Cy­toIm­mune CEO breaks down her 3 'pil­lars' of suc­cess; For­mer No­var­tis, Gilead ex­ec Alessan­dro Ri­va to lead an ul­tra low-pro­file cell ther­a­py out­fit

Christi­na Cough­lin

Christi­na Cough­lin loves cell ther­a­py — pret­ty much defin­ing her ca­reer since her post­doc days with Carl June in Penn­syl­va­nia.

Now as the new head hon­cho at Cy­toIm­mune as of Wednes­day, the first-time CEO gets to work with a new type of cell ther­a­py — CAR-NK cells, li­censed from long-time NK cell re­searcher Michael Caligiuri and Jian­hua Yu at the City of Hope Na­tion­al Med­ical Cen­ter.

And Yu is the sole mem­ber of Cy­toIm­mune’s sci­en­tif­ic ad­vi­so­ry board.

Cough­lin got in­to the bio­phar­ma space af­ter get­ting her dou­ble bach­e­lor’s at Tem­ple Uni­ver­si­ty in math­e­mat­ics and bi­ol­o­gy, and then she went to the Uni­ver­si­ty of Penn­syl­va­nia for med school, where she got her PhD and MD.

Af­ter Penn, she worked her way up in var­i­ous no­table bio­phar­mas such as Pfiz­er and No­var­tis, and then piv­ot­ing to work­ing with cells as CMO at Im­muno­core, Tmu­ni­ty, and red blood cell-fo­cused Ru­bius be­fore join­ing Cy­toIm­mune.

So, why ex­act­ly did she leave Ru­bius? For Cough­lin, it was three rea­sons: dis­rup­tive sci­ence with Caligiuri and Yu’s work, con­trol over in-house man­u­fac­tur­ing, and in her view, the com­pa­ny has po­ten­tial for both short-term and long-term suc­cess.

All that said, Cough­lin has goals to achieve — three “pil­lars,” as she called it — in her first 100 days as CEO. And at a biotech with less than 35 em­ploy­ees, it is go­ing to be all hands on deck, come 2022.

“The first is fundrais­ing. I’m one of those C-suites that ac­tu­al­ly like it. I en­joy fundrais­ing — you know, you can get a lot of great ideas from in­vestors,” Cough­lin said.

And to that end, Cy­toIm­mune ex­ecs filed a plan with the SEC to raise ap­prox­i­mate­ly $100 mil­lion in eq­ui­ty back in Au­gust. At the time they filed, Cy­toIm­mune had raised more than $36 mil­lion as part of that fi­nanc­ing, leav­ing just un­der $64 mil­lion to be raised from in­vestors as of three months ago. Cough­lin did con­firm that the round is still open, but she em­pha­sized that there “are some im­por­tant con­ver­sa­tions com­ing up” and they’re look­ing for­ward to clos­ing the round — with no date giv­en yet.

“The sec­ond pil­lar is peo­ple and re­al­ly build­ing. There’s a cou­ple of re­al­ly key roles that we’re go­ing to need to build. We have to build a clin­i­cal or­ga­ni­za­tion,” Cough­lin said.

It is her fourth time do­ing so, she told End­points News — the last three times were as CMO at pre­vi­ous biotechs, and this is her first as CEO.

And the last pil­lar? Ex­e­cu­tion. And this is where Cy­toIm­mune will start to get busy — Cough­lin said that INDs will be filed in 2022 and 2023, and next year, the biotech plans to treat their first pa­tients in clin­i­cal tri­als.

But there’s al­ways the ques­tion: What about fu­ture part­ner­ships? And while there are some con­tacts that Cough­lin has, she told End­points that there are on­go­ing con­ver­sa­tions with po­ten­tial part­ners, but noth­ing has been set in stone.

Paul Schloess­er

Alessan­dro Ri­va

Alessan­dro Ri­va’s lat­est turn as a CEO is with In­ti­ma Bio­science, a lit­tle-known biotech based in New York and the UK that of­fers even less on its bare-bones web­site. But we do know it’s a cell ther­a­py com­pa­ny that fo­cus­es on the im­mune check­point CISH, and Ri­va sure knows his way around the cell ther­a­py space. As glob­al head of on­col­o­gy ther­a­peu­tics and cell & gene ther­a­py at Gilead, Ri­va was in the thick of the Kite buy­out, which fea­tured Yescar­ta as the main prize. Be­fore that, he de­vot­ed 12 years to No­var­tis and was the Swiss phar­ma’s glob­al head of on­col­o­gy de­vel­op­ment and med­ical af­fairs. Ri­va re­cent­ly end­ed his two-year run as the CEO of Ich­nos Sci­ences, where ex-Al­lo­gene VP of clin­i­cal de­vel­op­ment Cyril Kon­to has now tak­en com­mand. (More about them lat­er.)

