PLT012 / Pilatus Biosci, Elixiron Immunotherap - LARVOL DELTA

Pilatus Biosciences…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 (Businesswire) - "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 protocol also includes HCC biomarker backfill cohorts and tumor-specific -expansion cohorts in HCC, CRLM and iCCA."

First-in-human • Trial status • Cholangiocarcinoma • Colorectal Cancer • Hepatocellular Cancer

A Phase I, Open-Label, Dose Escalation Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of PLT012 in Participants with Advanced Solid Tumors (ESMO 2026) - No abstract available

Clinical • Metastases • Oncology • Solid Tumor

Late Breaking Abstract - Targeting CD36 with PLT012 for Tissue Regeneration and Immune Modulation in COPD (ERS 2026) - "PLT012-mediated CD36 blockade reduced both type 2 and non-type 2 inflammation and preserved alveolar architecture, leading to improved lung mechanics in vivo. By disrupting the pathological vicious cycle via the novel mechanism of action, PLT012 is a promising disease-modifying therapeutic for COPD."

Late-breaking abstract • Chronic Obstructive Pulmonary Disease • Immune Modulation • Immunology • Inflammation • Respiratory Diseases • CD36 • ELANE • SCARB1

Pilatus Biosciences to Present New Preclinical Data Advancing PLT012 into COPD at the European Respiratory Society International Congress 2026 (Businesswire) - "The presentation will highlight PLT012's ability to selectively inhibit CD36, a central regulator of lipid metabolism, chronic inflammation and tissue repair. In preclinical models of COPD, PLT012 demonstrated the ability to reduce inflammation, preserve alveolar architecture and improve lung function, supporting its potential as a disease-modifying therapy."

Preclinical • Chronic Obstructive Pulmonary Disease • Immunology

Reprogramming lipid-driven immunometabolic dysfunction in metabolic dysfunction-associated steatohepatitis through PLT012 targeting CD36 (EASL 2026) - "Taken together, these results show that blocking CD36 with PLT012 reshapes the hepatic microenvironment toward a more balanced, homeostatic state, highlighting its therapeutic potential across steatotic liver diseases."

Fibrosis • Hepatology • Immunology • Inflammation • Metabolic Disorders • Metabolic Dysfunction-Associated Steatohepatitis • Obesity • ACACA • CCL2 • CD36 • COL1A1 • COL3A1 • FASN • IL1B • SCARB1 • TNFA

Pilatus Biosciences to Present Preclinical Data Highlighting Novel Metabolic Checkpoint Therapy PLT012 at EASL Congress 2026 (Businesswire) - "Preclinical findings to be presented demonstrate that PLT012, a humanized IgG4 antibody targeting CD36, modulates these processes by disrupting lipid uptake and reprogramming the hepatic microenvironment. Across multiple disease models, PLT012 reduced steatosis, inflammation, and fibrosis, while improving markers of liver injury and remodeling immune cell populations toward a more balanced, and less inflammatory state."

Preclinical • Metabolic Dysfunction-Associated Steatohepatitis

A sex-specific role of CD36 targeting therapy in colorectal cancer (AACR 2026) - "We recently developed PLT012, a humanized IgG4 antibody targeting the lipid-binding pockets of CD36, with cross-species reactivity and a superior safety profile in monkeys...Interestingly, our preliminary data further suggested that CD36 was enriched in cancer-associated fibroblasts (CAFs) in a female-biased manner. Taken together, our findings highlight CD36 as a promising therapeutic target for pMMR CRC, particularly in female patients."

IO biomarker • Colorectal Cancer • Liver Cancer • Oncology • Solid Tumor • CAFs • CD36 • SCARB1

PLT012, a humanized CD36-blocking antibody, is effective for unleashing anti-tumor immunity and against liver metastasis (AACR 2025) - "Notably, ex vivo studies with human HCC samples further confirm PLT012's capacity to remodel the immune microenvironment. Taken together, these findings position PLT012 as a first-in-class immunotherapy targeting CD36, addressing critical challenges in HCC and liver metastasis treatment."

