NEW YORK – Vedanta Biosciences announced on Tuesday that it would kick off the first-in-patient clinical study of VE800 in combination with Bristol-Myers Squibb's nivolumab (Opdivo) in patients with advanced or metastatic melanoma, gastric or gastroesophageal junction adenocarcinoma, or microsatellite-stable colorectal cancer.
Vedanta is a clinical-stage biopharmaceutical company focused on creating treatments for immune-related diseases using human microbiome-derived bacteria.
VE800 is a compound comprised of 11 bacterial strains that can activate cytotoxic CD8+ T-cells and improve their ability to invade tumors and suppress their growth. Nivolumab is Bristol-Myers Squibb's commercial programmed death-1 (PD-1) immune checkpoint inhibitor. By blocking the PD-1 protein found on T-cells, nivolumab can help the immune system kill cancer cells.
In preclinical studies, VE800's anti-tumor ability appeared to be enhanced when it was administered with PD-1 or CTLA4 immune checkpoint inhibitors.
The study, which will be open-label and non-randomized, aims to enroll over 100 patients diagnosed with various types of advanced metastatic cancers. It will evaluate the safety and tolerability of the drug combination in participants as well as the overall response rate to treatment. Vedanta expects to announce topline results from the trial in 2021.
"The role the gut microbiota plays in influencing responses to immunotherapies has been ignored by previous approaches," Vedanta CEO Bernat Olle said in a statement. "We are excited about the potential of microbiome modulation to open up an entirely new approach to cancer therapy."
This is the first clinical study to use a bacterial cocktail to treat cancer, Cambridge, Massachusetts-based Vedanta said.