Emily Conley, Racquel Bracken (Federation Bio)

Ven­rock takes the wrap off its first mi­cro­bio­me start­up, armed with $50M, a CEO from 23andMe and two founders from Stan­ford

Ven­rock has large­ly stayed on the side­lines of the mi­cro­bio­me space, watch­ing with keen in­ter­est as fel­low VCs and Big Phar­ma alike put mon­ey and re­sources be­hind the idea of har­ness­ing hu­man gut bac­te­ria as drugs. Biotechs have made head­way by ei­ther pro­cess­ing donor fe­ces in­to “crap­sules,” ze­ro­ing in on a hand­ful of strains as ther­a­peu­tics, or ge­net­i­cal­ly en­gi­neer­ing bugs to en­hance their ef­fect. But the plat­forms were of­ten want­i­ng.

Un­til they came across re­search out of Stan­ford by Michael Fis­chbach and Dy­lan Dodd, with whom Ven­rock is launch­ing a $50 mil­lion start­up named Fed­er­a­tion Bio.

Two fun­da­men­tal prin­ci­ples but­tress the com­pa­ny, said Emi­ly Con­ley, who left a decade-long BD ca­reer at 23andMe to take up the CEO post in Ju­ly.

First, Fed Bio be­lieves in tak­ing a com­mu­ni­ty ap­proach where they would iso­late all the bac­te­ria strains found in healthy donor fe­ces and grow them in cell lines be­fore giv­ing them all to­geth­er as a treat­ment — which they be­lieve would spur en­graft­ment and en­sure dura­bil­i­ty.

That gives them a com­mu­ni­ty that’s “an or­der of mag­ni­tude larg­er than” most of the al­ter­na­tives out there.

“We haven’t giv­en an ex­plic­it num­ber yet, which pains me. I’m dy­ing to give you a num­ber,” Con­ley said. “But it’s big.”

At the same time, the founders have fig­ured out ways to ge­net­i­cal­ly en­gi­neer spe­cif­ic bac­te­ria that are known to reg­u­late the im­mune sys­tem. While the con­cept of tin­ker­ing with bac­te­ria is not new, mod­i­fy­ing these com­men­sal bac­te­ria has been chal­leng­ing for sci­en­tists.

Com­pared with the pu­ri­fied bac­te­ria from Seres and the fe­ces-de­rived drug from Finch, Con­ley said, Fed Bio’s method promis­es to be more com­pre­hen­sive yet scal­able.

“To our knowl­edge, no one else is build­ing such large, di­verse mi­cro­bial con­sor­tia to treat spe­cif­ic meta­bol­ic dis­or­ders,” Rac­quel Brack­en, a Ven­rock part­ner and Fed Bio’s found­ing CEO, wrote in an email. “Sim­i­lar­ly, we be­lieve Fed­er­a­tion Bio is the first com­pa­ny to ge­net­i­cal­ly mod­i­fy cer­tain mi­crobes that have the unique abil­i­ty to po­tent­ly and specif­i­cal­ly mod­u­late the im­mune sys­tem, and live per­sis­tent­ly in a broad range of in­di­vid­u­als.”

Bryan Roberts Ven­rock

Un­der new norms in a world re­shaped by Covid-19, Con­ley and Brack­en have yet to meet in per­son. But to­geth­er with 19 em­ploy­ees, Ven­rock’s Bryan Roberts and Patrick Zhang of Hori­zon Ven­tures, they have sketched out plans to bring the lead pro­gram in­to the clin­ic for sec­ondary hy­per­ox­aluria in 2022 be­fore go­ing out for an­oth­er raise in 2023, with da­ta in hand.

Sev­en­ture co-led the round that will help get them there, joined by Al­ti­tude and Stan­ford.

As sec­ondary hy­per­ox­aluria is char­ac­ter­ized by ex­ces­sive uri­nary ox­alate, Fed Bio’s lead drug com­pris­es nat­u­ral­ly oc­cur­ring bac­te­ria that sub­sist en­tire­ly on ox­alate — com­bined with a large mix of sup­port­ive bugs. Novome, a ri­val mi­cro­bio­me play­er, is de­vel­op­ing a sin­gle strain of en­gi­neered mi­crobe as a po­ten­tial hy­per­ox­aluria treat­ment.

