Immune-Onc Therapeutics, Inc. announced a Phase 1b/2 clinical trial collaboration with Roche to evaluate Immune-Onc?s IO-108, a first-in-class antibody targeting LILRB2 (also known as ILT4), in combination with Roche?s atezolizumab and bevacizumab for the first-line treatment of patients with locally advanced or metastatic and/or unresectable hepatocellular carcinoma (HCC). Atezolizumab and bevacizumab is the first cancer immunotherapy combination regimen approved by the U.S. Food and Drug Administration for this setting and is the recommended standard of care by the National Comprehensive Cancer Network. Under the collaboration, Roche will sponsor and conduct the global, randomized Phase 1b/2 trial to evaluate the safety, efficacy and pharmacodynamics of IO-108 in combination with atezolizumab and bevacizumab compared to atezolizumab and bevacizumab, the standard of care treatment regimen for advanced liver cancer.

The Phase 1b/2 global, randomized HCC study is part of Roche?s Morpheus-Liver program. It will evaluate IO-108 in combination with atezolizumab and bevacizumab (triplet) versus atezolizumab and bevacizumab (doublet), the standard of care in patients with locally advanced or metastatic and/or unresectable HCC with no prior systemic treatment. Initially, 40 patients will be enrolled across 25 sites worldwide in the IO-108 triplet combination, which will be compared to an active control arm of the atezolizumab and bevacizumab doublet combination.

The study?s primary endpoint is objective response rate, and key secondary endpoints include progression-free survival and overall survival. Under the terms of the clinical collaboration agreement, Roche will manage the study operations, and Immune-Onc will supply IO-108 to support the trial while retaining global rights to IO-108. Tecentriq® (atezolizumab) and Avastin® (bevacizumab) are registered trademarks of Genentech, a member of the Roche Group.