Zio­pharm finds new CEO af­ter six-month search; CFO tran­si­tion at Lon­za to take place in De­cem­ber

Kevin Boyle

Less than a year re­moved from a suc­cess­ful ac­tivist at­tack, Zio­pharm On­col­o­gy ap­point­ed a new CEO this week. Tak­ing the reins will be Kevin Boyle, who comes over af­ter lead­ing Ku­ur Ther­a­peu­tics to a $185 mil­lion buy­out back in May.

It’s been a tough few years for Zio­pharm, which in ad­di­tion to tak­ing on the with­er­ing ac­tivist at­tack saw sig­nif­i­cant turnover at the C-suite lev­el, cul­mi­nat­ing in long­time CEO Lau­rence Coop­er hit­ting the ex­it in Feb­ru­ary. That kicked off a near­ly half-year search that has now found Boyle set to take charge.

“I un­der­stand the chal­lenges ahead and I look for­ward to work­ing dili­gent­ly with our ded­i­cat­ed and tal­ent­ed team to un­lock our in­cred­i­ble po­ten­tial as an in­no­v­a­tive, world-class on­col­o­gy com­pa­ny,” Boyle said in a state­ment. “My pri­or­i­ties will be to de­liv­er share­hold­er val­ue and to en­sure the suc­cess of the or­ga­ni­za­tion by dri­ving the TCR-T pro­gram for­ward, while seek­ing and ex­e­cut­ing val­i­dat­ing part­ner­ships across our en­tire port­fo­lio of sci­en­tif­ic as­sets.”

Boyle be­gan his jour­ney at Carnegie Mel­lon, earn­ing a bach­e­lor’s in in­dus­tri­al man­age­ment & eco­nom­ics be­fore get­ting a law de­gree from the Uni­ver­si­ty of Penn­syl­va­nia. He kicked off his ca­reer in in­vest­ment bank­ing and has tak­en on sev­er­al CFO roles, in­clud­ing at FloWorks In­ter­na­tion­al, Sig­ma3, Re­cov­er­Care, and SPT.

In 2018, Boyle joined Ku­ur — then known as Cell Med­ica — as its CFO, help­ing lead the com­pa­ny through a ma­jor re­struc­tur­ing in ear­ly 2020. Ear­li­er this year, Ku­ur re­vealed its first re­sults for its CAR-NKT cell ther­a­pies de­vel­oped with Bay­lor Uni­ver­si­ty, look­ing at pa­tients with neu­rob­las­toma.

Out of 10 evalu­able pa­tients dosed in the Phase I with the lead can­di­date, an au­tol­o­gous GD2-tar­get­ing CAR-NKT ther­a­py, re­searchers not­ed one com­plete re­sponse, one par­tial re­sponse, and three pa­tients with sta­ble dis­ease. A few months lat­er, the biotech was ac­quired by Athenex.

It re­mains to be seen what Boyle’s strat­e­gy will be at Zio­pharm, but he has the en­dorse­ment of the ac­tivists who suc­ceed­ed in their at­tack late last year. Robert Post­ma, CEO of Wa­ter­Mill As­set Man­age­ment Corp, served on Zio­pharm’s chief ex­ec­u­tive search com­mit­tee.

Post­ma led the charge against Zio­pharm start­ing last No­vem­ber, aim­ing to re­place three board mem­bers and the Zio­pharm chair­man in an ug­ly af­fair that stretched out for more than a month. The sides fought through the con­stant is­su­ing of press re­leas­es, in­clud­ing over Thanks­giv­ing, and Post­ma ul­ti­mate­ly suc­ceed­ed in re­plac­ing two of the board mem­bers and pres­sur­ing the chair­man to step down.

Though Post­ma him­self was up for a board seat in the vote, he did not join the board when the at­tack con­clud­ed in mid-De­cem­ber. He has since tak­en a board seat, how­ev­er.

Zio­pharm did man­age to re­ceive IND clear­ance around the time Coop­er left — news it de­scribed at the time as “fan­tas­tic” — but in­vestors have not been im­pressed much since. Fol­low­ing that an­nounce­ment on Feb. 25, Zio­pharm stock $ZIOP has sunk near­ly 67% as of Thurs­day’s clos­ing bell, drop­ping from $5.33 per share to $1.77.

Max Gel­man

→ Else­where at Boston-based Zio­pharm, Raf­faele Baf­fa and Adam Levy have both earned pro­mo­tions — Baf­fa to head of R&D and Levy to EVP, cor­po­rate de­vel­op­ment and in­vestor re­la­tions. Baf­fa, the ex-CMO at Servi­er and a Pfiz­er and Sanofi vet, re­tains the CMO ti­tle that he’s held since No­vem­ber. And Levy orig­i­nal­ly joined Zio­pharm around the same time as Baf­fa, get­ting the bump from his pre­vi­ous du­ties as EVP of in­vestor re­la­tions and cor­po­rate com­mu­ni­ca­tions.

