NextCure hires Cel­gene vet as CMO; José Ve­ga leaves Mer­ck to be­come Mod­er­na's chief safe­ty of­fi­cer

NextCure has found its new CMO af­ter the pre­vi­ous ex­ec­u­tive re­signed last Au­gust.

Han Myint, a bio­phar­ma and acad­e­mia vet­er­an of more than 20 years, joined the com­pa­ny Thurs­day af­ter serv­ing as CMO at Nex­Im­mune for a lit­tle over a year. Myint had over­seen the com­pa­ny’s Phase I/II tri­al for a cell ther­a­py in acute myeloid leukemia be­fore hop­ping over to NextCure.

“Han’s strong in­dus­try track record is high­light­ed by his in­volve­ment in the de­vel­op­ment of mul­ti­ple U.S. Food and Drug ap­proved prod­ucts,” CEO Michael Rich­man said in a state­ment.

At NextCure, Myint will turn his at­ten­tion to­ward the com­pa­ny’s two lead pro­grams: NC318, an im­munother­a­py tar­get­ing Siglec-15, and NC410, a re­com­bi­nant LAIR-2 fu­sion pro­tein de­signed to block im­mune sup­pres­sion me­di­at­ed by the im­mune mod­u­la­tor LAIR-1.

Be­fore join­ing Nex­Im­mune, Myint had a se­nior role at Cel­gene, serv­ing as VP of glob­al med­ical af­fairs and the myeloid dis­eases lead for more than six years. He helped shep­herd through a num­ber of FDA-ap­proved prod­ucts dur­ing his time there, NextCure said.

Myint had pre­vi­ous­ly worked at the Uni­ver­si­ty of Col­orado-Den­ver be­tween 2005 and 2012 as a pro­fes­sor and as the di­rec­tor of hema­to­log­i­cal ma­lig­nan­cies and stem cell trans­plant pro­gram, build­ing the pro­gram out.

NextCure’s for­mer CMO Kevin Heller re­signed af­ter be­ing named ex­ec­u­tive VP of R&D at Jasper Ther­a­peu­tics last year. — Max Gel­man

José Ve­ga

Stéphane Ban­cel is fill­ing out Mod­er­na’s ex­ec­u­tive team fur­ther af­ter the roll­out of their mR­NA Covid-19 vac­cine, bring­ing in José Ve­ga from Mer­ck to be chief safe­ty of­fi­cer. Re­port­ing to CMO Tal Zaks, Ve­ga had pre­vi­ous­ly been chief safe­ty of­fi­cer at Mer­ck Re­search Lab­o­ra­to­ries since 2013 in what was ac­tu­al­ly his sec­ond stint with the Big Phar­ma — from 1997-2003, he was a di­rec­tor first in clin­i­cal phar­ma­col­o­gy and then in clin­i­cal me­tab­o­lism. For the 10 years in be­tween, Ve­ga oc­cu­pied mul­ti­ple roles at Am­gen, the last five as VP, glob­al safe­ty be­fore his Mer­ck re­turn.

David Lawrence

→ Just when he thought he was out, they pull him back in: David Lawrence had orig­i­nal­ly planned to re­tire at the end of 2020 as CFO of French vac­cine biotech Val­ne­va, but he has been re-ap­point­ed act­ing CFO “po­ten­tial­ly un­til mid-2021,” ac­cord­ing to a re­lease this week. Lawrence an­nounced his re­tire­ment in Sep­tem­ber at Val­ne­va, which is claim­ing to de­vel­op the on­ly Ly­me dis­ease vac­cine in the in­dus­try and has inked a $308 mil­lion deal with Pfiz­er to com­mer­cial­ize it. In oth­er Val­ne­va de­vel­op­ments, Per­ry Ce­len­tano — who brings ex­pe­ri­ence from such phar­ma gi­ants as Mer­ck and No­var­tis — has joined the fray as in­ter­im COO.

