Se­quoia helps fu­el Whole Bio­me's planned launch for 'med­ical pro­bi­otic­s' in $35M Se­ries B

Im­age: Colleen Cut­cliffe WHOLE BIO­ME

The boom in mi­cro­bio­me ther­a­peu­tics has el­e­vat­ed the “good” gut bac­te­ria from pro­bi­otics to drug sta­tus, spurring some up­starts backed by promi­nent ven­ture in­vestors to take their ther­a­pies on the high­ly reg­u­lat­ed jour­ney to­ward an FDA ap­proval. But Whole Bio­me wants to go a sep­a­rate di­rec­tion by oc­cu­py­ing the mid­dle ground with what it’s call­ing “med­ical pro­bi­otics.”

“This is ba­si­cal­ly a prod­uct that has phar­ma­ceu­ti­cal grade ef­fi­ca­cy, clin­i­cal ef­fi­ca­cy, but it has es­sen­tial­ly got the safe­ty of a pro­bi­ot­ic,” CEO Colleen Cut­cliffe tells me as the com­pa­ny emerges from stealth mode with $35 mil­lion in Se­ries B cash.

Jim Bullard Whole Bio­me

Cut­cliffe, a vet­er­an of Elan Phar­ma­ceu­ti­cals, was work­ing at the DNA se­quenc­ing com­pa­ny Pa­cif­ic Bio­sciences when she met her co-founders, Jim Bullard and John Eid. Com­bin­ing their bio­chem­istry, bio­sta­tis­tics and physics back­ground, the trio built a plat­form that com­pares deep se­quenc­ing da­ta from dif­fer­ent pop­u­la­tions, ar­riv­ing at meta­bol­ic maps that sug­gest ex­act­ly which mi­crobes are miss­ing in pa­tients with cer­tain dis­eases.

Se­quoia Cap­i­tal was an ear­ly sup­port­er of the 6-year-old ven­ture, chip­ping in­to the cur­rent round with True Ven­tures, Khosla Ven­tures, Mayo Foun­da­tion, AME Cloud Ven­tures and oth­ers. Roelof Botha is join­ing the board.

John Eid Whole Bio­me

Whole Bio­me plans to com­mer­cial­ize its first off-the-shelf prod­uct, for type 2 di­a­betes, ear­ly next year. Da­ta from sev­er­al re­cent — though un­pub­lished — place­bo-con­trolled clin­i­cal tri­als show that their treat­ment achieved re­duc­tion in A1C and glu­cose spikes on top of the stan­dard met­formin reg­i­men, Cut­cliffe says.

The the­o­ry is that peo­ple with type 2 di­a­betes lack the mi­crobes that are en­tire­ly re­spon­si­ble for me­tab­o­liz­ing fiber, which then trig­gers GLP1 re­sponse for reg­u­lat­ing glu­cose and in­sulin. WBF-011, which Whole Bio­me in­tends to mar­ket as a med­ical food, is de­signed to put ex­act­ly those mi­crobes back.

With 40 staffers and its own man­u­fac­tur­ing op­er­a­tions at its San Fran­cis­co base, the com­pa­ny is al­so ex­plor­ing oth­er prod­ucts for ir­ri­ta­ble bow­el syn­drome and a third, undis­closed in­di­ca­tion.

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.

Pfiz­er's big block­buster Xel­janz flunks its post-mar­ket­ing safe­ty study, re­new­ing harsh ques­tions for JAK class

When the FDA approved Pfizer’s JAK inhibitor Xeljanz for rheumatoid arthritis in 2012, they slapped on a black box warning for a laundry list of adverse events and required the New York drugmaker to run a long-term safety study.

That study has since become a consistent headache for Pfizer and their blockbuster molecule. Last year, Pfizer dropped the entire high dose cohort after an independent monitoring board found more patients died in that group than in the low dose arm or a control arm of patients who received one of two TNF inhibitors, Enbrel or Humira.

