Akre­via scoops ex-Ar­sa­nis chief René Rus­so as CEO; Scott Got­tlieb jumps back in­to in­dus­try; Seat­tle Ge­net­ics raids As­traZeneca for CCO

René Rus­so Akre­via Ther­a­peu­tics

→ Months af­ter re­sign­ing from Ar­sa­nis — now rel­e­gat­ed to biotech his­to­ry books af­ter a re­verse merg­er with X4 Phar­maRené Rus­so has land­ed her next CEO gig at Akre­via Ther­a­peu­tics. The new role will shift her at­ten­tion from an­ti-in­fec­tives to im­muno-on­col­o­gy, but she will lean on her ex­pe­ri­ence scal­ing up biotech op­er­a­tions from an ear­ly stage. Backed by F-Prime Cap­i­tal and At­las Ven­ture, Akre­via em­ploys plat­form tech that pack­ages a CT­LA4 in­hibitor in a way that the an­ti­body would be in­ac­tive un­til it reach­es the tu­mor mi­croen­vi­ron­ment.

Scott Got­tlieb Twit­ter

→ Just a lit­tle more than a month af­ter his sur­prise ex­it from the FDA — sug­gest­ing he want­ed to spend more time with his fam­i­ly in Con­necti­cut, Scott Got­tlieb is jump­ing back in­to the mon­ey side of the in­dus­try and re­join­ing Wash­ing­ton DC-based New En­ter­prise As­so­ci­ates as a full-time in­vest­ing part­ner, where he ex­pects to start back­ing biotech star­tups and sit­ting on boards again.

 

Robin Tay­lor Seat­tle Ge­net­ics

Seat­tle Ge­net­ics $SGEN has raid­ed the top ranks of As­traZeneca $AZN for its first chief com­mer­cial of­fi­cer, Robin Tay­lor. Tay­lor’s stint at As­traZeneca last­ed 7 months, and pri­or to jump­ing to the com­pa­ny, he led the can­cer im­munother­a­py fran­chise at Roche’s Genen­tech for close to 18 years.

“Robin will play a key role in ex­tend­ing our com­mer­cial ex­e­cu­tion across six Ad­cetris lym­phoma in­di­ca­tions, while prepar­ing for the po­ten­tial launch of en­for­tum­ab ve­dotin and lead­ing our glob­al com­mer­cial­iza­tion strat­e­gy for pos­si­ble fu­ture prod­ucts, such as tu­ca­tinib,” not­ed Seat­tle Ge­net­ics CEO Clay Sie­gall.

David Apelian Twit­ter

→ Cur­rent COO and ex­ec­u­tive med­ical of­fi­cer of late-stage Eiger Bio­Phar­ma­ceu­ti­cals, David Apelian, will be step­ping down ef­fec­tive June 14, 2019. Apelian will join a pri­vate biotech as its CEO. Apelian’s de­par­ture is hap­pen­ing while the com­pa­ny’s Phase III pro­gram for ion­a­farnib — a preny­la­tion in­hibitor for the treat­ment of He­pati­tis Delta Virus (HDV) in­fec­tion — is be­ing prepped for an NDA and MAA to treat Hutchin­son-Gil­ford Prog­e­ria Syn­drome (HG­PS or Prog­e­ria) and Progeroid Laminopathies, with plans to file in 2019. Apelian will con­tin­ue to serve on the com­pa­ny’s board of di­rec­tors.

Pamela Gar­zone Scripps Re­search

→ The drug de­vel­op­ment arm of Scripps Re­search, Cal­i­br, has named Pamela Gar­zone as its CMO. Gar­zone has pre­vi­ous­ly served as vice pres­i­dent with­in the ear­ly on­col­o­gy de­vel­op­ment at Pfiz­er $PFE as well as oth­er lead­er­ship roles. Cal­i­br is cur­rent­ly de­vel­op­ing mul­ti­ple drug can­di­dates, such as KA34 — a po­ten­tial os­teoarthri­tis ther­a­py that is cur­rent­ly in a Phase I hu­man clin­i­cal tri­al stage, and lat­er this year the com­pa­ny plans to sub­mit IND ap­pli­ca­tions for two can­cer ther­a­pies.