→ Fol­low­ing this week’s sur­prise news that blue­bird bio will di­vide in­to two com­pa­nies — one for on­col­o­gy, one for rare dis­eases — CEO Nick Leschly will take the helm on the on­col­o­gy side while Sanofi Gen­zyme vet and Leschly’s head of Eu­rope An­drew Oben­shain will take over at blue­bird bio. Leschly latch­es on to blue­bird as ex­ec­u­tive chair, while Daniel Lynch has been cho­sen as chair of the new on­col­o­gy com­pa­ny. Ramy Ibrahim, who’s been CMO at the Park­er In­sti­tute for Can­cer Im­munother­a­py, has been elect­ed to the board of di­rec­tors to add some heft in the on­col­o­gy space.

Frank Neu­mann

→ Right when blue­bird bio is un­der­go­ing this new on­col­o­gy en­deav­or, Leschly ends up los­ing his head of clin­i­cal on­col­o­gy re­search. Frank Neu­mann has been tapped as CMO for Bri­an Stug­lik out at Ve­rastem On­col­o­gy. Be­fore his tenure at blue­bird, Neu­mann de­vot­ed five years to Take­da, lead­ing clin­i­cal de­vel­op­ment across their cell ther­a­py spec­trum in his fi­nal year there. He was Take­da’s glob­al clin­i­cal lead for Iclusig (pona­tinib) and med­ical team lead for Nin­laro (ix­a­zomib).

Si­mon Pim­stone

→ British Co­lum­bia neu­rol­o­gy out­fit Xenon Phar­ma­ceu­ti­cals is get­ting way out in front of a change at the top, an­nounc­ing that CEO Si­mon Pim­stone will step aside and Ian Mor­timer will of­fi­cial­ly take over as pres­i­dent and CEO at Xenon’s share­hold­ers meet­ing in June. Mor­timer has been CFO along with his role as pres­i­dent since 2018 and ini­tial­ly came on board back in 2013. Xenon and Neu­ro­crine took up a col­lab­o­ra­tion to de­vel­op epilep­sy drugs in De­cem­ber 2019, with Xenon col­lect­ing $50 mil­lion up­front.

→ On­col­o­gy, in­flam­ma­tion and in­fec­tious dis­ease biotech Tiziana Life Sci­ences has poached Neil Gra­ham from Re­gen­eron, mak­ing him CMO. Gra­ham had spent the last 10 years on Len Schleifer’s team as VP of strate­gic pro­gram di­rec­tion, im­munol­o­gy and in­flam­ma­tion, hav­ing a hand in de­vel­op­ing Dupix­ent and lead­ing prod­uct de­vel­op­ment of Kevzara. Be­fore his Re­gen­eron tenure, he was SVP, pro­gram and port­fo­lio man­age­ment for Ver­tex.

Louis Pas­carel­la

Louis Pas­carel­la is tak­ing con­trol as CEO of Gur­net Point Cap­i­tal-owned In­no­coll, suc­ceed­ing Rich Fante, who came on board as chief com­mer­cial of­fi­cer in 2015 and rose to the top spot in March 2019. A Janssen mar­ket­ing vet, Pas­carel­la makes the move to In­no­coll af­ter three years as an ex­ec at No­vo Nordisk, cul­mi­nat­ing in his time lead­ing US com­mer­cial op­er­a­tions.

James Frates

→ We now know where James Frates has land­ed af­ter his time was up at Alk­er­mes, and it’s at Amy­lyx as their new CFO. Join­ing a com­pa­ny fo­cused on ALS among oth­er neu­rode­gen­er­a­tive dis­eases is per­son­al for Frates, whose late cousin Pe­te Frates was in­stru­men­tal be­hind the ALS Ice Buck­et Chal­lenge. Frates had been the CFO at Alk­er­mes since 1998 be­fore be­ing re­placed by Iain Brown last week.

