By Fineline Cube 
China-based Bio-Thera Solutions, Ltd. (SHA: 688177) announced that it has received a Drug Clinical Trial Approval Notice from China’s National Medical Products Administration (NMPA). The approval covers the clinical trial application for a combination therapy using its investigational drugs: BAT1308 Injection, BAT4706 Injection, and BAT8008 for injection. This combination therapy is intended for the treatment of advanced solid tumors.
Drug Mechanisms
- BAT1308: A humanized IgG4 monoclonal antibody designed to restore T-cell activity and enhance immune response by blocking the binding of PD-1 to its ligands, PD-L1 and PD-L2.
- BAT4706: A humanized IgG1 monoclonal antibody that binds to CTLA-4 and blocks its inhibitory signals. It also possesses antibody-dependent cell-mediated cytotoxicity (ADCC), promoting T-cell activation and leading to Treg apoptosis in the tumor microenvironment.
- BAT8008: An antibody-drug conjugate (ADC) composed of a humanized monoclonal antibody targeting Trop2 conjugated to a topoisomerase I inhibitor via a cleavable linker. This allows for precise delivery of the cytotoxic payload to Trop2-overexpressing tumor cells and can also kill surrounding tumor cells through the bystander effect.
Synergistic Anti-Tumor Effect
The combination of these three drugs aims to achieve a synergistic anti-tumor effect through both immune checkpoint inhibition and targeted chemotherapy. This approach leverages multiple mechanisms to enhance the overall therapeutic impact for patients with advanced solid tumors.-Fineline Info & Tech