Cure­Vac gains COO and hands Flo­ri­an von der Mülbe new as­sign­ment in the midst of Covid-19 vac­cine trou­bles; As Ken Fra­zier re­tires, Mer­ck hires chief strat­e­gy of­fi­cer

Malte Gre­une

→ Aim­ing to bounce back and try­ing to ac­cen­tu­ate the pos­i­tive af­ter its mR­NA Covid-19 vac­cine took a ma­jor prat­fall, Cure­Vac is shak­ing things up by bring­ing in Malte Gre­une as COO and giv­ing new re­spon­si­bil­i­ties to co-founder and chief pro­duc­tion of­fi­cer Flo­ri­an von der Mülbe. Gre­une jumps on board from Sanofi af­ter a near­ly 10-year run where he was sta­tioned in Ger­many and spent the last sev­er­al months as gen­er­al man­ag­er and VP, car­tridges, de­vices & in­sulin tech­nol­o­gy group in Frank­furt.

As for von der Mülbe, who was COO at Cure­Vac for 18 years be­fore his tenure as chief pro­duc­tion of­fi­cer, he will now de­vote his en­er­gy to de­vel­op­ing its man­u­fac­tur­ing tech known as The RNA Print­er.

De­spite what amounts to train wreck-lev­el da­ta in which Cure­Vac’s vac­cine post­ed an in­ter­im ef­fi­ca­cy of 47% — a pal­try fig­ure com­pared to mR­NA coun­ter­parts Mod­er­na and Pfiz­er/BioN­Tech — and re­sults that still failed to hit 50% ef­fi­ca­cy over­all in the fi­nal analy­sis, CEO Franz-Wern­er Haas vowed to push for­ward, em­pha­siz­ing the num­bers in those aged 18 to 60. “In the cur­rent con­text of an in­creas­ing­ly di­verse en­vi­ron­ment of COVID-19 vari­ants, and with very lit­tle resid­ual preva­lence of the orig­i­nal strain,” Haas said in a state­ment, “we are con­fi­dent that the HER­ALD study of­fers clin­i­cal­ly rel­e­vant da­ta re­gard­ing the ef­fect of emerg­ing vari­ants on vac­cine ef­fi­ca­cy.”

→ The Rob Davis era is of­fi­cial­ly up­on us at Mer­ck af­ter Ken Fra­zier’s re­tire­ment, and the phar­ma gi­ant ad­di­tion­al­ly has tapped Michael Klobuchar as chief strat­e­gy of­fi­cer ef­fec­tive Tues­day, a new­ly-cre­at­ed po­si­tion. Klobuchar’s Mer­ck ca­reer got un­der­way in 1998 as a syn­thet­ic process de­vel­op­ment en­gi­neer, and in the en­su­ing 23 years he’s made a steady as­cent up the lad­der in count­less roles, even­tu­al­ly be­com­ing SVP, Mer­ck Re­search Lab­o­ra­to­ries fi­nance and glob­al project and al­liance man­age­ment.

Enoch Kar­iu­ki

Dave John­son’s get­ting the band back to­geth­er: Lengo Ther­a­peu­tics, the San Diego on­col­o­gy biotech where John­son is chair­man, has se­lect­ed Enoch Kar­iu­ki as CEO. Just last sum­mer, while John­son was still CEO of Velos­Bio, he named Kar­iu­ki CFO — and then Mer­ck bought the com­pa­ny for $2.75 bil­lion in a No­vem­ber 2020 an­nounce­ment. Be­fore his short tenure at Velos­Bio, Kar­iu­ki was SVP, cor­po­rate de­vel­op­ment for Lau­ra Shawver at Syn­thorx, and then it too was bought out by a Big Phar­ma, this time for $2.5 bil­lion by Sanofi. Kar­iu­ki’s ap­point­ment at Lengo comes af­ter Di­ana Haus­man earned the CMO spot a few weeks ago.

JoAnne Mi­cale Foody

Es­pe­ri­on has been fight­ing such an up­hill sales bat­tle with its cho­les­terol drug Nexle­tol that CEO Tim Mayleben stepped down last month and was re­placed by Shel­don Koenig, with Covid-19 shoul­der­ing most of the blame. JoAnne Mi­cale Foody now steps in as CMO af­ter six years with J&J. Since Au­gust, Foody had served as Janssen’s VP and head of da­ta sci­ences in the fol­low­ing ther­a­peu­tic ar­eas: car­dio­vas­cu­lar, me­tab­o­lism, reti­nal and pul­monary hy­per­ten­sion. Pri­or to those re­spon­si­bil­i­ties, her en­er­gy was di­rect­ed to­ward Xarel­to as VP and com­pound de­vel­op­ment team leader.

