Bio-Thera Solutions Receives NMPA Approval for BAT6005 and BAT1308 Combination Therapy Trial

Bio-Thera Solutions Ltd (SHA: 688177), a biopharmaceutical company based in China, has announced that it has received approval from the National Medical Products Administration (NMPA) to initiate a clinical study for its drug candidates BAT6005 in combination with BAT1308 for the treatment of locally advanced or metastatic solid tumors.

BAT6005 is an IgG1 subtype TIGIT monoclonal antibody (mAb) with normal Fc effector function, which is slated to enter development as a cancer therapy. TIGIT, an immunoglobulin superfamily protein, is highly expressed on the surface of activated natural killer (NK) cells, CD4+ T cells, CD8+ T cells, and immunosuppressive Tregs.

BAT1308 is an in-house developed programmed death-1 (PD-1) monoclonal antibody (mAb) that binds to PD-1 on the surface of T cells, alleviating the immune inhibitory effect of the PD-1 pathway. This action restores and enhances T cell immune killing function, thereby inhibiting tumor growth. The Phase I study for BAT6005 has completed the dosage escalation phase, demonstrating a good safety profile. Early studies for BAT1308 have shown active anti-tumor activity with good safety. The drug is also involved in multiple ongoing clinical studies as a combination therapy, including a Phase II/III study combining the drug with chemotherapy with/out bevacizumab for cervical cancer.- Flcube.com

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