Pilatus Biosciences, Inc., a biopharmaceutical company developing novel metabolic checkpoint immunotherapies for liver and gastrointestinal cancers, announced a clinical trial collaboration with Roche. 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).‍

PLT012 is Pilatus’ immunomodulatory candidate designed to reprogram the fibrotic and immunosuppressive tumor microenvironment (TME) characteristic of HCC. The investigational combination will be assessed in Pilatus-sponsored clinical trials to assess safety and tolerability.

“We are pleased to collaborate with Roche as we explore the potential synergy between PLT012 and atezolizumab in patients with HCC,” said Raven Lin, Ph.D., Chief Executive Officer, Pilatus Biosciences. “Current treatments, including checkpoint inhibitors as monotherapy, often fail to generate durable responses in liver cancer. PLT012’s ability to reshape the TME may enhance immune activation and unlock deeper, more sustained responses when administered in combination with anti-PD-L1 therapies such as atezolizumab,” added Lin.

“This collaboration represents an opportunity to investigate how modulation of the TME can enhance immune checkpoint blockade in liver cancer. Combining PLT012 with atezolizumab has the potential to overcome key mechanisms of resistance in HCC and potentially drive more durable patient response and potentially improve patient outcomes for this aggressive disease,” said Dr. Ann-Lii Cheng, NTU Chair professor and President Emeritus of the NTU Cancer Center of National Taiwan University, and scientific collaborator at Pilatus Biosciences.  Dr. Cheng also served as the global principal investigator of the landmark IMbrave150 trial (atezolizumab plus bevacizumab for HCC, published in NEJM 2020).

Atezolizumab, a standard of care treatment for first-line HCC in combination with bevacizumab (Avastin), will be provided by Genentech, a member of the Roche Group, for use in Pilatus’ clinical research. HCC is the most common type of primary liver cancer and remains one of the leading causes of cancer-related death worldwide.