Al­fred Bowie

→ Throw­ing the in­dus­try a bit of a curve­ball with this next step, ex-Mer­ck R&D lu­mi­nary Roger Perl­mut­ter leads the charge as CEO of drug dis­cov­ery biotech Eikon Ther­a­peu­tics and has ap­point­ed his first CFO. Al­fred Bowie heads to Hay­ward, CA-based Eikon af­ter two years as VP, cor­po­rate and busi­ness de­vel­op­ment at Ve­r­a­cyte, which has just un­der­gone a CEO tran­si­tion as Marc Sta­p­ley suc­ceeds Bon­nie An­der­son. Bowie has al­so been Roche sub­sidiary Foun­da­tion Med­i­cine’s se­nior di­rec­tor, cor­po­rate de­vel­op­ment & strat­e­gy.

Su­san Gal­braith is mov­ing up the ranks with her ap­point­ment as EVP of on­col­o­gy re­search at As­traZeneca’s new re­search and de­vel­op­ment home in Cam­bridge, UK. Her new po­si­tion comes months af­ter the trag­ic death of José Basel­ga from Creutzfeldt-Jakob dis­ease, af­ter the cel­e­brat­ed on­col­o­gist had been brought in to head can­cer R&D in an un­usu­al di­vi­sion of the lead R&D roles at the com­pa­ny. Gal­braith joined the can­cer R&D team at As­traZeneca in 2010 and most re­cent­ly served as the EVP and head of re­search and ear­ly de­vel­op­ment, on­col­o­gy R&D — which in­clud­ed ush­er­ing 7 can­cer drugs in­to Phase III stud­ies en­com­pass­ing Lyn­parza and Tagris­so.

Kate Cronin

Kate Cronin’s first day as chief brand of­fi­cer for Covid-19 vac­cine heavy­weight Mod­er­na will be Ju­ly 12. Be­fore this op­por­tu­ni­ty came along to build the brand of one of the hottest names in the in­dus­try, Cronin was a part of Ogilvy Health for 17 years and had been glob­al CEO there since Oc­to­ber 2020. “What Mod­er­na has achieved is tru­ly in­spi­ra­tional and I’m in­cred­i­bly ex­cit­ed to be join­ing a com­pa­ny that has such a tremen­dous im­pact on the world,” Cronin said in a state­ment. Our Nicole De­Feud­is has more here on Cronin’s ar­rival.

→ We’re not done with the Big Phar­ma fun. Awny Fara­jal­lah has left Ipsen to be Take­da’s head of glob­al med­ical af­fairs, on­col­o­gy busi­ness unit. Fara­jal­lah spent the last year at Ipsen as SVP, North Amer­i­ca med­ical af­fairs, pre­ced­ed by 15 years at Bris­tol My­ers Squibb where he even­tu­al­ly led the US med­ical af­fairs team and was al­so in­flu­en­tial in the launch­es of Op­di­vo and Yer­voy. In the last sev­er­al weeks the Japan­ese phar­ma gi­ant shared pos­i­tive piv­otal da­ta with the NSCLC can­di­date mobo­cer­tinib and notched a pri­or­i­ty re­view for its cy­tomegalovirus drug marib­avir.

An­dree Amels­berg

Bio­gen hit jack­pots on the reg­u­la­to­ry slot ma­chine through­out the month of June: first with the shock wave-in­duc­ing Aduhelm ap­proval that has been large­ly met with dis­be­lief and de­ri­sion, and then with a break­through ther­a­py des­ig­na­tion for Alzheimer’s drug lecanemab last week. Mean­while Bio­gen’s part­ner for lecanemab, Ei­sai, has locked in An­dree Amels­berg as VP US med­ical af­fairs, on­col­o­gy busi­ness group. Amels­berg has been an on­col­o­gy ex­ec at Boehringer In­gel­heim (14 years), Astel­las (three years) and Janssen (near­ly six years) and just had a snap-your-fin­ger-and-that’s-it tenure as SVP of med­ical af­fairs at Hutchmed, which is hop­ing for good news of its own from the FDA with its on­col­o­gy as­set su­r­u­fa­tinib.

