Core Tip: Phase I/Ib clinical trial of Mupadolimab, a humanized monoclonal antibody against CD73, and its combination with pabrolizumab received clinical trial approval from the NMPA Pharmacovigilance Center for use in patients with advanced solid tumors.
World Health Care Network (WCHN), a clinical development company specializing in oncology and autoimmune diseases, announced that it has received NMPA clinical trial approval for Mupadolimab, a humanized monoclonal antibody against CD73, and its combination with pabrolizumab in Phase I/Ib clinical trials for patients with advanced solid tumors. Hutchison Pharmaceuticals has the Greater China rights for Mupadolimab.
Mupadolimab is a humanised monoclonal antibody against CD73 with a unique mechanism to activate B cells to generate immune responses against tumour antigens and viruses. In preclinical studies, it has demonstrated immunomodulatory activity leading to lymphocyte activation, induction of antibody production by B cells and influencing lymphocyte transport. In contrast to other anti-CD73 antibodies and small molecule drugs in development, Mupadolimab stimulates B cells and blocks the production of immunosuppressive adenosine. The activation of B cells will likely enhance the immune response within the tumour microenvironment of these patients, resulting in improved clinical outcomes. A Phase 1/1b clinical trial of mupadolimab in combination with pembrolizumab in patients with advanced solid tumours has been completed outside of China.
Dr. Richard Miller, co-founder of Hutchison Pharmaceuticals, said: "We are delighted that Mupadolimab has been clinically approved in China and that the clinical data outside of China provides preliminary evidence of its safety and potential to deliver clinical benefit to patients with advanced solid tumours. The addition of Chinese experts will accelerate the global development of Mupadolimab." Dr. Tie-Fei Wang, co-founder of Hodor Pharmaceuticals, said, "We have completed local manufacturing of Mupadolimab in China and will be working with leading clinical research centres in China to advance Mupadolimab in clinical trials."
Professor Guo Ye, Deputy Secretary General of the China Society of Clinical Oncology (CSCO), Chairman of the Head and Neck Oncology Committee of the China Society of Clinical Oncology, and Department of Oncology, Dongfang Hospital, Tongji University, said, "CD73 is one of the key components in the formation of the immunosuppressive microenvironment in cancer, and a growing number of studies have demonstrated its impact in many solid tumours, making it an important emerging target in solid tumours The overall development of Mupadolimab is at the forefront of CD73 drugs in the world, and we hope that the clinical development of the product in China will progress smoothly and we look forward to its early launch to bring benefits to domestic cancer patients."
