E-Scape Bio in­stalls per­ma­nent CEO Julie Anne Smith; Fa­ther pass­es reins to son at Al­le­gro Oph­thalmics

→ A year af­ter E-Scape Bio leapt out of stealth mode with some strong back­ing, the San Fran­cis­co up­start is ready to put its work in neu­rode­gen­er­a­tion to a clin­i­cal test. Lead­ing that charge will be Julie Anne Smith, who’s been ap­point­ed to suc­ceed Or­bimed part­ner Leon Chen as CEO. A two-time chief ex­ec­u­tive and biotech vet­er­an, Smith brings ex­pe­ri­ence in small mol­e­cule ther­a­pies and lyso­so­mal stor­age dis­or­ders from her re­cent stints at Nure­dis and Rap­tor Phar­ma. That re­sume checks all the right box­es for E-Scape: While the com­pa­ny launched with a heavy fo­cus on a ge­net­ic ap­proach to tack­ling Alzheimer’s, it has since put that project on the back­burn­er in fa­vor of an S1P5 pro­gram from Ab­b­Vie, which is slat­ed for the clin­ic in 2019.

→ Af­ter build­ing Al­le­gro Oph­thalmics from scratch over the past sev­en years, Ham­par Kara­geoz­ian de­cid­ed it’s time pres­i­dent and CMO Vick­en Kara­geoz­ian — al­so his son — steps up for the CEO role. Kara­geoz­ian Sr. will move to the ex­ec­u­tive chair­man po­si­tion, re­spon­si­ble for strat­e­gy with an eye on dis­cov­ery and R&D, while the new CEO preps the com­pa­ny for Phase III tri­als of lead drug risute­ganib in di­a­bet­ic mac­u­lar ede­ma. An oph­thalmic sur­geon by train­ing, Vick­en Kara­geoz­ian had pre­vi­ous­ly co-found­ed two oph­thal­mol­o­gy biotechs based on ther­a­peu­tics he co-in­vent­ed.

→ Over the last 11 years, Ed­ward Hu has been COO, CFO and chief in­vest­ment of­fi­cer at WuXi AppTec. Now he’s been named co-CEO, with a spe­cial re­spon­si­bil­i­ty for small mol­e­cule drug dis­cov­ery, de­vel­op­ment, man­u­fac­tur­ing ser­vices, drug and med­ical de­vice test­ing ser­vices, plus some. He’s re­tain­ing his CFO re­spon­si­bil­i­ties for now un­til a re­place­ment is se­lect­ed. And Hu will con­tin­ue to re­port to com­pa­ny founder Ge Li, who’s been chiefly re­spon­si­ble for the rapid growth of the big Chi­na-based com­pa­ny.

→ Ven­ture cap­i­tal­ist James Kuo sees po­ten­tial in On­co­Track­er’s bio­mark­er test­ing busi­ness — so much so that he left his 11-year role as man­ag­ing di­rec­tor of Athena Bioven­tures to pur­sue the CEO job there. “While the ini­tial fo­cus will be on build­ing a prof­itable busi­ness in the rapid­ly grow­ing mul­ti­ple myelo­ma mar­ket, we in­tend to serve a broad­er can­cer pop­u­la­tion by in­te­grat­ing nov­el im­mune ther­a­pies with com­pan­ion di­ag­nos­tics,” he said of the com­pa­ny. Bor­row­ing from his stints at Syn­thet­ic Bi­o­log­ics and Pfiz­er, he plans to ex­pand the West Hol­ly­wood, CA com­pa­ny through li­cens­ing deals like the one it had with Juno Ther­a­peu­tics.

→ Gaithers­burg, MD-based Sen­sei Bio­ther­a­peu­tics has named Ildiko Csi­ki as its chief med­ical of­fi­cer. Csi­ki most re­cent­ly worked as vice pres­i­dent of im­muno-on­col­o­gy clin­i­cal de­vel­op­ment at In­ovio Phar­ma­ceu­ti­cals. Ear­li­er she worked as clin­i­cal de­vel­op­ment lead for Mer­ck‘s Keytru­da pro­gram. Re­port­ing to John Celebi — pres­i­dent and CEO since May — her first project will in­volve mov­ing for­ward the Phase I can­cer vac­cine SNS-301.

→ Bone heal­ing spe­cial­ist Kuros Bio­sciences has ap­point­ed Pas­cal Longlade to re­place re­tired CMO Vir­ginia Jamieson. Work­ing out of the Swiss biotech’s Nether­lands site, Longlade in­her­its a pipeline of bone graft sub­sti­tute prod­ucts and surgery sealants. He has moved be­tween phar­ma, biotech and med­ical de­vice com­pa­nies, most re­cent­ly over­see­ing med­ical and reg­u­la­to­ry af­fairs for France’s D&A Phar­ma.

