Sporos Bioven­tures taps first CEO dur­ing pe­ri­od of 'ex­plo­sive growth'; In the wake of murky Hunter syn­drome da­ta, De­nali bulks up C-suite

Al­most five months af­ter emerg­ing from stealth mode on a mis­sion to lever­age work be­ing done in “fly­over” states like Texas and Wis­con­sin, Sporos Bioven­tures has named its first of­fi­cial CEO.

Amit Rakhit left his role as pres­i­dent and CMO of Ovid Ther­a­peu­tics to take the helm at Sporos, a Hous­ton-based up­start launched by Gen­zyme vet Michael Wyz­ga, ex-MD An­der­son chief Ron De­Pin­ho, Bridge­Bio co-founder Pe­ter Fein­berg, Tvar­di Ther­a­peu­tics CSO Jeno Gyuris, and en­tre­pre­neur Alex Cran­berg.

Amit Rakhit

As an “in­quis­i­tive and cu­ri­ous” kid, Rakhit was al­ways play­ing with bugs and flow­ers, or look­ing for con­stel­la­tions. But it wasn’t un­til he was old­er that he de­cid­ed to pur­sue a ca­reer in health­care.

Af­ter get­ting his bach­e­lor’s de­gree in mol­e­c­u­lar bi­ol­o­gy from UC-Berke­ley, he went straight in­to med­ical school at Tufts Uni­ver­si­ty. He fol­lowed that up with a res­i­den­cy in pe­di­atrics at Tufts, a stint work­ing with the Moth­er Tere­sa at an or­phan­age in Kolkata, In­dia, and a fel­low­ship in car­di­ol­o­gy at Boston Chil­dren’s Hos­pi­tal.

Rakhit end­ed up on the staff at Boston Chil­dren’s for a while, but he even­tu­al­ly craved more. He be­gan toy­ing with the idea of a ca­reer in the bio­phar­ma in­dus­try, mak­ing drugs in­stead of pre­scrib­ing them.

“While as a physi­cian you can take care of one per­son, which is very, very mean­ing­ful… but in the in­dus­try, what we get to do is af­fect mil­lions of lives,” he told End­points News. 

In 2001, he took a job at Bris­tol My­ers Squibb, where he worked on the block­buster blood-thin­ning drug Plav­ix.

“That’s where I learned the busi­ness,” he said, adding that he re­mained at BMS for al­most 10 years, be­fore that “in­quis­i­tive­ness and cu­rios­i­ty” led him to Bio­gen.

“I re­al­ly want­ed to be in a small­er com­pa­ny and see what that was like,” he said.

Steve Holtz­man re­cruit­ed Rakhit to Bio­gen in 2011, where he joined the ALS team. Af­ter an un­suc­cess­ful Phase III read­out, he piv­ot­ed over to the Spin­raza team, which lat­er be­came the first drug ap­proved to treat spinal mus­cu­lar at­ro­phy (SMA). Rakhit re­called that dur­ing his res­i­den­cy, he treat­ed a child with SMA who died with­out an avail­able treat­ment.

“(That) re­al­ly brought it back home, why I got in­to med­i­cine and why I went in­to in­dus­try,” he said.

Rakhit con­tin­ued work­ing on neu­ro at Ovid, where he even­tu­al­ly worked his way up to CMO and pres­i­dent be­fore leav­ing for Sporos in Au­gust. Sporos touts it­self as an “in­no­va­tion hub,” sport­ing four port­fo­lio com­pa­nies as well as a suite of in-house small mol­e­cule pro­grams. The com­pa­ny nabbed $38.1 mil­lion in a Se­ries A round back in May, and soon plans to kick off its own in­ter­nal an­ti­body en­gine, ac­cord­ing to Rakhit, who said the up­start is ex­pe­ri­enc­ing a pe­ri­od of “ex­plo­sive growth.”

Nicole De­Feud­is


Katie Peng

→ At the fore­front of study­ing the blood-brain bar­ri­er, De­nali raised the win­dow on Hunter syn­drome da­ta in late Ju­ly in which the South San Fran­cis­co biotech found pos­i­tives — and an­a­lysts ex­pressed con­cerns. Two months lat­er, Katie Peng has been named chief com­mer­cial of­fi­cer at De­nali, even though none of its drugs are close to launch yet. Peng had been as­so­ci­at­ed with Roche and Genen­tech for the past 16 years, tak­ing charge of Genen­tech’s OM­NI (oph­thal­mol­o­gy, me­tab­o­lism, neu­ro­science, im­munol­o­gy) busi­ness unit be­fore leap­ing to De­nali.