Ri­ta Jain

→ Ex-Ake­bia Ther­a­peu­tics CMO Ri­ta Jain is tak­ing on the same role at Im­muno­vant, the au­toim­mune dis­ease-fo­cused com­pa­ny in Vivek Ra­maswamy’s sta­ble of Vants that boast­ed pos­i­tive proof-of-con­cept da­ta last March in its thy­roid eye dis­ease study. Be­fore her two years at Ake­bia, Jain was Ab­b­Vie’s VP of men’s and women’s health and meta­bol­ic de­vel­op­ment, as well as VP, phar­ma­ceu­ti­cal de­vel­op­ment for Ab­bott Lab­o­ra­to­ries.

→ Backed by Fra­zier Health­care Part­ners with one of the first IPOs of 2020, Cal­i­for­nia der­ma­tol­ogy biotech Ar­cutis Bio­ther­a­peu­tics has pegged Matthew Moore to be CBO. Moore was with For­est Lab­o­ra­to­ries, then Ac­tavis, then Al­ler­gan af­ter the 2015 Ac­tavis merg­er, serv­ing as Al­ler­gan’s VP, cor­po­rate busi­ness de­vel­op­ment the last four years.

Abid Ansari

→ Here’s a fol­low-up on Abid Ansari’s next move af­ter de­cid­ing to step away from Pre­ci­sion Bio­Sciences a month ago: He’s now the CFO at Ar­tios Phar­ma, the can­cer-fo­cused biotech out of the UK backed by Pfiz­er and No­var­tis. Ansari, who had been CFO at Pre­ci­sion Bio­Sciences since 2016, was in­volved in deal fi­nance and port­fo­lio man­age­ment with GSK from 2011-16. And be­fore join­ing the Big Phar­ma, he spent five years at Med­Im­mune.

→ It didn’t take long for Bryan Laf­fitte to earn a pro­mo­tion at San Diego RNA-fo­cused biotech DTx Phar­ma. Just this past Ju­ly, Laf­fitte took on the role of VP, bi­ol­o­gy; now he’s been bumped up to CSO. The ex-VP of bi­ol­o­gy at In­cep­tion Ther­a­peu­tics, Laf­fitte was di­rec­tor of re­gen­er­a­tive med­i­cine for the Ge­nomics In­sti­tute of the No­var­tis Re­search Foun­da­tion.

Er­ic Mos­brook­er

→ Autism-fo­cused Cog­noa out of Pa­lo Al­to has brought on Er­ic Mos­brook­er as COO. Be­fore his move to Cog­noa, which re­ceived a break­through des­ig­na­tion from the FDA for its dig­i­tal autism di­ag­nos­tic, Mos­brook­er was chief com­mer­cial of­fi­cer at a be­lea­guered Au­dentes that just weeks ago saw the FDA lift a hold on its gene ther­a­py AT132. Mos­brook­er is al­so a Jazz Phar­ma­ceu­ti­cals and Hori­zon Ther­a­peu­tics alum.

→ Fos­ter City, CA-based Mirum, which scooped up two of Shire’s liv­er dis­ease drugs af­ter launch­ing in No­vem­ber 2018, has made Alex­ey Ku­ta­hov gen­er­al man­ag­er of EMEA (Eu­rope, Mid­dle East and Africa). Ku­ta­hov re­cent­ly left Sarep­ta — hit­ting tur­bu­lence both with the FDA and with their da­ta re­vealed last week for their Duchenne mus­cu­lar dy­s­tro­phy gene ther­a­py — as their gen­er­al man­ag­er of Eu­rope. He has al­so been head of mar­ket ac­cess in­no­va­tion at Am­gen and head of cen­tral Eu­ro­pean mar­ket ac­cess at No­var­tis.

Jared Freed­berg

→ It’s a tu­mul­tuous time at In­ter­cept fol­low­ing last year’s NASH re­jec­tion at the FDA and de­part­ing CEO Mark Pruzan­s­ki’s salty words for the agency. This week the biotech has se­lect­ed a new gen­er­al coun­sel and sec­re­tary in 15-year Co­v­ance vet Jared Freed­berg. He comes off two years as gen­er­al coun­sel and sec­re­tary at Im­munomedics, and pri­or to that, he was Mallinck­rodt’s gen­er­al coun­sel, spe­cial­ty gener­ics op­er­at­ing di­vi­sion and VP, busi­ness de­vel­op­ment and li­cens­ing.

