Mark Smith, Finch Therapeutics CEO

FDA slaps hold on Finch's mi­cro­bio­me C. dif­fi­cile treat­ment, as biotech blames Covid-19 and old man­u­fac­tur­er

Drug­mak­ers work­ing on treat­ments for C. dif­fi­cile in­fec­tions are hav­ing a bad week.

Just one day af­ter Pfiz­er re­port­ed its C. dif­fi­cile vac­cine can­di­date did not hit the pri­ma­ry end­point in a Phase III study, Finch Ther­a­peu­tics is find­ing it­self in a sim­i­lar po­si­tion. The biotech said Tues­day its mi­cro­bio­me treat­ment for the in­fec­tion was placed on clin­i­cal hold by the FDA last week, with reg­u­la­tors seek­ing more in­fo on Finch’s screen­ing pro­to­cols.

News of the hold sent Finch shares $FNCH down about 14% af­ter Mon­day’s clos­ing bell.

Like Pfiz­er, Finch blamed the Covid-19 pan­dem­ic for its trou­bles, point­ing to an FDA safe­ty alert from March 2020 over the po­ten­tial SARS-CoV-2 trans­mis­sion risk through mi­cro­bio­me treat­ments. In con­junc­tion with the alert, reg­u­la­tors put Finch’s IND and then-man­u­fac­tur­er on par­tial hold so as to add Covid-19 test­ing to any donor ma­te­r­i­al re­ceived af­ter Dec. 1, 2019.

As Finch tells it, re­searchers were able to con­tin­ue dos­ing in an on­go­ing Phase II tri­al, us­ing donor sam­ples be­fore that date. In Jan­u­ary 2021, the man­u­fac­tur­er, Open­Bio­me, was re­leased from clin­i­cal hold and Finch then bought the man­u­fac­tur­ing tech two months lat­er. In No­vem­ber, Finch be­gan dos­ing par­tic­i­pants in a Phase III tri­al us­ing the same screen­ing meth­ods it says were used by Open­Bio­me and sub­se­quent­ly ac­quired.

But the FDA reached out in Jan­u­ary, os­ten­si­bly with some ques­tions, and sent the clin­i­cal hold no­tice on Feb. 24. As a re­sult, Finch is paus­ing en­roll­ment in that Phase III study, its sec­ond piv­otal study look­ing to eval­u­ate the mi­cro­bio­me treat­ment.

Finch did note that some pa­tients were dosed in this piv­otal study while the hold was in ef­fect. The com­pa­ny said in a press re­lease it is con­duct­ing a re­view of the mat­ter. End­points News has reached out for com­ment and will up­date ac­cord­ing­ly.

Pre­vi­ous­ly, the ther­a­py dubbed CP101 passed its first Phase III test with nom­i­nal sta­tis­ti­cal sig­nif­i­cance, hit­ting the pri­ma­ry end­point of a sus­tained clin­i­cal cure through week 8. Be­tween treat­ment and place­bo, Finch re­port­ed a 33.8% rel­a­tive risk re­duc­tion, good for a p-val­ue of p=0.0488.

The treat­ment re­mained durable too, the com­pa­ny said, not­ing 73.5% of par­tic­i­pants sus­tained the cure ef­fects through 24 weeks, com­pared to 59.4% on place­bo. Finch’s ther­a­py proved more sta­tis­ti­cal­ly sig­nif­i­cant here, notch­ing a p-val­ue of p=0.0347.

Where Finch goes from here is not yet clear, as the com­pa­ny said it’s still eval­u­at­ing how long a de­lay could be in its topline read­out. Finch is al­so test­ing CP101 in chron­ic he­pati­tis B, with stud­ies cur­rent­ly in the pre­clin­i­cal phase, and it’s al­so not clear how these stud­ies might be im­pact­ed.

Though Finch is in for some chop­py wa­ters ahead, it’s ar­guably in a more fa­vor­able po­si­tion than Pfiz­er or Sum­mit Ther­a­peu­tics, which is de­vel­op­ing an an­tibi­ot­ic for C. dif­fi­cile in­fec­tions. Nei­ther Pfiz­er nor Sum­mit record­ed sta­tis­ti­cal­ly sig­nif­i­cant Phase III re­sults and Finch al­ready has one un­der its belt.

Biotech in­vestors and CEOs see two paths to growth, but are they equal­ly vi­able?

The dynamic in the biotech market has been highly volatile in the last few years, from the high peaks immediately after the COVID vaccine in 2021, to the lowest downturns of the last 20 years in 2022. This uncertainty makes calling the exact timing of the market’s turn something of a fool’s errand, according to Dr. Chen Yu, Founder and Managing Partner of TCG Crossover (TCG X). He speaks with RBC’s Noël Brown, Head of US Biotechnology Investment Banking, about the market’s road ahead and two possible paths for growth.

Casey McPherson shows his daughters Rose (left) and Weston around Everlum Bio, a lab that he co-founded to spark a treatment for Rose and others with ultra-rare conditions. (Ilana Panich-Linsman)

Fa­ther starts lab af­ter in­tel­lec­tu­al prop­er­ty is­sues stymie rare dis­ease drug de­vel­op­ment

Under bright lab lights, Casey McPherson holds his 6-year-old daughter, Rose. His free hand directs Rose’s gaze toward a computer screen with potential clues in treating her one-of-a kind genetic condition.