Philippe Deecke

Philippe Deecke will take over as CFO at Lon­za on Dec. 1, re­plac­ing Rodol­fo Sav­itzky, who shuf­fles off af­ter five years in the po­si­tion “for a new op­por­tu­ni­ty on 31 De­cem­ber 2021,” ac­cord­ing to a re­lease. Af­ter more than six years at McK­in­sey, Deecke piv­ot­ed to No­var­tis in 2005, ris­ing through the ranks to even­tu­al­ly lead man­age­ment re­port­ing and cor­po­rate plan­ning for the No­var­tis Group, be­come head of fi­nance in Eu­rope, the Mid­dle East and Africa (EMEA) for Al­con, and most re­cent­ly step in­to the role of CFO at No­var­tis On­col­o­gy.

On­no van de Stolpe

→ In one of those CEO de­vel­op­ments you could prob­a­bly see com­ing af­ter a tu­mul­tuous year, On­no van de Stolpe un­sur­pris­ing­ly is step­ping down from Gala­pa­gos as soon as a suc­ces­sor can be found. Gilead’s $5 bil­lion al­liance with Gala­pa­gos start­ed to buck­le in Au­gust 2020 with the FDA’s re­jec­tion of fil­go­tinib, and then the whole thing col­lapsed in Feb­ru­ary with a Phase III fail for zir­i­tax­e­s­tat, prompt­ing them to scrap the pro­gram. More bad read­outs of oth­er drugs in the pipeline seemed to kick the part­ner­ship while it was down in Ju­ly. CSO Piet Wiger­inck was the first ex­ec­u­tive domi­no to fall at Gala­pa­gos when he split the scene in June.

Kris­ten Buck

→ Just last year, we fea­tured Kris­ten Buck at the top of Peer Re­view when she be­came CMO at Icon, and dur­ing her tenure the Dublin-based CRO plunked down a smooth $12 bil­lion for PRA Health Sci­ences in a ma­jor deal. But life moves pret­ty fast, and if you don’t stop and look around once in a while, you could miss an­oth­er ca­reer move: Buck has left Icon to take the same po­si­tion at New Jer­sey cell ther­a­py play­er Cal­adrius Bio­sciences. The ex-chief of clin­i­cal de­vel­op­ment at Op­tum, Buck was a glob­al safe­ty physi­cian and glob­al study physi­cian in her six years at As­traZeneca. Dou­glas Losor­do re­signed as Cal­adrius CMO in No­vem­ber 2020 with Robert Honig­berg pinch-hit­ting on an in­ter­im ba­sis be­fore Buck’s ap­point­ment.

→ Three weeks ago in this space, we out­lined the ex­its of CSO Christo­pher Roberts and CMO Rachel Humphrey at Black Di­a­mond, and we know Roberts’ next land­ing spot — he takes the helm at Deer­field-backed Civet­ta Ther­a­peu­tics, which made its de­but in late 2019 and takes aim at be­ta-pro­peller pro­teins to treat can­cer. Dur­ing Roberts’ stay at Glax­o­SmithK­line, the first-time chief ex­ec­u­tive was se­nior di­rec­tor of HCV med­i­c­i­nal chem­istry and lat­er led the host de­fense dis­cov­ery per­for­mance unit. Af­ter GSK, Roberts moved on to Sy­ros Phar­ma­ceu­ti­cals as their VP of chem­istry and ear­ly de­vel­op­ment, then spent two years as an en­tre­pre­neur in res­i­dence for SR One.

Lin­da Shapiro Man­ning

David Meek­er-led Rhythm Phar­ma­ceu­ti­cals, the mak­er of obe­si­ty drug Im­civree, will change CMOs on Sept. 10 as Mur­ray Stew­art pass­es the ba­ton to Lin­da Shapiro Man­ning. It’s a fast as­cent for Shapiro Man­ning, who showed up on Peer Re­view’s radar in Ju­ly when Rhythm ap­point­ed her as SVP, clin­i­cal. In her six-year stay at No­vo Nordisk, she was head of med­ical sci­ence and in­ter­na­tion­al med­ical di­rec­tor for the Dan­ish phar­ma’s GLP-1 and obe­si­ty glob­al de­vel­op­ment pro­grams. Stew­art will still be part of the Rhythm team as a se­nior med­ical ad­vi­sor.