“We in­dexed our li­brary of bugs [and found] a cou­ple of strains that are the stars, but we have a bunch of oth­er strains that eat some ox­alate and can tol­er­ate be­ing around ox­alate and those can be in the com­mu­ni­ty too,” Con­ley said.

She is less ready to dis­cuss Fed Bio’s work on the im­mune front, di­vulging on­ly that there’s a can­cer drug — an­i­mal da­ta for which there was a dri­ver for in­vestors in the Se­ries A fund­ing — and an­oth­er in an au­toim­mune in­di­ca­tion. A sec­ond IND is planned for 2022.

For on­col­o­gy, they will be look­ing at a mix of pro­grams with a sin­gle en­gi­neered strain alone and added to a sup­port­ive com­mu­ni­ty.

Bot­tom line: It is a plat­form that can go mul­ti­ple dif­fer­ent di­rec­tions. The state of mi­cro­bio­me re­search strikes Con­ley as “where the genome was five or 10 years ago,” with ge­net­ic tools now avail­able to se­quence bac­te­ria and un­der­stand their func­tion more in­ti­mate­ly. In a few years, when Fed Bio will be ready to talk part­ner­ships, she ex­pects there to be a de­cent ap­petite from larg­er bio­phar­ma com­pa­nies.

She ex­pects the first ap­proval for a mi­cro­bio­me-based drug to crack open the field even more — lead­ing to more re­sources to in­ves­ti­gate qual­i­ties unique to us­ing bugs as drugs, such as the re­la­tion­ship be­tween the treat­ments and pa­tients’ di­ets.

“That’s not some­thing Fed Bio is specif­i­cal­ly fo­cused on, but I’d love to see some­body kind of do a lit­tle bit like what 23andMe has done for the mi­cro­bio­me, like mas­sive mas­sive mas­sive datasets and start­ing to map these vari­ables and how they fit to­geth­er,” she said.

Paul Hudson, Sanofi CEO (Cyril Marcilhacy/Bloomberg via Getty Images)

FDA side­lines Paul Hud­son's $3.7B MS drug af­ter es­tab­lish­ing link to liv­er dam­age

One of Sanofi CEO Paul Hudson’s top picks in the pipeline — picked up in a $3.7 billion buyout 2 years ago — has just been sidelined in the US by a safety issue.

The pharma giant put out word early Thursday that the FDA has put their Phase III studies of tolebrutinib in multiple sclerosis and myasthenia gravis on partial clinical hold, halting enrollment and suspending dosing for patients who have been on the drug for less than 60 days. Patients who have completed at least 60 days of treatment can continue therapy as researchers explore a “limited” — but unspecified in Sanofi’s statement — number of cases of liver injury.

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Eric Hughes, incoming Teva EVP of global R&D and CMO

Te­va chief raids Ver­tex for his new glob­al head of re­search and de­vel­op­ment

Teva CEO Kåre Schultz has found his new R&D chief and CMO in Vertex’s ranks.

The global generics giant, which has some 3,500 staffers in the R&D group, has named Eric Hughes to the top research spot in the company. He’ll be replacing Hafrun Fridriksdottir, who held the role for close to five years, on Aug. 1.

Hughes hasn’t been at Vertex for long, though. He jumped from Novartis less than a year ago, after heading the immunology, hepatology & dermatology global development unit. Before that, he completed a five-year stint as head of early clinical research for the specialty discovery medicine department in the exploratory clinical & translational research group at Bristol Myers Squibb, according to his LinkedIn profile.

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#BIO22: Man­ag­ing a biotech in tur­bu­lent times. 'There's a per­fect shit­show out there'

On Tuesday, June 14, Endpoints News EIC John Carroll sat down with a group of biotech execs to discuss the bear market for industry stocks and how they were dealing with it. Here’s the conversation, which has been lightly edited for brevity.