Josep Bas­saganya-Ri­era

Josep Bas­saganya-Ri­era, who steered Lan­dos Bio­phar­ma to an IPO as 2021 dawned and then to an IBD part­ner­ship with Per­cep­tive’s Lian­Bio, has re­signed as chair­man, pres­i­dent and CEO. The change takes ef­fect im­me­di­ate­ly as Chris Garabe­di­an takes over as chair­man and ex-Es­pe­ri­on CEO Tim Mayleben — a board mem­ber at Lan­dos for six months — gets an­oth­er shot as a chief ex­ec­u­tive, al­beit on an in­ter­im ba­sis. Mayleben de­cid­ed to walk away from Es­pe­ri­on in May, open­ing the door for Shel­don Koenig to lead a staff that’s been sliced dra­mat­i­cal­ly for bud­getary rea­sons. The first biotech to emerge from Garabe­di­an’s Xon­toge­ny port­fo­lio, Lan­dos tar­gets au­toim­mune dis­eases with its AI-based LANCE plat­form.

Hugh O’Dowd will em­bark on his next chap­ter as a chief ex­ec­u­tive at the Bo­ca Ra­ton women’s health drug­mak­er Ther­a­peu­tic­sMD, re­plac­ing co-founder Robert Finizio “ef­fec­tive on or be­fore” Dec. 31. Finizio will main­tain a pres­ence at Ther­a­peu­tic­sMD as vice chair­man of the board. O’Dowd, a long­time No­var­tis ex­ec who chairs the board of ONK Ther­a­peu­tics, was pres­i­dent and CEO of Third Rock’s Neon Ther­a­peu­tics from 2016 un­til a lit­tle com­pa­ny called BioN­Tech snapped it up for a dis­count price in 2020, be­fore Covid-19 made BioN­Tech a house­hold name. Neon’s can­cer vac­cine da­ta nev­er im­pressed and the biotech was run­ning low on cash, trig­ger­ing lay­offs and caus­ing the stock to plum­met as much as 85 per­cent since it de­buted on Nas­daq.

Stephen Kanes

→ The fifth sub from Joe Jimenez and Mark Fish­man’s Adi­tum Bio port­fo­lio, An­co­ra Bio — which launched in June — has tapped Stephen Kanes as CEO, look­ing to push its se­lec­tive va­so­pressin 1b re­cep­tor (V1b) an­tag­o­nist ANC-501 for treat­ment-re­sis­tant de­pres­sion in­to the clin­ic by 2022. Kanes walks away from Sage af­ter an eight-year as­so­ci­a­tion in which he led clin­i­cal de­vel­op­ment on a pipeline that in­cludes de­pres­sion drugs Zul­res­so and zu­ra­nolone, and he’s an As­traZeneca vet in the ar­eas of in­flam­ma­tion, neu­ro­science and res­pi­ra­to­ry. Adi­tum Bio raised $133 mil­lion in No­vem­ber 2020 af­ter Jimenez and Fish­man co-found­ed the VC in 2019.

Christoph Koe­nen

Bay­er has plucked Christoph Koe­nen from Ot­su­ka, ap­point­ing him as the new glob­al head of clin­i­cal de­vel­op­ment and op­er­a­tions with­in R&D at its phar­ma­ceu­ti­cals di­vi­sion. Koe­nen, who was CMO at Ot­su­ka, has held clin­i­cal de­vel­op­ment gigs at Bris­tol My­ers Squibb (where he was head of car­dio­vas­cu­lar de­vel­op­ment), Glax­o­SmithK­line and No­vo Nordisk. Last week, Leaps by Bay­er an­nounced its back­ing of the George Church spin­out GRO Bio­sciences, spe­cial­iz­ing in lab-in­vent­ed amino acids.