Ste­fano Por­tolano is suc­ceed­ing Olivi­er Morand as CEO of Dutch biotech Aza­faros, launched in 2018 and tar­get­ing lyso­so­mal stor­age dis­eases with its lead can­di­date AZ-3102. Por­tolano takes the helm here af­ter five years as head of Eu­rope for Ul­tragenyx and an­oth­er 10 years wear­ing var­i­ous hats at Cel­gene, in­clud­ing VP, strat­e­gy & com­mer­cial op­er­a­tions. As AZ-3012 en­ters Phase I, For­bion in April con­tributed an ad­di­tion­al €2.75 mil­lion to the orig­i­nal Se­ries A, with to­tal fund­ing for Aza­faros sit­ting at €28.75 mil­lion.

Ma­lene Brond­berg

→ Af­ter tak­ing over as CEO near­ly 4 months ago, Pe­ter Braun is now leav­ing his post at Nordic Nanovec­tor for per­son­al rea­sons. In the mean­time, CFO Ma­lene Brond­berg is tak­ing over the reins as in­ter­im CEO as the board looks for a re­place­ment. Brond­berg came to Nordic as VP, in­vestor re­la­tions in Feb­ru­ary 2018.

EQRx, helmed by Blue­print co-founder Alex­is Borisy, has plucked up Car­los Gar­cia-Echev­er­ria as chief of Rx cre­ation. Gar­cia-Echev­er­ria is a Sanofi vet and served as COO of re­search and glob­al head of re­search plat­forms. Be­fore his gig at Sanofi, Gar­cia-Echev­er­ria held a va­ri­ety of po­si­tions at No­var­tis, re­spon­si­ble for man­ag­ing mul­ti­ple late-stage drug dis­cov­ery can­cer pro­grams.

Chao Zhang

→ Be­sides mov­ing its head­quar­ters from Berke­ley to South San Fran­cis­co, Plexxikon — a mem­ber of the Dai­ichi Sankyo Group — is mak­ing some changes to its C-suite with the pro­mo­tions of CSO Chao Zhang to CEO and Mar­guerite Hutchin­son to COO and gen­er­al coun­sel. Zhang is suc­ceed­ing Gideon Bol­lag, who will tran­si­tion to a part-time po­si­tion as chief bi­ol­o­gist.

Zhang has served as the com­pa­ny’s CSO since Au­gust 2018 and pre­vi­ous­ly held the role of SVP of re­search in his ear­ly days with the com­pa­ny in 2001. Mean­while, Hutchin­son joined Plexxikon in 2013.

Or­bit Dis­cov­ery has reeled in Neil Butt as CEO. Butt makes his way to Or­bit from ION­TAS, where he served as CBO. Be­fore that, he was part of the man­age­ment team at Abzena and An­ti­tope.

→ Ef­fec­tive June 25, a CEO change un­fold­ed at Ta­vo mak­er On­coSec as Bri­an Leuth­n­er was in­stalled on an in­ter­im ba­sis to re­place Dan O’Con­nor. A SPAC led by O’Con­nor, named Lark­spur Health Ac­qui­si­tion, filed for an IPO in mid-May. Leuth­n­er kicked off his ca­reer in the in­dus­try at Glax­o­SmithK­line as an HIV and on­col­o­gy prod­uct man­ag­er, and he has since been chief ex­ec­u­tive at sev­er­al com­pa­nies — in­clud­ing Edge Ther­a­peu­tics, which he co-found­ed and helped merge with PDS Biotech­nol­o­gy.

Su­san Blum

→ Else­where in In­ter­imville, the in­ter­im la­bel has been re­moved for Su­san Blum and she’s now CFO for Melin­ta Ther­a­peu­tics, which cap­tured an FDA ap­proval in March for its an­tibi­ot­ic Kimyr­sa to treat acute bac­te­r­i­al skin and skin struc­ture in­fec­tions. Blum, who had been in­ter­im CFO for Chris­tine Ann Miller’s team af­ter Pe­ter Mil­li­gan’s ex­it since March 31, was pre­vi­ous­ly VP of fi­nance & chief ac­count­ing of­fi­cer.

In­tel­lia is hav­ing it­self a week, start­ing with the mo­men­tous da­ta that showed CRISPR can be used to ed­it DNA di­rect­ly in hu­mans and let­ting the good times roll by pump­ing a whop­ping $600 mil­lion in­to its cof­fers. Run­ning along­side this news, In­tel­lia has named a Bio­gen vet as EVP, gen­er­al coun­sel and cor­po­rate sec­re­tary. James Bas­ta held var­i­ous le­gal po­si­tions at Bio­gen from 2006-19, leav­ing as chief cor­po­ra­tion coun­sel and then sign­ing on with Troy Wil­son’s team at Ku­ra On­col­o­gy, where he was chief le­gal of­fi­cer, sec­re­tary and chief com­pli­ance of­fi­cer.

