FDA Grants Orphan Drug Designation to 9MW2821 for Esophageal Cancer

CAR-T Digest - August 2020

08 May 2024: FDA Grants Orphan Drug Designation to 9MW2821 for Esophageal Cancer

9MW2821 is the first NECTIN-4–directed ADC developed by a Chinese company, Mabwell Therapeutics to enter clinical study
NECTIN-4, an adhesion molecule on solid tumors, is targeted by 9MW2821, which delivers MMAE to NECTIN-4 expressing cells
In phase 2 trial (NCT05216965), esophageal cancer patients on 1.25 mg/kg of 9MW2821 had a 30% ORR and 73.3% DCR
In February, the FDA awarded fast track designation to the 9MW2821 for the treatment of patients with advanced, recurrent, or metastatic ESCC
9MW2821 will be further investigated in a phase 3 trial (NCT06196736), which will evaluate the ADC vs investigator’s choice of chemotherapy