Ar­ti­zan com­pletes mi­cro­bio­me starter pack­age with Brii deal, CSO hire and some mon­ey to dash for the clin­ic

Three years af­ter giv­ing a syn­op­sis of its mi­cro­bio­me play with some seed fund­ing from Ma­lin and Hat­teras Ven­ture Part­ners, Ar­ti­zan is rais­ing the cur­tain on their first act in in­flam­ma­to­ry bow­el dis­ease.

James Rosen Ar­ti­zan

Armed with $12 mil­lion in to­tal Se­ries A cash, a part­ner­ship with Chi­na’ Brii Bio and a new CSO hire, the New Haven, CT-based biotech is ready to hun­ker down for some pre­clin­i­cal work. Mean­while, CEO James Rosen tells me he will be get­ting to work rais­ing a Se­ries B in­tend­ed to fund clin­i­cal op­er­a­tions.

Yale im­muno­bi­ol­o­gy pro­fes­sor Richard Flavell and two col­lab­o­ra­tors pi­o­neered a new way to iden­ti­fy dis­ease-caus­ing bac­te­ria by scan­ning for an an­ti­body coat­ing called im­muno­glo­bin A (IgA). That was 2014.

“The coat­ing is our body’s at­tempt to neu­tral­ize the bac­te­ria,” Flavell said in 2014. “It binds to the bad bac­te­ria. We on­ly make these IgA re­spons­es to a lim­it­ed num­ber of or­gan­isms.”

It’s a more ef­fi­cient ap­proach than the tra­di­tion­al method of screen­ing for harm­ful bac­te­ria, which typ­i­cal­ly in­volves com­par­ing vast amounts of se­quenc­ing da­ta be­tween healthy and sick in­di­vid­u­als.

Richard Flavell Ar­ti­zan

Ze­ro­ing on the mi­crobes to tar­get, though, is on­ly the first step. Ar­ti­zan is look­ing in­to a num­ber of ways to get rid of them, from small mol­e­cules and an­ti­bod­ies to a ther­a­peu­tic vac­cine that could help the im­mune sys­tem mount a more po­tent at­tack.

Un­like some well-known play­ers in the mi­cro­bio­me field such as Seres and Finch, “we’re very specif­i­cal­ly not bugs as drugs,” Rosen said.

That opens up a broad range of po­ten­tial ap­pli­ca­tions for Ar­ti­zan’s plat­form, he said, as man­i­fest­ed in Brii’s de­ci­sion to col­lab­o­rate on up to three pro­grams. Brii — a $260 mil­lion pow­er biotech play spear­head­ed by GSK vet Zhi Hong — will pick up Chi­na de­vel­op­ment and com­mer­cial­iza­tion once Ar­ti­zan pro­duces proof-of-con­cept in the next cou­ple of years.

The deal comes with an undis­closed set of up­front, mile­stone and roy­al­ty pay­ments in ad­di­tion to a ven­ture in­vest­ment, plac­ing Brii in a syn­di­cate that in­cludes John­son & John­son De­vel­op­ment In­no­va­tion – JJDC, Os­age Uni­ver­si­ty Part­ners and Elm Street Ven­tures.

Paul Miller Syn­log­ic

Co­or­di­nat­ing the whole re­search ef­fort from dis­cov­ery to drug de­vel­op­ment and join­ing the 11-per­son team would be Paul Miller, the new chief sci­en­tif­ic of­fi­cer. Miller, a sea­soned ex­ec groomed in As­traZeneca and Pfiz­er, jumps from Syn­log­ic, which spe­cial­izes in reengi­neer­ing bac­te­ria in­to ther­a­peu­tics.

“It’s an ex­cit­ing time to join Ar­ti­zan’s ef­forts to ad­dress the un­met treat­ment need in IBD, a dis­ease that af­fects more than 1.6 mil­lion Amer­i­cans,” Miller said in a state­ment.

UP­DAT­ED: In sur­prise switch, Bris­tol-My­ers is sell­ing off block­buster Ote­zla, promis­ing to com­plete Cel­gene ac­qui­si­tion — just lat­er

Apart from revealing its checkpoint inhibitor Opdivo blew a big liver cancer study on Monday, Bristol-Myers Squibb said its plans to swallow Celgene will require the sale of blockbuster psoriasis treatment Otezla to keep the Federal Trade Commission (FTC) at bay.

