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.

Nick Leschly via Getty

UP­DAT­ED: Blue­bird shares sink as an­a­lysts puz­zle out $1.8M stick­er shock and an un­ex­pect­ed de­lay

Blue­bird bio $BLUE has un­veiled its price for the new­ly ap­proved gene ther­a­py Zyn­te­glo (Lenti­Glo­bin), which came as a big sur­prise. And it wasn’t the on­ly un­ex­pect­ed twist in to­day’s sto­ry.

With some an­a­lysts bet­ting on a $900,000 price for the β-tha­lassemia treat­ment in Eu­rope, where reg­u­la­tors pro­vid­ed a con­di­tion­al ear­ly OK, blue­bird CEO Nick Leschly said Fri­day morn­ing that the pa­tients who are suc­cess­ful­ly treat­ed with their drug over 5 years will be charged twice that — $1.8 mil­lion — on the con­ti­nent. That makes this drug the sec­ond most ex­pen­sive ther­a­py on the plan­et, just be­hind No­var­tis’ new­ly ap­proved Zol­gens­ma at $2.1 mil­lion, with an­a­lysts still wait­ing to see what kind of pre­mi­um can be had in the US.

Ted Love. HAVERFORD COLLEGE

Glob­al Blood Ther­a­peu­tics poised to sub­mit ap­pli­ca­tion for ac­cel­er­at­ed ap­proval, with new piv­otal da­ta on its sick­le cell dis­ease drug

Global Blood Therapeutics is set to submit an application for accelerated approval in the second-half of this year, after unveiling fresh data from a late-stage trial that showed just over half the patients given the highest dose of its experimental sickle cell disease drug experienced a statistically significant improvement in oxygen-wielding hemoglobin, meeting the study's main goal.

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Gene ther­a­pies seize the top of the list of the most ex­pen­sive drugs on the plan­et — and that trend has just be­gun

Anyone looking for a few simple reasons why the gene therapy field has caught fire with the pharma giants need only look at the new list of the 10 most expensive therapies from GoodRx.

Two recently approved gene therapies sit atop this list, with Novartis’ Zolgensma crowned the king of the priciest drugs at $2.1 million. Right below is Luxturna, the $850,000 pioneer from Spark, which Roche is pushing hard to acquire as it adds a gene therapy group to the global mix.

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News­mak­ers at #EHA19: Re­gen­eron, Ar­Qule track progress on re­sponse rates

Re­gen­eron’s close­ly-watched bis­pe­cif­ic con­tin­ues to ring up high re­sponse rates

Re­gen­eron’s high-pro­file bis­pe­cif­ic REGN1979 is back in the spot­light at the Eu­ro­pean Hema­tol­ogy As­so­ci­a­tion sci­en­tif­ic con­fab. And while the stel­lar num­bers we saw at ASH have erod­ed some­what as more blood can­cer pa­tients are eval­u­at­ed, the re­sponse rates for this CD3/CD20 drug re­main high.

A to­tal of 13 out of 14 fol­lic­u­lar lym­phomas re­spond­ed to the drug, a 93% ORR, down from 100% at the last read­out. In 10 out of 14, there was a com­plete re­sponse. In dif­fuse large B-cell lym­phoma the re­sponse rate was 57% among pa­tients treat­ed at the 80 mg to 160 mg dose range. They were all com­plete re­spons­es. And 2 of these Cars were for pa­tients who had failed CAR-T ther­a­py.

Neil Woodford, Woodford Investment Management via YouTube

Un­der siege, in­vest­ment man­ag­er Wood­ford faces an­oth­er in­vest­ment shock

Em­bat­tled UK fund man­ag­er Neil Wood­ford — who has con­tro­ver­sial­ly blocked in­vestors from pulling out from his flag­ship fund to stem the blood­let­ting, af­ter a slew of dis­ap­point­ed in­vestors fled fol­low­ing a se­ries of sour bets — is now pay­ing the price for his ac­tions via an in­vestor ex­o­dus on an­oth­er fund.

Har­g­reaves Lans­down, which has in the past sold and pro­mot­ed the Wood­ford funds via its re­tail in­vest­ment plat­form, has re­port­ed­ly with­drawn £45 mil­lion — its en­tire po­si­tion — from the in­vest­ment man­ag­er’s In­come Fo­cus Fund.