Steven Men­to

Richard Pas­coe is out as pres­i­dent and CEO of San Diego re­gen­er­a­tive med­i­cine de­vel­op­er His­to­gen for the ever-pop­u­lar pur­suit of “dif­fer­ent op­por­tu­ni­ties,” while cur­rent board mem­ber Steven Men­to has been named in­ter­im pres­i­dent and CEO as well as ex­ec­u­tive chair­man. Men­to, the pres­i­dent and chief ex­ec­u­tive at Cona­tus un­til its merg­er with His­to­gen, al­so helmed Idun Phar­ma­ceu­ti­cals from 1997 un­til its sale to Pfiz­er in 2005. Pas­coe was chief ex­ec­u­tive at So­max­on Phar­ma­ceu­ti­cals and Apri­cus Bio­sciences be­fore join­ing His­to­gen in ear­ly 2019.

Mark Twyman

In­ovio was re­al­ly good at jump­ing ahead in the Covid-19 vac­cine race ear­ly on, but a spat with its con­tract man­u­fac­tur­er put the biotech be­hind the 8 ball while its com­pe­ti­tion roared by with their own vac­cines. This week, though, the FDA was more kind to In­ovio and al­lowed Phase III for INO-4800 to pro­ceed, and four mem­bers of the team are ready “to po­si­tion In­ovio for growth and up­com­ing com­mer­cial op­er­a­tions,” as the press re­lease states.

Mark Twyman has been pro­mot­ed to chief com­mer­cial of­fi­cer af­ter four years in var­i­ous com­mer­cial re­spon­si­bil­i­ties. Twyman, who was with Mer­ck from 1988-2006, has al­so been an ex­ec with Med­Im­mune, Sanofi Gen­zyme and No­vavax. Else­where, Rob Crot­ty (gen­er­al coun­sel) comes to In­ovio af­ter serv­ing in the same ca­pac­i­ty at Nabri­va Ther­a­peu­tics; Asli Gevgilili (chief hu­man re­sources of­fi­cer) is a Mer­ck alum who just fin­ished up nine years at Al­ler­gan, where she served as VP, hu­man re­sources since 2014; and Gene Kim (chief cor­po­rate af­fairs of­fi­cer) takes on this new­ly cre­at­ed role af­ter a year as pres­i­dent of In­ovio Asia.

John Maraganore

Sali­o­Gen is swing­ing for the fences by form­ing an ex­ec­u­tive ad­vi­so­ry board with some se­ri­ous grav­i­tas. Out­go­ing Al­ny­lam CEO John Maraganore, Bridge­Bio co-founder An­drew Lo from MIT and for­mer FDA com­mis­sion­er Mark Mc­Clel­lan make up the for­mi­da­ble trio, and our John Car­roll has CEO Ray Tabib­i­azar’s thoughts on the big-time moves.

Pamela Foulds

→ While tout­ing Phase I/II re­sults with its Fab­ry dis­ease drug FLT190 this week, Free­line Ther­a­peu­tics — un­der the new lead­er­ship of Michael Pari­nihas ap­point­ed Pamela Foulds as CMO. The one-time med­ical chief at Aege­ri­on Phar­ma­ceu­ti­cals, Foulds is a Gen­zyme vet whose eight years at Bio­gen (2006-14) cen­tered on he­mo­phil­ia and neu­rol­o­gy. She suc­ceeds Julie Krop, who an­nounced her de­par­ture in Ju­ly and then took the CMO job at PureTech the fol­low­ing month.

And what about Free­line’s in­ter­im CMO? Al­i­son Long has moved on to han­dle CMO du­ties at Kalei­do Bio­sciences, Flag­ship’s mi­cro­bio­me biotech that drew the ire of the FDA in Sep­tem­ber for “fail­ure to sub­mit INDs for the con­duct of clin­i­cal in­ves­ti­ga­tions with an in­ves­ti­ga­tion­al new drug.” Long led clin­i­cal de­vel­op­ment for Free­line at the time she took over as in­ter­im CMO, and she’s al­so been a clin­i­cal de­vel­op­ment ex­ec with Spark and uniQure.

David Huss

→ Seat­tle RNA edit­ing out­fit Shape Ther­a­peu­tics raised a Se­ries B in Ju­ly that to­taled $112 mil­lion, then struck a neu­ro deal with Roche in Au­gust that has the po­ten­tial to be worth in the neigh­bor­hood of $3 bil­lion. CEO Fran­cois Vi­gneault has now found a new chief sci­en­tist in-house to work along­side him at the gene ther­a­py biotech. David Huss, Shape’s head of re­search who’s been with the com­pa­ny since 2018, earns the pro­mo­tion to CSO while fel­low Juno Ther­a­peu­tics alum Lisa Tay­lor Ash gets el­e­vat­ed to gen­er­al coun­sel. While with Juno, Huss ran a T cell en­gi­neer­ing team and Ash was VP, head of health­care law and com­pli­ance be­fore she was named Shape’s head of le­gal in 2019.