Some an­a­lysts par­tic­u­lar­ly soured on De­nali’s mud­dled re­sults for the neu­ro­fil­a­ment bio­mark­er while giv­ing them­selves wig­gle room to be swayed down the road. “Bot­tom line, these da­ta are clear­ly not en­cour­ag­ing, but we don’t dis­agree with man­age­ment that it may be too ear­ly to see any­thing as we don’t ful­ly un­der­stand the ki­net­ics of NfL changes, es­pe­cial­ly in a treat­ment set­ting,” wrote Stifel’s Paul Mat­teis.

Michael Amoroso

Michael Amoroso should pay rent in Peer Re­view as much as he’s been here in the last year. He turns up again this week by re­plac­ing Matt Kane start­ing Oct. 15 as pres­i­dent and CEO of Durham, NC-based Pre­ci­sion Bio­Sciences, which got a shot in the arm from Jim Wil­son back in Feb­ru­ary when he used Pre­ci­sion’s AR­CUS gene edit­ing plat­form for his PC­SK9 study. We doc­u­ment­ed Amoroso’s me­te­oric as­cent through the ranks at Abeona in last week’s edi­tion when he was named chair­man and then passed the CEO torch to Vish­was Se­shadri. Be­fore join­ing Abeona, Amoroso was Kite’s chief com­mer­cial of­fi­cer, and ear­li­er he was SVP, Amer­i­c­as com­mer­cial, on­col­o­gy busi­ness group at Ei­sai.

Con­ley Chee

→ With its RARα ag­o­nist tamibarotene in a Phase II acute myeloid leukemia tri­al in com­bi­na­tion with vene­to­clax and azac­i­ti­dine, Sy­ros has looked to No­var­tis for its first CCO. Con­ley Chee has spent the last 15 years at the phar­ma gi­ant, con­clud­ing his tenure as glob­al head of port­fo­lio man­age­ment, glob­al pipeline strat­e­gy and pre­ci­sion med­i­cine. Chee’s Big Phar­ma back­ground doesn’t stop there: He’s al­so been Pfiz­er’s team leader of in­ter­na­tion­al busi­ness de­vel­op­ment. Dur­ing last year’s ASH con­fer­ence, Bain Cap­i­tal pumped in more than $90 mil­lion of fi­nanc­ing as Sy­ros charges ahead with a pipeline that’s al­so com­prised of SY-2101 and oral CDK7 in­hibitor SY-5609.

Mol­ly Harp­er

Mol­ly Harp­er is mov­ing on af­ter just a year as EVP of op­er­a­tions at Rel­ma­da Ther­a­peu­tics, grab­bing a C-suite gig as CBO of Cam­bridge, MA syn­bio play­er and Gink­go col­lab­o­ra­tor Syn­log­ic. We cov­ered Harp­er’s jump to Rel­ma­da in May 2020 from Akcea, where she was SVP and glob­al fran­chise gen­er­al man­ag­er, and at Sanofi Gen­zyme she led US en­docrinol­o­gy in the rare dis­ease di­vi­sion. In re­cent months she’s al­so tal­lied board seats at Pre­ciseDx and Cat­a­lyst Phar­ma­ceu­ti­cals.

Jose Menoyo

→ In this week’s first ex­am­ple of top tal­ent at Alex­ion pack­ing their bags af­ter the As­traZeneca takeover, UK-based iron de­fi­cien­cy biotech Shield Ther­a­peu­tics has wel­comed Sanofi Gen­zyme vet Jose Menoyo as CMO. Menoyo has ex­pe­ri­ence with com­pa­nies that As­traZeneca fan­cies, re­cent­ly lead­ing US med­ical af­fairs at Alex­ion and serv­ing as SVP of med­ical af­fairs at ZS Phar­ma, which As­traZeneca ac­quired in 2015. To­ward the end of his time at Sanofi, Menoyo was VP, re­nal glob­al med­ical af­fairs and di­vi­sion med­ical of­fi­cer, spe­cial­ty care di­vi­sion.

