Core Viewpoint - The company, Junshi Biosciences, has received FDA approval for its clinical trial application for JS207, a bispecific antibody targeting PD-1 and VEGF, for use in neoadjuvant therapy for AGA-negative non-small cell lung cancer patients in a Phase II/III study [1][2] Group 1: Product Overview - JS207 is a recombinant humanized bispecific antibody designed to target both PD-1 and VEGF, primarily for the treatment of advanced malignancies [1] - The drug effectively blocks the binding of PD-1 to PD-L1 and PD-L2, as well as the binding of VEGF to its receptors, showcasing both immunotherapy and anti-angiogenic properties [1] - By neutralizing VEGF, JS207 can inhibit endothelial cell proliferation, improve the tumor microenvironment, and enhance the infiltration of cytotoxic T lymphocytes, leading to better anti-tumor activity [1] Group 2: Clinical Development - JS207 is designed based on the clinically validated anti-PD-1 drug, Toripalimab, with a Fab structure to maintain high affinity for PD-1 [2] - The VEGF-targeting component of JS207 has binding affinity comparable to Bevacizumab [2] - Non-clinical in vitro studies indicate that the bispecific antibody shows significantly enhanced PD-1 antigen binding and internalization, as well as synergistic activation of immune cells in the tumor microenvironment compared to the combination of PD-1/PD-L1 and VEGF monoclonal antibodies [2] - As of the announcement date, JS207 has been approved to enter Phase II/III clinical research, with multiple ongoing Phase II studies exploring combinations with chemotherapy, monoclonal antibodies, and antibody-drug conjugates (ADCs) across various cancer types including non-small cell lung cancer, colorectal cancer, triple-negative breast cancer, and liver cancer [2]
君实生物(01877.HK):JS207用于非小细胞肺癌患者新辅助治疗的II/III期临床试验申请获得FDA批准