Mabwell Receives IND Clearance from FDA for Initiating Clinical Trials for its Anti-CD47/PD-L1 Bispecific Antibody

Release time:Aug 20, 2021

August 20, 2021, Shanghai — Mabwell Bioscience Co., Ltd. ("Mabwell") , an innovative biopharmaceutical company with the whole industrial chain, announced today that it has received IND clearance from FDA for initiating clinical trials towards advanced solid tumors for its anti-CD47/PD-L1 bispecific antibody (R&D code: 6MW3211). 

6MW3211 is a humanized bispecific antibody developed through Mabwell’s internal bispecific/bifunctional antibody development platform. It is designed to selectively bind to CD47 and PD-L1 on tumor cells to attenuate CD47-SIRPα signal and block the PD-1/PD-L1 checkpoint inhibition, thereby triggering stronger tumor cell phagocytosis and enhancing T cell activation. The IgG-like structure with a common light chain is the strategy to overcome pairing problem and simplify the production process. In addition, 6MW3211 specifically binds to CD47 on tumor cells, but doesn’t bind to erythrocytes of humans and monkeys, suggesting that 6MW3211 has a good safety potential for erythrocytes. A comprehensive battery of nonclinical studies has been designed and conducted to evaluate the target binding characteristics, mechanism of action, anti-cancer efficacy and safety to support the proposed clinical trial.

"I am so excited that it’s Mabwell’s first bispecific antibody and the first innovative biological medicine which receives IND clearance both in China and US,” said Dr. Datao Liu, Co-founder & CEO of Mabwell, “Meanwhile it demonstrates our robust capabilities in pharmaceutical development, registration and clinical development. We’ll have more clinical projects to be conducted both in China and US in the future and aim to provide more effective and accessible innovative medicines to fulfill global medical needs."