Amit Nath­wani

→ Close fol­low­ers of Peer Re­view know that Ro­muald Cor­bau was pro­mot­ed to CSO last fall at Free­line Ther­a­peu­tics. But Cor­bau is now leav­ing his post, and it’s Amit Nath­wani to the res­cue on an in­ter­im ba­sis. Nath­wani, who co-found­ed the AAV gene ther­a­py play­er out of the UK in 2015 and is a board mem­ber, re­turns to the job he’s held be­fore at Free­line, which is sad­dled with a tri­al de­lay for its he­mo­phil­ia B pro­gram as CDC is­sues are ad­dressed. Cor­bau will stay on as chief sci­en­tist un­til Aug. 20.

In oth­er Free­line de­vel­op­ments, James Bircher has been added to the ros­ter as chief tech­ni­cal op­er­a­tions of­fi­cer af­ter hold­ing the CTO job at Abeona.

Ellen Lefever

→ The mad dash from Gala­pa­gos has con­tin­ued apace af­ter the col­lapse of the Gilead part­ner­ship and CSO Piet Wiger­inck’s de­par­ture. Gala­pa­gos vets Ellen Lefever and Tim Van Kaem have turned up at AgomAb, which hauled in a $74 mil­lion Se­ries B in March for its lead can­di­date, an HGF-mimet­ic ag­o­nist of the MET re­cep­tor dubbed AGMB-101. Lefever (gen­er­al coun­sel) had held a hand­ful of le­gal roles at Gala­pa­gos since 2014, in­clud­ing deputy gen­er­al coun­sel, while Van Kaem (head of clin­i­cal op­er­a­tions) de­vot­ed nine years to the com­pa­ny in drug de­vel­op­ment and project man­age­ment. AgomAb CBO Paul van der Horst is al­so a Gala­pa­gos alum.

→ Med­ical de­vice com­pa­ny Pre­sidio Med­ical, which raised $30 mil­lion last sum­mer to ad­vance its neu­ro­mod­u­la­tion plat­form tech, has plucked Michael Onuscheck from Al­con to be CEO and chair­man ef­fec­tive Sept. 1. Onuscheck was pre­vi­ous­ly Al­con’s pres­i­dent, glob­al busi­ness­es and in­no­va­tion, and for three of his 10 years at Boston Sci­en­tif­ic, Onuscheck was pres­i­dent of the neu­ro­mod­u­la­tion di­vi­sion. Cred­it out­go­ing CEO Michael Ack­er­mann for es­chew­ing the usu­al mo­not­o­ny of press re­leas­es, say­ing, “Michael Onuscheck is the Le­Bron James of neu­ro­mod­u­la­tion and one of the world’s pre­mier lead­ers in med­ical tech­nol­o­gy … It feels great to pass the ball to an MVP.”

Leone Pat­ter­son

Leone Pat­ter­son re­signed as Ad­verum’s pres­i­dent and CFO last week, leav­ing CBO Chris DeRespino to slide in as act­ing CFO. We’ve learned about her land­ing spot as she be­comes chief fi­nan­cial and busi­ness of­fi­cer at Tenaya Ther­a­peu­tics, a biotech that scored $106 mil­lion worth of Se­ries C fund­ing for its heart dis­ease pro­grams in March. Pat­ter­son, whose five years at Ad­verum in­clud­ed a turn as CEO, was pre­vi­ous­ly a fi­nance ex­ec with such names as No­var­tis, Ex­elix­is and Di­adexus. That’s not the on­ly ap­point­ment at Tenaya: Matthew Poll­man has joined the fray as SVP, clin­i­cal de­vel­op­ment af­ter his time as EVP of Nav­i­Gate Car­diac Struc­tures. Poll­man is for­mer­ly the CMO of Ju­ven­tas Ther­a­peu­tics and di­rec­tor, car­dio­vas­cu­lar bi­ol­o­gy for Mil­len­ni­um Phar­ma­ceu­ti­cals.

Scripps spin­out Am­brx, shoot­ing for an IPO a sec­ond time af­ter the first at­tempt was with­drawn in 2014, has wel­comed Son­ja Nel­son as CFO. A new board ap­pointee at Mo­tus GI, Nel­son was Im­mu­ni­ty­Bio’s SVP of fi­nance af­ter the re­verse merg­er closed with Nan­tK­west in March. Be­fore the merg­er, she ini­tial­ly signed on to Patrick Soon-Sh­iong’s team in 2015 as chief ac­count­ing of­fi­cer and lat­er be­came CFO. Nel­son has al­so been VP, cor­po­rate con­troller at Alt­heaDx.

