On February 20, 2020 VBL Therapeutics (Nasdaq: VBLT) reported the launch of a phase 2 clinical trial of VB-111 in combination with nivolumab (Opdivo), an immune checkpoint inhibitor, in the treatment of metastatic colorectal cancer (Press release, VBL Therapeutics, FEB 20, 2020, View Source [SID1234554547]). The National Cancer Institute (NCI) will serve as the Investigational New Drug (IND) sponsor for this study and the IND application has been approved by the U.S. Food and Drug Administration (FDA). This new study will investigate if priming with VB-111 can drive immune cells into the tumor and turn the colorectal tumor from immunologically "cold" to "hot." The addition of nivolumab to VB-111 may further boost the anti-tumor immune response.

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"This phase 2 study is part of our strategy to broaden the potential indications for VB-111 and to explore its activity as part of combination therapies," said Dror Harats, M.D., Chief Executive Officer of VBL Therapeutics. "We look forward to collaborating with NCI on this clinical trial, as we continue to generate data which adds to our understanding of VB-111’s mechanism of action and therapeutic potential. We were particularly encouraged by results in ovarian cancer demonstrating the recruitment of infiltrating T cells into a tumor following treatment with VB-111, turning the tumor ‘hot’. This important finding suggests that VB-111 may be applied to other ‘cold’ tumors, in which checkpoint inhibitors show limited or no efficacy, including colorectal cancer, for which there remains a major unmet need."

VBL and the NCI have entered into a Cooperative Research and Development Agreement (CRADA) under the direction of Tim F. Greten, M.D., Deputy Branch Chief & Senior Investigator of the Thoracic and GI Malignancies Branch (TGMB) and Co-Director of the NCI Center for Cancer Research (CCR) Liver Cancer Program. The goal of this open-label, single-arm phase 2 study is to evaluate VB-111 in combination with an anti-PD-1 inhibitor, nivolumab, in patients with metastatic colorectal cancer. In addition to safety and tolerability, this study will evaluate efficacy endpoints including Best Overall Response, as well as immunological and histologic readouts from tumor biopsies. For additional information refer to View Source

For patients interested in enrolling in this clinical study, please contact NCI’s toll-free number 1-800-4-Cancer (1-800-422-6237) (TTY: 1-800-332-8615) and/or the Web site: View Source