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Cudarolimab (IBI101) is a recombinant, fully human anti-OX40 monoclonal antibody developed by Innovent Biologics. It targets OX40 (tumor necrosis factor receptor superfamily member 4), a co-stimulatory molecule expressed on activated T cells. By stimulating the OX40 pathway, cudarolimab activates effector T cells and mediates the clearance of regulatory T cells, thereby enhancing anti-tumor immune responses and inhibiting tumor growth. Preclinical studies have shown that IBI101 promotes T cell activation and proliferation, induces tumor antigen-specific CD8+ T-cell responses, decreases immunosuppressive regulatory T cells in tumors, and enhances immune response to PD-1 inhibition. The drug has demonstrated potent anti-tumor activity both as monotherapy and in combination with anti-PD-1 antibodies in animal models. Cudarolimab is being developed primarily for the treatment of advanced solid tumors[2][3][5][6][8].
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