Lori Es­cobe­do

→ Al­so putting the “ex” in Alex­ion, Lori Es­cobe­do has been named chief peo­ple of­fi­cer of bio­mol­e­c­u­lar con­den­sate spe­cial­ist Dew­point Ther­a­peu­tics, one of this year’s End­points 11 hon­orees. Es­cobe­do filled the VP of HR role sup­port­ing R&D, med­ical af­fairs, and le­gal func­tions at Alex­ion, and for 12 years be­fore that, she was in HR lead­er­ship at San­doz and No­var­tis. CSO Isaac Klein and SVP of chem­istry and drug dis­cov­ery Michael Wag­n­er are oth­er ex­ecs who have joined Dew­point since Ameet Nath­wani took the top spot al­most one year ago.

Karen-Leigh Ed­wards

→ Wrap­ping up this lit­tle sub-sec­tion, Karen-Leigh Ed­wards has bought her tick­et out of Alex­ion as well, sign­ing on to Bed­ford, MA-based eye dis­ease biotech Oc­u­lar Ther­a­peu­tix as SVP of tech­ni­cal op­er­a­tions. Ed­wards spent five years at Alex­ion, even­tu­al­ly lead­ing ex­ter­nal man­u­fac­tur­ing and op­er­a­tions be­fore this op­por­tu­ni­ty came in­to view. Ed­wards be­came as­so­ciate di­rec­tor, glob­al sup­ply chain dur­ing the sec­ond of her two tenures with Bio­gen.

Nicole Hayes

Bay­er has turned to Nicole Hayes to be di­rec­tor of US ex­ter­nal com­mu­ni­ca­tions af­ter near­ly three years with The Boun­ti­ful Com­pa­ny, whose core brands like Na­ture’s Boun­ty and Es­ter-C are now un­der the con­trol of Nestlé Health Sci­ence in a $5.75 bil­lion ac­qui­si­tion. Hayes has al­so led ex­ter­nal com­mu­ni­ca­tions at Toys “R” Us.

→ Ger­man an­ti­sense oligonu­cleotide biotech Is­ar­na Ther­a­peu­tics has tapped Claus Schalper as CEO. Schalper tries his hand at lead­ing an­oth­er com­pa­ny af­ter co-found­ing Pieris, where he was al­so CFO, and co-found­ing and han­dling CEO du­ties at XL-pro­tein GmbH. Putting its eggs in the oph­thal­mol­o­gy bas­ket for now, Is­ar­na’s lead can­di­date ISTH0036 will im­mi­nent­ly start Phase IIa tri­als for AMD and DME.

Mo­hit Rawat

→ Ra­dio­phar­ma is all the rage with ITM, Ak­tis and Rayze­Bio gath­er­ing up some se­ri­ous coin in the space this year — and Fu­sion Phar­ma­ceu­ti­cals is in the mid­dle of the ac­tion too, ap­point­ing Mo­hit Rawat pres­i­dent and CBO. Rawat hails from No­var­tis On­col­o­gy, where he was VP and glob­al dis­ease lead for the chron­ic myeloid leukemia (CML) fran­chise and at one time was the mar­ket­ing di­rec­tor for Cosen­tyx. In­ci­den­tal­ly, No­var­tis has made an­oth­er stride in with its ra­dio­phar­ma am­bi­tion with a break­through ther­a­py des­ig­na­tion for 177Lu-PS­MA-617, a prod­uct of its 2018 ac­qui­si­tion of En­do­cyte.

→ New York-based can­cer metas­ta­sis biotech Hi­ber­Cell has brought on Jonathan Lan­fear to be the new COO, com­ing short­ly af­ter Hi­ber­Cell bought out Ge­nu­ity Sci­ence in Au­gust with its ge­nomics tools and AI plat­form. Lan­fear, a Pfiz­er alum in busi­ness de­vel­op­ment, joins Hi­ber­Cell af­ter leav­ing Take­da last year, fin­ish­ing his nine years there as the glob­al head of busi­ness R&D.

