Pilatus Biosciences, Inc., a biotech startup dedicated to developing novel metabolic checkpoint immunotherapies for liver and gastrointestinal cancers, today announced a clinical trial collaboration with Roche. Under the agreement, Roche will provide its anti–PD-L1 therapy Atezolizumab (Tecentriq®) to support Pilatus’ upcoming first-in-human Phase I trial evaluating the safety and tolerability of PLT012 in combination with Atezolizumab for patients with hepatocellular carcinoma (HCC).
PLT012, Pilatus’ lead immunomodulatory candidate, is designed to remodel the fibrotic and immunosuppressive tumor microenvironment (TME) characteristic of HCC. The planned clinical trial, led by Pilatus, will assess the safety and tolerability of this novel combination regimen.
Dr. Lin Yun-Han, Chief Executive Officer of Pilatus Biosciences, stated: “We are delighted to collaborate with a world-class pharmaceutical company like Roche to explore the potential synergy of PLT012 and Atezolizumab in patients with HCC. Current liver cancer treatments, including checkpoint inhibitor monotherapies, often fail to deliver durable responses. By reshaping the tumor microenvironment, PLT012 enhances immune activation and, when combined with PD-L1 blockade such as Atezolizumab, may unlock deeper and more sustained therapeutic responses.”
Professor Ann-Lii Cheng, Honorary Director of the National Taiwan University Cancer Center, commented: “This cross-border collaboration marks an important opportunity to investigate how modulating the tumor microenvironment can enhance the efficacy of immune checkpoint inhibitors in liver cancer. Combining PLT012 with Atezolizumab has the potential to overcome key resistance mechanisms in HCC treatment, leading to more durable clinical benefits and improved patient outcomes.” Professor Cheng also served as the global principal investigator of the landmark IMbrave150 trial, which evaluated Atezolizumab plus Bevacizumab in HCC and was published in The New England Journal of Medicine in 2020.
Atezolizumab, typically used in combination with Bevacizumab (Avastin®), is a standard first-line therapy for HCC and will be supplied by Roche’s Genentech unit for Pilatus’ clinical program. HCC is the most common form of primary liver cancer and remains one of the leading causes of cancer-related deaths worldwide.
PLT012 is a humanized monoclonal antibody specifically designed to block CD36-mediated lipid uptake, a key driver of immune suppression and exclusion within the tumor microenvironment. By targeting lipid metabolism, PLT012 exerts a unique immunologic effect: depleting immunosuppressive cell populations such as regulatory T cells and pro-tumor macrophages, while enhancing the antitumor activity of natural killer (NK) cells and cytotoxic CD8+ T cells, preventing immune cell exhaustion from lipid accumulation.
In preclinical studies, PLT012 demonstrated robust single-agent activity across multiple liver cancer models, with favorable safety profiles observed in multi-species trials. With its distinctive mechanism, PLT012 has shown potential to sensitize immunologically “cold” tumors and liver metastases, thereby overcoming resistance when used in combination with PD-L1 inhibitors.
Resource: 佩圖思與羅氏達成PLT012臨床試驗合作！挑戰新一代肝細胞癌聯用療法
