• Fast Track designation granted to accelerate development of PLT012 for cancers with high unmet medical need, with Phase 1 study open for patient enrollment
• PLT012 designed to reprogram the tumor microenvironment by blocking CD36-mediated metabolic immune suppression

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 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.

“Receiving FDA Fast Track designation for PLT012 is an important milestone that reinforces the potential of our checkpoint therapy approach to transform the treatment of HCC,” said Raven Lin, Ph.D., Co-Founder and CEO, Pilatus Biosciences. “PLT012 was designed to address the metabolic adaptations that drive immune evasion in cancer. With IND clearance already secured and our Phase 1 trial open for patient enrollment, this designation will help accelerate clinical development and advance towards delivering a novel therapeutic option for patients, both in HCC and other solid tumors where patients do not benefit from existing immunotherapies.”

The Phase 1 study (NCT07337525) is currently open for patient enrollment at clinical sites in Dallas and Houston, Texas. The study will evaluate safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary signs of clinical activity, with expansion cohorts planned for tumor types strongly influenced by CD36-mediated metabolic dysregulation. In preclinical models, PLT012 demonstrated monotherapy activity across both immune-inflamed and immune-excluded tumors and showed potential synergy with PD-1/PD-L1 inhibitors, supporting development as both a single agent and a combination therapy.

“Targeting CD36 represents a promising new way to reshape the tumor microenvironment. Importantly, we also start to reveal its superior activity on treating metabolic disorders. The fast track represents the beginning of an exciting chapter for Pilatus Biosciences,” said Prof. Ping-Chih Ho, Chair of Scientific Advisory Board and Co-founder at Pilatus Biosciences. “Importantly, PLT012 has the potential to redefine how we approach the MASH-to-HCC continuum by intervening at the metabolic root of disease to treat and prevent progression.”

Pilatus has also received FDA Orphan Drug Designation for PLT012 for the treatment of liver and intrahepatic bile duct cancers.

Beyond oncology, PLT012's mechanism of action may also address upstream drivers of liver disease progression. By targeting CD36-mediated lipid uptake, PLT012 has demonstrated promising preclinical activity in metabolic dysfunction-associated steatohepatitis (MASH), including reductions in inflammation and fibrosis. By addressing the full disease continuum, from early hepatic dysfunction to advanced malignancy, PLT012 is well-positioned to intervene at the metabolic root of disease and potentially slow or halt progression.

About PLT012

PLT012 is a humanized monoclonal antibody designed to selectively block CD36-mediated lipid uptake, a key mechanism driving immunosuppression and immune exclusion within the tumor microenvironment. By targeting lipid metabolism, PLT012 exerts a unique mechanism of action: it reduces immunosuppressive cell populations, including Tregs and pro-tumor macrophages, while simultaneously enhancing anti-tumor activities of intratumoral NK cell and cytotoxic CD8+ T cell that are otherwise susceptible to lipid-induced exhaustion. In preclinical studies, PLT012 has demonstrated potent monotherapy efficacy in models of liver malignancies, with a favorable safety profile across species. Leveraging its distinct mechanism of action, PLT012 further acts as a potent sensitizer in combination with anti–PD-L1 therapies, effectively overcoming drug resistance in immune “cold” tumors and liver metastases.

About Pilatus Biosciences

Pilatus Biosciences is a biopharmaceutical company developing metabolic checkpoint immunotherapies to address unmet medical needs in cancer and immune-related diseases. Founded in 2022 from the Ludwig Institute for Cancer Research, and supported by the Cancer Research Institute, Pilatus operates internationally with R&D teams in Switzerland and Taiwan. The company’s lead program, PLT012, targets CD36 to reprogram the tumor microenvironment and restore anti-tumor immunity in solid tumors. For more information, visit www.pilatusbio.com.

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