Lise Lund Kjems has joined Gainesville, FL-based Cy­clo Ther­a­peu­tics as CMO. Kjems spent near­ly a decade at No­var­tis be­fore most re­cent­ly serv­ing as VP, head of clin­i­cal de­vel­op­ment at Al­bireo. At Cy­clo, she re­places act­ing CMO Ger­ald Cox, who now shifts to the com­pa­ny’s sci­en­tif­ic ad­vi­so­ry board.

Rus­sell Bey­er

→ With BAR­DA’s fi­nan­cial as­sis­tance, Sioux Falls-based SAB Bio­ther­a­peu­tics is on the march to Phase III with SAB-185, its in­tra­venous poly­clon­al an­ti­body treat­ment for Covid-19, and has wel­comed Big Phar­ma vet Rus­sell Bey­er as CFO. Start­ing well be­fore the 1999 merg­er, Bey­er was As­traZeneca’s CFO for Puer­to Ri­co and Mex­i­co, and he’s re­cent­ly been se­nior di­rec­tor of fi­nance at Te­va for sev­en years. At the be­gin­ning of the sum­mer, SAB an­nounced it would merge with Big Cy­press Ac­qui­si­tion Corp. in a $325 mil­lion SPAC deal.

→ Get­ting its house in or­der com­mer­cial­ly for BTK in­hibitor tirabru­ti­nib, Ono Phar­ma­ceu­ti­cal’s US sub Ono Phar­ma USA has re­cruit­ed David Trexler as CCO. Re­cent­ly the pres­i­dent and a board mem­ber at Mor­phoSys — which snapped up Con­stel­la­tion Phar­ma­ceu­ti­cals for $1.7 bil­lion a few months back — Trexler was the glob­al brand lead for Baven­cio and the SVP, US on­col­o­gy com­mer­cial for EMD Serono. He al­so logged 10 years at Ei­sai in var­i­ous busi­ness and mar­ket­ing po­si­tions.

Chun-Pyn Shen

Chun-Pyn Shen has made his way over to Im­pact Ther­a­peu­tics, where he’s tak­ing on the role of head of reg­u­la­to­ry af­fairs (VP). Shen hops aboard the Shang­hai-based com­pa­ny from Dy­man­i­Cure Biotech­nol­o­gy, where he served as VP, glob­al project head. Shen jump­start­ed his ca­reer at Mer­ck and spent a decade with the com­pa­ny be­fore head­ing over to Adap­ti­m­mune to served as di­rec­tor, clin­i­cal re­search and de­vel­op­ment and lat­er on Quest­cor/Mallinck­rodt. Ad­di­tion­al­ly, dur­ing his time at Mer­ck KGaA, Shen made sig­nif­i­cant con­tri­bu­tions to the ap­proval of Baven­cio.

Den­nis Cho

→ Strik­ing a huge deal with Boehringer In­gel­heim ear­li­er this month — up to $710 mil­lion in mile­stones — to al­low the Ger­man phar­ma to gain en­try in­to its an­ti­body “li­brary of li­braries,” Emi­ly Lep­roust’s DNA man­u­fac­tur­ing squad at Twist Bio­science has turned to Den­nis Cho as SVP, gen­er­al coun­sel and chief ethics and com­pli­ance of­fi­cer. Cho leaves Cy­tomX af­ter on­ly eight months as as­sis­tant gen­er­al coun­sel and has al­so brought his le­gal ex­per­tise to Seagen and, for nine years, Cel­gene.

Brii Bio cel­e­brat­ed its $320 mil­lion ar­rival on the Hong Kong stock ex­change with come­back da­ta in the NIH-backed tri­al for its Covid-19 an­ti­body com­bo last month. Zhi Hong-led Brii al­so has a new ex­ec on board with Coy Stout tak­ing the role of SVP and head of US mar­ket ac­cess and pa­tient ad­vo­ca­cy. Thus ends a 17-year re­la­tion­ship Stout had in sev­er­al ca­pac­i­ties with Gilead that drew to a close as VP of US com­mer­cial ac­cess and re­im­burse­ment.

James Cum­mings

Vaxart just re­vealed that James Cum­mings has tak­en over as CMO this month. Cum­mings was pre­vi­ous­ly pres­i­dent of Icon’s fed­er­al busi­ness unit, Icon GPHS, and VP of clin­i­cal de­vel­op­ment and trans­la­tion­al med­i­cine at No­vavax. It’s a piv­otal hire for An­drei Floroiu’s bunch at the South San Fran­cis­co vac­cine biotech as Phase II tri­als get un­der­way for its oral tablet Covid-19 vac­cine.

