VBL Therapeutics, a renowned Israeli biopharmaceutical company, reportedly announced the initiation of phase 2 clinical study of VB-111 combined with immune checkpoint inhibitor, nivolumab (Opdivo®). This study would be conducted to find a treatment for metastatic colorectal cancer. In addition to tolerability and safety, this trial would evaluate efficacy endpoints while including Best Overall Response, and histologic and immunological readouts from tumor biopsies.

The NCI (National Cancer Institute) would act as IND (Investigational New Drug) sponsor for this trial and this IND application has been authorized by the U.S. FDA (Food and Drug Administration). This novel trial would evaluate if priming along with VB-111 would drive immune cells in the tumor and further transform the colorectal tumor from cold to hot. The integration of nivolumab with VB-111 would possibly increase anti-tumor immune response.

Chief Executive Officer, VBL Therapeutics, Dror Harats, M.D., stated that this phase 2 trial is part of the company’s strategy to widen the VB-111’s potential indications as well as to explore its operation as a part of the integration treatments. The company looks forward to partnering with NCI over this clinical study, as it continues to generate information that adds to the company’s understanding of therapeutic potential and mechanism of action of VB-111.

Harats further added that the company is particularly motivated by the outcomes in ovarian cancer showcasing the infiltrating recruitment of T cells in a tumor following therapy with VB-111, changing the tumor to ‘hot’. This important data suggests that VB-111 might be applicable to other types of ‘cold’ tumors, where checkpoint inhibitors show very restricted or no efficacy at all, including colorectal cancer, which has a significant unmet demand.

The company is actively engaged in evaluating VB-111 as a therapy for other disorders or diseases. Recently, in January 2020, the company published Phase 2 and Phase 3 information of VB-111 for Recurrent Glioblastoma. 

Source credit: http://ir.vblrx.com/news-releases/news-release-details/vbl-therapeutics-announces-launch-new-clinical-trial-vb-111