Adding mar­quee in­vestors, Black­Thorn bags $76M to back an AI-dri­ven strat­e­gy for pre­ci­sion neu­ro med­i­cine

As ar­ti­fi­cial in­tel­li­gence and ma­chine learn­ing loom ever larg­er in drug dis­cov­ery and de­vel­op­ment, a biotech op­er­at­ing at the “nexus” of tech­nol­o­gy and neu­ro­sciences has cashed in with $76 mil­lion in fresh fi­nanc­ing.

The big idea at Black­Thorn Ther­a­peu­tics is to do for neu­robe­hav­ioral dis­or­ders what ge­net­i­cal­ly tar­get­ed ther­a­py has done for on­col­o­gy: Re­de­fine pa­tient pop­u­la­tions by the un­der­ly­ing bi­ol­o­gy — dys­reg­u­lat­ed brain cir­cuits, or neu­rotypes — in­stead of symp­toms, there­by find­ing the pa­tients who are most like­ly to ben­e­fit at en­roll­ment phase.

J&J gains an en­thu­si­as­tic en­dorse­ment from Pres­i­dent Don­ald Trump for their big new drug Spra­va­to

Pres­i­dent Don­ald Trump has lit­tle love for Big Phar­ma, but there’s at least one new drug that just hit the mar­ket which he is en­am­ored with.

Trump, ev­i­dent­ly, has been read­ing up on J&J’s new an­ti-de­pres­sion drug, Spra­va­to. And the pres­i­dent — who of­ten likes to break out in­to a full-throat­ed at­tack on greedy drug­mak­ers — ap­par­ent­ly en­thused about the ther­a­py in a meet­ing with of­fi­cials of Vet­er­ans Af­fairs, which has long grap­pled with de­pres­sion among vet­er­ans.

In a boost to Rit­ux­an fran­chise, Roche nabs quick ap­proval for po­latuzum­ab ve­dotin

Roche’s lat­est an­ti­body-drug con­ju­gate has crossed the FDA fin­ish line, gain­ing an ac­cel­er­at­ed ap­proval a full two months ahead of sched­ule.

Po­livy, or po­latuzum­ab ve­dotin, is a first-in-class drug tar­get­ing CD79b — a pro­tein promi­nent in B-cell non-Hodgkin lym­phoma. It will now be mar­ket­ed for dif­fuse large B-cell lym­phoma as part of a reg­i­men that al­so in­cludes the chemother­a­py ben­damus­tine and a ver­sion of rit­ux­imab (Rit­ux­an).

An in­censed Cat­a­lyst Phar­ma sues the FDA, ac­cus­ing agency of bow­ing to po­lit­i­cal pres­sure and break­ing fed­er­al law

Af­ter hint­ing it was ex­plor­ing the le­gal­i­ty of the FDA’s ap­proval of a ri­val drug from fam­i­ly-run com­pa­ny Ja­cobus Phar­ma­ceu­ti­cals, Cat­a­lyst Phar­ma­ceu­ti­cals on Wednes­day filed a law­suit against the health reg­u­la­tor — ef­fec­tive­ly ac­cus­ing the agency of bow­ing to po­lit­i­cal pres­sure sur­round­ing sky­rock­et­ing drug prices.

Be­fore Cat­a­lyst’s Fir­dapse (which car­ries an av­er­age an­nu­al list price of $375,000) was sanc­tioned for use in Lam­bert-Eaton myas­thenic syn­drome (LEMS) by the FDA, hun­dreds of pa­tients had been able to ac­cess a sim­i­lar drug from com­pound­ing phar­ma­cies for a frac­tion of the cost, or Ja­cobus’ for free, as part of an FDA-rat­i­fied com­pas­sion­ate use pro­gram. But the ap­proval of the Cat­a­lyst drug — ac­com­pa­nied by mar­ket ex­clu­siv­i­ty span­ning sev­en years — ef­fec­tive­ly pre­clud­ed Ja­cobus and com­pound­ing phar­ma­cies from sell­ing their ver­sions.