→ Is­rael-based MeMed has named Troy Boutelle as VP of com­mer­cial, North Amer­i­ca and gen­er­al man­ag­er, US. Boutelle’s pre­vi­ous ex­pe­ri­ence in­cludes roles at Eu­rofins-Vira­cor and Ther­mo Fish­er Sci­en­tif­ic.

→ France’s Trans­gene has pro­mot­ed Gaëlle Stadtler to the po­si­tion of di­rec­tor of hu­man re­sources. Stadtler joined the com­pa­ny as head of hu­man re­sources and in­ter­nal com­mu­ni­ca­tions in 2018. Pri­or to that, Stadtler served in roles at L&L Prod­ucts and Mars Inc.

→ UK-based Ax­ol Bio­science has made the ad­di­tions of Ross Wheat­croft as glob­al strate­gic ac­counts man­ag­er and Kim­ber­ly La­Pointe as glob­al head of prod­uct man­age­ment to its lead­er­ship team. Wheat­croft hails from Ab­cam, where he was com­mer­cial de­vel­op­ment man­ag­er, while La­Pointe comes from BBI So­lu­tions. 

→ As the dust set­tles on mi­nor­i­ty in­vestor Wa­ter­Mill’s suc­cess­ful ac­tivist at­tack and ouster of chair­man Scott Tar­riff, Zio­pharm On­col­o­gy has found Tar­riff’s re­place­ment: James Huang. A mem­ber of the board since Ju­ly, Huang is a dri­ving force be­hind Gen­Script, Leg­end Biotech and Zai Lab and has been man­ag­ing part­ner at Klein­er Perkins Cau­field & By­ers (KPCB) Chi­na since 2011. Ad­di­tion­al­ly, Vineti co-founder Hei­di Ha­gen has been cho­sen as Zio­pharm’s lead in­de­pen­dent di­rec­tor.

Tamar Thomp­son

→ As CSO Art Levin de­scribed his “dream” sce­nario work­ing on an­ti­body oligonu­cleotide con­ju­gates this week at JP Mor­gan, La Jol­la, CA-based Avid­i­ty Bio­sciences is mix­ing in some board news too with the de­par­tures of Todd Brady and Michael Mar­tin and the ad­di­tions of Tamar Thomp­son and Jean Kim to the board of di­rec­tors. Thomp­son, a Bris­tol My­ers Squibb alum, is Alex­ion’s VP, US gov­ern­ment af­fairs and pol­i­cy, while Kim was a part­ner at Deer­field Man­age­ment from 2006-20. Else­where, Ku­ra On­col­o­gy CEO Troy Wil­son is mov­ing from Avid­i­ty’s ex­ec­u­tive chair­man to chair­man.

Ryan Watts’ crew at De­nali has made Kally­ope CEO Nan­cy Thorn­ber­ry a mem­ber of the board of di­rec­tors. Be­fore lead­ing Kally­ope, Thorn­ber­ry end­ed a long ca­reer at Mer­ck in 2013 as SVP and fran­chise head, di­a­betes and en­docrinol­o­gy.

David Py­ott

→ Ex-Al­ler­gan chair­man and CEO David Py­ott has been giv­en a seat at the board of di­rec­tor of South San Fran­cis­co fi­bro­sis biotech Pli­ant Ther­a­peu­tics, which hauled in an IPO that end­ed up to­tal­ing near­ly $166 mil­lion back in June. Py­ott, who ran Al­ler­gan from 1998-2015, is a board mem­ber at Al­ny­lam and Bio­Marin.

Chris Now­ers-led nat­ur­al killer cell ther­a­py shop ONK Ther­a­peu­tics, which scored an $8 mil­lion fi­nanc­ing round in Oc­to­ber, has named long­time No­var­tis ex­ec Hugh O’Dowd chair­man. O’Dowd is com­ing off a four-year tenure as pres­i­dent and CEO of Neon Ther­a­peu­tics.