Mar­tin Tred­er Af­fimed

Af­fimed $AFMD has part­ed ways with CSO Mar­tin Tred­er just as the Ger­man biotech ex­e­cutes a pipeline cleanup and nar­rows its fo­cus. Its AFM11 pro­gram got in­to trou­ble with the FDA last Oc­to­ber due to a pa­tient death and two life-threat­en­ing episodes, and reg­u­la­tors re­cent­ly in­formed them that the Phase I tri­al can­not re­sume with­out more da­ta. CEO Adi Hoess notes that he has a strong team and is in no rush, if ever, to re­place Tred­er — who re­mains as a con­sul­tant. In the mean­time, COO Wolf­gang Fis­ch­er will over­see the dis­cov­ery and pre­clin­i­cal ef­forts.

Di­nah Sah Voy­ager Ther­a­peu­tics

→ Cam­bridge, Mass­a­chu­setts-based clin­i­cal-stage gene com­pa­ny, Voy­ager Ther­a­peu­tics an­nounced the re­tire­ment of its CSO Di­nah Sah and the ex­pan­sion of Omar Khwa­ja’s cur­rent role as CMO to now in­clude head of R&D. Both changes will be ef­fec­tive on June 28, 2019. Sah will con­tin­ue to serve as a con­sul­tant to the com­pa­ny and will al­so join its sci­en­tif­ic ad­vi­so­ry board.  

Mor­gan Sheng Genen­tech

Mor­gan Sheng is re­turn­ing to acad­e­mia fol­low­ing a decade at Roche’s Genen­tech. As VP of neu­ro­science, he spear­head­ed re­search projects dig­ging in­to new treat­ments for neu­rode­gen­er­a­tive dis­eases and pain. He now takes that back to MIT, al­beit in some­what dif­fer­ent po­si­tions than when he left — core mem­ber at the Broad In­sti­tute, and co-di­rec­tor of the Stan­ley Cen­ter for Psy­chi­atric Re­search — with a clear aim to ad­vance new ways to study, di­ag­nose and treat men­tal ill­ness.

Kirk Christof­fersen Linkedin

→ Well on its way in the clin­ic, an­ti-CD47 play­er Arch On­col­o­gy is ready to look be­yond its lead as­set for op­por­tu­ni­ties to grow. Kirk Christof­fersen has been tapped for the new­ly-cre­at­ed chief busi­ness of­fi­cer role, re­spon­si­ble for cor­po­rate strat­e­gy. Jump­ing from Com­pu­gen (pre­ced­ed by a 10-year run at GlobeIm­mune) Christof­fersen joins Arch short­ly af­ter it banked $50 mil­lion in Se­ries B cash, al­low­ing it to ex­pand both the cor­po­rate/clin­i­cal de­vel­op­ment team in the Bay Area and the re­search group at St. Louis.

Greg Rys­lik Linkedin

→ Cam­bridge, Mass­a­chu­setts-based Cel­sius Ther­a­peu­tics — start­ed in 2018 and backed by Third Rock Ven­tures and GV (for­mer­ly Google Ven­tures) — an­nounced its first key lead­er­ship ap­point­ments. Greg Rys­lik has joined the com­pa­ny as its chief da­ta of­fi­cer, and Michael Boret­ti has joined as its CBO.

Michael Boret­ti Linkedin

“Over the past year, we have been build­ing our team and as­sem­bling an in­te­grat­ed, in­dus­tri­al-scale plat­form that com­bines sin­gle-cell ge­nomics, ma­chine learn­ing, deep bi­ol­o­gy and drug dis­cov­ery, which has en­abled Cel­sius to ad­vance its un­der­stand­ing of the spe­cif­ic cells and ge­net­ic dri­vers that could play a key role in au­toim­mune dis­eases and can­cer,” said Alex­is Borisy, chair­man of Cel­sius.

→ Af­ter an­nounc­ing that it had en­tered the bio­me­chan­ics mar­ket launch­ing op­er­a­tion in Min­neapo­lis, Min­neso­ta, Subio­Med has now made ad­di­tions to its man­age­ment team. Patrick Kull­mann joins the com­pa­ny as CEO and board mem­ber af­ter his re­cent stint as COO and pres­i­dent for Medovex Corp.