→ Stan the Man: Stan Mu­sial has been named CFO at Vivek Ra­maswamy’s Aru­vant, which re­cent­ly start­ed putting their heads to­geth­er with Jasper Ther­a­peu­tics to col­lab­o­rate on sick­le cell dis­ease treat­ments. Mu­sial hails from Dutch biotech Xenikos, where he was CFO and CBO. He’s al­so held the CFO ti­tle at Zy­la Life Sci­ences (then known as Egalet) and Ital­ian biotech Ery­Del.

Stew­art Ab­bot

→ New York-based can­cer biotech Turn­stone Bi­o­log­ics con­tin­ues to fill out its team of ex­ecs with CSO Stew­art Ab­bot. The for­mer chief sci­en­tif­ic and op­er­at­ing of­fi­cer at Adicet Bio, Ab­bot has al­so been chief de­vel­op­ment of­fi­cer at Fate as well as ex­ec­u­tive di­rec­tor of in­te­gra­tive re­search and se­nior di­rec­tor of re­search for Cel­gene. In May, Turn­stone pro­mot­ed José Manuel Otero to chief tech­nol­o­gy of­fi­cer and Saryah Az­mat to CBO, while Mike Burgess si­mul­ta­ne­ous­ly be­came Turn­stone’s ex­ec­u­tive chair­man of R&D and re­placed act­ing head of R&D Stephen Squin­to at Spring­Works.

OcuTer­ra, which made head­lines in May when ex-Al­ler­gan CEO Brent Saun­ders was named chair­man, is shoring up its lead­er­ship fur­ther with David Tanz­er as CMO. Tanz­er, who was in charge of the Navy Re­frac­tive Surgery Pro­gram, makes the move to OcuTer­ra af­ter his time with the No­var­tis oph­thal­mol­o­gy fran­chise as glob­al ex­ec­u­tive med­ical di­rec­tor. OcuTer­ra’s lead pro­gram, OTT166 for pa­tients with di­a­bet­ic retinopa­thy, is look­ing to start Phase II stud­ies this year.

Rahul Agraw­al

→ Ger­man heart dis­ease biotech Car­dior Phar­ma­ceu­ti­cals, go­ing the non-cod­ing RNA (ncR­NA) route with its ther­a­pies, has called up­on Rahul Agraw­al to be CMO. At the tail end of his sev­en years at As­traZeneca, Agraw­al was VP and glob­al med­i­cines leader, car­dio­vas­cu­lar. Among oth­er po­si­tions at Bay­er from 2006-14, Agraw­al served as glob­al di­rec­tor of med­ical af­fairs and clin­i­cal, glob­al launch team, and pul­monary hy­per­ten­sion with Bay­er Health­Care.

→ With the PARP7 in­hibitor RBN-2397 top­ping its pipeline, Cam­bridge, MA-based Ri­bon Ther­a­peu­tics has tapped Paul Bran­nel­ly as CFO. Bran­nel­ly spent the last six years as CFO of Col­legium Phar­ma­ceu­ti­cal, pre­ced­ed by a brief stay at Karyopharm as SVP, fi­nance and ad­min­is­tra­tion. He’s al­so been Ve­rastem’s VP, fi­nance, trea­sur­er and sec­re­tary.

Mark Mul­vi­hill

→ Flush with $67.5 mil­lion from a Se­ries B raise, metasta­t­ic can­cer out­fit Hi­ber­Cell has pro­mot­ed Mark Mul­vi­hill to CSO. Mul­vi­hill, who ini­tial­ly punched his tick­et to Hi­ber­Cell in 2018, had served as SVP, chem­istry and drug dis­cov­ery. From 2001-13 he was with Astel­las sub­sidiary OSI Phar­ma­ceu­ti­cals, ris­ing to di­rec­tor of chem­istry & glob­al project leader.

BioSkryb has brought on Gary Har­ton as CSO. Pri­or to his new role, Har­ton was port­fo­lio di­rec­tor, preim­plan­ta­tion ge­net­ic test­ing at Perkin Elmer’s new preim­plan­ta­tion ge­net­ic test­ing prod­uct line. In ad­di­tion to Perkin Elmer, Har­ton has had stints at Igenomix US, Prog­y­ny, Il­lu­mi­na, BlueG­nome Lim­it­ed and Re­pro­g­e­net­ics.

