Peer Re­view: Ru­bius re­cruits BD chief; Epizyme hires No­var­tis vet as CFO

Kris Elverum

Ru­bius Ther­a­peu­tics — clin­i­cal-stage bio­phar­ma­ceu­ti­cal com­pa­ny de­vel­op­ing a new class of med­i­cines called red cell ther­a­peu­tics — made the ad­di­tion of Kris Elverum to its se­nior lead­er­ship team as SVP of busi­ness de­vel­op­ment and strat­e­gy. Elverum joins the com­pa­ny from Turn­stone Bi­o­log­ics and has pre­vi­ous­ly served at SQZ Biotech, No­var­tis and McK­in­sey & Co

→ As Epizyme preps a tran­si­tion to the com­mer­cial stage — which could come as ear­ly as next Jan­u­ary if the FDA comes through — it’s in­stalling Pao­lo Tombe­si as CFO. A No­var­tis vet, Tombe­si has over­seen a sim­i­lar tran­si­tion for In­smed, help­ing launch a sub­sidiary in Japan and bring­ing in more than $1 bil­lion by Epizyme’s count. Aside for the sar­co­ma ap­pli­ca­tion, now un­der pri­or­i­ty pre­view, a sec­ond NDA for tazeme­to­stat is slat­ed for lat­er this year, he added.

Jim Wil­son and Steve Squin­to has en­list­ed two more ex­ecs to their lean team at Pas­sage Bio in pur­suit of AAV gene ther­a­pies to treat rare mono­genic cen­tral ner­vous sys­tem dis­eases. Jill Quigley, who’s cred­it­ed for ad­vice and ne­go­ti­a­tions in the Shire/NPS and Gilead/Phar­mas­set ac­qui­si­tions, has been tapped as COO and gen­er­al coun­sel, while Bio­gen vet Alex Fo­topou­los is com­ing on board as CTO. Hav­ing over­seen tech­ni­cal op­er­a­tions at Ul­tragenyx’s gene ther­a­py unit (ac­quired from Di­men­sion), Fo­topou­los will now lead the buildup of Pas­sage’s man­u­fac­tur­ing ca­pa­bil­i­ties as it ad­vances lead pro­grams in GM1 gan­gliosi­do­sis, fron­totem­po­ral de­men­tia and Krabbe dis­ease in­to the clin­ic in 2020.”

Alex Fo­topou­los

Cor­bus Phar­ma­ceu­ti­cals — a Phase III clin­i­cal-stage com­pa­ny fo­cused on the de­vel­op­ment and com­mer­cial­iza­tion of ther­a­peu­tics to treat in­flam­ma­to­ry and fi­brot­ic dis­eases — re­cent­ly hired Kaizar Lehri as head of glob­al sup­ply chain. Lehri joins the com­pa­ny as their lead prod­uct can­di­date, lenaba­sum — a syn­thet­ic, oral, se­lec­tive cannabi­noid re­cep­tor type 2 (CB2) ag­o­nist —  is cur­rent­ly be­ing eval­u­at­ed in sys­temic scle­ro­sis, cys­tic fi­bro­sis, der­mato­myosi­tis and sys­temic lu­pus ery­the­mato­sus. Lehri has had stints as as­so­ciate di­rec­tor, sup­ply chain process op­ti­miza­tion and ef­fec­tive­ness at Bio­gen and di­rec­tor, sup­ply chain op­er­a­tions at Re­gen­eron.

