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.

Michel Vounatsos, Biogen CEO (via YouTube)

UP­DAT­ED: Bio­gen spot­lights a pair of painful pipeline set­backs as ad­u­canum­ab show­down looms at the FDA

Biogen has flagged a pair of setbacks in the pipeline, spotlighting the final failure for a one-time top MS prospect while scrapping a gene therapy for SMA after the IND was put on hold due to toxicity.

Both failures will raise the stakes even higher on aducanumab, the Alzheimer’s drug that Biogen is betting the ranch on, determined to pursue an FDA OK despite significant skepticism they can make it with mixed results and a reliance on post hoc data mining. And the failures are being reported as Biogen was forced to cut its profit forecast for 2020 as a generic rival started to erode their big franchise drug.

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A new chap­ter in the de­cen­tral­ized clin­i­cal tri­al ap­proach

Despite the promised decentralized trial revolution, we haven’t yet moved the needle in a significant way, although we are seeing far bolder commitments to this as we continue to experience the pandemic restrictions for some time to come. The vision of grandeur is one thing, but operationalizing and execution are another and recognising that change, particularly mid-flight on studies, is worthy of thorough evaluation and consideration in order to achieve success. Here we will discuss one of the critical building blocks of a Decentralized and Remote Trial strategy: TeleConsent; more than paper under glass, it is a paradigm change and key digital enabler.

Philipp Spycher

Promis­ing bet­ter link­er tech to ADC field, Araris has 'very, very am­bi­tious' plans for the clin­ic

A couple months after raising CHF 2.5 million ($2.76 million) in initial seed funding, one-year-old Araris Biotech is topping off the round with another CHF 12.7 million ($14 million).

The Paul Scherrer Institute and ETH Zurich spinout now has CHF 15.2 million to work with, and CEO Philipp Spycher has big plans. He hopes to bring one of the company’s antibody-drug conjugates (ADC) to the clinic by late 2022 or early 2023. “It’s very, very ambitious, but we are very optimistic that we actually can make it,” he said.

Stephen Hahn, FDA commissioner (AP Images)

As FDA sets the stage for the first Covid-19 vac­cine EUAs, some big play­ers are ask­ing for a tweak of the guide­lines

Setting the stage for an extraordinary one-day meeting of the Vaccines and Related Biological Products Advisory Committee this Thursday, the FDA has cleared 2 experts of financial conflicts to help beef up the committee. And regulators went on to specify the safety, efficacy and CMC input they’re looking for on EUAs, before they move on to the full BLA approval process.

All of this has already been spelled out to the developers. But the devil is in the details, and it’s clear from the first round of posted responses that some of the top players — including J&J and Pfizer — would like some adjustments and added feedback. And on Thursday, the experts can offer their own thoughts on shaping the first OKs.

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David Hung (file photo)

Mas­ter deal­mak­er David Hung re­tools a SPAC sedan in­to a fi­nanc­ing mus­cle ve­hi­cle that leaves his can­cer start­up with $850M and a place on Wall Street

It’s only right that one of the industry’s top dealmakers just completed one of the biggest SPAC-related deals in the pipeline.

David Hung, of Medivation fame, has completed a back flip into the market, merging with EcoR1 Capital’s SPAC Panacea and landing neatly on Wall Street with an $NUVB stock ticker after filling out the blank check in his name. In addition to the $144 million held in the SPAC — provided none of the investors opt out — Hung is getting ahold of $500 million more being chipped in by a slate of institutional investors who feel that Hung could have the keys to another Medivation-style success.

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Pfizer CEO Albert Bourla (Drew Angerer/Getty Images)

Pfiz­er is on the verge of claim­ing a multi­bil­lion-dol­lar first-mover ad­van­tage with their Covid-19 vac­cine — an­a­lyst

From the beginning, Pfizer CEO Albert Bourla eschewed government funding for his Covid-19 vaccine work with BioNTech, willing to take all the $2 billion-plus risk of a lightning-fast development campaign in exchange for all the rewards that could fall its way with success. And now that the pharma giant has seized a solid lead in the race to the market, those rewards loom large.

SVB Leerink’s Geoff Porges has been running the numbers on Pfizer’s vaccine, the mRNA BNT162b2 program that the German biotech partnered on. And he sees a $3.5 billion peak in windfall revenue next year alone. Even after the pandemic is brought to heel, though, Porges sees a continuing blockbuster role for this vaccine as people around the world look to guard against a new, thoroughly endemic virus that will pose a permanent threat.

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CEO Grace Colón (InCarda)

Look­ing to re­pur­pose an old drug to treat ir­reg­u­lar heart­beats, In­Car­da rais­es $30M in first Se­ries C close

A little less than two years after completing its $42 million Series B round, InCarda has returned to the venture well.

The San Francisco-based biotech announced the first portion of its Series C on Wednesday, pulling in $30 million in new funding. Most of the money will give enough runway for InCarda’s InRhythm program, an inhaled therapeutic aiming to treat sudden episodes of irregular heartbeats, through its Phase II trials and prepare it for Phase III.

UP­DAT­ED: CRISPR Ther­a­peu­tics gets a snap­shot of off-the-shelf CAR-T suc­cess in B-cell ma­lig­nan­cies — marred by the death of a pa­tient

Just days after scientific founder Emmanuelle Charpentier shared the Nobel prize for her work on CRISPR/Cas9, CRISPR Therapeutics $CRSP is showing off a snapshot of success in their early-stage study for an off-the-shelf CAR-T approach to CD19+ B cell malignancies — a snapshot marred by the death of a patient who had been given a high dose of the treatment.

Using their gene editing tech, researchers for CRISPR engineered cells from healthy donors into an attack vehicle aimed at cancer, something that has been achieved with great success using patients’ own cells — the autologous approach. But autologous CAR-T is hampered by the more complex vein-to-vein requirement that delays treatment, and now CRISPR Therapeutics along with other players like Allogene are determined to replace the pioneers with CAR-T 2.0.

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Steve Chen, Cellis Therapeutics president and CMO (Cellics)

UC San Diego spin­out award­ed up to $15M for nanosponge de­signed to soak up sep­sis-caus­ing tox­ins

CARB-X, a global partnership looking to spur the development of new antibacterial drugs, is awarding Cellics Therapeutics $3.94 million to do what president and CMO Steve Chen calls “looking at traditional drug development upside down.”

Instead of going after a target directly — in this case bacterial toxins and inflammatory cytokines that cause sepsis — Cellics researchers “flip it around” to examine the host cells being attacked. The UC San Diego spinout then creates what it calls “nanosponges” — nanoparticles cloaked in the fragments of macrophage cell membranes. Chen says the “sponges” are designed to trap the sepsis-causing endotoxins and cytokines on their cell membranes, neutralizing them.