Pilatus Biosciences a biopharmaceutical company developing novel metabolic checkpoint immunotherapies for cancer, today announced that the ongoing Phase 1 clinical trial of PLT012, its first-in-class monoclonal antibody targeting CD36, has been accepted for a Trials-in-Progress poster presentation at the European Society for Medical Oncology (ESMO) Congress 2026, held Oct. 23–27 in Madrid, Spain.

PLT012 targets CD36, a key fatty acid transporter, and is designed to inhibit lipid uptake in tumor-associated immune cells. By targeting this pathway and inhibiting CD36-mediated lipid uptake, PLT012 is intended to reduce metabolically driven immune suppression in the tumor microenvironment and support antitumor immune activity.

“Despite major advances in immuno-oncology, treatment resistance remains a significant challenge, particularly in tumors that have historically been difficult to treat with existing immunotherapies,” said Raven Lin, Ph.D., co-founder and CEO of Pilatus Biosciences. “PLT012 takes a differentiated approach by targeting the metabolic mechanisms that tumors exploit to suppress the immune system. We look forward to presenting the design of our ongoing Phase 1 study at ESMO as we evaluate the potential of this first-in-class approach in patients with advanced solid tumors.”

In preclinical spontaneous and orthotopic tumor models, PLT012 demonstrated potent efficacy across cold and recalcitrant malignancies, including hepatocellular carcinoma (HCC), colorectal liver metastasis (CRLM), muscle-invasive bladder cancer, intrahepatic cholangiocarcinoma (iCCA) and colorectal cancer (CRC). These findings provided the rationale for clinical evaluation in advanced solid tumors.

The ongoing first-in-human, open-label, multicenter Phase 1 study is evaluating the safety, tolerability and preliminary efficacy of PLT012 in adults with advanced solid tumors, who have heavily pre-treated, are intolerant of or are not candidates for available standard therapies. The dose-escalation trial utilizes Bayesian Optimal Interval (BOIN) design to evaluate sequential dose levels administered intravenously once every three weeks. The protocol also includes HCC biomarker backfill cohorts and tumor-specific -expansion cohorts in HCC, CRLM and iCCA.

The primary objectives are to characterize safety and tolerability, assess dose-limiting toxicities and adverse events and determination of the maximum tolerated dose and/or recommended Phase 2 dose. Secondary and exploratory objectives include objective response rate, duration of response, time to response, disease control rate, progression-free survival, overall survival, pharmacokinetics, anti-drug antibody and pharmacodynamic assessments.

ESMO 2026 Presentation Details

Title: A Phase I, Open-Label, Dose Escalation Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of PLT012 in Participants with Advanced Solid Tumors

Presentation Number: 2012TiP

Presenter: Anthony B. El-Khoueiry, M.D.

Date: Saturday, October 24, 2026

Time: 12:00–12:45 p.m.

“Targeting CD36 represents a novel approach to addressing the immunosuppressive tumor microenvironment by disrupting the metabolic pathways that tumors use to evade immune responses,” said Anthony El-Khoueiry, M.D., associate director for clinical research and chief of Section of Developmental Therapeutics at USC Norris Comprehensive Cancer Center, as well as associate professor of clinical medicine, Keck School of Medicine of USC. “The HCC biomarker backfill and planned tumor-specific expansions are important next steps in testing whether the biological effects of CD36 blockade can translate into clinically meaningful activity. The data remain preliminary, and we are applying a rigorous, evidence-driven approach as the study progresses.”

For more information about the conference, visit https://www.esmo.org/meeting-calendar/esmo-congress-2026.

About PLT012

PLT012 is the lead investigational therapy from Pilatus Biosciences’ first-in-class CD36 metabolic checkpoint platform. The humanized IgG4 monoclonal antibody selectively blocks CD36, a key regulator of lipid metabolism, inflammation and tissue repair. PLT012 is currently being evaluated in an ongoing Phase 1 oncology clinical trial, where it has demonstrated early evidence of disease control together with a favorable safety profile. In preclinical studies, PLT012 has demonstrated disease-modifying activity across oncology, MASH and COPD, supporting Pilatus’ Pipeline-in-a-Product strategy to develop a single differentiated mechanism across multiple high-unmet-need indications.

About Pilatus Biosciences

Pilatus Biosciences is a clinical-stage biopharmaceutical company pioneering metabolic checkpoint therapeutics for 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, U.S, 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 Pilatus Biosciences.

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