→ Since seal­ing a deal for Avi­ra­gen Ther­a­peu­tics to serve as Vaxart’s shell in a re­verse merg­er, Joseph Pat­ti has re­treat­ed to the back bench­es. But he’s jump­ing back to the front lines now as CEO of Ag­ilVax, tak­ing a stab at an­ti­body-based can­cer ther­a­pies. He suc­ceeds Fed­er­i­ca Per­i­cle, who is leav­ing the Al­bu­querque-based biotech for an­oth­er op­por­tu­ni­ty. Ag­ilVax prod­ucts go af­ter xCT, an amino-acid trans­porter over­ex­pressed in sev­er­al can­cers and sus­pect­ed to play a role in metas­ta­sis. Pat­ti — a sci­en­tif­ic co-founder of Bris­tol-My­ers Squibb ac­quired In­hib­i­tex — is tasked with steer­ing the two lead drugs in­to clin­i­cal tri­als, in com­bi­na­tion with chemo, check­point or KRAS in­hibitors. 

→ Five months af­ter leav­ing Vivek Ra­maswamy’s rare dis­ease off­shoot En­zy­vant, Alvin Shih has land­ed his next CEO job at Dis­arm Ther­a­peu­tics. In­cu­bat­ed out of At­las Ven­ture’s Cam­bridge, MA hatch­ing grounds, the biotech is ze­ro­ing in on SARM1 in hopes of dis­rupt­ing the process of ax­on­al de­gen­er­a­tion. Shih’s ex­pe­ri­ence with rare neu­ro­log­i­cal dis­eases preps him for the chal­lenge of ap­ply­ing this tech­nol­o­gy to a broad range of dis­eases in­clud­ing mul­ti­ple scle­ro­sis and ALS to pe­riph­er­al neu­ropathies, Dis­arm said.

Alvin Shih

→ France’s Im­Check Ther­a­peu­tics has put Re­cep­tos alum Paul Frohna in charge of its im­mune mod­u­la­tor pro­grams across can­cer and au­toim­mune dis­eases. As the com­pa­ny’s first CMO, Frohna will lead an an­tic­i­pat­ed en­try in­to the clin­ic by ear­ly 2020. He brings some fresh ex­pe­ri­ence from the same role at Bion­iz, a biotech in Irvine, Cal­i­for­nia he’d helped cre­ate. In­stead of cy­tokines, though, his new niche will be g9d2 T cells and a nov­el fam­i­ly of im­munomod­u­la­tors dubbed bu­ty­rophilins. 

→ With a num­ber of pro­grams for eye and neu­rode­gen­er­a­tive dis­eases in mid-stage stud­ies, Alka­h­est is ap­par­ent­ly con­fi­dent enough about its an­ti-ag­ing plat­form to be­gin scout­ing part­ner­ships. Robert Klein will be head­ing up that ef­fort as its new­ly-mint­ed CBO, lever­ag­ing his back­ground in neu­ro­science drug de­vel­op­ment as well as re­cent ex­po­sure to busi­ness de­vel­op­ment. Re­cent stints in­clude CEO at iKaryos Di­ag­nos­tics and CSO at Amnestix. Alka­h­est al­ready has an al­liance with Spain’s Gri­fols, an ear­ly be­liev­er in its pro­tein prod­ucts de­rived from blood plas­ma.

NeuBase Ther­a­peu­tics wel­comed Danith Ly aboard as their CSO. Ly is cred­it­ed as the pri­ma­ry in­ven­tor of the com­pa­ny’s pep­tide nu­cle­ic acid (PNA) an­ti­sense oligonu­cleotide (PA­TrOL) plat­form tech­nol­o­gy. Pri­or to join­ing the com­pa­ny, Ly co-found­ed PNA In­no­va­tions (now Tru­code Gene Re­pair) and held stints as a sci­en­tif­ic ad­vi­so­ry board mem­ber at He­lixBind and a mem­ber of the board of di­rec­tors of Karuna Com­mune En­ter­prise. He is a found­ing di­rec­tor of the Bio­mol­e­c­u­lar De­sign and Dis­cov­ery In­sti­tute (BDI) at Carnegie Mel­lon Uni­ver­si­ty. In ad­di­tion to his role at NeuBase, Dr. Ly will main­tain his fac­ul­ty ap­point­ment as pro­fes­sor of chem­istry at Carnegie Mel­lon Uni­ver­si­ty’s Mel­lon Col­lege of Sci­ence.

