May 25, 2024

Angel Pharma’s IND application for mupadolimab approved by CDE

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Angel Pharmaceuticals Ltd. (“Angel Pharma”), a clinical-stage biopharmaceutical company, recently announced that the IND application for mupadolimab (formerly CPI-006) has been approved by the Center for Drug Evaluation (CDE) to initiate a Phase 1/1b clinical trial in China. Angel Pharma owns mupadolimab’s rights 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. Compare with other anti-CD73 antibodies and smallmolecule 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. 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.

Dr. Richard Miller, co-founder of Angel Pharmaceuticals, commented, “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.” Dr. Ted Wang, Co-founder of Angel Pharmaceuticals, commented, “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”.

Professor Guo Ye, Deputy Secretary General of the Chinese Clinical Oncology Society (CSCO), Chairman of the Head and Neck Cancer Committee of the Chinese Clinical Oncology Society, and Department of Oncology, Shanghai East Hospital Affiliated with Tongji University, commented, “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.”

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