27 Feb 2024: 9MW2821 Receives Fast Track Designation from FDA
The FDA grants Fast Track Designation to 9MW2821, a new ADC drug by Mabwell, targeting Nectin-4 for advanced esophageal squamous cell carcinoma treatment
9MW2821 utilizes Mabwell’s ADC platform and automated high-throughput hybridoma antibody molecular discovery platform, binding to Nectin-4 and inducing tumor cell apoptosis, marking China’s first clinical-stage Nectin-4-targeting ADC
In a Phase II clinical trial with 30 advanced esophageal carcinoma patients at 1.25 mg/kg dose, 9MW2821 demonstrated a 30% ORR and a 73.3% DCR
9MW2821 is also the first to disclose preliminary clinical efficacy data for the indication of cervical cancer among drugs with the same target in the world