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REGN10597 is an experimental recombinant fusion protein developed by Regeneron Pharmaceuticals. It is designed as a multi-functional immunotherapy that combines inhibition of the interleukin-2 receptor alpha chain (IL2RA) and programmed cell death protein 1 (PD-1). The molecule acts as both an IL2RA inhibitor and a PD-1 inhibitor, aiming to enhance anti-tumor immune responses by blocking two key immunosuppressive pathways in the tumor microenvironment. It is being investigated for use in advanced malignant solid neoplasms, including melanoma and renal cell carcinoma. As of June 2025, it is undergoing Phase 1/2 clinical trials to assess its safety, tolerability, pharmacokinetics, and preliminary efficacy in patients with advanced solid tumors[1][2][3][4][5].
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