Mabwell (Shanghai) Bioscience Co., Ltd (SHA: 688062), a biopharmaceutical company based in China, has announced that the National Medical Products Administration (NMPA) has accepted for review a clinical trial filing for its pipeline candidate, 9MW2821. This antibody drug conjugate (ADC) targets Nectin-4 and is planned to be assessed in combination with a checkpoint inhibitor for the treatment of triple negative breast cancer (TNBC).
In a study where 9MW2821 was used as a monotherapy for TNBC, it demonstrated promising results. Among the 20 subjects with locally advanced or metastatic TNBC who received a 1.25mg/kg dose and had assessable tumors, the objective response rate (ORR) and disease control rate (DCR) were 50% and 80%, respectively.
9MW2821 is currently under multiple clinical studies in China, exploring its efficacy in various cancers such as esophageal cancer, urothelial carcinoma, and cervical cancer. Internationally, the drug has received fast-track designation (FTD) and orphan drug designation (ODD) from the U.S. for the treatment of advanced, recurrent, or metastatic esophageal squamous cell carcinoma and esophageal cancer in February and May 2024, respectively.- Flcube.com
