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.

Da­ta Lit­er­a­cy: The Foun­da­tion for Mod­ern Tri­al Ex­e­cu­tion

In 2016, the International Council for Harmonisation (ICH) updated their “Guidelines for Good Clinical Practice.” One key shift was a mandate to implement a risk-based quality management system throughout all stages of a clinical trial, and to take a systematic, prioritized, risk-based approach to clinical trial monitoring—on-site monitoring, remote monitoring, or any combination thereof.

Mer­ck scraps Covid-19 vac­cine pro­grams af­ter they fail to mea­sure up on ef­fi­ca­cy in an­oth­er ma­jor set­back in the glob­al fight

After turning up late to the vaccine development game in the global fight against Covid-19, Merck is now making a quick exit.

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Adeno-associated virus-1 illustration; the use of AAVs resurrected the gene therapy field, but companies are now testing the limits of a 20-year-old technology (File photo, Shutterstock)

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Paulk, who runs a gene therapy lab at the University of California, San Francisco, had planned to spend the day listening to talks at the American Association for Cancer Research annual meeting, which was taking place that week. Instead, she skipped the conference, canceled every work call on her calendar and began phoning colleagues across academia and industry, trying to figure out what happened and why. All the while, a single name hung in the back of her head.

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Jackie Fouse, Agios CEO

Agios scores its sec­ond pos­i­tive round of da­ta for its lead pipeline drug — but that won't an­swer the stub­born ques­tions that sur­round this pro­gram

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Eli Lil­ly demon­strates that 2 an­ti­bod­ies beat 1 for guard­ing against se­vere Covid-19. But can that solve the first an­ti­body’s prob­lem amid slow up­take?

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George Yancopoulos (L) and Len Schleifer (Regeneron)

Re­gen­eron touts pos­i­tive pre­lim­i­nary im­pact of its Covid an­ti­body cock­tail, pre­vent­ing symp­to­matic in­fec­tions in high-risk group

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Drug­mak­ers 'inch­ing ahead' in in­creas­ing ac­cess to drugs world­wide, with Glax­o­SmithK­line lead­ing the pack

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