On April 8, 2026 Pilatus Biosciences, Inc., a clinical-stage biopharmaceutical company developing novel metabolic checkpoint immunotherapies for cancer and immune-related diseases, reported it will present new preclinical data as a poster session at the 2026 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting, taking place April 17-22 in San Diego, California.
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The poster presentation highlights a sex-specific therapeutic effect of its lead antibody, PLT012, in colorectal cancer (CRC), a finding that could inform more precise treatment strategies for a historically difficult-to-treat patient population.
Colorectal cancer remains the second leading cause of cancer-related deaths globally, with the majority of patients classified as mismatch repair-proficient (pMMR), a subtype that shows limited response to current standard therapies, including immune checkpoint inhibitors and anti-VEGF agents. The data presented at AACR (Free AACR Whitepaper) highlight CD36, a fatty acid transporter implicated in tumor metabolism and immune suppression, as a promising and differentiated therapeutic target in this setting.
In preclinical orthotopic models of pMMR CRC, PLT012, a humanized IgG4 antibody targeting CD36, demonstrated significant tumor growth inhibition in both male and female subjects. Notably, the therapeutic effect was more pronounced in female models, a difference that correlated with higher CD36 expression levels observed in female tumors. Additional analyses showed that CD36 was enriched in cancer-associated fibroblasts (CAFs), with a female-biased distribution, suggesting a potential mechanistic basis for the observed sex-specific response.
"These findings provide compelling evidence that CD36 plays a central role in shaping the tumor microenvironment in colorectal cancer, particularly in ways that may differ by sex," said Jingying Zhou, Assistant Professor, School of Biomedical Sciences, Faculty of Medicine, The Chinese University of Hong Kong. "The ability to target metabolic pathways like lipid uptake represents an important and emerging strategy in oncology, and the observed enrichment of CD36 in tumor-associated stroma further underscores its relevance as a therapeutic target."
PLT012 is designed to inhibit CD36-mediated lipid uptake, modulating tumor metabolism and reversing immunosuppressive features of the tumor microenvironment. The antibody has demonstrated activity in liver cancer models and a favorable safety profile in non-human primates, supporting its continued advancement. Given its distinct mechanism, PLT012 has the potential to function both as a monotherapy and as a sensitizing agent in combination with immune checkpoint inhibitors, with the ability to reprogram metabolically constrained tumors and convert immunologically "cold" tumors into more responsive states, addressing a key limitation of current therapies.
"The data presented at AACR (Free AACR Whitepaper) reinforce our conviction that CD36 is a highly actionable target in cancer biology," said Raven Lin, CEO & Founder, Pilatus Biosciences. "What is particularly exciting is the potential to incorporate sex as a biological variable in treatment selection, enabling more tailored, effective therapies for patients with pMMR colorectal cancer, where patients urgently need new therapies."
These findings significantly broaden the therapeutic scope of PLT012, demonstrating activity beyond tumor-associated immune cells to encompass the critical tumor-associated stromal population. By simultaneously targeting the immune and stromal compartments of the microenvironment, PLT012 is designed to overcome key barriers of tumor progression and may have utility both as a monotherapy and in combination with existing therapies, to improve outcomes in underserved CRC populations.
PLT102 is currently in an ongoing Phase 1 clinical trial (NCT07337525) in patients with advanced solid tumors, including colorectal cancer. The study is designed to assess safety, pharmacokinetics, and early clinical evidence of target engagement and biological activity in CD36-driven tumors. Translational endpoints include the evaluation of CD36 expression, stromal composition, and immune cell reprogramming, with the goal of establishing a biomarker framework to guide patient selection and combination strategies in future trials. PLT102 has received both FDA Fast Track and Orphan Drug Designation.
AACR 2026 Poster Presentation Details:
Title: A Sex-Specific Role of CD36 Targeting Therapy in Colorectal Cancer
Date/Time: Tuesday, April 21, 2026, 9:00 am – 12:00 pm PT
Poster Number: 4351
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.
(Press release, Pilatus Biosciences, APR 8, 2026, View Source [SID1234664252])