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BI-1808 is a human IgG1 monoclonal antibody that targets tumor necrosis factor receptor 2 (TNFR2) by blocking its interaction with the ligand TNF-α. This blockade leads to FcγR-dependent depletion of regulatory T cells (Tregs) within the tumor microenvironment and expansion of intratumoral cytotoxic CD8+ T cells, thereby enhancing antitumor immune responses. The drug is being developed primarily for cancer therapy, including advanced solid tumors and T-cell lymphomas such as cutaneous T-cell lymphoma (CTCL). Preclinical studies have shown synergistic effects when combined with anti-PD-1 therapies. In March 2025, the FDA granted Orphan Drug Designation to BI-1808 for the treatment of T-cell lymphoma. The developer is BioInvent[1][3][4][5][6].
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