Bristol-Myers Squibb Company (NYSE: BMY) and Vedanta Biosciences announced on 12/10/18 a clinical trial collaboration to evaluate Bristol-Myers Squibb's programmed death-1 (PD-1) immune checkpoint inhibitor Opdivo (nivolumab) in combination with Vedanta Biosciences’ VE800, a rationally-defined human bacterial consortium, in patients with advanced or metastatic cancers.
In a range of preclinical models of cancer, including those sensitive and resistant to checkpoint inhibition, VE800 was shown to induce CD8+ T cells, potentiate the immune system’s attack of tumor cells, and significantly amplify the effects of anti-PD-1 therapy. These models support clinical research to explore whether modulating the microbiome with VE800 has the potential to broaden the efficacy of checkpoint inhibitors.
“Our lead, microbiome-based immuno-oncology candidate, VE800, is based on work conducted in collaboration with our co-founder, Dr. Kenya Honda, showing in preclinical models that certain gut-dwelling bacterial strains potentiate cytotoxic CD8+ T cells and enhance infiltration into tumors,” said Bernat Olle, Ph.D., Co-founder and Chief Executive Officer of Vedanta Biosciences. “Through this collaboration our goal is to determine whether VE800 in combination with Opdivo can improve outcomes for patients with advanced or metastatic cancers.”
“Checkpoint inhibitors, particularly PD-1 antibodies, have been a major advance in cancer therapy; however, a large proportion of patients either do not respond or have response of brief duration to those new therapies,” said Jeffrey Weber, M.D., Ph.D., Deputy Director, Laura and Isaac Perlmutter Cancer Center and Professor of Medicine, NYU Langone Health. “Alteration of the gut microbiome could play a significant role in enhancing the effectiveness of checkpoint inhibitors, and with increased understanding may also be used to select for patients who would benefit most from these immunotherapies.”
In conjunction with this collaboration, and subject to the completion of due diligence, the negotiation by the parties of definitive transaction agreements and the receipt by Bristol-Myers Squibb of all requisite approvals, Bristol-Myers Squibb currently intends to make an equity investment in Vedanta Biosciences. Vedanta Biosciences will maintain control of its VE800 program, including global R&D and commercial rights.
Vedanta currently has four products in development. Their programs seek to address serious infectious, immune, and other diseases by using defined consortia of immune-modulating bacteria that restore colonization resistance against gut pathogens and stimulate protective immune responses.