Seres president and CEO Eric Shaff

Aim­ing to jump ahead of Big Phar­ma heavy­weights, Seres moves to fi­nal­ize C. dif­fi­cile FDA pitch

C. dif­fi­cile pro­grams have flus­tered Big Phar­ma com­pa­nies and biotechs alike, but Seres is bar­rel­ing for­ward with its own mi­cro­bio­me treat­ment af­ter it says it’s con­firmed a Phase III win.

Seres un­veiled the re­sults of the open-la­bel ex­ten­sion study ECOSPOR IV ear­ly Tues­day, which was in­ves­ti­gat­ing drug can­di­date SER-109 to pre­vent rC­DI, or re­cur­rent C. dif­fi­cile in­fec­tion over the course of 24 weeks. It fol­lows a pre­vi­ous study, ECOSPOR III, which to­geth­er con­clude Seres’ Phase III de­vel­op­ment pro­gram and have it ready to start a rolling BLA sub­mis­sion, ac­cord­ing to the biotech.

The da­ta from to­day’s study showed that 91.3% of pa­tients had a sus­tained clin­i­cal re­sponse at eight weeks, pro­vid­ing re­sults sim­i­lar to the ECOSPOR III tri­al, and 86% at 24 weeks post-treat­ment. In terms of safe­ty, the drug was well-tol­er­at­ed, with a sim­i­lar safe­ty pro­file to the ear­li­er study as well.

Ex­ecs added on a con­fer­ence call Tues­day that ap­prox­i­mate­ly 12.5% of pa­tients — one in eight — ex­pe­ri­enced a se­vere ad­verse event in the tri­al. The biotech said that none of those were deemed “re­lat­ed or pos­si­bly re­lat­ed” to the study. It al­so ob­served eight deaths, and again, none were de­ter­mined to be re­lat­ed to the study.

Lisa von Moltke

One thing men­tioned along­side the da­ta was that the study al­lowed for ini­tial CDI di­ag­no­sis to be made with ei­ther a tox­in as­say or a PCR test. Seres CMO Lisa von Moltke told an­a­lysts and in­vestors on the con­fer­ence call that there was not much of a dif­fer­ence be­tween the two tests in terms of test­ing re­cur­rence.

“We have looked at the re­cur­rence rate, ac­cord­ing to en­try di­ag­nos­tic test­ing. And there re­al­ly isn’t any dif­fer­ence. The PCR is a bit low­er, but both were low­er than we had seen in ECOSPOR III. The tox­in test­ing was un­der 10%. The PCR test­ing was clos­er to 5%,” von Moltke said.

ECOSPOR III en­rolled 182 adults with rC­DI. Re­sults pub­lished back in Jan­u­ary showed that 88% of sub­jects in the SER-109 group were free from C. dif­fi­cile re­cur­rence at eight weeks post-treat­ment, com­pared to 60% in the place­bo group. At six months post-treat­ment, 79% of the SER-109 group were still free from C. dif­fi­cile re­cur­rence, com­pared to 53% in the place­bo group.

The ECOSPOR IV study, which en­rolled 263 sub­jects, was used to ful­fill FDA re­quire­ments on the drug’s safe­ty pro­file.

Da­ta from both stud­ies will be in­clud­ed as part of the rolling sub­mis­sion of Seres’s BLA. While ECOSPOR III will serve as the ba­sis for ef­fi­ca­cy, the FDA had re­quest­ed safe­ty da­ta from at least 300 sub­jects treat­ed with SER-109 at the com­mer­cial dose to prove its safe­ty pro­file.

CEO Er­ic Shaff said on the con­fer­ence call that Seres ex­pects to have the BLA done some­time in mid-2022. The drug can­di­date did se­cure break­through des­ig­na­tion, which could open the door to pri­or­i­ty re­view. Seres added in a state­ment that the com­pa­ny an­tic­i­pates a po­ten­tial com­mer­cial launch in H1 next year.

In­vestors jumped on the news, with Seres’ share price $MCRB up over 10% since the mar­ket opened Tues­day morn­ing.

This is the newest step for the com­pa­ny af­ter al­ter­ing its plans in ul­cer­a­tive col­i­tis af­ter a Phase IIb fail last year. The biotech had an­nounced back in April in an SEC fil­ing that it would not be mov­ing for­ward on a Phase Ib tri­al on its sec­ond UC can­di­date af­ter re­port­ing that none of the pa­tients achieved clin­i­cal re­mis­sion af­ter 10 weeks.

But Seres is bank­ing on the FDA ap­prov­ing SER-109, which if ap­proved. would be the first mi­cro­bio­me treat­ment giv­en the FDA green light for C. dif­fi­cile in­fec­tion. An ap­proval would vault the com­pa­ny ahead of heavy­weights like Pfiz­er and Sanofi, who each took the vac­cine route, as well as mi­cro­bio­me play­er Finch and Bob Dug­gan’s an­ti­body biotech Sum­mit Ther­a­peu­tics.

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.

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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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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Vlad Coric, Biohaven CEO

Vlad Coric charts course for new Bio­haven with neu­ro­science push and Big Phar­ma vets on board

What’s Biohaven without its CGRP portfolio? That’s what CEO Vlad Coric is tasked with deciding as he maps out the new Biohaven post-Pfizer takeover.

Pfizer officially scooped up Biohaven’s CGRP assets on Monday, including blockbuster migraine drug Nurtec and the investigational zavegepant, for $11.6 billion. As a result, Coric spun the broader pipeline into an independent company on Tuesday — with the same R&D team behind Nurtec but about 1,000 fewer staffers and a renewed focus on neuroscience and rare disease.

In AstraZeneca's latest campaign, wild eosinophils called Phils personify the acting up often seen in uncontrolled asthma

As­traZeneca de­buts an­noy­ing pur­ple ‘Phil’ crea­tures, per­son­i­fied asth­ma eosinophils ‘be­hav­ing bad­ly’

There are some odd-looking purple creatures lurking around the halls of AstraZenca lately. The “Phil” character cutouts are purple, personified eosinophils with big buggy eyes and wide mouths, and they’re a part of AZ’s newest awareness effort to help people understand eosinophilic asthma.

The “Asthma Behaving Badly” characters aren’t only on the walls at AZ to show the new campaign to employees, however. The “Phils” are also showing up online on the campaign website, and in digital and social ads and posts on Facebook and Instagram.

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.

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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.

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Rob Etherington, Clene CEO

Star­tup's gold nanocrys­tal ALS drug flops a PhII tri­al, a re­minder of the dis­ease's ob­sta­cles de­spite Amy­lyx OK

Despite the FDA approving an ALS drug for the first time in five years last week, the disease continues to fluster researchers, and another biotech is feeling the pain of a mid-stage failure.

Clene Nanomedicine reported early Monday that its ALS program, which uses gold nanocrystals to try to catalyze intracellular reactions, did not achieve its Phase II primary or secondary endpoints. And in a press release, the company noted for the first time that it’s speaking with “potential strategic partners” about the program — language that typically indicates a biotech is preparing to sell off an asset.

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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.