Drug intelligence / Profile preview

REGN10597

Development stage
Phase 2
Lead developer
Regeneron Pharmaceuticals
Modality
Fc-Fusion Proteins → Carrier/Scaffold Proteins → Recombinant Proteins and Enzymes, Immunomodulatory ADCs → Antibody-Drug Conjugates (ADCs) → Antibody Conjugates → Antibody-Based Therapeutics
Administration
Intravenous
01

Overview

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].

Other names
REGN10597REGN-10597REGN 10597
02

Targets

IL2RA (Interleukin-2 receptor alpha subunit)PDCD1 (Programmed cell death protein 1 receptor)

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