Tom Wig­gans

→ Ex-Der­mi­ra CEO Tom Wig­gans has been elect­ed ex­ec­u­tive chair­man of Boston-based an­dro­ge­net­ic alope­cia biotech Fol­li­ca. Wig­gans, who is al­so on the boards of An­nex­on Bio­sciences and For­ma Ther­a­peu­tics, will be joined on Fol­li­ca’s board by Michael Davin, the CEO of Cyno­sure from 2003-17.

→ Bel­gian CAR-T play­er Celyad On­col­o­gy has paved the way for Ma­ri­na Udi­er to be on their board of di­rec­tors. The CEO of Nous­com since last Febu­rary, Udi­er start­ed as the Swiss biotech’s COO in 2016.

Kate Walsh

Boston Med­ical Cen­ter Health Sys­tem pres­i­dent and CEO Kate Walsh is step­ping in as a board mem­ber of Cam­bridge, MA-based CRISPR base edit­ing play­er Beam Ther­a­peu­tics. Walsh is for­mer­ly COO of Brigham and Women’s Hos­pi­tal.

Anne Pren­er

→ Fol­low­ing its Se­ries D fund­ing with an $85 mil­lion IPO, fi­bro­sis biotech Galec­to has wel­comed Anne Pren­er to the board of di­rec­tors. The for­mer Free­line Ther­a­peu­tics CEO and No­vo Nordisk alum is pres­i­dent and CEO of Im­bria Phar­ma­ceu­ti­cals.

Mod­u­lus On­col­o­gy has tapped Tim Ed­wards as chair­man of its board of di­rec­tors. Ed­wards cur­rent­ly serves as ex­ec­u­tive chair of Karus Ther­a­peu­tics, non-ex­ec­u­tive chair of Storm Ther­a­peu­tics and di­rec­tor of As­to­nauTX Lim­it­ed. Ed­wards has pre­vi­ous­ly served at In­no­va­teUK and Enara Bio among oth­ers.

Teon Ther­a­peu­tics has pulled in Glen Gio­van­net­ti to its board of di­rec­tors. Gio­van­net­ti joins the board af­ter his re­tire­ment from EY (Ernst & Young), for­mer­ly serv­ing as glob­al biotech­nol­o­gy and life sci­ences leader.

Biotech and Big Phar­ma: A blue­print for a suc­cess­ful part­ner­ship

Strategic partnerships have long been an important contributor to how drugs are discovered and developed. For decades, big pharma companies have been forming alliances with biotech innovators to increase R&D productivity, expand geographical reach and better manage late-stage commercialization costs.

Noël Brown, Managing Director and Head of Biotechnology Investment Banking, and Greg Wiederrecht, Ph.D., Managing Director in the Global Healthcare Investment Banking Group at RBC Capital Markets, are no strangers to the importance of these tie-ups. Noël has over 20 years of investment banking experience in the industry. Before moving to the banking world in 2015, Greg was the Vice President and Head of External Scientific Affairs (ESA) at Merck, where he was responsible for the scientific assessment of strategic partnership opportunities worldwide.

No­var­tis' sec­ond at­tempt to repli­cate a stun­ning can­cer re­sult falls flat

Novartis’ hopes of turning one of the most surprising trial data points of the last decade into a lung cancer drug has taken another setback.

The Swiss pharma announced Monday that its IL-1 inhibitor canakinumab did not significantly extend the lives or slow the disease progression of patients with previously untreated locally advanced or metastatic non-small cell lung cancer when compared to standard of-care alone.

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Robert Califf (Pablo Martinez Monsivais, AP Images, File)

As buzz on Califf FDA nom heats up, in­dus­try and agency in­sid­ers of­fer a strong nod for the ‘per­fect’ choice

For once in this long, dramatic road to finding a new FDA commissioner, there’s been some continuity. Both CNN and Politico reported this weekend that Rob Califf met with President Biden to discuss the permanent commish role, following earlier news broken by the Washington Post that all signs point to Califf.