Jim Jogerst

→ With the un­con­ven­tion­al ap­proach of us­ing red blood cells to de­vel­op gene ther­a­pies for can­cer and au­toim­mune dis­eases, Ru­bius Ther­a­peu­tics has been min­ing for Big Phar­ma gold with its lead­er­ship — as do most Flag­ship com­pa­nies — and its lat­est move is bring­ing in Jim Jogerst as CBO. Jogerst had been with Janssen since 2018 and was se­nior di­rec­tor of busi­ness de­vel­op­ment for the in­fec­tious dis­eases and vac­cines port­fo­lio, and he was head of busi­ness de­vel­op­ment, li­cens­ing and M&A dur­ing a nine-year stay with Al­con. Ru­bius CEO Pablo Cagnoni gave End­points News an in­side look at the ear­ly da­ta for its can­cer drug RTX-240 that sent the stock climb­ing to its high­est lev­el of the year.

Jen­nifer Chow has been pro­mot­ed to CEO and man­ag­ing di­rec­tor of Aus­tralian CAR-T play­er Chimeric Ther­a­peu­tics af­ter tak­ing the COO job in No­vem­ber 2020. At one time the glob­al com­mer­cial CAR-T lead at Cel­gene, Chow then moved on to Kite, where she led glob­al mar­ket­ing, an­a­lyt­ics and com­mer­cial op­er­a­tions. CMO Syed Rizvi, VP of busi­ness and cor­po­rate de­vel­op­ment Eliot Bourk and VP of tech­ni­cal op­er­a­tions Li Ren are al­so Cel­gene vets who are with Chimeric, which has an on­go­ing Phase I tri­al at City of Hope for its chloro­tox­in cell ther­a­py to treat glioblas­toma.

Dale Pfost

→ Backed by Pe­ter Thiel and chaired by Stephen Squin­to, Is­raeli fi­bro­sis biotech Chemomab Ther­a­peu­tics has filled its CEO slot with Dale Pfost, suc­ceed­ing co-founder Adi Mor, who’s con­tin­u­ing her CSO du­ties and keep­ing her board seat. Pfost helmed Lo­do Ther­a­peu­tics from 2019 un­til its pur­chase in May by Zymer­gen, a rapid­ly falling star in the syn­bio field. Chemomab, which merged with An­chi­ano Ther­a­peu­tics this year, has a mon­o­clon­al an­ti­body in Phase II tri­als for those with pri­ma­ry scle­ros­ing cholan­gi­tis (PSC) and liv­er fi­bro­sis.

Shane Ward

→ San Diego-based Cidara — which paired with Janssen in April to de­vel­op and com­mer­cial­ize an an­tivi­ral to treat in­fluen­za — has re­tooled its lead­er­ship a bit by re­cruit­ing Pree­tam Shah (CFO and CBO) and Shane Ward (chief le­gal of­fi­cer and cor­po­rate sec­re­tary). Shah tack­les these dual roles at Cidara af­ter his tenure as Brain­Storm’s EVP, CFO and trea­sur­er, and as for Ward, the Gilead vet makes the switch here af­ter three years as chief le­gal and strat­e­gy of­fi­cer at bat­tered Bel­licum.

Con­ver­gent Ther­a­peu­tics, a ra­dio­phar­ma­ceu­ti­cal biotech tar­get­ing prostate can­cer with its lead can­di­date CONV 01-α, has tapped Alexan­der Brown as COO. Lend­ing some Big Phar­ma heft by with a re­cent stint at Sanofi as head of new prod­uct plan­ning, glob­al on­col­o­gy, Brown has al­so been se­nior di­rec­tor of glob­al com­mer­cial on­col­o­gy in charge of Baven­cio at EMD Serono. On Ju­ly 1, Con­ver­gent hand­ed the CEO reins to co-founder Philip Kantoff, the ex-chair­man of Memo­r­i­al Sloan Ket­ter­ing’s School of Med­i­cine.

Heike Keil­hack

→ Sev­er­al Big Phar­ma names con­tributed to what’s been la­beled as a $65 mil­lion Se­ries B1 round in Ju­ly, and it’s all sys­tems go for Ri­bon Ther­a­peu­tics with its two lead PARP in­hibitors as we now learn that Ri­bon has pro­mot­ed Heike Keil­hack to CSO and Kevin Kuntz to chief drug de­vel­op­ment of­fi­cer. Keil­hack is a five-year Ri­bon vet who was SVP of bi­o­log­i­cal sci­ences be­fore jump­ing to the C-suite, while Kuntz has been a Ri­bon ex­ec since 2015 and was pre­vi­ous­ly SVP of mol­e­c­u­lar dis­cov­ery. They al­so share an Epizyme con­nec­tion: Keil­hack held the se­nior di­rec­tor of bi­ol­o­gy post there at the same time Kuntz was head of chem­istry.

