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.

Un­lock­ing ESG strate­gies for growth with Gilead Sci­ences

RBC Capital Markets explores what is material in ESG for biopharma companies with the ESG leads at Gilead Sciences. Gilead has long focused on sustainability but recognized a more robust framework was needed. Based on a materiality assessment, Gilead’s ESG strategy today focuses first on drug access and pricing, while also addressing D&I and climate change. Find out why Gilead’s board is “acutely aware” of the contribution that ESG makes to firm’s overall success.

What con­tro­ver­sy? Eli Lil­ly plots Alzheimer's BLA fil­ing lat­er this year as FDA taps more an­ti-amy­loid drugs as break­throughs

The FDA is keeping the good news coming for Alzheimer’s drug developers. And Eli Lilly is taking them up on it.

Amid continued controversy around whether Biogen’s new flagship drug, Aduhelm, should have been approved at all — and swelling, heated debates surrounding its $56,000 price tag — the agency had no issue handing them and their Japanese partner Eisai a breakthrough therapy designation for a second anti-amyloid beta antibody, lecanemab, late Wednesday.

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Hervé Hoppenot, Incyte CEO (Jeff Rumans)

ODAC echoes FDA con­cern over In­cyte PD-1, as Paz­dur sig­nals broad­er shift for ac­cel­er­at­ed ap­proval

After the FDA lambasted their PD-1 ahead of an adcomm earlier this week, Incyte ran into new trouble Thursday as ODAC panelists voted against an accelerated OK by a wide margin.

Members of the Oncologic Drugs Advisory Committee recommended with a 13-4 vote to defer a regulatory decision on Incyte’s retifanlimab until after more data can be collected from a placebo-controlled trial. The PD-1 therapy is due for a PDUFA date in late July after receiving priority review earlier this year.

New FDA doc­u­ments show in­ter­nal dis­sent on Aduhelm ap­proval

In a lengthy review document and a pair of memos from top officials, the FDA released on Tuesday night its most detailed argument yet for approving Biogen’s intensely controversial Alzheimer’s drug aducanumab.

The documents amount to an agency attempt to quench the firestorm their decision kindled, as outside advisors members resigned and experts warned that an unproven drug now could stretch Medicare’s budget to a breaking point. Ultimately, the documents show how CDER director Patrizia Cavazzoni and Office of New Drugs director Peter Stein both concurred with FDA neuroscience head Billy Dunn on the accelerated approval while the staff at FDA’s Office of Biostatistics did not think an approval was warranted.

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Karen Flynn, Catalent

Q&A: When the pan­dem­ic struck, Catal­en­t's CCO had just joined the team

Karen Flynn came aboard Catalent’s team just in time.

The company was going through a surge of changes, and she had been brought over from her role as CCO of West Pharmaceutical Services to serve in the same capacity for the New Jersey-based CDMO. Then a few months later, the pandemic was in full-force.

Since then, Catalent’s been in hyper-expansion mode. In early May, it acquired Promethera’s Hepatic Cell Therapy Support SA subsidiary and its 32,40-square-foot facility in Gosselies, Belgium. Prior to that, the company acquired Belgian CDMO Delphi Genetics, wrapped up the expansion of an already-existing site in Madison, WI and added an ultra-low temperature freezer partner in Sterling. As Emergent has botched millions of doses of AstraZeneca’s vaccine, the company has swooped in to move that production to its Maryland plant as well.

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Richard Pazdur (vis AACR)

FDA en­cour­ages in­clud­ing in­cur­able can­cer pa­tients in tri­als, re­gard­less of pri­or ther­a­pies

The FDA on Thursday called to include those with incurable cancers (when there is no potential for cure or for prolonged/near normal survival) in appropriate clinical trials, regardless of whether they have received existing alternative treatments.

Historically, many cancer clinical trials have required that participating patients previously received multiple therapies, according to Richard Pazdur, director of the FDA’s Oncology Center of Excellence.

On heels of Aduhelm ap­proval, Bris­tol My­ers jumps back in­to Alzheimer's race

Bristol Myers Squibb last put major resources behind an Alzheimer’s drug nearly a decade ago, when their own attempt at targeting amyloid flamed out in mid-stage studies. They invented another molecule, a Tau-targeted antibody, but jettisoned it to Biogen in 2017 as they dropped out of neuroscience altogether.

But on Thursday, the New York pharma announced they were getting back in the game. Bristol Myers exercised an $80 million option to bring a tau-targeted antibody from Prothena into a Phase I study. The opt-in, which Bristol Myers triggered ahead of analyst expectations, opens the door for another $1.7 billion in milestones down the road.

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James Peyer, Cambrian

Can a cell ther­a­py treat mus­cu­lar dy­s­tro­phy? A Ger­man bil­lion­aire's an­ti-ag­ing start­up is try­ing to find out

Gene therapy companies have faced huge hurdles trying to deliver healthy genes into muscular dystrophy patients’ muscle cells, so here’s an idea: Why don’t we just replace the muscle cells themselves?

Over the last two years, Vita Therapeutics has been exploring that possibility, building on early stem cell work from Johns Hopkins professor Peter Andersen. And on Tuesday they announced a $32 million Series A to begin to move their first therapy into the clinic, where they hope it will help rebuild muscle in patients with a type of dystrophy that afflicts the arms and legs.

Alexis Borisy (file photo)

EQRx and Ex­sci­en­tia, a pair of self-styled dis­rup­tors, team up to over­turn the drug pric­ing ap­ple cart

The biotech industry has seen no shortage of innovation in recent years, but in one area — drug pricing — the field has been anything but innovative. Now, two brash startups taking different roads to upset the drug pricing model will partner up to create a sort of “super-disruptor.”

EQRx and UK-based AI specialist Exscientia will team up on a discovery-through-commercialization collaboration the partners hope will work better than the sum of its parts to bring cheaper medicines to patients faster, the companies said Thursday.