Robert Hoff­man

Sai­id Zarra­bi­an has stepped aside as pres­i­dent and CEO of San Diego can­cer play­er Kin­tara Ther­a­peu­tics to be­come head of strate­gic part­ner­ships, hand­ing the reins to chair­man Robert Hoff­man. The ex-CFO of Are­na, Anap­tys­Bio and Heron Ther­a­peu­tics, Hoff­man al­so sits on the boards of such com­pa­nies as Aslan Phar­ma­ceu­ti­cals and San­iona, and he won’t re­lin­quish his po­si­tion as chair­man — which he’s held since June 2018. Kin­tara showed op­ti­mism with da­ta from a Phase II tri­al of its glioblas­toma drug VAL-083, but the stock re­mains mired in pen­ny-stock ter­ri­to­ry since a pre­cip­i­tous drop sev­er­al years ago.

Prog­en­i­ty, the com­pa­ny fo­cused on women’s health, gas­troin­testi­nal health and oral bio­ther­a­peu­tics, has reeled in Adi Mo­han­ty as CEO. Pri­or to hop­ping aboard San Diego-based Prog­en­i­ty, Mo­han­ty was CEO of Bi­o­Time and VP at Tran­skary­ot­ic Ther­a­pies (ac­quired by Shire). Mo­han­ty spent a decade at Shire, which cul­mi­nat­ed in his role as pres­i­dent, re­gen­er­a­tive med­i­cine. Ear­li­er in his ca­reer, Mo­han­ty was with Bax­ter Health­care and served as a board mem­ber for On­co­Cyte.

Yong Chang

→ Fel­low­ship of the Ring: Flag­ship’s gene ther­a­py play Ring Ther­a­peu­tics, which fo­cus­es on anellovirus­es and raised $117 mil­lion in a Se­ries B round this sum­mer, has lined up a trio of new ex­ecs, with CSO Yong Chang lead­ing off. Chang over­saw de­vel­op­ment at Ko­r­ro Bio and was al­so VP of R&D at In­tel­lia af­ter stints at Aileron Ther­a­peu­tics and Med­Im­mune. John Huynh, who joins Ring as SVP of tech­ni­cal op­er­a­tions, is an ex-sci­en­tist at WuXi AppTec who was pre­vi­ous­ly VP of gene ther­a­py tech­ni­cal op­er­a­tions for PTC Ther­a­peu­tics. Fi­nal­ly, chief reg­u­la­to­ry of­fi­cer Kevin John­son has been in­volved in reg­u­la­to­ry af­fairs with com­pa­nies large and small, in­clud­ing GSK, Vtesse/Su­cam­po, Imara and, just be­fore seiz­ing this lat­est op­por­tu­ni­ty, In­ozyme.

Ruhi Khan

Jen­nifer Doud­na’s CRISPR up­start Cari­bou Bio­sciences has en­joyed an event­ful 2021 — part­ner­ing with Ab­b­Vie in Feb­ru­ary for a pair of off-the-shelf CAR-Ts and fol­low­ing up its $115 mil­lion Se­ries C with a smooth $304 mil­lion IPO in Ju­ly. With its chRD­NA tech­nol­o­gy (pro­nounced “chardon­nay”), Cari­bou has popped the cork for its new CBO, Ruhi Khan, who has pre­vi­ous­ly held busi­ness de­vel­op­ment posts at Acor­da Phar­ma­ceu­ti­cals and Lex­i­con Phar­ma­ceu­ti­cals. Mean­while, ex-Pfiz­er chief patent of­fi­cer Dara Richard­son-Heron has been added to Cari­bou’s board of di­rec­tors, and Cari­bou CEO Rachel Hau­r­witz grabbed a board seat of her own at pro­teomics play­er Seer.

