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REGN15505 is a bispecific monoclonal antibody designed to target Prostate-Specific Membrane Antigen (PSMA) and the costimulatory receptor 4-1BB (CD137). Developed by Regeneron Pharmaceuticals, it is currently in Phase 1/2 clinical development for the treatment of metastatic castration-resistant prostate cancer (mCRPC) and clear cell renal cell carcinoma (ccRCC). The molecule belongs to a class of costimulatory bispecific antibodies that aim to provide a localized 'Signal 2' to T cells within the tumor microenvironment by cross-linking 4-1BB only upon binding to the tumor-associated antigen PSMA. This approach is intended to enhance the activity of T cells, including those activated by 'Signal 1' (e.g., via PD-1 inhibition or CD3-based bispecifics), while avoiding the systemic toxicity typically associated with non-targeted 4-1BB agonists. REGN15505 is being evaluated as a monotherapy and in combination with cemiplimab (a PD-1 inhibitor) or REGN4336 (a PSMAxCD3 bispecific antibody).
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