Pamela Yanchik Con­nealy

Pyx­is On­col­o­gy con­tin­ues to ex­pand with its ad­di­tion of Pamela Yanchik Con­nealy as CFO. Con­nealy, who brings over two decades of fi­nan­cial and busi­ness op­er­a­tions ex­pe­ri­ence, served as CFO for Im­muno­vant and COO at Ki­va. In June, chief tech­ni­cal of­fi­cer Steve Monks and COO Ritu Shah made their way to Pyx­is, which launched in 2019 and col­lect­ed $152 mil­lion in Se­ries B fund­ing ear­li­er this year to ad­vance a trio of AD­Cs in­to the clin­ic.

→ Tak­ing flight with its $125 mil­lion Se­ries C haul in May and siz­ing up the pos­si­bil­i­ty of an IPO, pre­ci­sion on­col­o­gy biotech Hum­ming­bird Bio­science has pegged Josh House as CFO. Af­ter three years at Atara Bio­ther­a­peu­tics, House jumped ship in Sep­tem­ber 2020 to be­come VP of busi­ness de­vel­op­ment for Con­so­nance-HFW Ac­qui­si­tion Corp, which merged with Sur­rozen in April in a $212 mil­lion SPAC deal.

Nan­na Lüneborg

→ Dutch VC For­bion has named Nan­na Lüneborg as a gen­er­al part­ner as­signed to the €360 mil­lion For­bion Growth Op­por­tu­ni­ties Fund. Lüneborg had spent near­ly a decade at No­vo Ven­tures and sits on the board of di­rec­tors at such biotechs as La­va Ther­a­peu­tics and NodThera.

→ Ab­sorb­ing the Nas­daq at­mos­phere thanks to a mod­est IPO this sum­mer, Der­ma­ta Ther­a­peu­tics — fo­cused on fresh­wa­ter sponge treat­ments for skin con­di­tions like ac­ne and rosacea — has wel­comed Kyri Van Hoose as CFO, suc­ceed­ing Thomas In­s­ley. Van Hoose just com­plet­ed a year as CFO at Tega Ther­a­peu­tics, and dur­ing her 11 years at Aca­dia Phar­ma­ceu­ti­cals, she was se­nior di­rec­tor of fi­nance and cor­po­rate con­troller. In­s­ley will stay on at Der­ma­ta as a fi­nan­cial con­sul­tant.

Michael Di­docha

→ Mel­bourne-based Telix Phar­ma­ceu­ti­cals — aim­ing to fight a va­ri­ety of can­cers with mol­e­c­u­lar­ly-tar­get­ed ra­di­a­tion (MTR) ther­a­pies — has tapped Michael Di­docha as CFO, Amer­i­c­as. Di­docha walks away from Roche af­ter a 16-year run that be­gan as a man­u­fac­tur­ing en­gi­neer in di­a­betes care, even­tu­al­ly climb­ing to di­rec­tor of fi­nance in 2017. Just last week, Telix named Saman­tha Mc­Sh­er­ry di­rec­tor of com­mer­cial op­er­a­tions for Aus­tralia and New Zealand.

Jeff Knight

Jeff Knight steps in­to the new­ly cre­at­ed COO po­si­tion at Cri­net­ics Phar­ma­ceu­ti­cals. Be­fore join­ing Cri­net­ics, Knight was a mem­ber of the ex­ec­u­tive lead­er­ship team at Po­sei­da, which ear­li­er this week of­fered End­points an ear­ly snap­shot of proof of ef­fi­ca­cy for a next-gen sol­id tu­mor CAR-T. Pri­or to that, he spent six years climb­ing the ranks at Am­gen, Onyx, and Halozyme. Cri­net­ics’ lead prod­uct can­di­date, pal­tuso­tine, re­vealed pos­i­tive da­ta in Phase II and forges ahead in its Phase III pro­gram for treat­ment of acromegaly.

