Pilatus Biosciences, 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 granted Fast Track designation for PLT012, the company’s first-in-class anti-CD36 monoclonal antibody for the treatment of hepatocellular carcinoma (HCC). Pilatus is also developing PLT012 in additional solid tumor indications.
FDA Fast Track designation is intended to facilitate the development and expedite the review of therapies that treat serious conditions and address unmet medical needs. The designation enables more frequent interactions with the FDA and potential eligibility for rolling review, priority review, and accelerated approval pathways.
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 immune-metabolic regulator highly expressed on exhausted T cells, NK cells, regulatory T cells, and tumor-associated macrophages, but far less prevalent in healthy tissues. By targeting CD36, PLT012 is engineered to invigorate innate and adaptive effector cells, reduce immunosuppressive cell populations, and promote stronger anti-tumor immune responses.