Verb Sur­gi­cal — the ro­bot­ic surgery joint ven­ture from Ver­i­ly and J&J —  tapped Kurt Azarbarzin as its pres­i­dent and CEO. Azarbarzin joins the com­pa­ny from his la­paro­scop­ic surgery start­up, SurgiQuest — known for its FDA-ap­proved AirSeal de­vice. Azarbarzin was CEO of SurgiQuest un­til its ac­qui­si­tion in 2015 by Con­med, where he then be­came Con­med’s chief tech­nol­o­gy of­fi­cer.

Joseph Pa­pan­drea

Joseph Pa­pan­drea hopped to Zynex — a com­pa­ny that sells elec­trother­a­py med­ical de­vices used for pain man­age­ment, such as Neu­ro­Move — as their COO. Pri­or to jump­ing aboard Zynex, Pa­pan­drea was the vice pres­i­dent of op­er­a­tions at Ar­row Elec­tron­ics — a glob­al provider of elec­tron­ic com­po­nents and en­ter­prise com­put­ing so­lu­tions. Pa­pan­drea has al­so held var­i­ous stints in Aus­tralia, Sin­ga­pore, Ger­many, the UK, Chile and the US in a va­ri­ety of se­nior lead­er­ship roles. 

KE­PRO ap­points John Malanows­ki as chief peo­ple of­fi­cer. In this new role, Malanows­ki will be in charge of tal­ent man­age­ment, lead­er­ship de­vel­op­ment and com­pen­sa­tion and ben­e­fits. Malanows­ki re­cent­ly served as the in­ter­im chief hu­man re­source of­fi­cer for Virence Health Tech­nolo­gies and Uni­ver­si­ty of Texas, South­west­ern Med­ical Cen­ter. 

Ar­cis Biotech­nol­o­gy — a nu­cle­ic acid sam­ple prepa­ra­tion provider — has tapped pro­fes­sor Steve How­ell as non-ex­ec­u­tive chair­man to suc­ceed Paul Foul­ger, who was serv­ing as the in­ter­im chair­man on be­half of the board. How­ell joins the com­pa­ny af­ter their re­cent an­nounce­ments of strate­gic dis­tri­b­u­tion and li­cens­ing agree­ments with Open­trons and Mir­nax Biosens re­spec­tive­ly. How­ell found­ed In­no­va Part­ner­ships in 2006, where he helped cre­ate over a dozen life sci­ence start-ups and raised in ex­cess £100M in fi­nanc­ing. How­ell has al­so held po­si­tions at Unilever, Alere and Uni­path. In 2015, he was made vis­it­ing pro­fes­sor of com­mer­cial in­no­va­tion at King’s Col­lege, Lon­don.

Brian Kaspar. AveXis via Twitter

AveX­is sci­en­tif­ic founder fires back at No­var­tis CEO Vas Narasimhan, 'cat­e­gor­i­cal­ly de­nies any wrong­do­ing'

Brian Kaspar’s head was among the first to roll at Novartis after company execs became aware of the fact that manipulated data had been included in its application for Zolgensma, now the world’s most expensive therapy.

But in his first public response, the scientific founder at AveXis — acquired by Novartis for $8.7 billion — is firing back. And he says that not only was he not involved in any wrongdoing, he’s ready to defend his name as needed.

I reached out to Brian Kaspar after Novartis put out word that he and his brother Allen had been axed in mid-May, two months after the company became aware of the allegations related to manipulated data. His response came back through his attorneys.

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Novartis CEO Vas Narasimhan [via Bloomberg/Getty]

I’m not per­fect: No­var­tis chief Vas Narasimhan al­most apol­o­gizes in the wake of a new cri­sis

Vas Narasimhan has warily stepped up with what might pass as something close to a borderline apology for the latest scandal to engulf Novartis.