Hepatocellular Cancer • Oncology • Solid Tumor • CD36 • CD8 • SCARB1

Pilatus Biosciences…announced it will present new preclinical data as a poster session at the 2026 American Association for Cancer Research (AACR) Annual Meeting (Businesswire) - "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."

pMMR • Preclinical • Colorectal Cancer

Revitalizing anti-tumor immunity through PLT012 monoclonal antibody, targeting CD36 for metabolic rewiring in the tumor microenvironment (AACR 2024) - "Taken together, these results reveal that blocking CD36-mediated metabolic alterations in Treg and CD8+ TILs with PLT012 treatment can elicit robust tumor growth inhibition and shift the immunosuppressive nature within the TME toward an immunosupportive one. This study further provides the pillar for harnessing immunometabolic targeting in cancer immunotherapy."

Biomarker • Tumor microenvironment • Oncology • CD36 • CD8 • SCARB1

Reprogramming the tumor microenvironment with a single punch- our journey from bench to bedside (AACR 2025) - "Notably, PLT012 also reprograms immune landscape of human HCC ex vivo. Our findings provide proof-of-concept evidence that PLT012 effectively reprograms anti-tumor immunity in HCC, positioning it as a first-in-class immunotherapy targeting CD36."

Biomarker • Tumor microenvironment • Hepatocellular Cancer • Oncology • Solid Tumor • CD36 • SCARB1

Pilatus Biosciences Announces First Patient Dosed in Phase 1 Trial of First-in-Class Metabolic Checkpoint Antibody PLT012 in Solid Tumors (Businesswire) - "The first patient was treated at Next Oncology in Houston, Texas....The open-label, multi-center Phase 1 study is evaluating PLT012 in patients with advanced solid tumors, with expansion cohorts planned in tumor types characterized by lipid-driven metabolic dysregulation, including, but not limited to, liver cancers and tumors with liver metastases."

First-in-human • Trial status • Hepatocellular Cancer • Solid Tumor

A First in Human Study of PLT012 in Participants With Solid Tumor Cancers (clinicaltrials.gov) - P1 | N=36 | Recruiting | Sponsor: Pilatus Biosciences Inc | Not yet recruiting ➔ Recruiting

Enrollment open • First-in-human • Hepatocellular Cancer • Oncology • Solid Tumor

Pilatus Biosciences Receives FDA Fast Track Designation for Metabolic Checkpoint Inhibitor PLT012 in Hepatocellular Carcinoma (Businesswire) - "The Phase 1 study (NCT07337525) is currently open for patient enrollment at clinical sites in Dallas and Houston, Texas."

Fast track • Trial status • Hepatocellular Cancer

A First in Human Study of PLT012 in Participants With Solid Tumor Cancers (clinicaltrials.gov) - P1 | N=36 | Not yet recruiting | Sponsor: Pilatus Biosciences Inc

First-in-human • New P1 trial • Hepatocellular Cancer • Oncology • Solid Tumor

Pilatus Biosciences Announces FDA Clearance of IND Application for PLT012, a First-in-Class Anti-CD36 Metabolic Checkpoint Antibody in Solid Tumors - "'Targeting CD36 represents a promising new way to reshape the tumor microenvironment,' said the trial lead principal investigator, Anthony El-Khoueiry, MD...'PLT012's ability to modulate metabolic dysfunction and reinvigorate exhausted T cells positions it as a potentially important therapeutic option for tumors that do not respond to current immunotherapies.'"

Media quote • Regulatory

Pilatus Biosciences Announces FDA Clearance of IND Application for PLT012, a First-in-Class Anti-CD36 Metabolic Checkpoint Antibody in Solid Tumors (Businesswire) - "Pilatus plans to initiate this Phase 1 clinical trial in the first quarter of 2026....The upcoming Phase 1, first-in-human clinical trial will evaluate safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary signs of clinical activity, with expansion cohorts planned for tumor types strongly influenced by CD36-mediated metabolic dysregulation. Pilatus has also received FDA Orphan Drug Status for PLT012 for the treatment of liver and intrahepatic bile duct cancers."

IND • New P1 trial • Orphan drug • Cholangiocarcinoma • Hepatocellular Cancer

PLT012, a Humanized CD36-Blocking Antibody, Induces Durable Anti-Tumor Immunity via Immunometabolic Reprogrammig (SITC 2025) - "By enhancing effector T cell function and reducing suppressive cell populations, PLT012 overcomes ICI resistance and induces durable tumor control in both HCC and liver metastases. These findings underscore the promise of immunometabolic targeting in lipid-enriched malignancies."

