Take­da part­ners with an up­start drugs-from-bugs mi­cro­bio­me play­er in­spired by a fe­cal trans­plan­ta­tion biz

Back when Mark Smith was work­ing on his PhD at MIT about 6 years ago, his girl­friend’s cousin was in­fect­ed with C.diff. Af­ter 7 re­oc­cur­rences fol­low­ing treat­ment with van­comycin, though, the cousin fi­nal­ly beat it by get­ting a fe­cal trans­plant, with his room­mate as the donor.

That in­ci­dent both in­trigued him and in­spired Smith’s first jump in­to a start­up, Open­Bio­me, which us­es screened fe­cal sam­ples for a more sys­tem­at­ic ap­proach in cre­at­ing a safe, re­li­able sup­ply of trans­plants to a grow­ing mar­ket.

Smith’s sec­ond start­up was a nat­ur­al ex­ten­sion of the first ven­ture: Finch Ther­a­peu­tics, a mi­cro­bio­me com­pa­ny which is de­vel­op­ing new drugs-from-bugs — an ap­proach which has helped in­spire a ros­ter of star­tups over the last two years. And to­day, the low-pro­file biotech — which has mush­roomed overnight in Somerville, MA in­to a 65-em­ploy­ee com­pa­ny that’s deeply en­gaged in man­u­fac­tur­ing work and fo­cus­ing on two de­vel­op­ment pro­grams – is un­veil­ing its first in­dus­try part­ner­ship.

Take­da, the Japan­ese phar­ma com­pa­ny with a grow­ing Boston R&D op­er­a­tion, is pay­ing $10 mil­lion up front on a very ear­ly-stage deal to part­ner on FIN-524, a pre­clin­i­cal pro­gram for IBD.

Work­ing with col­leagues at MIT, Smith has been work­ing on a “suite of al­go­rithms to ap­ply to da­ta on fe­cal trans­plan­ta­tion, to re­verse en­gi­neer ef­fec­tive ther­a­pies, then iden­ti­fy with com­pu­ta­tion­al ap­proach­es which bugs dri­ve clin­i­cal re­spons­es.”

“The core of our com­pa­ny is built around hu­man-first dis­cov­ery,” says Smith. While ri­vals look to an­i­mal mod­els to val­i­date their ideas, Finch li­censed a data­base de­rived from 22,000 pa­tients at Open­Bio­me dosed with fe­cal trans­plan­ta­tion. If they see an in­ter­est­ing phe­no­type, they can “se­quence the sam­ple, look at the or­gan­isms gen­er­at­ing a re­sponse, and go back to the freez­er and pull the strain.”

You start with some­thing that works, like fe­cal trans­plan­ta­tion, says Smith, and then work back­wards to get a drug. That is how they came up with the lead pro­gram for C.diff, now head­ed in­to a Phase II study.

Why 65 work­ers at this stage? Smith ex­plains that 40 staffers in­volved in man­u­fac­tur­ing at Open­Bio­me came over to the spin­out.

Ten mil­lion dol­lars isn’t a huge amount of cash in the biotech busi­ness. But Smith has man­aged to start a com­pa­ny and get in­to pipeline build­ing with­out hand­ing over a lot of eq­ui­ty to the VCs. He start­ed with an­gel mon­ey, then raised $5.5 mil­lion in an A round, and is now work­ing on a siz­able se­ries B. That $10 mil­lion from Take­da — along with an un­de­fined pack­age of mile­stones — goes a long way to fund their growth.

The Take­da pro­gram prob­a­bly has two-and-a-half to three years to go be­fore they hit the clin­ic, Smith adds, tar­get­ing ul­cer­a­tive col­i­tis.

UP­DAT­ED: In a stun­ning turn­around, Bio­gen says that ad­u­canum­ab does work for Alzheimer's — but da­ta min­ing in­cites con­tro­ver­sy and ques­tions

Biogen has confounded the biotech world one more time.

In a stunning about-face, the company and its partners at Eisai say that a new analysis of a larger dataset on aducanumab has restored its faith in the drug as a game-changer for Alzheimer’s and, after talking it over with the FDA, they’ll now be filing for an approval of a drug that had been given up for dead.

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Vas Narasimhan. Getty Images

UP­DAT­ED: Failed PhI­II fe­vip­iprant tri­als pour more cold wa­ter on No­var­tis' block­buster R&D en­gine — and briefly spread the chill to a high-pro­file biotech

Back in July, during an investor call where Novartis execs ran through an upbeat assessment of their Q2 performance, CEO Vas Narasimhan and development chief John Tsai were pressed to predict which of the two looming Phase III readouts — involving cardio drug Entresto and asthma therapy fevipiprant, respectively — had a higher likelihood of success. Tsai gave the PARAGON-HF study with Entresto minimally better odds, but Narasimhan emphasized that their strategy of giving fevipiprant to more severe patients gave them confidence.

