VBL Therapeutics has initiated a Phase II clinical trial of a VB-111 and Opdivo (nivolumab) combination to treat patients with metastatic colorectal cancer (CRC).

VB-111, also called ofranergene obadenovec, is a gene therapy being developed to treat various solid tumours, while nivolumab is a human monoclonal antibody targeting PD-1.

The open-label, single-arm Phase II trial will assess the safety and tolerability of the combination in patients with refractory, metastatic CRC. It aims to determine if the anti-tumour immunity triggered by VB-111 can be boosted by PD-1 inhibition.

Treatment with VB-111 is expected to stimulate immune cells to enter the tumour, turning the colorectal tumour from immunologically ‘cold’ to ‘hot.’ The further addition of nivolumab may boost the anti-tumour immune response.

The trial will also track efficacy endpoints including best overall response, along with immunological and histologic analysis using tumour biopsies.

This study will be funded by the National Cancer Institute (NCI), which signed a cooperative research and development agreement with VBL.

VBL Therapeutics CEO Dror Harats said: “This Phase II study is part of our strategy to broaden the potential indications for VB-111 and to explore its activity as part of combination therapies.

“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 tumour following treatment with VB-111, turning the tumour ‘hot’.”

Last month, the company published clinical data from the Phase II and Phase III studies of VB-111 in recurrent glioblastoma (rGBM). Results were published in the peer-reviewed medical journal Neuro-Oncology.

VB-111 is also currently being studied in a Phase III study in ovarian cancer.