Pe­tra Molan

→ As it’s tak­ing the leap in­to man­u­fac­tur­ing with the pur­chase of an Irish plant, Hori­zon Ther­a­peu­tics has brought on Pe­tra Molan as group VP, gen­er­al man­ag­er of Eu­rope, Mid­dle East and Africa (EMEA). Pe­tra makes her way to Hori­zon af­ter serv­ing as SVP, head of com­mer­cial op­er­a­tions at Arvelle Ther­a­peu­tics. Pri­or to that, Molan was with Take­da, Shire, Bay­er and Eli Lil­ly. In June, Hori­zon forked over $40 mil­lion up­front for the glob­al rights to Ar­row­head‘s RNAi drug ARO-XDH.

→ In­duced pluripo­tent stem cell play­er Shore­line Bio­sciences, which just inked a $45 mil­lion iP­SC deal with BeiGene a few short weeks ago, has named Mo­ham­mad El-Kalay SVP and head of CMC. Be­fore his tran­si­tion to the San Diego-based biotech, El-Kalay was VP, tech­ni­cal op­er­a­tions for Er­ic Os­tertag’s crew at Po­sei­da Ther­a­peu­tics. Ear­li­er, El-Kalay held ex­ec­u­tive roles in tech­ni­cal op­er­a­tions at San­Bio and Sang­amo.

Man­ju­nath Ra­ma­rao

Part­ner­ing with Genen­tech at the start of this year in a dis­cov­ery deal aimed at drug­ging RNA, Re­search Tri­an­gle biotech Ri­bometrix has ap­point­ed Man­ju­nath Ra­ma­rao SVP of re­search, leav­ing Bris­tol My­ers Squibb af­ter a dozen years. Based in Ban­ga­lore, In­dia, Ra­ma­rao was ex­ec­u­tive di­rec­tor, head of dis­cov­ery and trans­la­tion­al med­i­cine at the Bio­con-Bris­tol-My­ers Squibb R&D Cen­ter.

→ Next-gen­er­a­tion se­quenc­ing com­pa­ny DNAe has named Al­i­son Howie VP of com­mer­cial. Howie has spent the last decade at Ther­mo Fish­er Sci­en­tif­ic, where she was VP of mar­ket­ing & prod­uct de­vel­op­ment and VP of R&D and busi­ness de­vel­op­ment for the com­pa­ny’s mi­cro­bi­ol­o­gy busi­ness. Pri­or to that, she was CCO and chief prod­uct of­fi­cer at Ix­i­co.

Mary Beth Dorr

Mary Beth Dorr takes on a new role as VP, clin­i­cal sci­ence at Penn­syl­va­nia-based Ve­na­torx Phar­ma­ceu­ti­cals, which dosed its first pa­tient this week in a Phase I tri­al of its an­tivi­ral com­pound VN­RX-9945 for HBV. Dorr hails from Mer­ck, where she was prod­uct de­vel­op­ment team leader and clin­i­cal lead, in­fec­tious dis­eases, con­cen­trat­ing on be­zlo­tox­um­ab — a C. dif­fi­cile an­ti­body ap­proved by the FDA in 2016.

→ Ul­tragenyx has reeled a big fish on­to its board of di­rec­tors with the ap­point­ment of for­mer Cel­gene CMO Corsee Sanders. This will be yet an­oth­er ad­di­tion to Sanders’ long list of board seats — which in­cludes BeiGene, Mol­e­c­u­lar Tem­plates, Leg­end, Al­tru­Bio and the Fred Hutchin­son Can­cer Re­search Cen­ter.

Daphne Qui­mi

Joshua Co­hen and Justin Klee have swung the door open for Daphne Qui­mi as the next mem­ber of ALS-cen­tered Amy­lyx’s board of di­rec­tors. A J&J and Bris­tol My­ers vet, Qui­mi is the CFO at Am­i­cus and is in her 14th year with John Crow­ley’s bunch.

Kin­nate’s en­su­ing lead­er­ship move af­ter Ne­ha Kr­ish­namo­han took on the CFO job in ear­ly June is elect­ing He­len Sabze­vari to the board of di­rec­tors. Sabze­vari — the for­mer SVP of im­muno-on­col­o­gy at Mer­ck KGaA sub­sidiary EMD Serono — is now the pres­i­dent and CEO of Pre­ci­gen.

