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

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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.

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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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