→ Achillion $ACHN is on a hir­ing spree un­der new CEO Joseph Tru­itt. Just a week af­ter bring­ing Leerink banker An­tho­ny Gib­ney on as chief busi­ness of­fi­cer, the biotech has scooped Steven Ze­lenkofske from uniQure to be its chief med­ical of­fi­cer. Switch­ing his fo­cus from gene ther­a­pies to com­ple­ment in­hibitors for rare dis­eases, Ze­lenkofske will lead a clin­i­cal de­vel­op­ment team along­side new VPs Lau­ra Bar­row and Marc Uk­nis. His reg­u­la­to­ry ex­pe­ri­ence will be key as Achillion hus­tles along its Phase II pro­grams and pre­pare for reg­is­tra­tional tri­als, Tru­itt said.

Ran­dall Sze has been pro­mot­ed to CFO at Athenex, tak­ing over the fi­nance and ac­count­ing de­part­ment while con­tin­u­ing to spear­head cor­po­rate de­vel­op­ment ac­tiv­i­ties. While Sze on­ly joined the com­pa­ny late last year, he’s known CEO John­son Lau and the man­age­ment team since steer­ing Athenex’s IPO $AT­NX as the lead ex­e­cu­tion banker.

Michael Garone has re­signed from Im­munomedics $IM­MU af­ter a two-year CFO run that fea­tured a brief gig as in­ter­im CEO. Chief busi­ness of­fi­cer Us­ama Ma­lik will step in to shoul­der the fi­nan­cial du­ties, while con­troller William Frick­er has been named prin­ci­pal ac­count­ing of­fi­cer. The com­pa­ny em­pha­sized that his de­par­ture “is not the re­sult of any dis­agree­ment with the com­pa­ny,” its lead­er­ship or op­er­a­tions, and not­ed that Garone will stay on as VP of fi­nance for tran­si­tion un­til May 2019, ex­act­ly one year af­ter Im­munomedics sub­mit­ted a BLA for its an­ti­body-drug con­ju­gate.

→ San Diego-based Cidara Ther­a­peu­tics $CDTX has lost CFO Matthew On­aitis to med­ical de­vice com­pa­ny Main­stay Med­ical. Jef­frey Stein, the CEO, and Brady John­son, di­rec­tor of fi­nance and con­troller, are split­ting up his re­spon­si­bil­i­ties in the in­ter­im.

Bio­gen vet Anne Marie de Jonge Schuer­mans is jump­ing to So­bi to head its tech­ni­cal op­er­a­tions — a new union of the man­u­fac­tur­ing, bi­o­log­i­cal de­vel­op­ment & sup­ply chain and en­vi­ron­ment & safe­ty units. The Swedish rare dis­ease com­pa­ny likes her skills in “putting process­es and sys­tems in place, and of dri­ving trans­for­ma­tion in cross-func­tion­al and cross-cul­tur­al set­tings.” She starts in Oc­to­ber.

→ As Si­mon Bed­son re­tires from the in­ter­na­tion­al com­mer­cial op­er­a­tions at Ver­tex $VRTX, the com­pa­ny has re­cruit­ed Lu­dovic Fe­naux from Bris­tol-My­ers Squibb to take his place in its Lon­don head­quar­ters. Fe­naux, who’s al­so worked at As­traZeneca and Glax­o­SmithK­line, joins Ver­tex amid some tough fights it’s hav­ing with sin­gle Eu­ro­pean pay­ers over cov­er­ing its cys­tic fi­bro­sis drugs.

Aerie Phar­ma­ceu­ti­cals $AERI has tapped Jef­frey White to join its R&D team as di­rec­tor, tox­i­col­o­gy and phar­ma­co­ki­net­ics. He joins from a sim­i­lar po­si­tion at Al­con, the eye care busi­ness No­var­tis is look­ing to spin out.

→ As ApoGen Biotech­nolo­gies goes pub­lic with its ex­pand­ed Se­ries A — with $11 mil­lion from the cor­po­rate ven­ture arms of Mer­ck KGaA, Ab­b­Vie, Eli Lil­ly, J&J and WuXi AppTec — it’s al­so an­nounc­ing the ap­point­ment of two new ex­ecs. Stephen Gwalt­ney, for­mer­ly of Glob­al Blood Ther­a­peu­tics and Take­da, is the new VP of chem­istry; Pe­ter de Vries joins from Fred Hutchin­son Can­cer Re­search Cen­ter to take on the se­nior di­rec­tor of bi­ol­o­gy po­si­tion. ApoGen is de­vel­op­ing ther­a­peu­tics to tack­le re­sis­tance to can­cer drugs.