→ Swiss uter­ine fi­broid biotech Ob­sE­va has named Lui­gi Mar­ro as its new chief trans­for­ma­tion of­fi­cer ef­fec­tive to­day. An alum of Fi­nox Biotech as CFO and Mer­ck Serono in glob­al strat­e­gy, Mar­ro is added to the lead­er­ship ros­ter af­ter Mer­ck spin­out Organon inked a $500 mil­lion deal in Ju­ly for world­wide rights to Ob­sE­va’s preterm la­bor treat­ment ebopiprant.

Mark Berg­er

→ Af­ter Avinash De­sai earned a pro­mo­tion to CMO of Ac­tini­um, his pre­de­ces­sor Mark Berg­er is tak­ing the same job in the Lone Star State at Austin-based gene ther­a­py out­fit Gen­prex. Pri­or to his time at Ac­tini­um, Berg­er was SVP of clin­i­cal re­search at Kad­mon and the CMO at De­ci­phera Phar­ma­ceu­ti­cals. The C-suite at Gen­prex al­so grows with He­mant Ku­mar, a Big Phar­ma vet who set­tles in­to the new po­si­tion of chief man­u­fac­tur­ing and tech­nol­o­gy of­fi­cer. Ku­mar’s been in­volved in man­u­fac­tur­ing and tech­ni­cal op­er­a­tions with heavy hit­ters like Mer­ck, Lon­za and Janssen, and he heads to Gen­prex af­ter a stint as VP, glob­al head of man­u­fac­tur­ing, sup­ply chain, and strat­e­gy at Arc­turus.

→ The Cen­ter for Break­through Med­i­cines has tapped Pe­ter Car­bone as its COO. Car­bone hails from Ac­cor­da Ther­a­peu­tics, where he most re­cent­ly served as EVP, qual­i­ty. In ad­di­tion to his stint at Ac­cor­da, Car­bone joins with ex­pe­ri­ence from his times at No­var­tis, Bay­er and Am­gen.

Nanocan Ther­a­peu­tics has brought on Eliz­a­beth Char­lotte Moser as CSO. Moser joins the Prince­ton, NJ-based com­pa­ny from Galera Ther­a­peu­tics, where she was VP for clin­i­cal de­vel­op­ment. Pri­or to that, she held po­si­tions at Elek­ta and Cham­pal­i­maud Foun­da­tion.

Rob Rode takes over the CCO po­si­tion at Ap­n­imed as the com­pa­ny ex­pands its lead­er­ship fol­low­ing such ap­point­ments as CFO Michael Rogers and SVP of med­ical af­fairs David White. Be­fore join­ing Ap­n­imed, which fo­cus­es on de­vel­op­ing treat­ments for sleep ap­nea, Rode served as VP of com­mer­cial op­er­a­tions for car­dio­vas­cu­lar and meta­bol­ic dis­eases at Mer­ck.

Chris Knibb

Prime Ther­a­peu­tics has reeled in Chris Knibb to be its new CFO, tak­ing over for Dave Schlett, who is tran­si­tion­ing to the role of EVP, chief client re­la­tion­ship and ad­min­is­tra­tive of­fi­cer. Knibb most re­cent­ly served as CFO at SOC Telemed and pre­vi­ous­ly served as Ex­press Scripts’ SVP of fi­nance and chief ac­count­ing of­fi­cer.

→ Sand­wiched in be­tween The Ohio State Uni­ver­si­ty and the famed Jack Nick­laus-de­signed Muir­field Vil­lage Golf Club in Dublin, im­mun­odi­ag­nos­tic and im­munother­a­py biotech Navidea Bio­phar­ma­ceu­ti­cals has tapped Michel Mikhail as chief reg­u­la­to­ry of­fi­cer. Mikhail has been a reg­u­la­to­ry ex­ec for a va­ri­ety of com­pa­nies, in­clud­ing BioN­Tech, Fre­se­nius Kabi, Glax­o­SmithK­line when it was SmithK­line Beecham, and Boehringer In­gel­heim.

