Vedanta Biosciences

Fierce 15

Snagging the first major pharma microbiome deal with Johnson & Johnson and slated to head into the clinic next year with the pharma and on its own

CEO: Bernat Olle
Based: Cambridge, MA
Founded: 2010
Clinical focus: Microbiome

The scoop: The microbiome is complex, mysterious--and subtle. Most industry observers expect that may mean a difficult development path as biotechs work to sort out how to use microbiome-based therapeutics to treat diseases.

Startup Vedanta is a gut microbiome play that PureTech created after years of meditating on the current state of research. It got a major partnership with Johnson & Johnson in 2014 that’s now ready to advance an irritable bowel disease (IBD) candidate into the clinic during the first half of next year. Vedanta also expects to progress an infectious disease program into the clinic in the same time frame.

“Our relationship with Johnson & Johnson was facilitated by the local Boston J&J Innovation Center team,” Vedanta CEO Bernat Olle told FierceBiotech. "They had a shared interest in immunology and IBD. It has an important IBD franchise in Remicade; they have lots of clinical development capabilities in IBD and a big presence in immunology in general.”

The deal includes an investment from J&J, as well as upfront and potential milestone payments of up to $339 million.

Olle continued, “We were in discussions with them and other pharmas. They had a lot of interest around VE-202, optimized microbes in the Clostridium genus that’s been shown to be useful to treat and prevent IBD in preclinical models. This was the package that piqued the interest of Johnson & Johnson. We moved forward into manufacturing and the next step is a first-in-human trial.”

“It is, in my opinion, the pharma company that’s been the most serious about the microbiome to date,” he added. In fact, J&J has created the Janssen Human Microbiome Institute specifically to pursue such research. It has centers in Cambridge, MA, and Beerse, Belgium.

What makes Vedanta Fierce: Vedanta expects to be able to manipulate the microbiome to have an effect on immune responses. Not only is it focused on autoimmune and infectious disease indications, but now it’s also expanding into cancer.

“The microbiome is affecting metabolism, the ability to resist infection, and it plays a role in cancer. This is where I feel some of the highest caliber scientific work is coming from,” Olle said.

He sees cancer as a natural extension for the startup--and like many, Vedanta hopes to play a role in boosting immuno-oncology.

“The microbiome can promote stronger immune responses. This could be an avenue to improve the efficacy of cancer immunotherapy,” Olle said. “By leveraging the microbiome, we are stimulating these immune cells in the intestine, we could potentially enhance checkpoint inhibitors. That’s one of the hypotheses we want to test in this field.”

In August, Vedanta did a deal with NYU Langone Medical Center specifically to explore the mechanisms by which the gut microbiome influences checkpoint inhibitor efficacy in cancer treatment.

Microbiome competitor Seres suffered a Phase II setback with its candidate to cut the risk of Clostridium difficile infection. Olle notes that using fecal donations as a source, as the Seres candidate did, is very crude and that Vedanta uses cultures that start from pure cell banks. He added that there were substantial changes in the Seres clinical trial design between Phase I and Phase II.

Microbiome-based candidates have previously shown substantial efficacy in the clinic in infectious disease, Olle argued, and even fecal transplants have shown efficacy in IBD that’s comparable to the standard anti-TNF drugs.

Investors: PureTech Health, Johnson & Johnson, Rock Springs Capital, Invesco Asset Management and Health For Life Capital (Seventure)

Vedanta Biosciences