Pilatus Biosciences Announces FDA Clearance of IND Application for PLT012, a First-in-Class Anti-CD36 Metabolic Checkpoint Antibody in Solid Tumors

• PLT012 is a first-in-class anti-CD36 monoclonal antibody and the first metabolic checkpoint therapy designed to reprogram the tumor microenvironment
• Phase 1 trial expected to begin in 1Q 2026

Excerpt from the Press Release:

DOVER, Del. & EPALINGES, Switzerland–(BUSINESS WIRE)–Pilatus Biosciences Inc., a biopharmaceutical company developing novel metabolic checkpoint immunotherapies for liver and gastrointestinal cancers, today announced that the U.S. Food and Drug Administration (FDA) has cleared the company’s Investigational New Drug (IND) application for PLT012, a first-in-class anti-CD36 monoclonal antibody, to enter clinical development for the treatment of solid tumors. Pilatus plans to initiate this Phase 1 clinical trial in the first quarter of 2026.

PLT012 is a first-in-class metabolic checkpoint antibody designed to block CD36-mediated lipid uptake and immune suppression within the tumor microenvironment. CD36 is an immunometabolic regulator highly expressed on exhausted T cells, regulatory T cells, and tumor-associated macrophages, but is far less prevalent in healthy tissues.

By targeting CD36, PLT012 is engineered to restore metabolic fitness in cytotoxic T cells, reduce immunosuppressive cell populations, and promote stronger anti-tumor immune responses. In preclinical models, PLT012 demonstrated monotherapy activity across immune-hot and immune-cold tumors and showed potential synergy with PD-1/PD-L1 inhibitors, supporting its development as both a single agent and a combination therapy.

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