Gray specks on the screen show her cells that scientists reprogrammed with the goal of zeroing in on a custom medicine. McPherson co-founded the lab, Everlum Bio, to spark a treatment for Rose — and others like her. A regarded singer-songwriter, McPherson never imagined going into drug development.

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Astel­las, Pan­th­er­na add or­gan to mR­NA tie-up; Rock­et launch­es sale of six fig­ures worth of stock

Astellas and Pantherna have expanded their November 2021 pact surrounding the latter’s mRNA platform to include a new target organ, the duo announced Tuesday morning, though they did not specify what that target is.

German biotech Pantherna is home to two platform technologies — one that designs mRNAs for non-vaccine therapies and another that designs LNPs. Astellas and Pantherna’s deal appears to mainly revolve around the first platform, which Astellas said it is using to research direct reprogramming, or turning cells from one kind into another without an intermediate stem cell phase.

Benjamine Liu, TrialSpark CEO

Paul Hud­son and Tri­alSpark's mu­tu­al de­sire to speed up de­vel­op­ment con­verges in three-year, six-drug goal

A unicorn startup that originally set out to hasten clinical studies for biopharma partners dug further into its revised path of internal drug development by linking arms with Sanofi in a pact that the biotech’s CEO said originated from the top.

TrialSpark and the Big Pharma on Tuesday committed to in-licensing and/or acquiring six Phase II/Phase III drugs within the next three years.

“I’ve known Paul Hudson for a while and we were discussing the opportunity to really re-imagine a lot of different parts of pharma,” TrialSpark CEO Benjamine Liu told Endpoints News, “and one of the things that we discussed was this opportunity to accelerate the development of new medicines in mutual areas of interest.”

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Dave Marek, Myovant CEO

My­ovant board balks as ma­jor­i­ty own­er Sum­it­o­mo swoops in with a $2.5B deal to buy them out

Three years after Sumitomo scooped up Roivant’s 46% stake in the publicly traded Myovant $MYOV as part of a 5-company, $3 billion deal, they’re coming back for the whole thing.

But these other investors at Myovant want more than what the Japanese pharma company is currently offering to pay at this stage.

Sumitomo is bidding $22.75 a share for the outstanding stock, which now represents 48% of the company after Sumitomo bumped its ownership since the original deal with Roivant. Myovant, however, created a special committee on the board, and they’re shaking their heads over the offer.

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Andrew Crockett, KalVista CEO

KalVista ends a PhII study ear­ly af­ter pa­tients suf­fer se­vere and life-threat­en­ing side ef­fects

KalVista took a beating Tuesday after announcing it would scrap a Phase II trial for one of its experimental drugs.

The biotech said in an early morning press release that it is terminating the study for KVD824 after multiple patients in every treatment group saw unsafe, elevated levels of certain liver enzymes. By ending the trial now, KalVista hopes to save some money and funnel it toward another study for its lead program, CEO Andrew Crockett said in a statement.

Pen­ny stock play­er to re­view all op­tions to try stay­ing afloat af­ter clin­i­cal tri­al fail

Adamis Pharmaceuticals is slowly tumbling down, and the biotech is looking at all its options.

After a Phase II/III trial failure last month that sent the penny stock player down an additional 50% to just 15 cents a share, the company said Monday that it is examining options to get the best value for its investors. A statement from Adamis indicates that alternatives include anything from a partnership to a sale of Adamis’ two commercial products, Zimhi and Symjepi.

Take­da to pull key hy­poparathy­roidism drug from the mar­ket en­tire­ly by end of 2024 af­ter years of man­u­fac­tur­ing woes

Takeda on Tuesday morning made an announcement that almost 3,000 people with the rare disease known as hypoparathyroidism were fearing.

Due to unresolved supply issues and manufacturing woes, Takeda said it will cut its losses and discontinue its hypoparathyroidism drug, known as Natpara (parathyroid hormone), halting all manufacturing of the drug by the end of 2024.

The decision to not re-commercialize Natpara will be a blow to not only the 2,400 people who were awaiting supplies of their reliable injection since 2019, but also the additional nearly 400 people who were accessing the drugs via the company’s Special Use Program as Takeda sought to resolve these manufacturing issues over the past five years.

Marc Dunoyer, Alexion CEO (AstraZeneca via YouTube)

Up­dat­ed: As­traZeneca nabs a small rare dis­ease gene ther­a­py play­er for 667% pre­mi­um

AstraZeneca is kicking off the fourth quarter with a little M&A Monday for a gene editing player recently overcoming a second clinical hold to its only program in human studies.

The Big Pharma and its subsidiary Alexion are buying out little LogicBio for $2.07 per share. That’s good for a massive 667% premium over its Friday closing price, when it headed into the weekend at 27 cents and just weeks after Nasdaq said LogicBio would have to delist, which has been put on hold as the biotech requests a hearing. It’s one of two biotech deals to commence October, alongside the news of Incyte buying a vitiligo-focused biotech.

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