Brad Lon­car

Bar­bara Re­go­ni­ni has tak­en on the new­ly cre­at­ed post of fi­nance di­rec­tor at Mi­lan-based hematopoi­et­ic stem cell gene ther­a­py biotech Genen­ta Sci­ence, which is in Phase I/II with Tem­fer­on for pa­tients with glioblas­toma mul­ti­forme. Re­go­ni­ni, for­mer­ly a se­nior man­ag­er at PwC, was re­cent­ly CFO at OAM, an Ital­ian fi­nan­cial bro­ker­age com­pa­ny. Else­where at Genen­ta, Brad Lon­car — an in­valu­able End­points re­source — is on board as a strate­gic ad­vi­sor, along with Alec Ross and Rock­et Phar­ma­ceu­ti­cals CEO Gau­rav Shah.

→ Backed by MPM and Or­biMed, Re­Code Ther­a­peu­tics has been me­thod­i­cal­ly as­sem­bling its lead­er­ship since tak­ing the wraps off its lipid nanopar­ti­cle (LNP) de­liv­ery plat­form to the tune of an $80 mil­lion Se­ries A in March 2020. Re­Code now brings in Nick France as SVP of clin­i­cal de­vel­op­ment af­ter two years as Es­cape Bio’s head of clin­i­cal re­search. At Roivant and Ax­o­vant, France was se­nior di­rec­tor, clin­i­cal de­vel­op­ment for neu­ro­sciences and rare dis­eases, and he’s al­so held clin­i­cal de­vel­op­ment posts at Strong­bridge Bio­phar­ma, CSL Behring and GSK.

Craig Masse has been pro­mot­ed to SVP of dis­cov­ery re­search at Ajax Ther­a­peu­tics out of New York, co-found­ed by part­ner Schrödinger and tak­ing aim at hema­to­log­ic ma­lig­nan­cies us­ing com­pu­ta­tion­al chem­istry. Masse, who first joined Ajax in 2019, was the head of med­i­c­i­nal chem­istry dur­ing his eight-year run at Nim­bus. Fur­ther­more, Ajax has brought on Christi­na Ri­or­dan as VP of pre­clin­i­cal de­vel­op­ment. Ri­or­dan brings a wealth of ex­pe­ri­ence in tox­i­col­o­gy from Bio­gen, Epizyme, Agenus, Sur­face On­col­o­gy and un­til her move to Ajax, Cer­tara.

Rob Wood­man

→ The Ital­ian ven­ture cap­i­tal firm Panakès Part­ners has named Rob Wood­man as part­ner, lead­ing the firm’s new­ly cre­at­ed biotech in­vest­ment team. Most re­cent­ly, Wood­man served as se­nior part­ner at Take­da Ven­tures. Panakès en­tered the biotech sec­tor back in Ju­ly with its $180 mil­lion fund to sup­port “un­der­served” life sci­ences com­pa­nies in Eu­rope.

→ Right on the heels of an $11.5 bil­lion ac­qui­si­tion of Ac­celeron, Mer­ck has pro­mot­ed Thomas Glo­cer to in­de­pen­dent lead di­rec­tor. A mem­ber of Mer­ck’s board of di­rec­tors since 2007, he comes from the fi­nance world as the cur­rent lead di­rec­tor of Mor­gan Stan­ley.

Kathy Giusti

EQRx has ap­point­ed Kathy Giusti to its board of di­rec­tors. Giusti, who found­ed and serves as chief mis­sion of­fi­cer at the Mul­ti­ple Myelo­ma Re­search Foun­da­tion, al­so found­ed the Har­vard Busi­ness School Kraft Pre­ci­sion Med­i­cine Ac­cel­er­a­tor. Look­ing to shake up drug pric­ing, EQRx re­verse merged with the CM Life Sci­ences III SPAC back in Au­gust, net­ting the new biotech $1.8 bil­lion, while ap­point­ing Melanie Nal­licheri as CEO. She takes over from Alex­is Borisy, who be­comes the ex­ec­u­tive chair­man of EQRx’s board of di­rec­tors.

