July 21, 2021, Shanghai— Mabwell Bioscience Co., Ltd. ("Mabwell") , an innovative biopharmaceutical company with a whole industrial chain, announced today that its IND application for 6MW3211, an anti-CD47/PD-L1 bispecific antibody drug candidate, has been formally approved by the Center for Drug Evaluation (CDE) of China National Medical Products Administration. The clinical trials will be conducted for late-stage malignant tumor.

6MW3211 is a Class I drug candidate developed by Mabwell. 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.