De­bra Sil­berg

Zain Kas­sam has de­cid­ed to walk away as CMO at mi­cro­bio­me play­er Finch Ther­a­peu­tics “in or­der to re­turn to Cana­da to at­tend to a fam­i­ly health mat­ter,” ac­cord­ing to a re­lease. The Finch co-founder will be re­placed in the in­ter­im by De­bra Sil­berg, the for­mer glob­al lead in gas­troen­terol­o­gy at Shire who then be­came Take­da’s glob­al VP, head of clin­i­cal sci­ence and de­vel­op­ment for GI dis­eases. A search for a per­ma­nent CMO is on­go­ing at Finch, which re­leased pos­i­tive Phase II da­ta on Tues­day for its drug CP101 in C. dif­fi­cile.

→ The same day Calithera Bio­sciences tossed its KEAP­SAKE tri­al for its NSCLC drug tela­gle­na­s­tat in­to the scrapheap last week, the South San Fran­cis­co biotech pro­mot­ed Emil Kuri­akose to CMO. Kuri­akose moved to Calithera from the No­var­tis In­sti­tutes for Bio­Med­ical Re­search in 2017 and had been head of clin­i­cal de­vel­op­ment since Feb­ru­ary 2020. He suc­ceeds Kei­th Or­ford, who will take Jean George’s seat on the board of di­rec­tors. Calithera now turns its at­ten­tion to sapanis­ert­ib and mi­vavo­tinib, two can­cer drugs that once be­longed to Take­da.

Kameel Farag

→ Co-found­ed by Jeanne Lor­ing and led by first-year CEO Damien McDe­vitt from Akcea, San Diego-based Parkin­son’s start­up As­pen Neu­ro­science has brought on Kameel Farag as CFO. Farag closed out his 16 years at Am­gen as a re­gion­al CFO, leav­ing the drug gi­ant in 2018 to take the SVP, fi­nance job at Io­n­is. Or­biMed took top billing for As­pen’s $70 mil­lion Se­ries A in April 2020, with ARCH Ven­ture Part­ners al­so con­tribut­ing.

→ Van­cou­ver-based Zymeworks has for­mal­ly ap­point­ed Neil Joseph­son as CMO. Joseph­son had been serv­ing as the com­pa­ny’s in­ter­im CMO since May, and his tran­si­tion to per­ma­nent CMO will take place on Mon­day. Joseph­son joined Zymeworks in 2019 as VP, clin­i­cal re­search and was lat­er pro­mot­ed to SVP.

An­tho­ny Kim

→ A re­fash­ion­ing of the com­mer­cial team kicks in­to gear at Re­lief Ther­a­peu­tics with the de­par­ture of CCO Chris Sti­j­nen, ef­fec­tive Nov. 30. Re­lief Eu­rope pres­i­dent Pao­lo Galfet­ti, along with staffers at Re­lief sub APR Ap­plied Phar­ma Re­search, will take care of EU and UK com­mer­cial op­er­a­tions, and An­tho­ny Kim will step in Dec. 1 as SVP and head of US com­mer­cial op­er­a­tions. Fin­ish­ing out his three-year tenure as VP of glob­al com­mer­cial de­vel­op­ment at Novo­cure, Kim is a Genen­tech and Alex­ion vet who al­so had a quick stop as ex­ec­u­tive di­rec­tor of mar­ket­ing at Igny­ta, which Roche ac­quired in a $1.7 bil­lion buy­out.

Don Mar­vin

→ Like any head coach in any sport, you go with who you trust to fill out your staff (think Tex Win­ter with Phil Jack­son on those great Bulls and Lak­ers teams). We ob­vi­ous­ly see this dy­nam­ic play out in biotech all the time, and this week Don Mar­vin is back with Dale Pfost as Chemomab’s CFO, EVP and COO. In March 2020, Mar­vin took the CFO job at Lo­do Ther­a­peu­tics while Pfost was CEO there, but Lo­do was then pur­chased by Zymer­gen be­fore that big­ger com­pa­ny suf­fered its ig­no­min­ious face­plant in Au­gust. Pfost took con­trol at Chemomab in Sep­tem­ber, and it didn’t take long for Mar­vin to join him.

Charles Tri­ano has been ap­point­ed CFO at Diem Nguyenled Xalud Ther­a­peu­tics. The gene ther­a­py biotech lured Tri­ano over from Pfiz­er, where he served as SVP of in­vestor re­la­tions since 2008. Be­fore join­ing Pfiz­er, Tri­ano was VP of in­vestor re­la­tions at For­est Lab­o­ra­to­ries.