Otis Braw­ley

In­cyte dou­bled its fun last week with FDA ap­provals of rux­oli­tinib for atopic der­mati­tis and chron­ic graft-ver­sus-host dis­ease, and Otis Braw­ley now joins In­cyte’s board of di­rec­tors. Braw­ley, the chief med­ical and sci­en­tif­ic of­fi­cer of the Amer­i­can Can­cer So­ci­ety from 2007-18, is the Bloomberg Dis­tin­guished Pro­fes­sor of On­col­o­gy and Epi­demi­ol­o­gy at Johns Hop­kins.

→ GSK neu­ro part­ner Alec­tor has giv­en ex-No­var­tis SVP glob­al head of clin­i­cal de­vel­op­ment Eliz­a­beth Garo­fa­lo a seat on the board of di­rec­tors along­side Till­man Gern­gross and Ter­ry McGuire, among oth­ers. The prin­ci­pal for EAG Phar­ma Con­sult­ing, Garo­fa­lo is a board mem­ber at Xenon Phar­ma­ceu­ti­cals, Ex­i­cure and Aca­dia Phar­ma­ceu­ti­cals.

Ann Tay­lor

→ New­ly re­tired from As­traZeneca, Ann Tay­lor has signed on to the board of di­rec­tors at Terns Phar­ma­ceu­ti­cals, which has rea­sons for op­ti­mism with its June da­ta in a thorny NASH field. Tay­lor was head of clin­i­cal bi­o­log­ics at As­traZeneca sub Med­Im­mune be­fore be­com­ing CMO at As­traZeneca in April 2019.

An­drew Allen has joined the board of di­rec­tors at Verge Ge­nomics, Al­ice Zhang’s AI-dri­ven up­start that’s team­ing up with Eli Lil­ly in the neu­ro space, par­tic­u­lar­ly ALS. Allen, who co-found­ed and is pres­i­dent and CEO of Grit­stone Bio, is al­so on the boards of Epizyme, TCR² Ther­a­peu­tics and Sier­ra On­col­o­gy.

Ran Zheng has tak­en a seat on the board of di­rec­tors at Jen­nifer Doud­na‘s CRISPR genome edit­ing up­start Cari­bou Bio­sciences. The cur­rent CEO of Land­mark Bio is a long­time Am­gen vet who was al­so chief tech­ni­cal of­fi­cer of Or­chard Ther­a­peu­tics.

Eliz­a­beth Tal­lett

→ New York-based Phos­platin Ther­a­peu­tics has en­list­ed Eliz­a­beth Tal­lett to its board of di­rec­tors. This isn’t Tal­lett’s first board ap­point­ment. Cur­rent­ly, she has seats on the boards of Mod­er­na, An­them and Qi­a­gen. Tal­lett was the for­mer pres­i­dent and CEO of Tran­scell Tech­nolo­gies and a prin­ci­pal at Hunter Part­ners. Pri­or to those roles, Tal­lett was pres­i­dent of Cen­to­cor Phar­ma­ceu­ti­cals.

→ Ox­ford “dark anti­gen” start­up Enara Bio — in a part­ner­ship with Boehringer In­gel­heim to de­vel­op ther­a­pies that tar­get lung and GI can­cers — has added Robert Ang to the board of di­rec­tors. Since 2019, Ang has been pres­i­dent and CEO of Vor Bio­phar­ma.

MA­IA Biotech­nol­o­gy has ap­point­ed Steven Chaou­ki to its board of di­rec­tors. Chaou­ki cur­rent­ly served as pres­i­dent, US mar­kets & con­sumer in­ter­ac­tive of Tran­sUnion and pre­vi­ous­ly served as EVP, fi­nan­cial ser­vices for the com­pa­ny.

Derek Graf and Paul Schloess­er con­tributed to this edi­tion.

A cor­rec­tion has been made to the spelling of Dew­point CSO Isaac Klein’s name. 

Biotech Half­time Re­port: Af­ter a bumpy year, is biotech ready to re­bound?

The biotech sector has come down firmly from the highs of February as negative sentiment takes hold. The sector had a major boost of optimism from the success of the COVID-19 vaccines, making investors keenly aware of the potential of biopharma R&D engines. But from early this year, clinical trial, regulatory and access setbacks have reminded investors of the sector’s inherent risks.

RBC Capital Markets recently surveyed investors to take the temperature of the market, a mix of specialists/generalists and long-only/ long-short investment strategies. Heading into the second half of the year, investors mostly see the sector as undervalued (49%), a large change from the first half of the year when only 20% rated it as undervalued. Around 41% of investors now believe that biotech will underperform the S&P500 in the second half of 2021. Despite that view, 54% plan to maintain their position in the market and 41% still plan to increase their holdings.