Ezra Lowe

→ Af­ter mak­ing head­lines in the spring by bring­ing in for­mer HUD Sec­re­tary Ben Car­son as a spe­cial ad­vi­sor, Geor­gia-based NASH out­fit Galectin Ther­a­peu­tics is break­ing out the di­rec­tor’s chairs for four new staffers. Dak­shi­na Red­dy (ex­ec­u­tive di­rec­tor, reg­u­la­to­ry af­fairs) piv­ots to Galectin af­ter 10 years at No­var­tis, the last five of those as glob­al pro­gram reg­u­la­to­ry di­rec­tor. Ezra Lowe (ex­ec­u­tive di­rec­tor, clin­i­cal and pre­clin­i­cal phar­ma­col­o­gy) was most re­cent­ly se­nior di­rec­tor of clin­i­cal phar­ma­col­o­gy in glob­al R&D at Bausch Health. Mar­la Mills-Wil­son (ex­ec­u­tive di­rec­tor, clin­i­cal op­er­a­tions) start­ed her ca­reer as a clin­i­cal sci­en­tist at GSK in the Glax­oW­ell­come days and brings man­age­r­i­al ex­pe­ri­ence in clin­i­cal op­er­a­tions from Parex­el and Novel­la Clin­i­cal. Fi­nal­ly, Jes­si­ca Kopaczews­ki (as­so­ciate di­rec­tor, clin­i­cal op­er­a­tions) is a for­mer clin­i­cal op­er­a­tions man­ag­er at In­ter­cept and CymaBay.

Richard Mur­ray joins clin­i­cal-stage med­ical de­vice com­pa­ny Avisa Di­ag­nos­tics as CMO. Mur­ray has spent most of his ca­reer at Mer­ck, where he start­ed as re­gion­al med­ical di­rec­tor in the mid 1990s. From there, he climbed up the lad­der to be­come VP and deputy chief pa­tient of­fi­cer in 2016. Avisa hopes that Mur­ray’s ex­pe­ri­ence with pul­monolo­gy can help get their piv­otal tri­als in post-Covid-19 bronchiec­ta­sis and ven­ti­la­tor-as­so­ci­at­ed pneu­mo­nia across the fin­ish line.

Mon­i­ca Luchi

→ Boul­der, CO-based Brick­ell Biotech, which snapped up ex­clu­sive rights this week from South Ko­rea’s Voronoi to de­vel­op drugs from a DYRK1A in­hibitor plat­form, has brought on Mon­i­ca Luchi as CMO. Luchi, a No­var­tis and In­cyte alum who de­camps from her in­ter­im CMO post with the Brack­en Group, is the for­mer SVP, clin­i­cal R&D for Celu­lar­i­ty and Sor­ren­to. She’s al­so been the ther­a­peu­tic area head for im­munol­o­gy at Mesoblast.

Avac­ta Group has reeled in Fiona McLaugh­lin as CSO of its ther­a­peu­tics di­vi­sion. McLaugh­lin jump­start­ed her ca­reer at GSK be­fore head­ing to An­ti­so­ma as VP, trans­la­tion­al re­search, and Al­ge­ta (ac­quired by Bay­er) as VP of new op­por­tu­ni­ties.

→ Swiss-based Im­munOs Ther­a­peu­tics has nabbed Jef­frey Abbey as COO. Abbey comes aboard from Ar­gos Ther­a­peu­tics, where he served as CEO and pre­vi­ous­ly as VP, busi­ness de­vel­op­ment and CBO. Af­ter his time at Ar­gos, Abbey was CEO of No­vadip Bio­sciences, Bel­gium.

In ad­di­tion to his ap­point­ment, Im­munOs has cre­at­ed a clin­i­cal ad­vi­so­ry board with the ad­di­tions of An­drew Scott (di­rec­tor, de­part­ment of mol­e­c­u­lar imag­ing and ther­a­py, Austin Health); Dmitriy Za­marin (med­ical on­col­o­gist and trans­la­tion­al re­search di­rec­tor in the gy­ne­co­log­ic med­ical on­col­o­gy ser­vice at the Memo­r­i­al Sloan Ket­ter­ing Can­cer Cen­ter); Dirk Jäger (man­ag­ing di­rec­tor of the Na­tion­al Cen­ter for Tu­mor Dis­eases); and Jef­frey Bock­man (leader of the on­col­o­gy and vi­rol­o­gy prac­tices at Cel­lo Health Bio­Con­sult­ing).

Chris­tine Pel­liz­zari

Sci­ence 37, which hit uni­corn sta­tus in May through its merg­er with LifeSci Ac­qui­si­tion II, has tapped Chris­tine Pel­liz­zari as chief le­gal of­fi­cer. Pel­liz­zari comes to the LA-based com­pa­ny from In­smed, where she most re­cent­ly served as chief le­gal of­fi­cer. In ad­di­tion to her new role, Pel­liz­zari sits on the boards of Cel­sion and Tem­pest Ther­a­peu­tics.