Nordic Nanovec­tor has ap­point­ed Pierre Do­di­on as CMO. Do­di­on has made the rounds at such Big Phar­mas as Pfiz­er, No­var­tis and Roche, and he has al­so served as med­ical chief at Ari­ad Phar­ma­ceu­ti­cals and In­nate Phar­ma­ceu­ti­cals. Back in Sep­tem­ber, Erik Skullerud joined the Oslo-based biotech as CEO.

Samik Ba­su

→ Penn spin­out Ca­balet­ta Bio, a biotech zoom­ing in on chimeric au­toan­ti­body re­cep­tors (CAAR-Ts, or dou­ble-A CAR-Ts), has pro­mot­ed Samik Ba­su to CSO and Heather Harte-Hall to chief com­pli­ance of­fi­cer. Ba­su, a for­mer Adap­ti­m­mune staffer, will cel­e­brate two years with Ca­balet­ta in De­cem­ber and had spent the past year as VP of pre­clin­i­cal re­search and trans­la­tion­al med­i­cine. Harte-Hall, who worked with Ba­su at Adap­ti­m­mune, had been VP of qual­i­ty and com­pli­ance since her ar­rival at Ca­balet­ta in March 2019.

Er­ic Feld­man has tak­en over as CMO at Ich­nos Sci­ences, where he will al­so co-chair the R&D lead­er­ship team. Feld­man pre­vi­ous­ly served as SVP, CMO at Gly­coMimet­ics; he boasts an im­pres­sive aca­d­e­m­ic ca­reer, in­clud­ing a stint as pro­fes­sor of med­i­cine and di­rec­tor of the hema­to­log­i­cal ma­lig­nan­cies ser­vice at Weill-Cor­nell/New York Pres­by­ter­ian Hos­pi­tal. One oth­er de­vel­op­ment: Ich­nos has al­so ap­point­ed for­mer Kymab CMO So­nia Quarati­no to its board of di­rec­tors.

Tanya Bor­suk

→ Backed by GSK and part­ner­ing with Eli Lil­ly on au­toim­mune dis­eases, Sit­ryx has en­list­ed Tanya Bor­suk as CBO. Bor­suk worked in busi­ness de­vel­op­ment with Cel­gene and lat­er Bris­tol My­ers, and she makes the tran­si­tion to Sit­ryx from a brief stay at Flag­ship Pi­o­neer­ing, where she was VP, port­fo­lio strat­e­gy and BD al­liances. Pri­or to Cel­gene, Bor­suk was a se­nior man­ag­er with­in the glob­al on­col­o­gy busi­ness unit at Ei­sai.

Miguel San­juan

Proven­tion Bio an­nounced its CFO tran­si­tion on Nov. 4, and a day lat­er the au­toim­mune dis­ease play­er se­lect­ed Miguel San­juan as SVP of re­search and ear­ly de­vel­op­ment. San­juan brings abun­dant Big Phar­ma ex­pe­ri­ence from J&J and As­traZeneca, and he al­so led im­muno-on­col­o­gy small mol­e­cule dis­cov­ery bi­ol­o­gy at Bris­tol My­ers be­fore jump­ing to Gos­samer Bio in 2020 as VP, head of trans­la­tion­al bi­ol­o­gy. As Peer Re­view men­tioned last week, Thier­ry Chauche will suc­ceed the re­tir­ing An­drew Drech­sler as Proven­tion Bio’s fi­nance chief on Dec. 1.

Ac­tym Ther­a­peu­tics, the mi­cro­bial-based im­muno-on­col­o­gy biotech us­ing its STACT (Sal­mo­nel­la Ty­phimuri­um-At­ten­u­at­ed Can­cer Ther­a­py) plat­form, has named Chan Whit­ing as chief de­vel­op­ment of­fi­cer. Whit­ing pre­vi­ous­ly led R&D at Tem­pest Ther­a­peu­tics be­fore set­ting off for Berke­ley-based Ac­tym, which pulled to­geth­er its Se­ries A fund­ing with the help of Boehringer In­gel­heim Ven­ture Fund in April 2020.

