Mabwell, a biopharmaceutical company, has announced that its novel Nectin-4 targeting antibody-drug conjugate (ADC), 9MW2821, has received approval from China's National Medical Products Administration (NMPA) for two new clinical trials. These trials will explore the drug's efficacy in combination therapies for urothelial carcinoma and advanced solid tumors, potentially broadening its therapeutic application.
Clinical Trial Expansion
The first clinical trial will assess the combination of 9MW2821 with a PD-1 monoclonal antibody in patients with perioperative urothelial carcinoma. The second trial will investigate 9MW2821 in conjunction with other antitumor agents for the treatment of advanced solid tumors. This expansion follows previous approvals for multi-drug combination treatments in cervical and esophageal cancers, indicating a growing interest in 9MW2821's potential across various cancer types.
9MW2821: A Novel Nectin-4 ADC
9MW2821 is the first clinical-stage drug candidate developed by a Chinese company that targets Nectin-4. It is currently being evaluated in clinical studies across multiple tumor indications. For urothelial carcinoma, 9MW2821 monotherapy has reached Phase III clinical trials and has been granted Breakthrough Therapy Designation (BTD) by the Center for Drug Evaluation (CDE). A combination therapy with a PD-1 inhibitor is also in Phase III trials. Additionally, a combination therapy with a PD-1 inhibitor for perioperative urothelial carcinoma has been approved for clinical research.
In cervical cancer, 9MW2821 is the first Nectin-4 targeting drug to enter Phase III clinical trials globally. Combination therapy with a PD-1 inhibitor and other drugs has been approved for clinical research, and the drug has received Fast Track Designation (FTD) from the U.S. Food and Drug Administration (FDA).
For triple-negative breast cancer (TNBC), 9MW2821 monotherapy (post-chemotherapy and topoisomerase ADC treatment) has entered Phase II clinical trials, as has combination therapy with a PD-1 inhibitor. The FDA has also granted FTD for this indication.
In esophageal cancer, 9MW2821 monotherapy has reached Phase II clinical trials. Combination therapy with a PD-1 inhibitor and other drugs has been approved for clinical research. The FDA has granted FTD for esophageal squamous cell carcinoma (ESCC) and Orphan Drug Designation (ODD) for esophageal cancer.