→ CEO Per­ci­val Bar­ret­to-Ko is still build­ing out his ex­ec team at Astel­las, with two new pro­mo­tions this week. Ro­dri­go Fer­nan­dez, pre­vi­ous­ly ex­ec­u­tive di­rec­tor of Astel­las’ in­ter­na­tion­al busi­ness, is now VP, Latin Amer­i­ca, play­ing a su­per­vi­so­ry role across all coun­tries in the re­gion. Shon­telle Dod­son has been tapped SVP, health sys­tems, tasked with a slate of re­spon­si­bil­i­ties across pric­ing and mar­ket ac­cess.

We­bi­nar: Re­al World End­points — the brave new world com­ing in build­ing fran­chise ther­a­pies

Several biopharma companies have been working on expanding drug labels through the use of real world endpoints, combing through the data to find evidence of a drug’s efficacy for particular indications. But we’ve just begun. Real World Evidence is becoming an important part of every clinical development plan, in the soup-through-nuts approach used in building franchises.

I’ve recruited a panel of 3 top experts in the field — the first in a series of premium webinars — to look at the practical realities governing what can be done today, and where this is headed over the next few years, at the prodding of the FDA.

ZHEN SU — Merck Serono’s Senior Vice President and Global Head of Oncology

ELLIOTT LEVY — Amgen’s Senior Vice President of Global Development

CHRIS BOSHOFF — Pfizer Oncology’s Chief Development Officer

A premium subscription to Endpoints News is required to attend this webinar. Please upgrade to either an Insider or Enterprise plan for access. Already have Endpoints Premium? Please sign-in below. You can contact our Subscriptions team at help@endpointsnews.com with any issues.

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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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UP­DAT­ED: Pay­back? An­a­lysts say Sarep­ta was blind­sided by an FDA re­jec­tion dri­ven by reg­u­la­to­ry re­venge

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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FDA de­ci­sion on Ver­tex's CF triple will come just ahead of planned CEO shake­up

Vertex has clinched a priority review for the all-important cystic fibrosis triple that will blaze the trail for treating a large group of patients unhelped by its current drugs.

FDA regulators have set a PDUFA date of March 19, 2020, just a year after the Boston biotech posted positive Phase III results showing that people with two F508del mutations experienced statistically significant improvements in lung function after a 4-week regimen of VX-445, tezacaftor and ivacaftor. After reviewing 24-week data among patients with one F508del mutation and one minimal function mutation — and thoroughly comparing the VX-445 triple with another combo featuring VX-659 on scores like safety, drug-drug interactions, and photosensitivity — Vertex ultimately went with VX-445.

An MIT spin­out kills one of its ‘liv­ing ther­a­peu­tics’ af­ter flunk­ing an ear­ly-stage study — shares rout­ed

Just a few weeks after bagging $80 million in a deal to collaborate with Gingko Bioworks on its special blend of engineered bacteria used for “living therapeutics,” little Synlogic in Boston $SYBX is tossing one of its two clinical programs after watching an early-stage study go down in defeat.

Their Phase Ib/IIa study for SYNB1020 to counter the accumulation of ammonia in the body, a condition called hyperammonemia or urea cycle disorder, floundered at the interim readout, forcing the biotech to kill it and reserve its cash for pipeline therapies with greater potential.

Elan­co to buy Bay­er's an­i­mal health busi­ness for $7.6B, as deal­mak­ing gath­ers steam in the sec­tor

Last week, Elanco explicitly dodged answering questions about its rumored interest in Bayer’s animal health business in its post-earnings call. On Tuesday, the Eli Lilly spinoff disclosed it was purchasing the German drug maker’s veterinary unit in a cash-and-stock deal worth $7.6 billion. 

Elanco $ELAN has been busy on the deal-making front. In April, it laid out plans to swallow its partner, Kansas-based pet therapeutics company Aratana $PETX. A July report by Reuters suggested a potential Bayer deal was being explored, and Bloomberg last week said the deal was imminent, citing sources. 

As­traZeneca's di­a­betes drug Farx­i­ga helps pa­tients with heart dis­ease and with­out di­a­betes in land­mark tri­al

Months ago, data on J&J’s $JNJ Invokana indicated the diabetes drug conferred cardiovascular (CV) benefit in patients who do and do not have preexisting CV disease. On Tuesday, AstraZeneca’s $AZN rival treatment, Farxiga, was shown to cut the risk of CV death or the worsening of heart failure in patients with heart disease, in a landmark trial.

The treatments, in addition to Jardiance from Eli Lilly $LLY, belong to a class of diabetes drugs called sodium-glucose co-transporter 2 (SGLT2) inhibitors, which work by curbing the absorption of glucose via the kidneys so that surplus glucose is excreted through urination.

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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