Greg Covi­no

→ Af­ter abrupt­ly walk­ing away from his CFO post at No­vavax — where he is still an ex­ec­u­tive ad­vi­sor — Greg Covi­no is resur­fac­ing as part of the board of di­rec­tors at Ren­o­va­cor once the $116 mil­lion SPAC deal clos­es with Chardan Health­care Ac­qui­si­tion 2 Corp. Covi­no will be joined on the board by Spirovant co-founder and CEO Joan Lau.

Tal­ly­ing a shade more than $40 mil­lion in a Se­ries B round in May, bac­te­rio­phage biotech Adap­tive Phage Ther­a­peu­tics has elect­ed three new board mem­bers. The tri­umvi­rate con­sists of Paratek CEO Evan Loh, Deer­field Man­age­ment part­ner and Deer­field In­sti­tute chair­man Jonathan Leff, and Deer­field Dis­cov­ery and De­vel­op­ment COO Jana Jensen.

Lau­ra Williams

→ Boston-based Imara has waved in Ab­bott/Ab­b­Vie vet Lau­ra Williams to its board of di­rec­tors. Williams served as SVP of glob­al ther­a­peu­tic strate­gies and pa­tient ad­vo­ca­cy at Arde­lyx. Pri­or to that, Williams was with AM­AG Phar­ma­ceu­ti­cals and My­ovant Sci­ences.

→ The ra­dio­phar­ma­ceu­ti­cals jew­el be­hind Pe­ter Kolchin­sky’s first SPAC, Point Bio­phar­ma has brought on Big Phar­ma alum Myra Rosario Her­rle as EVP of reg­u­la­to­ry af­fairs. Her­rle, who has held reg­u­la­to­ry posts at Ab­b­Vie and No­var­tis, spent the last year as VP of reg­u­la­to­ry af­fairs at Gly­coMimet­ics.

Mol­ly Harp­er

Mol­ly Harp­er ap­peared in Peer Re­view last May when she joined Rel­ma­da Ther­a­peu­tics as EVP of op­er­a­tions, and this week we find out she’s on the board of di­rec­tors at Cat­a­lyst Phar­ma­ceu­ti­cals. Be­fore Rel­ma­da, Harp­er was Akcea’s SVP and glob­al fran­chise gen­er­al man­ag­er.

→ CD47-fo­cused Tril­li­um Ther­a­peu­tics has made room for Cather­ine Mack­ey on its board of di­rec­tors. Mack­ey, the SVP, glob­al R&D and di­rec­tor of Pfiz­er’s La Jol­la Lab­o­ra­to­ries from 2001-10, has been a di­rec­tor be­fore at Po­sei­da, GW Phar­ma­ceu­ti­cals and YM Bio­sciences (bought by Gilead in 2012).

Ca­balet­ta Bio, fo­cus­ing on B cell-me­di­at­ed au­toim­mune dis­eases and col­lab­o­rat­ing with fel­low cell ther­a­py com­pa­ny Ar­ti­san Bio, has made Scott Brun a mem­ber of the board of di­rec­tors. The Ab­b­Vie and Ab­bott vet re­places Bri­an Daniels, who re­signed from his seat June 24.

Adap­tive De­sign Meth­ods Of­fer Rapid, Seam­less Tran­si­tion Be­tween Study Phas­es in Rare Can­cer Tri­als

Rare cancers account for 22 percent of cancer diagnoses worldwide, yet there is no universally accepted definition for a “rare” cancer. Moreover, with the evolution of genomics and associated changes in categorizing tumors, some common cancers are now characterized into groups of rare cancers, each with a unique implication for patient management and therapy.

Adaptive designs, which allow for prospectively planned modifications to study design based on accumulating data from subjects in the trial, can be used to optimize rare oncology trials (see Figure 1). Adaptive design studies may include multiple cohorts and multiple tumor types. In addition, numerous adaptation methods may be used in a single trial and may facilitate a more rapid, seamless transition between study phases.

Matt Gline (L) and Pete Salzmann

UP­DAT­ED: Roivant bumps stake in Im­muno­vant with a $200M deal. But with M&A off the ta­ble, shares crater

Roivant has worked out a deal to pick up a chunk of stock in its majority-owned sub Immunovant $IMVT, but the stock buy falls far short of its much-discussed thoughts about buying out all of the 43% of shares it doesn’t already own.

Roivant, which recently inked a SPAC move to the market at a $7 billion-plus valuation, has forged a deal to boost its ownership in Immunovant by 6.3 points, ending with 63.8% of the biotech’s stock following a $200 million injection. That cash will bolster Immunovant’s cash reserves, giving it a $600 million war chest to fund a slate of late-stage studies for its big drug: the anti-FcRn antibody IMVT-1401.

