Mupadolimab is a humanized monoclonal antibody directed against CD73. In preclinical studies, it has demonstrated immunomodulatory activity resulting in activation of lymphocytes, induction of antibody production from B cells and effects on lymphocyte trafficking.
Clinical trial in China
Richard Miller, co-founder of Angel Pharma, said: “We are pleased that mupadolimab has been approved for clinical trial in China. Data from overseas clinical studies has demonstrated its safety and potential to benefit patients with advanced cancers. We look forward to working with clinical experts in China to accelerate its development.”
Compared to other anti-CD73 antibodies and small molecule drugs in development, mupadolimab is designed to react with a region of the molecule that acts to stimulate B cells and block production of immunosuppressive adenosine with a proposed unique mechanism of activating B cells to generate immune responses to tumor antigens and viruses.
Ted Wang, co-founder of Angel Pharma, added: “We have completed the local manufacture of mupadolimab in China, and will work closely with top clinical sites to bring it to market to benefit patients in China.”
Outside China, mupadolimab has been studied in combination with pembrolizumab in a Phase 1/1b trial in patients with advanced head and neck cancers and in patients with NSCLC that have failed chemotherapy and anti-PD(L)1 therapy.
Guo Ye, deputy secretary general of the Chinese Clinical Oncology Society (CSCO), said: “CD73 plays a key role in the formation of the immunosuppressive microenvironment in cancer, and studies have demonstrated its importance on solid tumors. Mupadolimab is a unique CD73 antibody and we hope its clinical development will progress successfully in China to benefit cancer patients.”