BERNAT OLLE, CEO,

VEDANTA BIOSCIENCES

"Our ultimate vision is to enable defined consortia of bacteria as a new drug modality, in the same way that Genentech enabled protein biologics and Alnylam enabled RNAi therapies as new modalities."

What was the inspiration behind establishing Vedanta Biosciences?

A few years ago, I was part of a private venture creation team at PureTech, who had funding to start projects in new areas of science. I became very interested in the human microbiome field because I had seen several interesting research publications, including some that suggested that immune system responses can be calibrated by microbes that live in the intestine. There was also research showing that the gut microbiota could influence how we resist infection and certain metabolic processes, such as how much energy we harvest from food and ultimately how much weight we gain. Around the same time, the NIH declared the Human Microbiome Project, where investments of public funds were made available for the cartographic work of establishing what bacteria live in the intestine and what they do. This work provided a foundation of knowledge that our industry has been built upon. I then thought it would be an interesting idea to explore establishing a company in this field and I reached out to academic researchers who had been doing, in my view, the pioneering work to help understand how microbes in the intestine shape immune responses. Together, we discussed what aspects of microbiome work we thought could make the biggest impact in medicine, analyzed many technologies, and ultimately formulated a vision for what would become Vedanta.

We decided to focus on how microbes in the intestine shape immune responses, and from a modality point of view, we focused on using defined consortia of bacteria. We can screen libraries of bacterial isolates just like a pharmaceutical company would screen their library of small molecules to identify the best potential bacterial components for a product, and then assemble them as a consortium. We found that if you pick the right combination of bacteria, you can consistently surpass the potency of any given individual bacterial strain.

How does Vedanta’s VE202 compare to Seres Therapeutics’ SER-287?

VE202 is a standardized product. There is no donor step in VE202. We start from clonal cell banks of bacteria that are sitting in a freezer, which we then expand by fermentation to create a product that is always going to have the exact same composition, potency and dose. We can also make sure the drug does not carry any pathogens because we deliberately only include the specific bacteria that we want to allow in the product. Importantly, by producing the drug by fermentation, we can scale up the production to make as much as we need at a much lower cost of goods than a donor-derived procedure.

How do Vedanta’s partnerships with BARDA and the Gates Foundation illustrate the scalability of defined consortia of bacteria?

BARDA and the Gates Foundation care about scalability, among other considerations. For a product to be considered for addition to the National Strategic Stockpile, or for use in the developing world, one has to imagine a path to produce a fairly large number of doses at a cost that is not prohibitive. That is something that we believe we can do very effectively with our approach. We are the company that has pioneered this standardized product type of approach to the microbiome with defined consortia of bacteria.

What is your long term vision for Vedanta?

Our ultimate vision is to enable defined consortia of bacteria as a new drug modality, in the same way that Genentech enabled protein biologics and Alnylam enabled RNAi therapies as new modalities. Since inception, we have been relentlessly removing the technical risks involved in making the modality a reality: we first showed how to rationally select a drug candidate based on a defined bacterial consortium. We then developed the technical capabilities in-house to be able to manufacture GMP-grade defined consortia for use in human studies. Later, we conducted several PK-PD studies in humans to map out a rational way to select a dosing regimen for such a new modality. Now, we are testing the efficacy of these dosing regimens in patients in Phase 2 studies. All of those are logical steps to follow to remove the risks inherent in a new modality. We have applied the learnings across our pipeline, with multiple programs in infectious and immune diseases now in the clinic.