Past a turning point, Finch scores $90M to complete the final stretch for oral microbiome therapy
Back in 2017, Finch Therapeutics was born, shrouded in the ashes of an implosion at Seres Therapeutics that clouded the whole microbiome field. But co-founder Mark Smith managed to pool together some angel money and a $5.5 million Series A before landing $10 million upfront from a pact with Takeda.
Smith slowly attracted more believers — racking up a breakthrough therapy designation, grabbing a new lead program through a merger with Crestovo, expanding the Takeda partnership — and brought in $53 million in Series B cash to fund a crucial Phase II study.
The data came in June, right ahead of the deadline Smith has set for his team. And they were positive.
That triggered a phase shift, Smith said. Even investors who have been sitting on the sidelines are chiming in for a $90 million C round, designed to propel Finch into the final confirmatory study and get the commercial-scale manufacturing setup in place.
“We’ve been really building up to this summer for quite a long time,” he told Endpoints News. “Now all of a sudden everyone is like, ‘Oh wait, this could be the next big modality, we want to make sure we don’t miss it.’”
Next stop: A second trial testing CP101 in C. difficile to confirm that the oral capsule can indeed cure patients and prevent the infection from returning, up to eight weeks. Slated for the first half of 2021, the study will likely have a similar design and size with PRISM-3 — where, among 206 patients, those given CP101 had a 74.5% chance of recurrence-free bacteria clearance versus 61.5% on the placebo arm.
Almost a decade into a career entrenched in the microbiome (starting with the stool bank OpenBiome), Smith sees Finch’s data contributing to a turning point for the idea that one can pack all the benefits of a fecal microbiota transplant (FMT) into a pill and skip the cumbersome procedure. Having clinical data behind FMT is a “unique superpower” — but the challenge has been to preserve those benefits in the translation process.
Seres took more risk, Smith suggested, in going fast. The scientists there had selected certain bacteria that they thought had the best effects to make their drug candidate — which failed a Phase II.
In contrast, Finch takes the entire community of bacteria present in donor samples and, after screening for pathogens, freeze-dries the material, mills it, and puts the resulting powder in a capsule. And unlike with blood products, where you need 330,000 donors to deliver a million units of blood, Smith said it only takes 2,000 donors to make a million units of CP-101 — which patients only need to take once, at least for C. diff.
For its part, Seres concluded that misdiagnosis contributed to the failure, and just recently claimed a comeback with a new Phase III readout that they said should take them straight to the FDA.
To be sure, Finch isn’t ruling out the potential value of isolating individual bacteria and growing them artificially. CP101 is their only full spectrum product, Smith pointed out. Both the ulcerative colitis and Crohn’s compounds in the Takeda collaboration are “rationally designed,” consisting of individual organisms that appear to be driving positive outcomes across clinical studies of FMT.
Then there’s FIN-211, the hybrid program for autistic constipation that combines CP101 with a special strain, not found in most donor samples, that seemed important in inducing oxytocin production in the lab.
The first-in-human study should take place later in 2021, following another trial for CP101 in chronic hepatitis B. Emerging research in the gut-brain axis suggests FIN-211 might have an impact on behavioral symptoms of autism — something Smith said Finch would monitor as they stay close to their roots in GI.
“The way I think about this space in general, I sort of see this journey of reductionism where we’re gonna start off with, OK, just take the entire intact community from a healthy donor, deliver that to patients, see if that works. Over time, we’ll identify the individual bugs that make it work, isolate those, develop those as therapies. and maybe someday we’ll figure out the specific effector molecules that are driving those effects and deliver those as third generation products,” he said. “We want to crawl before we walk before we run.”