Vedanta Biosciences’ three-year-old collaboration with Johnson & Johnson on microbiome therapies has moved to the clinical stage, triggering a $12 million milestone payment.
The first healthy volunteers are now being treated in a phase 1 trial of VE202, a bacteria-based treatment for inflammatory bowel disease (IBD) that was the centerpiece of the two companies’ 2015 pact focused on the microbiome—the population of gut bacteria that when out of balance are thought to play a role in many diseases.
J&J’s Janssen division is taking the lead on the clinical development of VE202, which is based on the hypothesis that IBD patients deficient in Clostridia bacteria in the gut lack the T-regulatory cell component necessary for controlling inflammation.
Delivering ‘consortia’ of live bacterial strains that can colonize the gut can overcome this deficiency, says the biotech, stimulating T-reg activity that in turn dampens down that inflammatory response and should give IBD patients relief from symptoms.
Vedanta CEO Bernat Olle, Ph.D., thinks his company is the first to start trials of a “rationally defined bacterial consortium”—as opposed to probiotic supplements—in an autoimmune disease.
He also reckons VE202 could have advantages over current drugs for IBD, as well as fecal microbiota transplants (FMT) that have shown varying clinical success, likely due to inconsistencies in their composition.
“There is significant evidence highlighting the role of the microbiome in the pathogenesis of IBD,” according to Olle. “Current treatments effectively block mediators of inflammation, but they do not address the underlying alterations in the gut microbiota that may be driving the inflammation in the first place, leaving a need for safe approaches that address this aspect of the disease.”
When the deal with J&J was first announced, the financial terms were set at an undisclosed upfront payment and $241 million in milestones, and Vedanta now says the collaboration includes development and commercialization milestone payments of up to a total of $339 million, in addition to royalties.
J&J first came across Vedanta via its innovation center in Boston, one of a series of incubators around the world that were set up to get close to companies in biotech hot spots and unlock licensing opportunities.