Everett Cun­ning­ham

→ Can­cer di­ag­nos­tic de­vel­op­er Ex­act Sci­ences has found a CCO in for­mer Pfiz­er ex­ec Everett Cun­ning­ham. Cun­ning­ham makes the leap over to Ex­act from GE Health­care, where he served as CEO and pres­i­dent of the com­pa­ny’s US and Cana­da re­gion. Pri­or to his stint at GE, Cun­ning­ham was SVP, com­mer­cial at Quest Di­ag­nos­tics. Dur­ing his time at Pfiz­er, Cun­ning­ham served in a va­ri­ety of roles in­clud­ing, re­gion­al pres­i­dent, es­tab­lished prod­ucts for Asia Pa­cif­ic; VP sales for US phar­ma­ceu­ti­cals; and VP of glob­al cor­po­rate hu­man re­sources.

Ap­plied Ge­net­ic Tech­nolo­gies Cor­po­ra­tion (AGTC) has wel­comed Hope D’Oy­ley-Gay as gen­er­al coun­sel. D’Oy­ley-Gay comes aboard from Spirovant, where she served as gen­er­al coun­sel and VP of ad­min­is­tra­tion. Pri­or to that role, D’Oy­ley-Gay had stints at Reed Smith and GSK.

Al­go­Ther­a­peu­tix — the Paris-based com­pa­ny work­ing on de­vel­op­ing a non-opi­oid top­i­cal treat­ment for pe­riph­er­al neu­ro­path­ic pain — has named Jens Ell­rich as CMO. This isn’t Ell­rich’s first run as CMO of a com­pa­ny — hav­ing served in the same role at Cer­bomed, EBS Tech­nolo­gies, Pre­ci­sis, Sapi­ens and WISE.

Jes­si­ca Tr­uscel­lo

→ Three new staffers have poured in­to La­va Ther­a­peu­tics, the Dutch-Amer­i­can gam­ma delta T cell biotech that crossed the $100 mil­lion mark for its March IPO. Jes­si­ca Tr­uscel­lo (VP of clin­i­cal op­er­a­tions) was Bahi­ja Jal­lal’s head of clin­i­cal op­er­a­tions dur­ing her six-year tenure at Im­muno­core, and she al­so car­ries clin­i­cal op­er­a­tions ex­pe­ri­ence with her from Pfiz­er. Sumeet Am­barkhane (ex­ec­u­tive med­ical di­rec­tor) is a UCB alum who spent near­ly sev­en years at Mor­phoSys, where he rose through the ranks to be­come se­nior glob­al pro­gram med­ical di­rec­tor. Fi­nal­ly, Wouter van Hun­nik (VP of hu­man re­sources) gets a fresh start here af­ter 11 years in HR with Philips.

Toni Brans­ford

→ Boston-based Imara has named Toni Brans­ford to take charge of clin­i­cal de­vel­op­ment for tovi­non­trine, a drug for sick­le cell dis­ease and be­ta tha­lassemia that’s al­so be­ing stud­ied for heart fail­ure with pre­served ejec­tion frac­tion (HF­pEF). A for­mer glob­al clin­i­cal lead for the HF­pEF pro­gram at No­var­tis, Brans­ford leaves her se­nior med­ical di­rec­tor post at Kalei­do Bio­sciences, and ear­ly on in her ca­reer she held sev­er­al roles at Scher­ing-Plough.

Jaya Goy­al

Pep­Gen just keeps adding more pep to the team, pluck­ing Jaya Goy­al from Wave Life Sci­ences and ap­point­ing her EVP of re­search and pre­clin­i­cal de­vel­op­ment. Goy­al, a 16-year Bio­gen vet, first joined Wave Life Sci­ences in 2017 and be­came the Take­da part­ner’s SVP, pre­clin­i­cal and clin­i­cal de­vel­op­ment sci­ences a year ago. Since James McArthur took the helm in Feb­ru­ary, Pep­Gen’s team has grown at a brisk pace with the re­cent ap­point­ment of CFO Noel Don­nel­ly and sev­er­al oth­er ex­ecs.

→ San Diego pre­ci­sion on­col­o­gy play­er Turn­ing Point Ther­a­peu­tics has re­cruit­ed Adam Levy as SVP of in­vestor re­la­tions. That’s a wrap for Levy at Zio­pharm On­col­o­gy, where he was EVP of cor­po­rate de­vel­op­ment and in­vestor re­la­tions. He’s al­so made stops at Alex­ion, Bris­tol My­ers and No­var­tis and was Gilead’s ex­ec­u­tive di­rec­tor of in­vestor re­la­tions and head of cor­po­rate strat­e­gy. In oth­er Turn­ing Point news, se­nior di­rec­tor of cor­po­rate and busi­ness de­vel­op­ment Scott Lip­man is now the com­pa­ny’s first chief of staff.