→ As Mark Rothera read­ies him­self for year two at siR­NA (short in­ter­fer­ing RNA) biotech Si­lence Ther­a­peu­tics, John Straf­ford has been pro­mot­ed to SVP, busi­ness de­vel­op­ment, al­liance man­age­ment and new prod­uct de­vel­op­ment. Straf­ford has led busi­ness de­vel­op­ment since 2019 and orig­i­nal­ly joined Lon­don-based Si­lence in 2018 as busi­ness de­vel­op­ment di­rec­tor. Since Rothera took the helm in Sep­tem­ber 2020, Si­lence’s oth­er lead­er­ship ad­di­tions in­clude CFO Craig Tooman and head of mol­e­c­u­lar de­sign Marie Wik­ström Lind­holm.

Jane Larkin­dale

→ Ear­li­er this month, Pep­Gen racked up near­ly $113 mil­lion in a Se­ries B in an ef­fort to gain trac­tion in the Duchenne mus­cu­lar dy­s­tro­phy field, and the James McArthur-led Ox­ford spin­out had been mak­ing its share of hires this sum­mer in be­tween fi­nanc­ing rounds. But it’s a pro­mo­tion Pep­Gen is high­light­ing: Jane Larkin­dale joined the biotech in April as se­nior di­rec­tor of clin­i­cal sci­ence af­ter six years at the Crit­i­cal Path In­sti­tute, and she’s been el­e­vat­ed to VP. Pep­Gen is al­so di­rect­ing at­ten­tion to its board of di­rec­tors by ush­er­ing in Pare­des Bio­sciences CFO Hei­di Hen­son, the for­mer CFO at Ku­ra On­col­o­gy among oth­er stops.

→ Hot off the grill at Onc­ter­nal Ther­a­peu­tics, Steven Ham­burg­er is now over­see­ing reg­u­la­to­ry af­fairs and qual­i­ty as­sur­ance. Be­fore em­bark­ing up­on this SVP gig at the San Diego can­cer biotech, Ham­burg­er was a mem­ber of Art Krieg and Bar­ry Labinger’s squad at Check­mate as VP and head of reg­u­la­to­ry af­fairs. And in a ca­reer that’s spanned more than 35 years, he’s al­so been a reg­u­la­to­ry ex­ec with Tarve­da Ther­a­peu­tics, Cas­tle Creek Phar­ma­ceu­ti­cals, Bax­al­ta and Im­munomedics.

George Samuel

George Samuel has signed on to Carls­bad, CA-based Lin­eage Cell Ther­a­peu­tics as gen­er­al coun­sel. In his pre­vi­ous biotech for­ay, Samuel spent three years as VP, gen­er­al coun­sel and cor­po­rate sec­re­tary at Cardiff On­col­o­gy, then known as Trovagene. Ear­li­er this sum­mer, Kevin Cook re­placed Bran­di Roberts as CFO of the al­lo­gene­ic cell ther­a­py play­er.

Bound­less Bio made a splash ear­li­er this year by rais­ing $105 mil­lion to reimag­ine tar­get­ed can­cer ther­a­py — specif­i­cal­ly by go­ing af­ter ecD­NA. This week, the San Diego biotech an­nounced that Jes­si­ca Oien will join their team as gen­er­al coun­sel and cor­po­rate sec­re­tary. Oien held the same po­si­tion at Cidara and has a num­ber of oth­er le­gal roles to her cred­it, in­clud­ing with Elan Phar­ma­ceu­ti­cals and Oton­o­my. Bound­less Bio hopes to bring its ecD­NA re­search to the clin­ic by 2023.

CM Life Sci­ences II and So­ma­Log­ic have ap­point­ed Todd John­son as EVP of busi­ness de­vel­op­ment and strat­e­gy and Ruben Gutier­rez as gen­er­al coun­sel. John­son pre­vi­ous­ly served as SVP for care trans­for­ma­tion at AVIA and CEO of HealthLoop. Mean­while, Gutier­rez for­mer­ly served as VP, le­gal and cor­po­rate af­fairs for Nat­era and gen­er­al coun­sel of Hu­man Longevi­ty.

→ San Diego-based Med­van­tx has brought on Nabil Badr as chief tech­nol­o­gy of­fi­cer and Dar­lene Mitchell as chief com­pli­ance of­fi­cer. Badr hails from City Na­tion­al Bank, where he served as VP of dig­i­tal trans­for­ma­tion; while Mitchell was for­mer­ly with Ad­van­tia Health and lead com­pli­ance of­fi­cer for the Planned Par­ent­hood Fed­er­a­tion of Amer­i­ca.

Yi Xia has been named SVP of sta­tis­tics and da­ta sci­ence at Chi­nese bio­con­ju­gate de­vel­op­er GeneQuan­tum Health­care, tack­ing on an­oth­er ap­point­ment af­ter CMO Kai­da Wu joined the com­pa­ny a cou­ple weeks ago. Xia has worked in bio­sta­tis­tics at Ei­sai and Dai­ichi Sankyo, and just had a very short tenure as VP, head of bio­sta­tis­tics and da­ta man­age­ment at Al­pham­ab On­col­o­gy.