The announcement — which has potentially delayed the completion of the takeover to early 2020 — irked investors, triggering the New York-based drugmaker’s shares to tumble Monday morning in premarket trading.

Celgene’s Otezla, approved in 2014 for psoriasis and psoriatic arthritis, is a rising star. It generated global sales of $1.6 billion last year, up from the nearly $1.3 billion in 2017. Apart from the partial overlap of Bristol-Myers injectable Orencia, the company’s rival oral TYK2 psoriasis drug is in late-stage development, after the firm posted encouraging mid-stage data on the drug, BMS-986165, last fall. With Monday’s decision, it appears Bristol-Myers is favoring its experimental drug, and discounting Otezla’s future.

The move blindsided some analysts. Credit Suisse’s Vamil Divan noted just days ago:

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Novotech CEO Dr. John Moller

Novotech CRO Award­ed Frost & Sul­li­van Best Biotech CRO Asia-Pa­cif­ic 2019

Known in the in­dus­try as the Asia-Pa­cif­ic CRO, Novotech is now lead CRO ser­vices provider for the grow­ing num­ber of in­ter­na­tion­al biotechs se­lect­ing the re­gion for their stud­ies.

Re­flect­ing this Asia-Pa­cif­ic growth, Novotech staff num­bers are up 20% since De­cem­ber 2018 to 600 in-house clin­i­cal re­search peo­ple across a full range of ser­vices, across the re­gion.

Novotech’s ca­pa­bil­i­ties have been rec­og­nized by an­a­lysts like Frost & Sul­li­van, most re­cent­ly with the pres­ti­gious Asia-Pa­cif­ic CRO Biotech of the year award for best prac­tices in clin­i­cal re­search for biotechs for the fifth year. See oth­er awards here.

Evotec CEO Werner Lanthaler, File Photo

Ox­ford, Evotec ramp up LAB10x with AI ex­perts at Sen­syne — fo­cused on biotech spin­outs

Ox­ford is al­ly­ing it­self with Evotec and ar­ti­fi­cial in­tel­li­gence out­fit Sen­syne Health to ramp up some new biotech spin­outs while look­ing to “ac­cel­er­ate da­ta-dri­ven drug dis­cov­ery and de­vel­op­ment.”

The big idea here is that Ox­ford sci­en­tists — some of the best drug hunters in the world — can uti­lize Sen­syne’s AI plat­form for their work, re­ly­ing on the chemists and hands-on de­vel­op­ers at Evotec to push ahead to a crit­i­cal proof of con­cept mo­ment. And they’ll do it through a project leader called LAB10x, which gets £5 mil­lion over the next three years to fund the work.

Fol­low­ing news of job cuts in Eu­ro­pean R&D ops, Sanofi con­firms it’s of­fer­ing US work­ers an 'ear­ly ex­it'

Ear­li­er in the week we learned that Sanofi was bring­ing out the bud­get ax to trim 466 R&D jobs in Eu­rope, re­tool­ing its ap­proach to car­dio as re­search chief John Reed beefed up their work in can­cer and gene ther­a­pies. And we’re end­ing the week with news that the phar­ma gi­ant has al­so been qui­et­ly re­duc­ing staff in the US, tar­get­ing hun­dreds of jobs as the com­pa­ny push­es vol­un­tary buy­outs with a fo­cus on R&D sup­port ser­vices.

Suf­fer­ing No­var­tis part­ner Cona­tus is pack­ing it in on NASH af­ter a se­ries of un­for­tu­nate tri­al events

The NASH par­ty is over at No­var­tis-backed Cona­tus. And this time they’re turn­ing off the lights.

More than 2 years af­ter No­var­tis sur­prised the biotech in­vest­ment com­mu­ni­ty with its $50 mil­lion up­front and promise of R&D sup­port to part­ner with the lit­tle biotech on NASH — ig­nit­ing a light­ning strike for the share price — Cona­tus $CNAT is back with the lat­est bit­ter tale to tell about em­ri­c­as­an, which once in­spired con­fi­dence at the phar­ma gi­ant.