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UP­DAT­ED: The FDA sets a reg­u­la­to­ry speed record, pro­vid­ing a snap OK for Ver­tex's break­through triplet for cys­tic fi­bro­sis

The FDA has approved Vertex’s new triplet for cystic fibrosis at a record-setting speed.

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David Liu, Liu Group

David Liu un­veils newest ad­vance­ment in CRISPR tech: Prime edit­ing

The researcher behind base-editing is out with what some scientists are hailing as the biggest advancement in CRISPR technology since that 2016 breakthrough: “prime editing.” The new molecular gadget is capable of erasing any base pair and stenciling in another and cutting or adding long segments of DNA without breaking both strands of the helix.

David Liu, base editing pioneer and founder of Beam Therapeutics, published the findings in Nature alongside Andrew Anzalone. They estimated that the breakthrough “in principle” puts 89% of human diseases in purview — although experts cautioned that human therapies were a long way off.

Bhaskar Chaudhuri. Frazier Healthcare Partners

Fra­zier Health­care Part­ner­s' der­ma­tol­ogy up­start at­tracts a mar­quee syn­di­cate, $94M+ for 'in-be­tween' top­i­cal drug

For the past three years Frazier Healthcare Partners’ Bhaskar Chaudhuri has been carefully and quietly grooming Arcutis Therapeutics, a new dermatology play he co-founded to deliver topical formulations of well-known drugs. Now that the biotech is poised to enter Phase III, he’s being joined by a marquee syndicate for its $94.5 million Series C.

HBM Healthcare Investments, Vivo Capital, BlackRock, Omega Funds, Pivotal BioVentures, and Goldman Sachs jumped on board, joining Bain Capital Life Sciences, OrbiMed and RA Capital Management in backing Arcutis’ lead topical cream for plaque psoriasis.

A new com­pa­ny en­ters the Tec­fidera fight, of­fer­ing to kill two birds

The remedy for the most common side effect for one of the most common multiple sclerosis drugs is simple: aspirin.

Taking aspirin with Biogen’s Tecfidera will reduce the flush, a sometimes painful form of red skin irritation, many patients experiences. The problem is that the aspirin has to be taken at least 30 minutes before Tecfidera, turning a simple twice-a-day, one-dose oral drug into a staggered two-drug regimen.

UP­DAT­ED: Bris­tol-My­ers makes Op­di­vo pitch for front­line lung can­cer with open la­bel PhI­II study

Despite a head start, when Bristol-Myers Squibb and its pioneering checkpoint inhibitor Opdivo suffered a key lung cancer setback in 2016, they found themselves relegated to the backseat as Merck’s Keytruda seized the wheel on the road to immunotherapy stardom. Bristol-Myers has since suffered blow after blow in its quest to take a big slice of the lucrative market, peppered with some small successes. On Tuesday, the New Jersey drugmaker touted positive data from a Phase III open-label study in a bid to carve itself a piece of the frontline lung cancer market.

Take­da tees up $420M deal for celi­ac an­ti­dote, con­tin­u­ing R&D re­fo­cus

Sometime in the 1st century AD, a patient presented to Arataeus looking like a varicose ghost. He was “emaciated and atrophied, pale, feeble and incapable of performing any of his accustomed works,” the Greek physician wrote, with hollow temples and huge veins running all over his body.

A dysfunctional digestive system, Arataeus concluded – an imbalance he attributed to a “heat” deficiency in a system he and other Greeks regarded as functioning similarly to an oven – and coined a term: coeliac disease, after the Greek word for abdomen.

IM­brave150: Roche’s reg­u­la­to­ry crew plans a glob­al roll­out of Tecen­triq com­bo for liv­er can­cer as PhI­II scores a hit

Just weeks after Bristol-Myers Squibb defended its failed pivotal study pitting Opdivo against Nexavar in liver cancer, Roche says it’s beat the frontline challenge with a combination of their PD-L1 Tecentriq with Avastin. And now they’re rolling their regulatory teams in the US, Europe and China in search of a new approval — badly needed to boost a trailing franchise effort.
Given their breakthrough and Big Pharma status as well as the use of two approved drugs, FDA approval may well prove to be something of a formality. And the Chinese have been clear that they want new drugs for liver cancer, where lethal disease rates are particularly high.
Researchers at their big biotech sub, Genentech, say that the combo beat Bayer’s Nexavar on both progression-free survival as well as overall survival — the first advance in this field in more than a decade. We won’t get the breakdown in months of life gained, but it’s a big win for Roche, which has lagged far, far behind Keytruda and Opdivo, the dominant PD-1s that have captured the bulk of the checkpoint market so far.
Researchers recruited hepatocellular carcinoma — the most common form of liver cancer — patients for the IMbrave150 study who weren’t eligible for surgery ahead of any systemic treatment of the disease.
Roche has a fairly low bar to beat, with modest survival benefit for Nexavar, approved for this indication 12 years ago. But they also plan to offer a combo therapy that could have significantly less toxicity, offering patients a much easier treatment regimen.
Cowen’s Steven Scala recently sized up the importance of IMbrave150, noting:

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