VBL Therapeutics announced the first two patients have been enrolled in the Phase 2 clinical trial of VB-111 in combination with nivolumab (Opdivo?), an immune checkpoint inhibitor, for the treatment of metastatic colorectal cancer. The study is being conducted under a Cooperative Research and Development Agreement (CRADA) between the National Cancer Institute (NCI) and VBL.

“Colon cancer is one of the most common cancers worldwide, but immune-based approaches in gastrointestinal cancers have unfortunately been largely unsuccessful,” said Tim F. Greten, M.D., Deputy Branch Chief & Senior Investigator of the Thoracic and GI Malignancies Branch (TGMB), Co-Director of the NCI Center for Cancer Research (CCR) Liver Cancer Program, and the principal investigator of the study. “The reasons for this are unclear, but no doubt relate to the fact that, in advanced disease, GI cancer appears to be less immunogenic. The goal of this Phase 2 study is to investigate whether priming with VB-111 followed by the addition of nivolumab may induce anti-tumor immune response in metastatic colorectal cancer, for which there remains a major unmet need.”

“We are pleased to see beginning of enrollment in this study, despite the challenges of COVID-19,” said Dror Harats, M.D., Chief Executive Officer of VBL Therapeutics. “We look forward to collaborating with the NCI on investigating VB-111 for the potential benefit of patients with colorectal cancer.”