Dean Hum. Nasdaq via YouTube

Gen­fit goes to Chi­na with a deal worth up to $228M for NASH drug

Fresh off the high of its Nas­daq IPO de­but, and the low of com­par­isons to Cymabay — whose NASH drug re­cent­ly stum­bled — Gen­fit on Mon­day un­veiled an up to $228 mil­lion deal with transpa­cif­ic biotech Terns Phar­ma­ceu­ti­cals to de­vel­op its flag­ship ex­per­i­men­tal liv­er drug — elafi­bra­nor — in Greater Chi­na.

The deal comes weeks af­ter Gen­fit $GN­FT is­sued a fiery de­fense of its dual PPAR ag­o­nist elafi­bra­nor, when com­peti­tor Cymabay’s PPARδ ag­o­nist, se­ladel­par, fiz­zled in a snap­shot of da­ta from an on­go­ing mid-stage tri­al. The main goal at the end of 12 weeks was for se­ladel­par to in­duce a sta­tis­ti­cal­ly sig­nif­i­cant im­prove­ment in liv­er fat con­tent, but da­ta showed that pa­tients on the place­bo ac­tu­al­ly per­formed bet­ter.

Alex­ion wins pri­or­i­ty re­view for Ul­tomiris' aHUS in­di­ca­tion; FDA ex­pands ap­proval of Ver­tex's Symdeko

→ Alex­ion $ALXN has scored a speedy re­view for Ul­tomiris for pa­tients with atyp­i­cal he­molyt­ic ure­mic syn­drome (aHUS) af­ter post­ing pos­i­tive da­ta from a piv­otal study in Jan­u­ary. The drug is the rare dis­ease com­pa­ny’s shot at pro­tect­ing its block­buster blood dis­or­der fran­chise that is cur­rent­ly cen­tered around its flag­ship drug, Soliris, which is a com­ple­ment in­hibitor typ­i­cal­ly ad­min­is­tered every two weeks. Ul­tomiris has a sim­i­lar mech­a­nism of ac­tion but re­quires less-fre­quent dos­ing — every eight weeks. The de­ci­sion date has been set to Oc­to­ber 19. Late last year, Ul­tomiris se­cured ap­proval for noc­tur­nal he­mo­glo­bin­uria (PNH) pa­tients.

Bet­ter than Am­bi­en? Min­er­va soars on PhI­Ib up­date on sel­torex­ant for in­som­nia

A month af­ter roil­ing in­vestors with what skep­tics dis­missed as cher­ry pick­ing of its de­pres­sion da­ta, Min­er­va is back with a clean slate of da­ta from its Phase IIb in­som­nia tri­al.

In a de­tailed up­date, the Waltham, MA-based biotech said sel­torex­ant (MIN-202) hit both the pri­ma­ry and sev­er­al sec­ondary end­points, ef­fec­tive­ly im­prov­ing sleep in­duc­tion and pro­long­ing sleep du­ra­tion. In­ves­ti­ga­tors made a point to note that the ef­fects were con­sis­tent across the adult and el­der­ly pop­u­la­tions, with the lat­ter more prone to the sleep dis­or­der.

Gene ther­a­py biotech sees its stock rock­et high­er on promis­ing re­sults for rare cas­es of but­ter­fly dis­ease

Shares of Krys­tal Biotech took off this morn­ing $KRYS af­ter the lit­tle biotech re­port­ed promis­ing re­sults from its gene ther­a­py to treat a rare skin dis­ease called epi­der­mol­y­sis bul­losa.

Fo­cus­ing on an up­date with 4 new pa­tients, re­searchers spot­light­ed the suc­cess of KB103 in clos­ing some stub­born wounds. Krys­tal says that of 4 re­cur­ring and 2 chron­ic skin wounds treat­ed with the gene ther­a­py, the KB103 group saw the clo­sure of 5. The 6th — a chron­ic wound, de­fined as a wound that had re­mained open for more than 12 weeks — was par­tial­ly closed. That brings the to­tal so far to 8 treat­ed wounds, with 7 clo­sures.