Pilatus Biosciences, a clinical-stage biopharmaceutical company developing novel metabolic checkpoint immunotherapies for liver and gastrointestinal cancers, today announced that the first patient has been dosed in Hong Kong, in the hepatocellular carcinoma (HCC) biomarker backfill cohort of its ongoing Phase 1 clinical trial of PLT012.

The dosing follows authorization from the Hong Kong Department of Health in July 2026 to conduct the PLT012 clinical study in Hong Kong. The Hong Kong site, based at the Phase I Clinical Trial Centre under the Department of Clinical Oncology of The Chinese University of Hong Kong, will support the HCC backfill and dose expansion cohorts as part of the broader PLT012 Phase 1 study.

The backfill cohorts are intended to evaluate preliminary clinical activity and generate biomarker data in patients with advanced HCC, including those with underlying liver dysfunction. By integrating clinical outcomes with biomarker findings from this cohort, the study aims to further inform PLT012’s future clinical development and support a deeper understanding of its potential role across the liver disease continuum, from chronic liver dysfunction to malignancy.

PLT012 is a first-in-class investigational monoclonal antibody targeting CD36, a key regulator of lipid metabolism within the tumor microenvironment. By blocking CD36-mediated lipid uptake, PLT012 is designed to reprogram the tumor microenvironment by reducing immunosuppressive cell populations while restoring the activity of antitumor immune cells.

“Dosing the first patient in Hong Kong represents an important milestone for the PLT012 program and for Pilatus as we continue expanding the global clinical development of our lead program,” said Raven Lin, Ph.D., Chief Executive Officer and Co-Founder, Pilatus Biosciences. “By collecting clinical and biomarker data from patients with HCC, we aim to better understand PLT012’s broader anti-tumor activity, inform its next stage of development supported by FDA Fast Track Designation, and further explore mechanisms associated with response to immunotherapy in HCC. We appreciate the collaboration of our investigators in Hong Kong.”

“There remains a significant need for new treatment approaches for patients with advanced Liver cancers, particularly those with underlying liver dysfunctions,” said Stephen Chan, M.D., Principal Investigator and Clinical Professor at the Department of Clinical Oncology of The Chinese University of Hong Kong. “The HCC biomarker backfill cohort will help characterize clinical findings and selected biomarker profile of patients receiving PLT012 treatment. We are pleased to begin dosing patients from Asia in Hong Kong.”

The current Hong Kong study cohort forms part of Pilatus’ broader clinical development program for PLT012. Pilatus established its Hong Kong subsidiary earlier this year as part of the Company’s expansion in Asia and is leveraging the region’s clinical research infrastructure to support the developments of PLT012, as well as further academic and metabolic chokepoints immunotherapies strategic collaborations.

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 depletes immunosuppressive cell populations, including Tregs and pro-tumor macrophages, while simultaneously enhancing antitumor 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 oncology therapies, effectively overcoming drug resistance in immune “cold” tumors and liver metastases.

About Pilatus Biosciences

Pilatus Biosciences is a clinical-stage 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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