William Fairey

→ A cou­ple weeks ago, William Fairey scored a board ap­point­ment at Mirum Phar­ma­ceu­ti­cals af­ter Ti­ba Aynechi’s res­ig­na­tion, and now comes word that he’s been added to the board of di­rec­tors at Austin, TX-based Lung Ther­a­peu­tics. The long­time Acte­lion vet is the ex-EVP and CCO at MyoKar­dia.

→ Seek­ing to treat neu­rode­gen­er­a­tive dis­eases by ze­ro­ing in on tox­ic oligomers, Toron­to-based ProMIS Neu­ro­sciences has cho­sen Josh Man­del-Brehm to be on the board of di­rec­tors. Man­del-Brehm spent four years at Bio­gen in BD and M&A be­fore his ap­point­ment as pres­i­dent and CEO of Camp4 in 2017.

Anne Whitak­er

→ Hop­ing to ri­val EpiPen, ana­phy­lax­is start­up Bryn Phar­ma out of the Re­search Tri­an­gle has elect­ed Anne Whitak­er to the board of di­rec­tors. The long­time GSK ex­ec chairs the board at Aera­mi Ther­a­peu­tics, where she was once CEO.

Se­qua­na Med­ical has plucked up Jack­ie Field­ing to join the com­pa­ny as non-ex­ec­u­tive di­rec­tor, re­plac­ing Ja­son Han­non who is step­ping down. Field­ing spent the last 28 years with Medtron­ic, most re­cent­ly serv­ing as VP UK/Ire­land.

→ New York-based See­los Ther­a­peu­tics has pulled in Mar­garet Dale­san­dro as part of its board of di­rec­tors. Most re­cent­ly, Dale­san­dro served as VP of project, port­fo­lio and al­liance man­age­ment at Im­Clone Sys­tems. Ear­li­er in her ca­reer, Dale­san­dro served as di­rec­tor of car­dio­vas­cu­lar/on­col­o­gy project/port­fo­lio/al­liance man­age­ment at GSK.

ZS Per­spec­tive: 3 Pre­dic­tions on the Fu­ture of Cell & Gene Ther­a­pies

The field of cell and gene therapies (C&GTs) has seen a renaissance, with first generation commercial therapies such as Kymriah, Yescarta, and Luxturna laying the groundwork for an incoming wave of potentially transformative C&GTs that aim to address diverse disease areas. With this renaissance comes several potential opportunities, of which we discuss three predictions below.

Allogenic Natural Killer (NK) Cells have the potential to displace current Cell Therapies in oncology if proven durable.

Despite being early in development, Allogenic NKs are proving to be an attractive new treatment paradigm in oncology. The question of durability of response with allogenic therapies is still an unknown. Fate Therapeutics’ recent phase 1 data for FT516 showed relatively quicker relapses vs already approved autologous CAR-Ts. However, other manufacturers, like Allogene for their allogenic CAR-T therapy ALLO-501A, are exploring novel lymphodepletion approaches to improve persistence of allogenic cells. Nevertheless, allogenic NKs demonstrate a strong value proposition relative to their T cell counterparts due to comparable response rates (so far) combined with the added advantage of a significantly safer AE profile. Specifically, little to no risk of graft versus host disease (GvHD), cytotoxic release syndrome (CRS), and neurotoxicity (NT) have been seen so far with allogenic NK cells (Fig. 1). In addition, being able to harness an allogenic cell source gives way to operational advantages as “off-the-shelf” products provide improved turnaround time (TAT), scalability, and potentially reduced cost. NKs are currently in development for a variety of overlapping hematological indications with chimeric antigen receptor T cells (CAR-Ts) today, and the question remains to what extent they will disrupt the current cell therapy landscape. Click for more details.

Lat­est news on Pfiz­er's $3B+ JAK1 win; Pacts over M&A at #JPM22; 2021 by the num­bers; Bio­gen's Aduhelm reck­on­ing; The sto­ry of sotro­vimab; 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.

For those of you who attended #JPM22 in any shape or form, we hope you had a fruitful time. Regardless of how you spent the past hectic week, may your weekend be just what you need it to be.

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A $3B+ peak sales win? Pfiz­er thinks so, as FDA of­fers a tardy green light to its JAK1 drug abroc­i­tinib

Back in the fall of 2020, newly crowned Pfizer chief Albert Bourla confidently put their JAK1 inhibitor abrocitinib at the top of the list of blockbuster drugs in the late-stage pipeline with a $3 billion-plus peak sales estimate.