Martin Meeson, sponsor opening:

Thank you, John. Hello everyone. My name’s Martin Meeson, I’m the CEO of Fujifilm Diosynth. For those of you who don’t know Fujifilm Diosynth, we operate in the development of clinical and commercial product scale up, we have facilities in Europe and the US, and around about 4,000 employees. We run on average about 150 programs, so when it comes to managing in turbulent times over the last two years, we’ve had quite a lot of experience of that. Not just keeping the clinical pipelines and the commercial pipelines open, but also our response to the pandemic and the molecules that we’ve had within there. One of the phrases that I coined probably about a year ago when we were talking at JP Morgan, was I talked about managing through turbulent times. Well, it’s become the fact that we are not managing and leading through these times, we are managing in them, which is why that’s really the purpose of and the topic that we’ve got today.

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On Friday, Lonza announced plans to construct a large-scale commercial drug product fill and finish facility in the town of Stein, Switzerland.

Lon­za to in­vest $500M+ on fill-fin­ish fa­cil­i­ty on its home turf

Lonza has been expanding its reach across the globe, bringing sites in China and the US online this year, but now they are looking closer to home for their next major investment.

The Swiss manufacturer on Friday announced plans to construct a large-scale commercial drug fill and finish facility in the town of Stein, Switzerland. The new facility will be delivered through an investment of approximately CHF 500 million, or $519 million, and is expected to be completed in 2026. The facility will also be constructed on the same campus as Lonza’s current clinical drug product facility.

Amgen's taking social media followers around the globe as it introduces the many different

From Tam­pa to Mu­nich, Am­gen’s ‘Places’ cam­paign in­tro­duces its lo­ca­tions around the world

Amgen is taking social media followers around the world with its latest corporate campaign. Called “Places of Amgen,” the twice monthly posts highlight the biopharma’s different offices and sites – and the people who work there.

Each post runs on LinkedIn, Facebook and Instagram with details about the work Amgen does in that location, when it was established, comments from people who work there and other interesting facts. The most recent one about Paris, France, for example, notes that Amgen France last year signed a French association charter committed to the inclusion of LBGT+ people in the workplace.

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Credit: Shutterstock

Bio­haven takes mi­graine cam­paign to pa­tients' Twit­ter feeds, months ahead of Pfiz­er takeover

Two weeks ago, Biohaven hit an all-time high in weekly Nurtec prescriptions. CEO Vlad Coric attributes at least some of that success to a new interactive Twitter campaign that encourages patients to free their feed of potential migraine triggers.

Earlier this month, Biohaven in partnership with Twitter launched the #RelieveYourFeed campaign that allows users to customize their app settings based on their migraine triggers.

Oncologists on Twitter are talking up ASCO studies, health equity and burnout, according to new deep dive research from Harris Poll (via Shutterstock)

What’s been on in­flu­en­tial on­col­o­gist­s' minds? Most­ly AS­CO, but al­so health eq­ui­ty, ac­cord­ing to new Har­ris Poll re­search

Over the past few months, oncologists have been talking a lot about the ASCO conference. Not surprising considering its import and the study data presented, but what may be less expected is the second most talked about topic of health equity.

That’s according to data from The Harris Poll and the new expert network the researcher is building out. While the company has been doing deep data dives into specific health issues or conditions for pharma clients, it’s now monitoring influencer networks of therapy area specialists to find out what experts are really thinking about.

Paula Ragan, X4 Pharmaceuticals CEO

Small Mass­a­chu­setts biotech tries to beat back the bears with $55M PIPE

As the bear market continues to hold down biotechs of several shapes and sizes, one company is selling shares to extend its runway.

Boston-based X4 Pharmaceuticals announced Friday that it has agreed to sell over 50 million shares of common stock to certain investors in a PIPE financing. The company is anticipating that gross proceeds from the PIPE will be approximately $55 million and close on July 6, with a purchase set at $1.09.

With chance to take on Bris­tol My­er­s' $13B heart drug, Cy­to­ki­net­ics preps for piv­otal stud­ies with $450M debt raise

As Cytokinetics traded near its one-year high earlier this week, execs decided to take on a load of debt. But investors aren’t liking what they’ve seen.

The San Francisco biotech announced after market close Wednesday that it would raise $450 million in debt in the form of a convertible senior notes offering, sending the company’s stock $CYTK down nearly 20% on Thursday. The move was ostensibly made to satiate investor concerns, but the market did not react accordingly.