On December 15, 2023, BIO-THERA Bio-Pharmaceutical Co., Ltd. announced that it had received a Notice of Approval of Drug Clinical Trial from the State Drug Administration, which approved the application for a Phase II/III clinical trial of the investigational drug BAT1308 injection in combination with platinum-containing chemotherapy for the first-line treatment of advanced or recurrent mismatch-modification-repaired protein-deficient (dMMR) endometrial cancer.

BAT1308 is a humanized anti-PD-1 monoclonal antibody independently developed by BIO-THERA, which belongs to IgG4κ subtype and is expressed by Chinese hamster ovary cells.PD-1 is mainly expressed by activated T-lymphocytes, and is an inhibitory immune checkpoint.PD-L1 and PD-L2 are the two ligands of PD-1, and when PD-L1 or PD-L2 bind to PD-1, it can inhibit immune activation of T-cells through the downstream signaling pathway to inhibit immune activation of T cells. It has been found that a variety of tumor cells can express PD-L1 and PD-L2 and bind to PD-1 on T cells, inhibiting the activity and proliferation of T cells and causing T cells to lose their killing effect on tumor cells, thus promoting the occurrence of cancer.BAT1308 is able to bind with high affinity to PD-1 on T cells, block the interaction between PD-1 and its ligands, and lift the inhibitory effect of PD-1 on T cells, thus promoting the development of cancer. inhibitory effect on T cells, thus restoring the immunocidal function of T cells and inhibiting tumor growth.

Dr. Yu Jinquan, Deputy General Manager of BIO-THERA, said, "The development of BAT1308 Injection in combination with platinum-containing chemotherapy will provide a new potential treatment option for endometrial cancer patients. We are conducting or planning to conduct a series of exploratory studies on the co-administration of BAT1308, including the co-administration of antibody-drug couplings and related products, in anticipation of providing patients with safer and more effective treatment options."

https://mp.weixin.qq.com/s/bvyZNc-6qNkYSHPugocZFw