Vedanta Biosciences, Inc. has unveiled the initiation of a first-in-patient clinical study of VE800 in combination with Bristol-Myers Squibb's programmed death-1 (PD-1) immune checkpoint inhibitor Opdivo (nivolumab) in patients with select types of advanced or metastatic cancer. Vedanta also announced the formation of its Immuno-Oncology Scientific Advisory Board (SAB), which is comprised of experts in immunology, immuno-oncology and the microbiome, to support the planned clinical development of VE800.
The study, which is being conducted at clinical centers in the United States, will evaluate the safety and tolerability and clinical activity of VE800 in combination with Opdivo, as measured by the confirmed overall response rate, in addition to other parameters. The open-label, non- randomized study will target enrollment of over 100 patients diagnosed with advanced or metastatic melanoma, gastric/gastroesophageal junction adenocarcinoma, or microsatellite-stable colorectal cancer. Eligible patients will receive daily VE800 dosing in combination with Opdivo. Topline results are anticipated in 2021.
VE800 is made up of 11 commensal bacterial strains that act in concert to activate cytotoxic CD8+ T cells, which are the vanguard of the immune system's response to tumors and thus a key driver of effective immunotherapies. In preclinical studies, VE800 has been shown to enhance the ability of these T cells to infiltrate tumors, thereby promoting suppression of tumor growth and potentially enhancing survival. Preclinical data also suggest that VE800 may enhance the effects of checkpoint inhibitors.
Foundational work demonstrating VE800's novel anti-tumor activity and cooperatively potentiated responses to checkpoint inhibitor therapies and various immune challenges was published in Nature by Vedanta and its scientific co-founder Kenya Honda, M.D., Ph.D., of Keio University School of Medicine. The research also showed that mice colonized with...