- 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
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.
"PLT012 represents a fundamentally new approach to treating solid tumors by addressing the metabolic dysfunction that underlies immune exhaustion," said Raven Lin, Ph.D., Co-Founder and CEO, Pilatus Biosciences. "Leveraging our deep expertise in metabolic immunology, PLT012 was developed to simultaneously enhance effector T cell function and suppress tumor-promoting immune populations, while maintaining a favorable safety profile. We believe this dual-action metabolic checkpoint mechanism has the potential to deliver meaningful benefits for patients whose tumors do not respond to existing immunotherapies. We look forward to initiating our Phase 1 clinical trial of PLT012 early next year."
"Targeting CD36 represents a promising new way to reshape the tumor microenvironment," said the trial lead principal investigator, Anthony El-Khoueiry, M.D., Verna R. Richter Chair in Cancer Research, Associate Director for Clinical Research and Chief of Section of Developmental Therapeutics/Phase I Program at USC Norris Comprehensive Cancer Center, part of Keck Medicine of USC, and Associate Professor of Clinical Medicine at Keck School of Medicine of USC. "PLT012's ability to modulate metabolic dysfunction and reinvigorate exhausted T cells positions it as a potentially important therapeutic option for tumors that do not respond to current immunotherapies."
The upcoming Phase 1, first-in-human clinical trial 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. Pilatus has also received FDA Orphan Drug Status for PLT012 for the treatment of liver and intrahepatic bile duct cancers.
"The hepatic microenvironment is tolerogenic and macrophage-rich which can dampen effector T-cell activity, contributing to weaker responses to immunotherapy treatments for HCC and liver metastases," said Anthony W Tolcher, M.D., FRCPC, FACP of New Experimental Therapeutics (NEXT), San Antonio, Texas. "Preclinical data has shown that PLT012 can overcome this immunogenically cold environment and elicit strong anticancer effects, which we hope will be translated into improved patient outcomes in the planned Phase 1 clinical trial."
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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