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.”

Op­ti­miz­ing Cell and Gene Ther­a­py De­vel­op­ment and Pro­duc­tion: How Tech­nol­o­gy Providers Like Corn­ing Life Sci­ences are Spurring In­no­va­tion

Remarkable advances in cell and gene therapy over the last decade offer unprecedented therapeutic promise and bring new hope for many patients facing diseases once thought incurable. However, for cell and gene therapies to reach their full potential, researchers, manufacturers, life science companies, and academics will need to work together to solve the significant challenges facing the industry.

Pfiz­er, Sarep­ta and two oth­ers sug­gest Duchenne drug safe­ty is­sues tied to "class ef­fect"

Since the first experimental Duchenne gene therapy programs came about, the space has proven rife with safety issues and patient deaths in clinical trials. Pfizer and three biotechs now think they’ve found a reason why.

The four companies suggested there may be a “class effect” causing the adverse events in Duchenne gene therapies, they wrote in a new study. They specifically highlighted how side effects in five patients across three trials, who all showed muscle weakness with cardiac involvement, were “strikingly similar.”

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Pre­sent­ing a live End­points News event: Man­ag­ing a biotech in tur­bu­lent times

Biotech is one of the smartest, best educated industries on the planet. PhDs abound. We’ve had a long enough track record to see a new generation of savvy, experienced execs coming together to run startups.

And in these times, they are being tested as never before.

Biotech is going through quite a rough patch right now. For 2 years, practically anyone with a decent resume and some half-baked ideas on biotech could start a company and get it funded. The pandemic made it easy in many ways to pull off an IPO, with traditional road shows shut down in exchange for a series of quick Zoom meetings. Generalist investors flocked as the numbers raised soared into the stratosphere.

Martin Shkreli (Dennis Van Tine/MediaPunch/IPX)

In­fa­mous biotech ex­ec Mar­tin Shkre­li gets out of prison, hits the street

Martin Shkreli, the infamous biotech CEO who made headlines for his jeering assault on a legion of critics in and out of Congress, is back on the streets after 4 years inside a federal penitentiary.

Shkreli’s attorney put out a statement Wednesday afternoon saying that the “pharma bro” had been transferred to a halfway house in New York with a few more months to go under federal custody, slated to end September 14. Attorney Benjamin Brafman acknowledged the release and vowed that he and Shkreli are keeping quiet.

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De­spite fed­er­al ef­forts to di­ver­si­fy clin­i­cal tri­als, progress re­mains 'stag­nan­t' — re­port

While calls to diversify clinical trials have grown louder in recent years — gaining support from federal agencies such as the FDA and NIH — progress has largely stalled, according to a new report from the National Academies of Sciences, Engineering and Medicine.

Swaths of patients in racial and ethnic minority groups, as well as LGBTQIA+, pregnant and older adult populations continue to be left out of clinical trials. While some advances have been made in the last 30 years — women now account for roughly half of clinical trial participants — growth in other areas remains stagnant, according to the report, which was mandated by Congress and sponsored by the NIH.

Paul Chaplin, Bavarian Nordic president and CEO

Bavar­i­an Nordic se­cures BAR­DA con­tract for small­pox vac­cine

It seems that smallpox vaccination production is weighing on the mind of the US government. And manufacturer Bavarian Nordic is the latest company to benefit.

Just a few days after Emergent, a company that has made government contracts its lifeblood, acquired the exclusive rights to Tembexa from Chimerix, with a $225 million cash payment and an expected BARDA contract, the agency has offered a contract for smallpox vaccine production.

Frank Pallone (D-NJ), House Energy and Commerce Committee chair (Kevin Dietsch/Pool via AP Images)

House com­mit­tee unan­i­mous­ly ad­vances FDA user fee leg­is­la­tion with ac­cel­er­at­ed ap­proval tweaks

The House Energy and Commerce Committee on Wednesday offered a rare show of bipartisan support for a bill that would provide the FDA with user fees for the next five years.

The committee voted 55-0 to advance the quinquennial user fee bill to the full House floor, which if approved, will allow the FDA to use biopharma funds to hire new reviewers, and hit new marks as outlined in the user fee deals that the FDA and biopharma companies forged over the past several years.

Lina Khan, FTC chair (Saul Loeb/Pool via AP)

New FTC com­mis­sion­er could turn the tide for an in­ves­ti­ga­tion in­to PBMs

The Senate last week voted along party lines, 51-50, with Vice President Kamala Harris casting the tie-breaker, to make President Biden appointee Alvaro Bedoya the deciding vote on a split 2-2 Federal Trade Commission.

The addition of Bedoya to the FTC could not only spell more trouble for biopharma M&A activity, as he may align with his Democrat partners to break the FTC ties, but it may also mean that FTC Chair Lina Khan has what she needs to move forward on a study around the pharma middlemen known as pharmacy benefit managers.

Henrietta Lacks

UP­DAT­ED: Fed­er­al judge weighs mo­tion to dis­miss HeLa law­suit against Ther­mo Fish­er

The story of Henrietta Lacks’ immortal cell line and her family’s fight for justice caught the attention of national media outlets and Hollywood years ago. Now, the case faces an uncertain fate as a Baltimore federal judge considers tossing the case.

After a hearing on Tuesday, Judge Deborah Boardman is weighing Thermo Fisher’s motion to dismiss the claims against it on the grounds that the statute of limitations has passed, and the continuing harm doctrine does not apply. Boardman is grappling with the “extraordinarily unique facts” of the case, according to Maryland Matters, which first reported the news.