Release time：Sep 27, 2021
Mabwell, an innovative biopharmaceutical company with the whole industrial chain, announced today that the first patient dosed in the Phase I study of CD47/PD-L1 Bispecific Antibody (R&D code: 6MW3211) in China.
This study (CTR20211936) is an international multicenter trial in patients with advanced solid tumors with the primary objective of investigating the safety, tolerability, PK/PD, immunogenicity and preliminary efficacy of 6MW3211 in patients with advanced solid tumors.
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.
Dr. Shuhai Wang, CMO of Mabwell, said," With a differential affinity design, 6MW3211 has strong binding to PD-L1, enhancing the targeting to tumor cells; weak binding to CD47, greatly reducing the toxic and side effects of CD47; and selective binding to CD47 on tumor cells, reducing the risk of erythrocyte toxicity. In preclinical studies, 6MW3211 demonstrated significant anti-tumor activity and good safety and tolerability in both solid tumor and hematological tumor animal models. In addition, 6MW3211 has a natural antibody-like structure, which can greatly simplify the manufacturing process and reduce the production cost. Therefore, 6MW3211 bispecific antibody is expected to provide an effective, safe and economical treatment option for patients with advanced tumors. We hope that 6MW3211 will benefit more patients with tumors."