Mark Smith, Finch Therapeutics CEO

One week af­ter Take­da walked away, Finch faces sec­ond round of lay­offs, pipeline prun­ing

Finch may be an inch un­der­ground at this point.

Somerville, MA-based Finch Ther­a­peu­tics has had a rough year, start­ing with the FDA slap­ping a clin­i­cal hold on its late-stage C. dif­fi­cile treat­ment in March. While that hold was lift­ed at the end of April, it had al­ready tak­en its toll, with Finch lay­ing off 37 of its work­ers and cut­ting its he­pati­tis B pro­gram in the in­ter­im.

Then, last week, Take­da end­ed its five-year al­liance with the biotech, giv­ing back glob­al rights to two pre­clin­i­cal pro­grams in ul­cer­a­tive col­i­tis and Crohn’s dis­ease. In re­ac­tion to that, Finch is lay­ing off an ad­di­tion­al 50 em­ploy­ees, about an­oth­er third of its work­force, ac­cord­ing to an SEC fil­ing this morn­ing.

Finch will al­so be sidelin­ing its treat­ment for chil­dren with autism who have sig­nif­i­cant GI symp­toms. Ac­cord­ing to its Q2 re­port, it was plan­ning to sub­mit an IND in the fourth quar­ter of the year, but that won’t be hap­pen­ing any­more as the biotech looks to elon­gate its cash run­way.

On its C. dif­fi­cile treat­ment, Finch hasn’t got­ten back to en­rolling in its Phase III tri­al yet. The biotech said in its Q2 re­port that it had sub­mit­ted an amend­ed pro­to­col for its study and is wait­ing on FDA feed­back.

At the time, Finch said it had just over $100 mil­lion in cash, just enough to get it through to the first quar­ter of 2024. Finch said in to­day’s re­lease that it will up­date its run­way pro­jec­tions in the fu­ture.

Both biotechs and Big Phar­mas have strug­gled in their search for new op­tions for C. dif­fi­cile, a bac­te­ria that caus­es di­ar­rhea, colon dam­age and in the worst cas­es, death. Sanofi saw its C. diff vac­cine flop in a Phase III tri­al in 2017. Ear­li­er this year, Pfiz­er joined its fel­low Big Phar­ma in that pool, as its vac­cine al­so failed to pre­vent in­fec­tion.

And on the treat­ment end, the new an­tibi­ot­ic at Bob Dug­gan’s Sum­mit Ther­a­peu­tics failed in a late-stage tri­al last year — though no­tably, the tri­al was run on su­pe­ri­or­i­ty as op­posed to non-in­fe­ri­or­i­ty, which an­tibi­ot­ic tri­als are tra­di­tion­al­ly run on.

But there have been a few glim­mers of po­ten­tial among late-stage prospects re­cent­ly. Seres is plan­ning to file a BLA for its C. diff treat­ment, made from pu­ri­fied bac­te­ria spores, in the com­ing weeks. Seres made a come­back on a Phase III win af­ter falling flat on a Phase II read­out.

And the FDA is hold­ing an ad­comm lat­er in Sep­tem­ber on a poop trans­plant-based drug from Swiss drug­mak­er Fer­ring Phar­ma­ceu­ti­cals. In a Phase III tri­al, Fer­ring’s can­di­date out­per­formed place­bo and had a com­pa­ra­ble safe­ty pro­file. Poop trans­plants, while not ap­proved by the FDA, are one of the few treat­ments that work for re­cur­rent C. diff.

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.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 150,300+ biopharma pros reading Endpoints daily — and it's free.

Mar­ket­ingRx roundup: No­var­tis re­cruits NFL coach for Leqvio cam­paign; Pfiz­er pro­motes ‘Sci­ence’ merch on so­cial me­dia

Novartis is turning to a winning coach to talk about Leqvio and the struggles of high cholesterol — including his own. Bruce Arians, the retired NFL head coach of the Arizona Cardinals and Super Bowl-winning Tampa Bay Buccaneers, is partnering with the pharma for its “Coaching Cholesterol” digital, social and public relations effort.

In the campaign, Arians talks about the potential for “great comebacks” in football and heart health. Once nicknamed a “quarterback whisperer,” he is now retired from fulltime coaching (although still a front-office consultant for Tampa Bay), and did a round of media interviews for Novartis, including one with People and Forbes.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 150,300+ biopharma pros reading Endpoints daily — and it's free.

Amy West, Novo Nordisk head of US digital innovation and transformation (Illustration: Assistant Editor Kathy Wong for Endpoints News)

Q&A: No­vo Nordisk dig­i­tal in­no­va­tion chief Amy West dis­cuss­es phar­ma pain points and a health­care 'easy but­ton’

Amy West joined Novo Nordisk more than a decade ago to oversee marketing strategies and campaigns for its US diabetes portfolio. However, her career path shifted into digital, and she hasn’t looked back. West went from leading Novo’s first digital health strategy in the US to now heading up digital innovation and transformation.

She’s currently leading the charge at Novo Nordisk to not only go beyond the pill with digital marketing and health tech, but also test, pilot and develop groundbreaking new strategies needed in today’s consumerized healthcare world.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

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.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 150,300+ biopharma pros reading Endpoints daily — and it's free.

Bob Duggan (Duggan Investments)

Biotech bil­lion­aire Bob Dug­gan flies the white flag as Sum­mit hunts a new own­er, or part­ner, for sole clin­i­cal-stage ef­fort

Bob Duggan’s Summit Therapeutics $SMMT is running out of moves for its sole clinical-stage candidate.

The biotech issued a terse statement in an SEC filing that it’s pulling the plug on the only active clinical trial for ridinilazole, which has been through a failed late-stage trial for C. difficile. A pediatric study is being curtailed as Summit says it decided a few days ago to either partner out the therapy or get a buyer — if they can find one.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 150,300+ biopharma pros reading Endpoints daily — and it's free.

User fees in ac­tion: FDA un­veils new short­ened sup­ple­ment re­view, rare dis­ease pi­lots

Thanks to PDUFA VII, signed into law last Friday by President Joe Biden, the FDA this week unveiled two new industry-friendly pilot programs to advance new rare disease endpoints via additional meetings, and to shorten FDA review times for supplemental apps aimed at unmet medical needs.

The agency this week released eagerly-awaited details behind the shortened pilot, known as the Split Real Time Application Review or STAR pilot program, which will speed up certain FDA reviews of efficacy supplements across all therapeutic areas (thanks to earlier submissions of data), but only for those that propose addressing an unmet medical need.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 150,300+ biopharma pros reading Endpoints daily — and it's free.

New Chroma Medicine board member Jeff Marrazzo

Jeff Mar­raz­zo has found a buzzy new biotech cause to cham­pi­on. And once again, he's all in

Jeff Marrazzo is one of those biotech execs who has always been focused on the next big goal. He has a track record for meeting objectives, relentlessly staying on message, and breaking new ground.

The fact that he stayed around for a couple of years after Roche’s $4.3 billion Spark buyout, making sure the organization he founded weathered Covid-19, is one example. And that came after he carefully guided the company to the first-ever US approval of a gene therapy — no easy task.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 150,300+ biopharma pros reading Endpoints daily — and it's free.

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.