Evelo Biosciences, Inc. (EVLO) Q3 2020 Earnings Call

Investor webinar replay

Replay transcript excerpt

very interesting and would in principle support potentially going to later stage clinical trials. Obviously, if we see something at a lower level, then it potentially is still interesting in terms of supporting activation of systemic immunity consistent with what I've just described. So that's what we're waiting for there. Let me pass over to Mark who can talk about maybe I'd suggest Mark do the EV response first and then you can respond on neuro-inflam and if there's anything you don't get to, Duncan can talk about neuro-inflam. Sure. Hello, Chris. Mark here. The drug product is a natural component of the fermentation. It's the part we normally throw away because the extracellular vesicles are shed from the bacteria into the medium. Rather than harvesting the cells, We harvest the medium and we purify it by a mixture of centrifugation and filtration. It's fairly straightforward. I'm going to answer your questions about purity and content in a regulatory context because I suspect that's part of what you have in mind in asking it. And we have discussed these questions with regulatory authorities both in the U.S. and in the U.K. with very positive outcomes because they recognized that the extracellular vesicles were part of or likely to be part of the types of products that we are already using in the clinic as whole microbes. So actually the preclinical development requirements we have for EVs at the moment don't look to be any different for the microbes, which is hugely beneficial because as you'll recall, we haven't had to do preclinical toxicology testing. And because these are natural products, orally delivered, the requirements for purity are completely different than they would be, for instance, if we were making a mammalian exosome and trying to inject it intra...