But he couldn’t quite get there.

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FDA to Sarep­ta: Your wide­ly an­tic­i­pat­ed fol­lowup to Ex­ondys 51 is not get­ting an ac­cel­er­at­ed OK for Duchenne MD

In one of the least anticipated moves of the year, the FDA has rejected Sarepta’s application for an accelerated approval of its Duchenne MD drug golodirsen after fretting over safety issues.

In a statement that arrived after the bell on Monday, Sarepta explained the CRL, saying:

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Levi Garraway. Broad Institute via Youtube

Roche raids Eli Lil­ly for its next chief med­ical of­fi­cer as San­dra Horn­ing plans to step down

We found out Monday morning where Levi Garraway was headed after he left Eli Lilly as head of oncology R&D a few days ago. Roche named Garraway as their new chief medical officer, replacing Sandra Horning, who they say is retiring from the company.

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Af­ter a posse of Wall Street an­a­lysts pre­dict a like­ly new win for Sarep­ta, we're down to the wire on a crit­i­cal FDA de­ci­sion

As Bloomberg notes, most of the Wall Street analysts that cover Sarepta $SRPT are an upbeat bunch, ready to cheer on the team when it comes to their Duchenne MD drugs, or offer explanations when an odd setback occurs — as happened recently with a safety signal that was ‘erroneously’ reported last week.

Ritu Baral Cowen
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UP­DAT­ED: No­var­tis spin­off Nabri­va fi­nal­ly scores its first an­tibi­ot­ic ap­proval

In May, Nabriva Therapeutics suffered a setback after the FDA rejected its antibiotic for complicated urinary tract infections — the Novartis spinoff has now had some better luck with the US agency, which on Monday approved its other drug for community-acquired bacterial pneumonia.

The drug, lefamulin, has been developed as an intravenous and oral formulation and been tested in two late-stage clinical trials. The semi-synthetic compound, whose dosing can be switched between the two formulations, is engineered to inhibit the synthesis of bacterial protein by binding to a part of the bacterial ribosome.

Saqib Islam. CheckRare via YouTube

Spring­Works seeks $115M to push Pfiz­er drugs across fin­ish line while Sat­suma sells mi­graine play in $86M IPO

SpringWorks and Satsuma — both biotech spinouts that have closed B rounds in April — are loading up with IPO cash to boost their respective late-stage plans.
SpringWorks

Bain-backed SpringWorks is the better-known company of the two, and it’s gunning for a larger windfall of $115 million to add to $228 million from previous financings. In the process, the Stamford, CT-based team is also drawing the curtains on the partnerships it has in mind for the pair of assets it had initially licensed from Pfizer.

Mi­nor­i­ty racial groups con­tin­ue to be dis­mal­ly rep­re­sent­ed in can­cer tri­als — study

Data reveal that different racial and ethnic groups — by nature and/or nurture — can respond differently in terms of pharmacokinetics, efficacy, or safety to therapeutics, but this disparity is not necessarily accounted for in clinical trials. A fresh analysis of the last decade of US cancer drug approvals suggests the trend continues, cementing previous research that suggests oncology trials are woefully under-representative of the racial makeup of the real world.

Van­da shares slide af­ter FDA spurns their big end­point and re­jects a pitch on jet lag re­lief

Back in the spring of last year, Vanda Pharmaceuticals $VNDA served up a hot stew of mixed data for a slate of endpoints related to what they called clear evidence that their melatonin sleep drug Hetlioz (tasimelteon) could help millions of travelers suffering from jet lag.

Never mind that they couldn’t get a planned 90 people in the study, settling for 25 instead; Vanda CEO Mihael H. Polymeropoulos said they were building on a body of data to prove it would help jet-lagged patients looking for added sleep benefits. And that, they added, would be worth a major upgrade from the agency as they sought to tackle a big market.