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Nezastomig (REGN5678) is a bispecific monoclonal antibody developed by Regeneron in collaboration with Bayer. It is designed to target Prostate-Specific Membrane Antigen (PSMA) on tumor cells and the CD28 costimulatory receptor on T cells. By binding to both targets, nezastomig provides a localized 'signal 2' to T cells specifically in the presence of PSMA-expressing tumor cells, thereby enhancing T-cell activation, proliferation, and effector function within the tumor microenvironment. This approach aims to improve the efficacy of T-cell-directed therapies while limiting systemic immune-related adverse events. Nezastomig is currently being investigated in Phase 1 and Phase 2 clinical trials for the treatment of prostate cancer (specifically metastatic castration-resistant prostate cancer) and renal cell carcinoma, often in combination with PD-1 inhibitors or PSMAxCD3 bispecific antibodies.
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