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Sanofi preps a multi­bil­lion-dol­lar buy­out of an mR­NA pi­o­neer af­ter falling be­hind in the race for a Covid-19 jab — re­port

It looks like Sanofi CEO Paul Hudson is dead serious about his intention to vault directly into contention for the future of mRNA vaccines.

A year after paying Translate Bio a whopping $425 million in an upfront and equity payment to help guide the pharma giant to the promised land of mRNA vaccines for Covid-19, Sanofi is reportedly ready to close the deal with a buyout.

Translate’s stock $TBIO soared 78% after the market closed Monday. A spokesperson for Sanofi declined to comment on the report, telling Endpoints News that the company doesn’t comment on market rumors.

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UP­DAT­ED: Watch out Glax­o­SmithK­line: As­traZeneca's once-failed lu­pus drug is now ap­proved

Capping a roller coaster journey, AstraZeneca has steered its lupus drug anifrolumab across the finish line.

Saphnelo, as the antibody will be marketed, is the only treatment that’s been approved for systemic lupus erythematosus since GlaxoSmithKline’s Benlysta clinched an OK in 2011. The British drugmaker notes it’s also the first to target the type I interferon receptor.

Mirroring the population that the drug was tested on in late-stage trials, regulators sanctioned it for patients with moderate to severe cases who are already receiving standard therapy — setting up a launch planned for the end of August, according to Ruud Dobber, who’s in charge of AstraZeneca’s biopharmaceuticals business unit.

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Not all mR­NA vac­cines are cre­at­ed equal. Does it mat­ter?; Neu­ro is back; Pri­vate M&A af­fair; 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.

As part of our broader and deeper drive, Endpoints has been pairing webinars with our special reports to cover more angles on a given topic. In conjunction with Max Gelman’s neuroscience feature, Kyle Blankenship moderated an insightful panel to discuss where the field is headed. You can register to watch it on demand here.

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Bris­tol My­ers pulls lym­phoma in­di­ca­tion for Is­to­dax af­ter con­fir­ma­to­ry tri­al falls flat

Amid an industrywide review of cancer drugs with accelerated approval, Bristol Myers Squibb had to make the tough call last month to yank an approval for leading I/O drug Opdivo after flopping a confirmatory study. Now, a second Bristol Myers drug is on the chopping block.

Bristol Myers has pulled aging HDAC inhibitor Istodax’s indication in peripheral T cell lymphoma after a Phase III confirmatory study for the drug flopped on its progression-free survival endpoint, the drugmaker said Monday.

Rick Pazdur (via AACR)

FDA's on­col­o­gy head Rick Paz­dur de­fends the ac­cel­er­at­ed ap­proval path­way, claim­ing it is 'un­der at­tack'

The FDA is sounding the alarm over its accelerated approval pathway as backlash continues over the recent nod in favor of Biogen’s Alzheimer’s drug Aduhelm, and an ODAC meeting on six such approvals that could potentially be pulled from the market — two of which already have.

“Do you think accelerated approval is under attack? I do,” Rick Pazdur, head of FDA’s Oncology Center of Excellence, said at a Friends of Cancer Research webinar on Thursday.

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FTC pulls re­main­ing case against Ab­b­Vie; New EU clin­i­cal tri­als sys­tem com­ing in 2022; Abing­worth bets big on CymaBay

The Federal Trade Commission on Friday withdrew its remaining case against AbbVie after the Supreme Court declined to review a lower court’s ruling.

The punt by SCOTUS means that while the Illinois pharma company illegally blocked patients’ access to lower-cost alternatives to its testosterone drug AndroGel, the FTC will no longer be able to return about $500 million directly to AndroGel consumers.

Alan Hirzel, Abcam

Drug sup­pli­er Ab­cam brings a long­time col­lab­o­ra­tor in house as part of $340M buy­out pact

BioVision has supplied Abcam with research tools since 1999, and now the two are making it official as part of a merger unveiled Monday.

Abcam will buyout BioVision as part of a $340 million acquisition deal to bring aboard the supplier’s biochemical and cell-based assays for biological research, as well as recombinant proteins, antibodies and enzymes.

The deal will give Abcam control of BioVision’s portfolio and allow for both the expansion of research existing areas of focus such as oncology, neuroscience and epigenetics and preparation to expand into new products. As a part of the deal, Abcam will develop and supply products and services to NKY, the previous owner of BioVision and receive support for ongoing development and commercialization of in vitro diagnostic products.