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.”

Biotech and Big Phar­ma: A blue­print for a suc­cess­ful part­ner­ship

Strategic partnerships have long been an important contributor to how drugs are discovered and developed. For decades, big pharma companies have been forming alliances with biotech innovators to increase R&D productivity, expand geographical reach and better manage late-stage commercialization costs.

Noël Brown, Managing Director and Head of Biotechnology Investment Banking, and Greg Wiederrecht, Ph.D., Managing Director in the Global Healthcare Investment Banking Group at RBC Capital Markets, are no strangers to the importance of these tie-ups. Noël has over 20 years of investment banking experience in the industry. Before moving to the banking world in 2015, Greg was the Vice President and Head of External Scientific Affairs (ESA) at Merck, where he was responsible for the scientific assessment of strategic partnership opportunities worldwide.

No­var­tis' sec­ond at­tempt to repli­cate a stun­ning can­cer re­sult falls flat

Novartis’ hopes of turning one of the most surprising trial data points of the last decade into a lung cancer drug has taken another setback.

The Swiss pharma announced Monday that its IL-1 inhibitor canakinumab did not significantly extend the lives or slow the disease progression of patients with previously untreated locally advanced or metastatic non-small cell lung cancer when compared to standard of-care alone.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 120,600+ biopharma pros reading Endpoints daily — and it's free.

Robert Califf (Pablo Martinez Monsivais, AP Images, File)

As buzz on Califf FDA nom heats up, in­dus­try and agency in­sid­ers of­fer a strong nod for the ‘per­fect’ choice

For once in this long, dramatic road to finding a new FDA commissioner, there’s been some continuity. Both CNN and Politico reported this weekend that Rob Califf met with President Biden to discuss the permanent commish role, following earlier news broken by the Washington Post that all signs point to Califf.

Although there may be a few Democrats who continue to grandstand about the dangers of COI (Califf has worked for Verily, sits on the board of Centessa Pharmaceuticals, and has other ties to industry research), with the pandemic ongoing and the need for some kind of continuity at FDA mounting, Califf is likely to meet the same fate as when he first won Senate confirmation in 2016, by a vote of 89-4 — Bernie Sanders and 6 others didn’t vote.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 120,600+ biopharma pros reading Endpoints daily — and it's free.

AstraZeneca CEO Pascal Soriot (Raphael Lafargue/Abaca/Sipa USA)

A com­bo of As­traZeneca's Imfinzi and chemo wins where oth­ers have failed in piv­otal bil­iary tract test

Looking to run with the big dogs in the PD-(L)1 class, AstraZeneca’s Imfinzi has a tall hill to climb to compete in an increasingly bustling market. An aggressive combo strategy for the drug has paid off so far, and now AstraZeneca is adding another notch to its belt.

A combo of Imfinzi (durvalumab) and chemotherapy significantly extended the lives of first-line patients with advanced biliary tract cancer over chemo alone, according to topline results from the Phase III TOPAZ-1 study revealed Monday.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 120,600+ biopharma pros reading Endpoints daily — and it's free.

Sean Ianchulev, Eyenovia CEO and CMO

Re­cent court de­ci­sion push­es FDA to re­ject and re­clas­si­fy drug-de­vice com­bo, crush­ing shares

Back in April, the FDA lost a crucial court case in which its broad discretion of regulating medical products that might satisfy the legal definitions of either “drug” and/or “medical device” was sharply curtailed.

In addition to the appeals court ruling that Genus Medical Technologies’ contrast agent barium sulfate (aka Vanilla SilQ) should not be considered a drug, as the FDA had initially ruled, but as a medical device, the agency also was forced to spell out which drugs would transition to devices as a result of the ruling.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 120,600+ biopharma pros reading Endpoints daily — and it's free.

Peter Greenleaf, Aurinia CEO

Af­ter pass­ing on Ac­celeron, Bris­tol My­ers eyes bolt-on ac­qui­si­tion of au­toim­mune spe­cial­ist — re­port

Bristol Myers Squibb is looking to beef up its autoimmune portfolio by scooping up Aurinia Pharmaceuticals, Bloomberg reported.

The recent overtures to Aurinia, relayed by anonymous insiders, came just as Bristol Myers turned down buyout talks with partners at Acceleron — which Merck ultimately struck a deal to acquire for $11.5 billion. Bristol Myers has reportedly decided to cash out on its minority stake, likely bagging $1.3 billion in the process, while keeping the royalty deals on two of Acceleron’s blood disorder drugs.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 120,600+ biopharma pros reading Endpoints daily — and it's free.

So — that pig-to-hu­man trans­plant; Po­ten­tial di­a­betes cure reach­es pa­tient; Ac­cused MIT sci­en­tist lash­es back; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

We’re incredibly excited to welcome Beth Bulik, seasoned pharma marketing reporter, to the team. You can find much of her work in our new Marketing channel — and in her weekly newsletter, Endpoints PharmaRx, which will launch in early November. Add it to your subscriptions here.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 120,600+ biopharma pros reading Endpoints daily — and it's free.

NYU surgeon transplants an engineered pig kidney into the outside of a brain-dead patient (Joe Carrotta/NYU Langone Health)

No, sci­en­tists are not any clos­er to pig-to-hu­man trans­plants than they were last week

Steve Holtzman was awoken by a 1 a.m. call from a doctor at Duke University asking if he could put some pigs on a plane and fly them from Ohio to North Carolina that day. A motorcyclist had gotten into a horrific crash, the doctor explained. He believed the pigs’ livers, sutured onto the patient’s skin like an external filter, might be able to tide the young man over until a donor liver became available.

UP­DAT­ED: Agenus calls out FDA for play­ing fa­vorites with Mer­ck, pulls cer­vi­cal can­cer BLA at agen­cy's re­quest

While criticizing the FDA for what may be some favoritism towards Merck, Agenus on Friday officially pulled its accelerated BLA for its anti-PD-1 inhibitor balstilimab as a potential second-line treatment for cervical cancer because of the recent full approval for Merck’s Keytruda in the same indication.

The company said the BLA, which was due for an FDA decision by Dec. 16, was withdrawn “when the window for accelerated approval of balstilimab closed,” thanks to the conversion of Keytruda’s accelerated approval to a full approval four months prior to its PDUFA date.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 120,600+ biopharma pros reading Endpoints daily — and it's free.