Mabwell (Shanghai) Bioscience Co., Ltd (SHA: 688062) has announced that China’s National Medical Products Administration (NMPA) has granted approval for a Phase II clinical study of its antibody drug conjugate (ADC) 9MW2821, which targets Nectin-4, in patients with triple negative breast cancer (TNBC). The study will evaluate the efficacy and safety of 9MW2821, either as a monotherapy or in combination with a PD-1 inhibitor.
The trial will include two cohorts: Cohort A for patients who have previously received treatment with paclitaxel/anthracycline and ADCs containing topoisomerase inhibitors, and Cohort B for patients who have not yet received systemic treatment, who will receive the combination therapy. This development follows 9MW2821’s previous fast-track designations (FTDs) by the U.S. FDA for the treatment of certain types of esophageal squamous cell carcinoma, cervical cancer, and locally advanced or metastatic Nectin-4 positive TNBC .
9MW2821 is a promising therapeutic candidate that has shown potential in treating various cancers, including esophageal, urothelial carcinoma, and cervical cancer. The drug’s innovative mechanism of action offers hope for patients with limited treatment options. Mabwell’s commitment to advancing this drug candidate reflects the company’s dedication to addressing significant unmet medical needs and improving patient outcomes .- Flcube.com