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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How to col­lect and sub­mit RWD to win ap­proval for a new drug in­di­ca­tion: FDA spells it out in a long-await­ed guid­ance

Real-world data are messy. There can be differences in the standards used to collect different types of data, differences in terminologies and curation strategies, and even in the way data are exchanged.

While acknowledging this somewhat controlled chaos, the FDA is now explaining how biopharma companies can submit study data derived from real-world data (RWD) sources in applicable regulatory submissions, including new drug indications.

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David Livingston (Credit: Michael Sazel for CeMM)

Renowned Dana-Far­ber sci­en­tist, men­tor and bio­phar­ma ad­vi­sor David Liv­ingston has died

David Livingston, the Dana-Farber/Harvard Med scientist who helped shine a light on some of the key molecular drivers of breast and ovarian cancer, died unexpectedly last Sunday.

One of the senior leaders at Dana-Farber during his nearly half century of work there, Livingston was credited with shedding light on the genes that regulate cell growth, with insights into inherited BRCA1 and BRCA2 mutations that helped lay the scientific foundation for targeted therapies and earlier detection that have transformed the field.

No­vo CEO Lars Fruer­gaard Jør­gensen on R&D risk, the deal strat­e­gy and tar­gets for gen­der di­ver­si­ty

 

I kicked off our European R&D summit last week with a conversation involving Novo Nordisk CEO Lars Fruergaard Jørgensen. Novo is aiming to launch a new era of obesity management with a new approval for semaglutide. And Jørgensen had a lot to say about what comes next in R&D, how they manage risk and gender diversity targets at the trendsetting European pharma giant.

John Carroll: I’m here with Lars Jørgensen, the CEO of Novo Nordisk. Lars, it’s been a really interesting year so far with Novo Nordisk, right? You’ve projected a new era of growing sales. You’ve been able to expand on the GLP-1 franchise that was already well established in diabetes now going into obesity. And I think a tremendous number of people are really interested in how that’s working out. You have forecast a growing amount of sales. We don’t know specifically how that might play out. I know a lot of the analysts have different ideas, how those numbers might play out, but that we are in fact embarking on a new era for Novo Nordisk in terms of what the company’s capable of doing and what it’s able to do and what it wants to do. And I wanted to start off by asking you about obesity in particular. Semaglutide has been approved in the United States for obesity. It’s an area of R&D that’s been very troubled for decades. There have been weight loss drugs that have come along. They’ve attracted a lot of attention, but they haven’t actually ever gained traction in the market. My first question is what’s different this time about obesity? What is different about this drug and why do you expect it to work now whereas previous drugs haven’t?

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Marty Duvall, Oncopeptides CEO

On­copep­tides stock craters as it pulls can­cer drug Pepax­to from the mar­ket

Shares of Oncopeptides crashed more than 70% in early Friday trading after the company said it’s pulling its multiple myeloma drug Pepaxto (melphalan flufenamide) from the US market after failing a confirmatory trial. The move will force the company to close its US and EU business units and enact significant layoffs.

The FDA had scheduled an adcomm meeting next Thursday to discuss Pepaxto, which first won accelerated approval in February and costs about $19,000 per course of treatment. The committee was to weigh in on whether the confirmatory trial demonstrated a worse overall survival in the treatment arm compared to the control arm.

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Pfiz­er pitch­es its Covid-19 vac­cine for younger chil­dren ahead of ad­comm next week

Pfizer will present its case to the FDA’s vaccine adcomm next week, seeking authorization for a lower-dose version of its Covid-19 vaccine for kids ages 5 through 12, which the Biden administration said will likely begin rolling out early next month.

Two primary doses of the 10 µg vaccine (the dose for those ages 12 and up is 30 μg) given 3 weeks apart in this group of children “have shown a favorable safety and tolerability profile, robust immune responses against all variants of concern including Delta, and vaccine efficacy of 90.7% against laboratory-confirmed symptomatic COVID-19,” the company said in briefing documents ahead of next Tuesday’s meeting of the FDA’s Vaccines and Related Biological Products Advisory Committee.