Oncology • CD36 • CD8 • SCARB1

Pilatus Biosciences to Present New Preclinical Data Highlighting PLT012's Ability to Induce Durable Anti-Tumor Immunity Through Immunometabolic Reprogramming of the Tumor Microenvironment at SITC 2025 Annual Meeting (PRNewswire) - "Preclinical findings highlight PLT012's first-in-class anti-CD36 mechanism of action that reprograms immune-metabolic pathways to suppress Tregs, enhance CD8 ⁺ T-cell responses, and induce durable tumor control....'Alongside a favorable GLP toxicology profile, these data support our planned Phase I study, with first patient in (FPI) targeted for Q1 2026'."

New P1 trial • Preclinical • Solid Tumor

Pilatus Biosciences…announced the granting of its foundational patent in Europe and Australia, entitled “Methods for Modulating Regulatory T Cells and Inhibiting Tumor Growth.” (Businesswire) - "The patent covers Pilatus’ first-in-class antibody program targeting CD36, a key metabolic checkpoint expressed on regulatory T cells (Tregs) that play a critical role in suppressing anti-tumor immune responses."

Patent • Oncology

Pilatus Biosciences Announces Clinical Trial Collaboration with Roche to Evaluate PLT012 in First-in-Human Study in Hepatocellular Carcinoma (Businesswire) - "Under the terms of the agreement, Roche will provide atezolizumab (Tecentriq), its anti-PD-L1 therapy, to support Pilatus’ upcoming first-in-human Phase 1 trial evaluating PLT012 in combination with atezolizumab in patients with hepatocellular carcinoma (HCC)."

Commercial • New P1 trial • Hepatocellular Cancer

PLT012, a Humanized CD36-Blocking Antibody, Is Effective for Unleashing Antitumor Immunity Against Liver Cancer and Liver Metastasis. (PubMed, Cancer Discov) - "Despite the success of cancer immunotherapies, like immune checkpoint inhibitors, many patients still fail to demonstrate significant responses because of metabolic constraints in tumors. PLT012 rejuvenates antitumor immunity by targeting metabolic pathways to reprogram the immune landscape of liver cancer and liver metastasis, with potential to influence future HCC immunotherapy."

Journal • Hepatocellular Cancer • Hepatology • Liver Cancer • Oncology • Solid Tumor • CD36 • SCARB1

Pilatus Biosciences Publishes Preclinical Data in Cancer Discovery on PLT012 First-in-Class CD36-Targeting Antibody for Liver Cancer (Businesswire) - "Pilatus Biosciences...announced a preclinical publication in Cancer Discovery detailing the mechanism and therapeutic potential of its lead candidate, PLT012....PLT012 monotherapy drives tumor regression in both immune-inflamed and immune-excluded HCC models, including β-catenin–driven tumors resistant to checkpoint blockade. In combination with anti-PD-L1 and anti-VEGF therapies, PLT012 significantly improves tumor control and increases complete response rates. In colorectal cancer models with liver metastases, PLT012 restores responsiveness to PD-1 blockade and reprograms macrophage phenotypes."

Preclinical • Colorectal Cancer • Hepatocellular Cancer

Pilatus Biosciences to Present Research on PLT012 at AACR 2025 (PRNewswire) - "Pilatus Biosciences...will present new research on its lead candidate, PLT012, at the American Association for Cancer Research (AACR) 2025 Annual Meeting. The presentations will include an oral symposium by co-founder and Chair of the Scientific Advisory Board (SAB), Prof. Ping-Chih Ho, and a poster session by Lead Scientist, Dr. Yi-Ru Yu. These efforts highlight PLT012's potential as a novel therapeutic approach for immune-cold solid tumors. PLT012 is currently in late-stage preclinical development and progressing toward its first-in-human clinical trial."

Preclinical • Solid Tumor

Pilatus Biosciences Inc. Secures FDA Orphan Drug Designation for PLT012: A Breakthrough in Liver and Intrahepatic Bile Duct Cancer Treatment (PRNewswire) - "Pilatus Biosciences Inc. announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to its leading molecule, PLT012, for treating liver and intrahepatic bile duct cancer (HCC/ICCA). Achieved in November 2024, this designation marks a crucial advancement in developing innovative therapies for patients facing these challenging cancers. Dr. Raven Lin, CEO, emphasized the company's commitment to addressing urgent medical needs, while Prof."

Orphan drug • Biliary Cancer • Cholangiocarcinoma • Hepatocellular Cancer • Oncology