Mabwell’s Novel Nectin-4 Targeting ADC 9MW2821 Approved for 2 Clinical Trials by CDE of NMPA

CAR-T Digest - August 2020

14 Nov 2024: Mabwell’s Novel Nectin-4 Targeting ADC 9MW2821 Approved for 2 Clinical Trials by CDE of NMPA

Mabwell’s novel Nectin-4 targeting ADC, 9MW2821, has received IND approval for two clinical studies in China
The first trial will test 9MW2821 combined with a PD-1 monoclonal antibody for perioperative urothelial carcinoma, while the second will explore its use with other antitumor agents for advanced solid tumors
The approval includes a multi-drug combination program for cervical cancer and esophageal squamous cell carcinoma, significantly broadening the drug’s therapeutic potential
9MW2821 is the first clinical-stage Nectin-4 targeting ADC from a Chinese company, with ongoing clinical studies for multiple tumor types, including urothelial carcinoma, cervical cancer, triple-negative breast cancer, and esophageal cancer
The drug has advanced to Phase III trials for urothelial carcinoma monotherapy and combination therapy with PD-1, and has received Breakthrough Therapy Designation (BTD) by the CDE
9MW2821 has also received FDA Fast Track Designation (FTD) for cervical cancer, triple-negative breast cancer, and esophageal squamous cell carcinoma, and is being studied in various combination therapies