Mark Smith (Finch)

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.”

5AM Ven­tures: Fu­el­ing the Next Gen­er­a­tion of In­no­va­tors

By RBC Capital Markets
With Andy Schwab, Co-Founder and Managing Partner at 5AM Ventures

Key Points

Prescription Digital Therapeutics, cell therapy technologies, and in silico medicines will be a vital part of future treatment modalities.
Unlocking the potential of the microbiome could be the missing link to better disease diagnosis.
Growing links between academia, industry, and venture capital are spinning out more innovative biotech companies.
Biotech is now seen by investors as a growth space as well as a safe haven, fuelling the recent IPO boom.

Janet Woodcock (AP Images)

End­points poll: Janet Wood­cock takes the (in­ter­im) helm at the FDA. And a large ma­jor­i­ty of our read­ers want her to stay there

It’s official: Janet Woodcock is now the acting chief of the FDA.

And — according to an Endpoints poll — most industry readers would like her to stay there, although a significant minority is strongly opposed.

To recap: Joe Biden is reportedly choosing between Woodcock and former deputy FDA commissioner Joshua Sharfstein as his nominee for the permanent position. Given their respective track records, the decision is set to determine the agency’s lodestar for years to come.

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What’s next for End­points — and how to sup­port our in­de­pen­dent bio­phar­ma news mis­sion

The firehose of biopharma news is gushing these days.

That’s why broader and deeper is the theme for 2021 at Endpoints. You can expect new coverage outside our core R&D focus, with deeper reporting in some key areas. When John Carroll and I launched Endpoints nearly five years ago, we were wading in waist-high waters. Now we’re a team of 25 full-time staffers (and growing) with plans to cover the flood of biopharma news, Endpoints-style.

Mike Grey, Plexium chairman (Horizon Therapeutics)

Plex­i­um adds in­dus­try vet Mike Grey to the brain trust with new in­vestor cash fund­ing its pro­tein degra­da­tion play

About 15 months since closing a $28 million Series A, a San Diego protein-degradation upstart returned to the venture well Thursday with an extension of that round and some new hires, including one of the city’s best-connected biotech execs.

Plexium has bagged an additional $35 million in financing, the biotech said, money that will push undisclosed oncology and immuno-oncology programs into the clinic. In addition, longtime industry vet Mike Grey is jumping on as chairman of the board, and two others from Thursday’s leads — Adam Goulburn from Lux Capital and Rob Hopfner from Pivotal BioVentures — joined the board too.

Eli Lil­ly's an­ti­body cuts risk of Covid-19 by up to 80% among the most vul­ner­a­ble — but will it have a place next to vac­cines?

Eli Lilly says bamlanivimab lowered the risk of contracting symptomatic Covid-19 in a first-of-its-kind trial involving nursing home residents and staff, paving the way for a new option to protect against the virus.

But how big of an impact it might have, and what role it will play, at a time vaccines are being rolled out to the exact population it is targeting still remains unclear.

Among 965 participants in the study — all of whom tested negative for the coronavirus at baseline — the number of symptomatic cases reported in the bamlanivimab arm was 57% lower than that in the placebo arm (odds ratio 0.43, p=0.00021). In addition to that primary endpoint, all secondary endpoints reached statistical significance.

Michelle McMurry-Heath, BIO CEO (BIO via YouTube)

BIO looks to re­struc­ture, lay­ing off staff amid chal­lenge to the trade org's nor­mal face-to-face style

The biopharma industry, on the whole, had a red-letter year in 2020 amid Covid-19, with fundraising at an all-time high and major players speeding vaccines ahead to approval. But for BIO, the industry’s leading trade organization, the pandemic has prompted a reconsideration of the game plan.

BIO will pivot to digital as the Covid-19 pandemic continues to rage, making “some staff reductions” as it looks to bring its roughly 37,000 in-person meetings each year to the web, the organization said Thursday.

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Covid-19 roundup: Italy won­ders aloud if it can sue Pfiz­er for vac­cine short­falls; US recom­mits to WHO un­der Biden ad­min­is­tra­tion

As reports crop up that deliveries of Pfizer and BioNTech’s Covid-19 vaccine are being unexpectedly cut, Italy wonders if it can take the vaccine developers to court, according to the Wall Street Journal. 

After its shipment for this week was cut by 29%, the Italian government consulted its attorney general about taking legal action, the WSJ reported. Pfizer and BioNTech had warned the EU and Canada last week that their allocations would be reduced as Pfizer upgrades its Belgium factory. What Italy says it doesn’t appreciate, though, is the short notice.

Hal Barron, GSK R&D chief (GSK via YouTube)

Glax­o­SmithK­line's $4B bis­pe­cif­ic can­cer drug al­liance with Mer­ck KGaA hit by big set­back with a PhI­II fail­ure on NSCLC

Close to 2 years ago, GSK’s R&D team eagerly agreed to pay up to $4 billion-plus to ally itself with Merck KGaA on a mid-stage bispecific called bintrafusp alfa, which intrigued them with the combination of a TGF-β trap with the anti-PD-L1 mechanism in one fusion protein.

But today the German pharma company says that their lead study on lung cancer was a bust, as independent monitors said there was no reason to believe that the experimental drug — targeting PD-L1/TGF-Beta — could beat Keytruda.

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Janet Woodcock and Joshua Sharfstein (AP, Images)

Poll: Should Joshua Sharf­stein or Janet Wood­cock lead the FDA from here?

It’s time for a new FDA commissioner to come on board, a rite of passage for Joe Biden’s administration that should help seal the new president’s rep on seeking out the experts to lead the government over the next 4 years.

As of now, the competition for the top job appears to have narrowed down to 2 people: The longtime CDER chief Janet Woodcock and Joshua Sharfstein, the former principal deputy at the FDA under Peggy Hamburg. Both were appointed by Barack Obama.