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.”

Un­lock­ing ESG strate­gies for growth with Gilead Sci­ences

RBC Capital Markets explores what is material in ESG for biopharma companies with the ESG leads at Gilead Sciences. Gilead has long focused on sustainability but recognized a more robust framework was needed. Based on a materiality assessment, Gilead’s ESG strategy today focuses first on drug access and pricing, while also addressing D&I and climate change. Find out why Gilead’s board is “acutely aware” of the contribution that ESG makes to firm’s overall success.

What con­tro­ver­sy? Eli Lil­ly plots Alzheimer's BLA fil­ing lat­er this year as FDA taps more an­ti-amy­loid drugs as break­throughs

The FDA is keeping the good news coming for Alzheimer’s drug developers. And Eli Lilly is taking them up on it.

Amid continued controversy around whether Biogen’s new flagship drug, Aduhelm, should have been approved at all — and swelling, heated debates surrounding its $56,000 price tag — the agency had no issue handing them and their Japanese partner Eisai a breakthrough therapy designation for a second anti-amyloid beta antibody, lecanemab, late Wednesday.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 110,100+ biopharma pros reading Endpoints daily — and it's free.

Hervé Hoppenot, Incyte CEO (Jeff Rumans)

ODAC echoes FDA con­cern over In­cyte PD-1, as Paz­dur sig­nals broad­er shift for ac­cel­er­at­ed ap­proval

After the FDA lambasted their PD-1 ahead of an adcomm earlier this week, Incyte ran into new trouble Thursday as ODAC panelists voted against an accelerated OK by a wide margin.

Members of the Oncologic Drugs Advisory Committee recommended with a 13-4 vote to defer a regulatory decision on Incyte’s retifanlimab until after more data can be collected from a placebo-controlled trial. The PD-1 therapy is due for a PDUFA date in late July after receiving priority review earlier this year.

From left: Rajul Jain, Stefan Vitorovic, Arjun Goyal, Arie Belldegrun, Jean-Philippe (JP) Kouakou-Zebouah, Helen Kim

Arie Bellde­grun's Vi­da Ven­tures goes back to the well with $825M mega­fund and its eyes set on more in­no­v­a­tive meds

Among the list of bright names in biopharma, few shine brighter than Kite founder and serial entrepreneur Arie Belldegrun, who has rattled off a remarkable run of success in recent years. Now, a Belldegrun investment team is locking up a massive third fund to keep chasing the cutting edge in therapeutics.

Vida Ventures closed its third investment fund at a whopping $825 million — its largest yet — as the ever-expanding VC firm hits 30 companies in its portfolio developing new routes to hard-to-treat diseases, the company said Thursday.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 110,100+ biopharma pros reading Endpoints daily — and it's free.

New FDA doc­u­ments show in­ter­nal dis­sent on Aduhelm ap­proval

In a lengthy review document and a pair of memos from top officials, the FDA released on Tuesday night its most detailed argument yet for approving Biogen’s intensely controversial Alzheimer’s drug aducanumab.

The documents amount to an agency attempt to quench the firestorm their decision kindled, as outside advisors members resigned and experts warned that an unproven drug now could stretch Medicare’s budget to a breaking point. Ultimately, the documents show how CDER director Patrizia Cavazzoni and Office of New Drugs director Peter Stein both concurred with FDA neuroscience head Billy Dunn on the accelerated approval while the staff at FDA’s Office of Biostatistics did not think an approval was warranted.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 110,100+ biopharma pros reading Endpoints daily — and it's free.

Karen Flynn, Catalent

Q&A: When the pan­dem­ic struck, Catal­en­t's CCO had just joined the team

Karen Flynn came aboard Catalent’s team just in time.

The company was going through a surge of changes, and she had been brought over from her role as CCO of West Pharmaceutical Services to serve in the same capacity for the New Jersey-based CDMO. Then a few months later, the pandemic was in full-force.

Since then, Catalent’s been in hyper-expansion mode. In early May, it acquired Promethera’s Hepatic Cell Therapy Support SA subsidiary and its 32,40-square-foot facility in Gosselies, Belgium. Prior to that, the company acquired Belgian CDMO Delphi Genetics, wrapped up the expansion of an already-existing site in Madison, WI and added an ultra-low temperature freezer partner in Sterling. As Emergent has botched millions of doses of AstraZeneca’s vaccine, the company has swooped in to move that production to its Maryland plant as well.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 110,100+ biopharma pros reading Endpoints daily — and it's free.

Richard Pazdur (vis AACR)

FDA en­cour­ages in­clud­ing in­cur­able can­cer pa­tients in tri­als, re­gard­less of pri­or ther­a­pies

The FDA on Thursday called to include those with incurable cancers (when there is no potential for cure or for prolonged/near normal survival) in appropriate clinical trials, regardless of whether they have received existing alternative treatments.

Historically, many cancer clinical trials have required that participating patients previously received multiple therapies, according to Richard Pazdur, director of the FDA’s Oncology Center of Excellence.

On heels of Aduhelm ap­proval, Bris­tol My­ers jumps back in­to Alzheimer's race

Bristol Myers Squibb last put major resources behind an Alzheimer’s drug nearly a decade ago, when their own attempt at targeting amyloid flamed out in mid-stage studies. They invented another molecule, a Tau-targeted antibody, but jettisoned it to Biogen in 2017 as they dropped out of neuroscience altogether.

But on Thursday, the New York pharma announced they were getting back in the game. Bristol Myers exercised an $80 million option to bring a tau-targeted antibody from Prothena into a Phase I study. The opt-in, which Bristol Myers triggered ahead of analyst expectations, opens the door for another $1.7 billion in milestones down the road.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 110,100+ biopharma pros reading Endpoints daily — and it's free.

James Peyer, Cambrian

Can a cell ther­a­py treat mus­cu­lar dy­s­tro­phy? A Ger­man bil­lion­aire's an­ti-ag­ing start­up is try­ing to find out

Gene therapy companies have faced huge hurdles trying to deliver healthy genes into muscular dystrophy patients’ muscle cells, so here’s an idea: Why don’t we just replace the muscle cells themselves?

Over the last two years, Vita Therapeutics has been exploring that possibility, building on early stem cell work from Johns Hopkins professor Peter Andersen. And on Tuesday they announced a $32 million Series A to begin to move their first therapy into the clinic, where they hope it will help rebuild muscle in patients with a type of dystrophy that afflicts the arms and legs.