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.

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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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.

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.

Un­fazed by PhII miss, Roche ush­ers Prothena's Parkin­son's drug in­to late-stage tri­al — a $60M move

Prothena’s prasinezumab may not have met the primary endpoint in Phase II, but its partners at Roche are seeing enough to move it into a late-stage trial for Parkinson’s disease.

The Phase IIb will build on the Phase II PASADENA study, adding a subgroup of early Parkinson’s patients on stable levodopa therapy to the population.

It’s a significant milestone for a $600 million deal that dates back to 2013, as dosing of the first patient — expected next year — will trigger a $60 million milestone payment to Prothena.

Spar­ingVi­sion rais­es $52M to kick off long jour­ney for a next-gen gene ther­a­py that goes much, much broad­er than Lux­tur­na

Until Spark Therapeutics’ pioneering gene therapy, Luxturna, came along, patients with retinitis pigmentosa had few treatment options. Even after it was approved, though, the majority were left with the exact same options.

Because it’s targeting mutations in a specific gene known as RPE65, Luxturna can only address 2 to 3% of the entire RP population, Stephane Boissel told Endpoints News.

Boissel is the newly-minted CEO of SparingVision, a French biotech co-founded by José-Alain Sahel and Thierry Léveillard at the Institut de la Vision. They have their sight set on a new kind of AAV construct — a next-generation gene therapy if you will — that can treat all patients of RP independent of genetic mutations.

Giovanni Caforio, Bristol Myers Squibb CEO (Christopher Goodney/Bloomberg via Getty Images)

Here's how Bris­tol My­er­s' CEO Gio­van­ni Caforio com­plet­ed a $13B buy­out: He moved fast, upped the bid quick­ly and de­mand­ed every­one to keep up

Bristol Myers Squibb CEO Giovanni Caforio does not waste time. He also likes everyone around him to keep up.

Anyone reading over the insider account filed with the SEC of the back-and-forth over his $13 billion buyout of MyoKardia $MYOK could reach only one conclusion: The CEO who had willingly crafted a $74 billion Celgene acquisition had found something else he liked — and he was willing to pay a nice premium to get it.

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Sean McClain, AbSci

UP­DAT­ED: Months af­ter strik­ing a deal with Sanofi, Ab­Sci nails its largest fundraise yet to sup­port its pro­tein print­ing tech

Months after nailing down a $10.4 million Series D and a partnership with French pharma giant Sanofi, AbSci is pulling in its largest fundraise yet — $65 million to advance what it calls its protein printing tech.

The Vancouver, WA-based biotech is working on a more efficient way to manufacture proteins — from full-length antibodies to insulin — using E. coli. The company says it’s on a quest to make protein production “as simple as DNA synthesis,” allowing for swift production of difficult-to-produce biotherapeutics. It’s tagging the Series E for expansion of its production capacity, which includes a new 60,000-square-foot facility in Vancouver.

Roche finds a home for a new, $500M man­u­fac­tur­ing lo­gis­tics hub, promis­ing 500 jobs

Roche is pouring $500 million into its Canadian headquarters in Mississauga, Ontario to set up a new hub that will coordinate logistics for its global supply chain.

Over the 5-year investment, the Swiss pharma giant expects to add 200 jobs over next year and another 300 by the end of 2023.

Introduced as a $190 million global pharmaceutical development site in 2011, the campus currently houses Roche’s Canadian commercial unit as well as product development, global procurement and pharma informatics. The new expansion will see it organize manufacturing across 13 plants and 11 sites, according to FiercePharma.

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