Pilatus Biosciences to Showcase New Data on Sex-Specific Efficacy of CD36-Targeting Antibody in Colorectal Cancer at AACR 2026
Pilatus Biosciences has announced that it will present new preclinical findings at the upcoming AACR Annual Meeting 2026, scheduled to take place from April 17–22 in San Diego. The data, which will be shared in a poster presentation, highlight a potentially important breakthrough in colorectal cancer research, revealing a sex-specific therapeutic response associated with the company’s lead antibody candidate, PLT012.
The findings represent a significant advancement in the understanding of how metabolic pathways and biological differences between patients may influence treatment outcomes. In particular, the results suggest that PLT012, a humanized IgG4 antibody targeting the CD36 receptor, may exhibit enhanced efficacy in certain patient populations based on sex-specific tumor biology. This insight could pave the way for more personalized and precise therapeutic strategies in colorectal cancer, a disease that remains one of the most challenging to treat effectively.
Colorectal cancer continues to be one of the leading causes of cancer-related mortality worldwide, ranking as the second most common cause of cancer death globally. A large proportion of patients are classified as having mismatch repair-proficient (pMMR) tumors, a subtype that is notoriously resistant to many currently available therapies. Standard treatment options, including immune checkpoint inhibitors and anti-angiogenic agents targeting vascular endothelial growth factor (VEGF), have shown limited efficacy in this population. As a result, there is a pressing need for novel therapeutic approaches that can overcome resistance mechanisms and improve outcomes for these patients.
Pilatus Biosciences is addressing this challenge through its focus on metabolic checkpoint immunotherapy, an emerging field that seeks to target the metabolic processes that tumors rely on for growth and survival. One of the key targets under investigation is CD36, a fatty acid transporter that plays a central role in lipid uptake and metabolism within tumor cells and the surrounding microenvironment. CD36 has also been implicated in immune suppression, making it an attractive target for therapies aimed at both disrupting tumor metabolism and enhancing anti-tumor immune responses.
The preclinical data presented by Pilatus Biosciences demonstrate that PLT012 can significantly inhibit tumor growth in orthotopic models of pMMR colorectal cancer. These models, which more closely mimic the natural tumor environment, provide valuable insights into how the therapy may perform in clinical settings. Notably, the study revealed that while PLT012 was effective in both male and female models, the magnitude of tumor growth inhibition was greater in female subjects.
Further investigation into this sex-specific difference revealed that tumors in female models exhibited higher levels of CD36 expression. This increased expression was associated with enhanced sensitivity to PLT012, suggesting a potential biological mechanism underlying the observed therapeutic disparity. Additional analyses identified that CD36 was particularly enriched in cancer-associated fibroblasts (CAFs), a key component of the tumor microenvironment. These stromal cells are known to play a critical role in tumor progression, immune evasion, and resistance to therapy.
Interestingly, the distribution of CD36 within these fibroblasts appeared to be biased toward female tumors, providing further evidence of a sex-dependent biological factor that could influence treatment response. This discovery underscores the importance of considering sex as a variable in cancer research and drug development, an area that has historically been underexplored.
Jingying Zhou, Assistant Professor at the School of Biomedical Sciences, Faculty of Medicine at The Chinese University of Hong Kong, commented on the significance of the findings. She emphasized that CD36 appears to play a central role in shaping the tumor microenvironment in colorectal cancer, particularly through its involvement in lipid metabolism and immune regulation. According to Zhou, targeting metabolic pathways such as lipid uptake represents a promising and rapidly evolving strategy in oncology, with the potential to address some of the limitations of existing therapies.
PLT012 is specifically designed to inhibit CD36-mediated lipid uptake, thereby disrupting the metabolic processes that support tumor growth and survival. By interfering with these pathways, the antibody aims to modulate the tumor microenvironment, reducing immunosuppressive features and enhancing the activity of immune cells. This dual mechanism—targeting both tumor metabolism and immune suppression—positions PLT012 as a potentially powerful therapeutic option in cancers that are resistant to conventional treatments.
In addition to its activity in colorectal cancer models, PLT012 has demonstrated efficacy in preclinical models of liver cancer, further supporting its broad therapeutic potential. The antibody has also shown a favorable safety profile in non-human primate studies, an important consideration as it advances toward clinical development. These findings suggest that PLT012 could be used not only as a standalone therapy but also in combination with other treatments, such as immune checkpoint inhibitors.
One of the key challenges in oncology is the presence of so-called “cold” tumors—tumors that lack sufficient immune cell infiltration and therefore do not respond well to immunotherapy. By reprogramming the tumor microenvironment and enhancing immune activity, PLT012 has the potential to convert these cold tumors into “hot” tumors that are more responsive to treatment. This capability could significantly expand the applicability of immunotherapies to a broader range of patients.
Raven Lin, CEO and Founder of Pilatus Biosciences, highlighted the broader implications of the data. He noted that the findings reinforce the company’s belief that CD36 is a highly actionable target in cancer biology. More importantly, he emphasized the potential to incorporate sex as a biological variable in treatment selection, enabling the development of more tailored and effective therapies. This approach aligns with the growing trend toward precision medicine, where treatments are customized based on individual patient characteristics.
The data also suggest that PLT012 may have a broader scope of activity than initially anticipated. In addition to targeting tumor-associated immune cells, the antibody appears to impact the stromal compartment of the tumor microenvironment, including cancer-associated fibroblasts. By simultaneously addressing multiple components of the tumor ecosystem, PLT012 is designed to overcome key barriers to effective treatment and improve overall therapeutic outcomes.
While PLT012 represents a promising preclinical candidate, Pilatus Biosciences is also advancing a related program, PLT102, which is currently being evaluated in a Phase 1 clinical trial. This study, registered under NCT07337525, is enrolling patients with advanced solid tumors, including colorectal cancer. The trial is designed to assess the safety, pharmacokinetics, and early signs of biological activity associated with CD36 inhibition.
Importantly, the clinical study includes a range of translational endpoints aimed at deepening the understanding of how CD36-targeted therapies interact with the tumor microenvironment. These include analyses of CD36 expression levels, stromal composition, and immune cell reprogramming. The goal is to establish a robust biomarker framework that can guide patient selection and inform future combination strategies.
PLT102 has already received both Fast Track and Orphan Drug Designation from the U.S. Food and Drug Administration, reflecting its potential to address a significant unmet medical need. These designations provide regulatory advantages that can help accelerate the development and review process, bringing promising therapies to patients more quickly.
The upcoming presentation at the AACR Annual Meeting 2026 will provide an important opportunity for Pilatus Biosciences to share its findings with the broader scientific and medical community. As one of the leading conferences in cancer research, AACR serves as a platform for showcasing cutting-edge discoveries and fostering collaboration among researchers, clinicians, and industry leaders.
Overall, the data presented by Pilatus Biosciences highlight the growing importance of targeting metabolic pathways in cancer therapy and underscore the potential of CD36 as a novel therapeutic target. By integrating insights into tumor biology, immune regulation, and patient-specific factors such as sex, the company is advancing a new paradigm in oncology that prioritizes precision, innovation, and improved patient outcomes.
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.
About Pilatus Biosciences
Pilatus Biosciences is a clinical-stage biopharmaceutical company developing novel 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.
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