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Covid-19 roundup: EU and As­traZeneca trade blows over slow­downs; Un­usu­al unions pop up to test an­ti­bod­ies, vac­cines

After coming under fire for manufacturing delays last week, AstraZeneca’s feud with the European Union has spilled into the open.

The bloc accused the pharma giant on Wednesday of pulling out of a meeting to discuss cuts to its vaccine supplies, the AP reported. AstraZeneca denied the reports, saying it still planned on attending the discussion.

Early Wednesday, an EU Commission spokeswoman said that “the representative of AstraZeneca had announced this morning, had informed us this morning that their participation is not confirmed, is not happening.” But an AstraZeneca spokesperson later called the reports “not accurate.”

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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)

Af­ter 3 deaths rock the field, gene ther­a­py re­searchers con­tem­plate AAV's fu­ture

Nicole Paulk was scrolling through her phone in bed early one morning in June when an email from a colleague jolted her awake. It was an article: Two patients in an Audentes gene therapy trial had died, grinding the study to a halt.

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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Pascal Soriot, AP

As­traZeneca CEO Pas­cal So­ri­ot sev­ers an un­usu­al board con­nec­tion, steer­ing clear of con­flicts while re­tain­ing im­por­tant al­liances

CSL Behring chief Paul Perreault scored an unusual coup last summer when he added AstraZeneca CEO Pascal Soriot to the board, via Zoom. It’s rare, to say the least, to see a Big Pharma CEO take any board post in an industry where interests can simultaneously connect and collide on multiple levels of operations.

The tie set the stage for an important manufacturing connection. The Australian pharma giant agreed to supply the country with 10s of millions of AstraZeneca’s Covid-19 vaccine, once it passes regulatory muster.

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Yanay Ofran (L) and Anat Binur (Ukko)

Leaps by Bay­er backs a pro­tein en­gi­neer­ing start­up tak­ing on Aim­mune — and Nestlé — in peanut al­ler­gy

Little capsules of peanut powder drove Nestlé’s $2.6 billion buyout of Aimmune. Now, with $40 million in new funding, a fledgling biotech is promising to bring a more sophisticated version of that protein therapy that can go much, much further.

Ukko’s goal is two-pronged — with the initial products spanning therapeutic and food — but it’s grounded in the same protein engineering platform, co-founder and CEO Anat Binur told Endpoints News.

As tar­get­ed ther­a­pies get ever more pre­cise, Deer­field un­veils $50M bet on an Har­vard pro­fes­sor's chem­istry in­sights

Behind the seemingly simple concept of targeted cancer therapies is the drug developer’s headache that the target is always changing. Each generation of kinase inhibitors may be ostensibly hitting the same oncogene, but in addition to blocking the wildtype oncogene, they must now also address the mutations that have developed along the way, spurring resistance to current drugs.

The more those target kinases evolve, too, the more they could resemble off-target kinases you don’t want to bind. So each iteration requires more selectivity — sometimes down to differences of a few atoms.

Vincent Sandanayaka (file photo)

UP­DAT­ED: Ex-MD An­der­son chief De­Pin­ho is help­ing launch an­oth­er biotech — and he's stick­ing with fa­mil­iar ground

Years after co-founding SINE-focused Karyopharm and stirring up controversy at MD Anderson, Ronald DePinho is helping uncloak a new biotech targeting solute carrier transporter proteins — and Karyopharm’s former head of chemistry is leading the charge.

Nirogy Therapeutics emerged from stealth mode on Tuesday with a $16.5 million Series A round and plans to hit the clinic by 2022. The financing should be enough to carry the startup’s lead program, a small molecule lactate transport inhibitor, through Phase I, CEO Vincent Sandanayaka said.

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.

The pharma giant is reporting this morning that it’s decided to drop development of 2 vaccines — V590 and V591 — after taking a look at Phase I data that simply don’t measure up to either the natural immune response seen in people exposed to the virus or the vaccines already on or near the market.

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