Patrick Kull­mann Linkedin

Kull­mann has al­so served lead­er­ship po­si­tion at J&J, Boston Sci­en­tif­ic and Medtron­ic and mul­ti­ple start-up med­ical tech­nol­o­gy com­pa­nies. Bri­an Bowen joins the com­pa­ny as ex­ec­u­tive VP and board mem­ber with 32 years of ex­pe­ri­ence in mar­ket­ing strat­e­gy and lead­er­ship. Ad­di­tion­al­ly, John Deedrick — co-founder and ex­ec­u­tive chair­man of Ac­tivOrtho, co-founder and di­rec­tor of DyaMX, co-Founder and di­rec­tor of CHIP II and Pres­i­dent of CHIP So­lu­tions — and Mar­tin Emer­son — pres­i­dent and CEO of Mon­teris Med­ical — have joined the com­pa­ny’s board.

Karin Schmitt Linkedin

→ UK- based com­pa­ny Mo­gri­fy has re­lo­cat­ed to the Bio-In­no­va­tion Cen­tre at the Cam­bridge Sci­ence Park, af­ter adding 15 new staff mem­bers to its sci­en­tif­ic and man­age­ment teams, in­clud­ing Karin Schmitt as CBO and Joe Fos­ter as COO. The com­pa­ny says that “these new hires and fa­cil­i­ties will aid Mo­gri­fy in build­ing a scal­able in­fra­struc­ture to gen­er­ate IP around nov­el cell con­ver­sion to pow­er the de­vel­op­ment and man­u­fac­ture of new cell ther­a­pies across mul­ti­ple ther­a­peu­tic ar­eas.”

Rob Jack­son Linkedin

→ Ramp­ing up prepa­ra­tions for the po­ten­tial launch of RHB-105 — or Tal­i­cia as it’s al­ready call­ing the an­ti-in­fec­tive com­bat­ting H. Py­loriRed­Hill Bio­phar­ma has added three sea­soned ex­ec to its com­mer­cial team. Rob Jack­son, VP of mar­ket­ing, joins from Bioven­tus; Syn­er­gy Phar­ma’s for­mer VP of mar­ket ac­cess, Robert Gilkin, as­sumes the same role at Red­Hill; Steven Thomasian brings ex­pe­ri­ence from Kala and Cem­pra to his role as VP of sup­ply chain.

Je­re­my Grun­stein Linkedin

Am­gen $AMGN vet Je­re­my Grun­stein is the new VP of busi­ness de­vel­op­ment at Xen­cor $XN­CR, tasked with scout­ing new col­lab­o­ra­tions and deals for its an­ti­body tech, with sev­er­al po­ten­tial ap­pli­ca­tions in­clud­ing in bis­pe­cif­ic — re­cent­ly en­tic­ing Genen­tech to sign up for an al­liance.

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.

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.

Bris­tol-My­ers star Op­di­vo fails sur­vival test in a matchup with Nex­avar aimed at shak­ing up the big HCC mar­ket

Bris­tol-My­ers Squibb has suf­fered an­oth­er painful set­back in its years-long quest to ex­pand the reach of Op­di­vo. The phar­ma gi­ant this morn­ing not­ed that their Check­mate-459 study com­par­ing Op­di­vo with Bay­er’s Nex­avar in front­line cas­es of he­pa­to­cel­lu­lar car­ci­no­ma — the most com­mon form of liv­er can­cer — failed to hit the pri­ma­ry end­point on over­all sur­vival.

This was a sig­nif­i­cant mile­stone in Bris­tol-My­ers’ tal­ly of PD-1 cat­a­lysts this year. Nex­avar (so­rafenib) has been the stan­dard of care in front­line HCC for the past decade, though Op­di­vo has been mak­ing head­way in sec­ond-line HCC cas­es, where it’s go­ing toe-to-toe with Bay­er’s Sti­var­ga (re­go­rafenib) af­ter re­cent ap­provals shook up the mar­ket.

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 more than a week 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.