Although there may be a few Democrats who continue to grandstand about the dangers of COI (Califf has worked for Verily, sits on the board of Centessa Pharmaceuticals, and has other ties to industry research), with the pandemic ongoing and the need for some kind of continuity at FDA mounting, Califf is likely to meet the same fate as when he first won Senate confirmation in 2016, by a vote of 89-4 — Bernie Sanders and 6 others didn’t vote.

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AstraZeneca CEO Pascal Soriot (Raphael Lafargue/Abaca/Sipa USA)

A com­bo of As­traZeneca's Imfinzi and chemo wins where oth­ers have failed in piv­otal bil­iary tract test

Looking to run with the big dogs in the PD-(L)1 class, AstraZeneca’s Imfinzi has a tall hill to climb to compete in an increasingly bustling market. An aggressive combo strategy for the drug has paid off so far, and now AstraZeneca is adding another notch to its belt.

A combo of Imfinzi (durvalumab) and chemotherapy significantly extended the lives of first-line patients with advanced biliary tract cancer over chemo alone, according to topline results from the Phase III TOPAZ-1 study revealed Monday.

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Sean Ianchulev, Eyenovia CEO and CMO

Re­cent court de­ci­sion push­es FDA to re­ject and re­clas­si­fy drug-de­vice com­bo, crush­ing shares

Back in April, the FDA lost a crucial court case in which its broad discretion of regulating medical products that might satisfy the legal definitions of either “drug” and/or “medical device” was sharply curtailed.

In addition to the appeals court ruling that Genus Medical Technologies’ contrast agent barium sulfate (aka Vanilla SilQ) should not be considered a drug, as the FDA had initially ruled, but as a medical device, the agency also was forced to spell out which drugs would transition to devices as a result of the ruling.

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Peter Greenleaf, Aurinia CEO

Af­ter pass­ing on Ac­celeron, Bris­tol My­ers eyes bolt-on ac­qui­si­tion of au­toim­mune spe­cial­ist — re­port

Bristol Myers Squibb is looking to beef up its autoimmune portfolio by scooping up Aurinia Pharmaceuticals, Bloomberg reported.

The recent overtures to Aurinia, relayed by anonymous insiders, came just as Bristol Myers turned down buyout talks with partners at Acceleron — which Merck ultimately struck a deal to acquire for $11.5 billion. Bristol Myers has reportedly decided to cash out on its minority stake, likely bagging $1.3 billion in the process, while keeping the royalty deals on two of Acceleron’s blood disorder drugs.

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So — that pig-to-hu­man trans­plant; Po­ten­tial di­a­betes cure reach­es pa­tient; Ac­cused MIT sci­en­tist lash­es back; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

We’re incredibly excited to welcome Beth Bulik, seasoned pharma marketing reporter, to the team. You can find much of her work in our new Marketing channel — and in her weekly newsletter, Endpoints PharmaRx, which will launch in early November. Add it to your subscriptions here.

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NYU surgeon transplants an engineered pig kidney into the outside of a brain-dead patient (Joe Carrotta/NYU Langone Health)

No, sci­en­tists are not any clos­er to pig-to-hu­man trans­plants than they were last week

Steve Holtzman was awoken by a 1 a.m. call from a doctor at Duke University asking if he could put some pigs on a plane and fly them from Ohio to North Carolina that day. A motorcyclist had gotten into a horrific crash, the doctor explained. He believed the pigs’ livers, sutured onto the patient’s skin like an external filter, might be able to tide the young man over until a donor liver became available.

UP­DAT­ED: Agenus calls out FDA for play­ing fa­vorites with Mer­ck, pulls cer­vi­cal can­cer BLA at agen­cy's re­quest

While criticizing the FDA for what may be some favoritism towards Merck, Agenus on Friday officially pulled its accelerated BLA for its anti-PD-1 inhibitor balstilimab as a potential second-line treatment for cervical cancer because of the recent full approval for Merck’s Keytruda in the same indication.

The company said the BLA, which was due for an FDA decision by Dec. 16, was withdrawn “when the window for accelerated approval of balstilimab closed,” thanks to the conversion of Keytruda’s accelerated approval to a full approval four months prior to its PDUFA date.

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