Pilatus Biosciences Announces Hong Kong Clinical Trial Application Approval for PLT012 and Expansion into Hong Kong

CTA approval marks an important milestone in advancing PLT012 into the clinic and strengthens the Company's presence in one of Asia’s leading biotech hubs

DOVER, Del. & EPALINGES, Switzerland--(BUSINESS WIRE)--Pilatus Biosciences, Inc., a clinical-stage biopharmaceutical company developing novel metabolic checkpoint immunotherapies for liver and gastrointestinal cancers, today announced that the Hong Kong Department of Health has granted the Certificate for Clinical Trial / Medicinal Test for lead investigational therapy, PLT012 in patients with advanced solid tumors.

The study will be conducted at the Phase I Clinical Trial Centre, under the Department of Clinical Oncology of The Chinese University of Hong Kong. The regulatory approval authorizes Pilatus to initiate a clinical trial evaluating PLT012 in Hong Kong, and represents an important milestone in advancing the Company's global clinical development program to advance the novel therapy for patients with advanced solid tumors, including liver cancer and gastrointestinal cancers.

Pilatus also announced the establishment of its Hong Kong subsidiary, expanding its presence in one of Asia's leading biotechnology and clinical-research hubs. The company has worked closely with Invest Hong Kong (InvestHK) to establish its regional operations and plans to leverage Hong Kong's growing life sciences ecosystem to support clinical development, academic and strategic collaborations, and engagement with regional investment opportunities.

“We are pleased to receive CTA approval, which enables the PLT012 clinical study to commence in Hong Kong. We look forward to working with the study team to evaluate the safety and clinical potential of this investigational therapy in patients with advanced solid tumors,” said Dr. Stephen Chan, principal study investigator and clinical professor at the Department of Clinical Oncology of The Chinese University of Hong Kong.

“We are pleased to establish our presence in Hong Kong as we continue executing our global development strategy," said Raven Lin, CEO & Co-founder, Pilatus Biosciences. “Hong Kong offers a world-class clinical research environment, a strong regulatory framework, and a growing biotechnology ecosystem. We appreciate the support of InvestHK and look forward to becoming an active participant in Hong Kong's innovation ecosystem while advancing PLT012 toward the clinic.”

PLT012 is a first-in-class therapeutic targeting CD36, a key regulator of metabolic dysfunction and inflammation. The program is being developed for indications where modulation of CD36 has the potential to improve patient outcomes.

The establishment of Pilatus' Hong Kong operations strengthens the Company's presence in Asia, enabling deeper regional collaborations, accelerating clinical development, and expanding engagement with investors and strategic partners.

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 anti–PD-L1 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.