Since then it’s been subjected to serious criticism for the safety warnings associated with the class, held back by a cautious FDA and questioned when researchers rolled out a top-line boast that their heavyweight contender had beaten the champ in the field of atopic dermatitis — Dupixent — in a head-to-head study.

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Robert Califf, FDA commissioner nominee (Graeme Sloan/Sipa USA/Sipa via AP Images)

Rob Califf ad­vances as Biden's FDA nom­i­nee, with a close com­mit­tee vote

Rob Califf’s second confirmation process as FDA commissioner is already much more difficult than his near unanimous confirmation under the Obama administration.

The Senate Health Committee on Thursday voted 13-8 in favor of advancing Califf’s nomination to a full Senate vote. Several Democrats voted against Califf, including Sen. Bernie Sanders and Sen. Maggie Hassan. Several other Democrats who aren’t on the committee, like West Virginia’s Joe Manchin and Ed Markey of Massachusetts, also said Thursday that they would not vote for Califf. Markey, Hassan and Manchin all previously expressed reservations about the prospect of Janet Woodcock as an FDA commissioner nominee too.

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Michel Vounatsos, Biogen CEO (World Economic Forum/Ciaran McCrickard)

Bio­gen vows to fight CM­S' draft cov­er­age de­ci­sion for Aduhelm be­fore April fi­nal­iza­tion

Biogen executives made clear in an investor call Thursday they are not preparing to run a new CMS-approved clinical trial for their controversial Alzheimer’s drug anytime soon.

As requested in a draft national coverage decision from CMS earlier this week, Biogen and other anti-amyloid drugs will need to show “a meaningful improvement in health outcomes” for Alzheimer’s patients in a randomized, placebo-controlled trial to get paid for their drugs, rather than just the reduction in amyloid plaques that won Aduhelm its accelerated approval in June.

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CRO own­er pleads guilty to ob­struct­ing FDA in­ves­ti­ga­tion in­to fal­si­fied clin­i­cal tri­al da­ta

The co-owner of a Florida-based clinical research site pleaded guilty to lying to an FDA investigator during a 2017 inspection, revealing that she falsely portrayed part of a GlaxoSmithKline pediatric asthma study as legitimate, when in fact she knew that certain data had been falsified, the Department of Justice said Wednesday.

Three other employees — Yvelice Villaman Bencosme, Lisett Raventos and Maytee Lledo — previously pleaded guilty and were sentenced in connection with falsifying data associated with the trial at the CRO Unlimited Medical Research.

Susan Galbraith, AstraZeneca EVP, Oncology R&D

Can­cer pow­er­house As­traZeneca rolls the dice on a $75M cash bet on a buzzy up­start in the on­col­o­gy field

After establishing itself in the front ranks of cancer drug developers and marketers, AstraZeneca is putting its scientific shoulder — and a significant amount of cash — behind the wheel of a brash new upstart in the biotech world.

The pharma giant trumpeted news this morning that it is handing over $75 million upfront to ally itself with Scorpion Therapeutics, one of those biotechs that was newly birthed by some top scientific, venture and executive talent and bequeathed with a fortune by way of a bankroll to advance an only hazily explained drug platform. And they are still very much in the discovery and preclinical phase.

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‘Skin­ny la­bels’ on gener­ics can save pa­tients mon­ey, re­search shows, but re­cent court de­ci­sions cloud fu­ture

New research shows how generic drug companies can successfully market a limited number of approved indications for a brand name drug, prior to coming to market for all of the indications. But several recent court decisions have created a layer of uncertainty around these so-called “skinny” labels.

While courts have generally allowed generic manufacturers to use their statutorily permitted skinny-label approvals, last summer, a federal circuit court found that Teva Pharmaceuticals was liable for inducing prescribers and patients to infringe GlaxoSmithKline’s patents through advertising and marketing practices that suggested Teva’s generic, with its skinny label, could be employed for the patented uses.

A patient in Alaska receiving an antibody infusion to prevent Covid hospitalizations in September. All but one of these treatments has been rendered useless by Omicron (Rick Bowmer/AP Images)

How a tiny Swiss lab and two old blood sam­ples cre­at­ed one of the on­ly ef­fec­tive drugs against Omi­cron (and why we have so lit­tle of it)

Exactly a decade before a novel coronavirus broke out in Wuhan, Davide Corti — a newly-minted immunologist with frameless glasses and a quick laugh — walked into a cramped lab on the top floor of an office building two hours outside Zurich. He had only enough money for two technicians and the ceiling was so low in parts that short stature was a job requirement, but Corti believed it’d be enough to test an idea he thought could change medicine.

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