Pilatus PLT012 Wins FDA IND Clearance for Anti-CD36 Solid Tumor Therapy

DOVER, Del. and EPALINGES, Switzerland — Pilatus Biosciences Inc. recently announced that the FDA has cleared its IND application for PLT012, a first-in-class anti-CD36 monoclonal antibody and the metabolic checkpoint therapy. This enables clinical development of it for patients with solid tumors. Pilatus plans to initiate a Phase 1 trial in the first quarter of 2026.

A Novel Metabolic Checkpoint Strategy Reprogramming Immune Function in Solid Tumors

PLT012 is a first-in-class anti-CD36 monoclonal antibody. It is the first metabolic checkpoint therapy designed to reprogram the tumor microenvironment. The antibody blocks CD36-mediated lipid uptake and immune suppression within tumors. CD36 is an immunometabolic regulator enriched on exhausted T cells, regulatory T cells, and tumor-associated macrophages. Its expression remains limited in most healthy tissues. This profile supports selective targeting within tumors.

By inhibiting CD36, PLT012 aims to restore metabolic fitness in cytotoxic T cells. The therapy also reduces immunosuppressive immune cell populations. Together, these effects promote stronger anti-tumor immune responses.

In preclinical studies, it demonstrated monotherapy activity across immune-hot and immune-cold tumor models. The antibody also showed potential synergy with PD-1 and PD-L1 inhibitors. These findings support both standalone and combination development.

Phase 1 Clinical Plans and Leadership Insights

“PLT012 represents a fundamentally new approach to solid tumor immunotherapy,” said Raven Lin, Ph.D., Co-Founder and CEO of Pilatus Biosciences. “It addresses metabolic dysfunction as a core driver of immune exhaustion.”

“PLT012 was engineered to enhance effector T cell function while suppressing tumor-promoting immune populations,” Lin added. “We believe this mechanism can benefit patients resistant to current immunotherapies.”

The upcoming Phase 1, first-in-human study will evaluate safety and tolerability. The trial will also assess pharmacokinetics, pharmacodynamics, and early signals of clinical activity. Expansion cohorts will focus on tumor types strongly influenced by CD36-mediated metabolic dysregulation. Pilatus has also received FDA Orphan Drug Designation for PLT012 in liver and intrahepatic bile duct cancers.

Experts Discuss PLT012 Impact on Liver Tumor Immunology

“Targeting CD36 offers a promising strategy to reshape the tumor microenvironment,” said Anthony El-Khoueiry, M.D., of USC Norris Comprehensive Cancer Center. “PLT012 may reinvigorate exhausted T cells in resistant tumors.”

“The hepatic microenvironment is tolerogenic and macrophage-rich,” said Anthony W. Tolcher, M.D., FRCPC, FACP, of NEXT Oncology. “This biology often limits immunotherapy responses in liver cancers.”

“Preclinical data suggest PLT012 can overcome this immune resistance,” Tolcher added. “We hope this translates into improved patient outcomes.”

Author

Steven Chung

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