Mark Boys

→ Af­ter nam­ing Jen­nifer Di­a­mond CMO a few weeks back, Boul­der, CO-based OnKure Ther­a­peu­tics has carved out space for Mark Boys as VP of dis­cov­ery chem­istry. Boys steps away from his sec­ond stint with Pfiz­er af­ter two years in med­i­c­i­nal chem­istry with the phar­ma gi­ant, and he al­so has 12 years un­der his belt from Ar­ray Bio­Phar­ma, co-found­ed by OnKure CEO Tony Pis­co­pio.

Jayson Pun­wani has signed on as a part­ner with Kurt von Em­ster’s San Fran­cis­co team at Abing­worth, whose lat­est fund — Abing­worth Bioven­tures 8 — clocked in at $465 mil­lion in Feb­ru­ary. Pun­wani is an ex-part­ner at Take­da Ven­tures who co-found­ed Co­ho Ther­a­peu­tics with Fred Hutch’s Bruce Clur­man.

Alex Gorsky

→ Out­go­ing J&J CEO Alex Gorsky has joined the board of di­rec­tors of Ap­ple, chaired by ex-Genen­tech CEO and cur­rent Cal­i­co chief Art Levin­son. In Au­gust, Gorsky an­nounced he would leave the phar­ma gi­ant af­ter nine years at the top, paving the way for Joaquin Du­a­to to re­place him on Jan. 3. Ap­ple’s board al­so in­cludes for­mer Vice Pres­i­dent Al Gore and Black­Rock co-founder Sue Wag­n­er.

Rafaèle Tord­j­man

Rafaèle Tord­j­man has been named chair of Alen­tis Ther­a­peu­tics, a Swiss fi­brot­ic dis­ease biotech fi­nanced by her VC, Jeito Cap­i­tal. Alen­tis has al­so made room for Vec­tivBio CEO Lu­ca Santarel­li on the board.

→ With new CEO Michael Amoroso in place, Pre­ci­sion Bio­Sciences has elect­ed Sam Wadsworth and Shari Lisa Piré to the board of di­rec­tors. Wadsworth, a Sanofi Gen­zyme vet, is CSO at Ul­tragenyx Gene Ther­a­py, and Piré — the for­mer chief le­gal of­fi­cer for CD­MO Cog­nate BioSer­vices — is chief le­gal & sus­tain­abil­i­ty of­fi­cer with Plume De­sign.

Ilise Lom­bar­do

→ Ex-Sage CEO Jeff Jonas as­sumed the role of chair­man a month ago at Swiss neu­ro biotech Noe­ma Phar­ma, and the board is ex­pand­ing with the ad­di­tions of Cather­ine Moukheibir and Ilise Lom­bar­do. This is an­oth­er in a long line of board ap­point­ments for Moukheibir, which in­cludes seats at DNA Script, Iron­wood Phar­ma­ceu­ti­cals and Or­p­hazyme. Mean­while, Lom­bar­do is the new CMO at Shankar Ra­maswamy’s Kriya Ther­a­peu­tics.

My­ovant’s board of di­rec­tors has a new ad­di­tion with Nan­cy Va­lente. Be­gin­ning her as­so­ci­a­tion with Genen­tech in 2003, Va­lente re­cent­ly served as Roche’s SVP in glob­al prod­uct de­vel­op­ment, on­col­o­gy, hema­tol­ogy de­vel­op­ment ther­a­peu­tic area.

Roshawn Blunt

Nor­bert Bischof­berg­er’s Kro­nos Bio has named J&J and Am­gen alum Roshawn Blunt to the board of di­rec­tors. Blunt, the man­ag­ing di­rec­tor of 1798 Con­sul­tants, joins an il­lus­tri­ous group on the board that in­cludes Bischof­berg­er, chair­man Arie Bellde­grun, Bay­er’s Mar­i­anne De Backer and Otel­lo Stam­pac­chia.

Mark San­tos

→ New York can­cer biotech Be­yond­Spring has a new plinab­u­lin part­ner in Jiang­su Hen­grui af­ter pos­i­tive da­ta for the drug stopped in­vestors and an­a­lysts in their tracks. Lan Huang’s crew has now ap­point­ed Mark San­tos to the board of di­rec­tors. San­tos, the for­mer pres­i­dent of ION So­lu­tions, is SVP of phar­ma strat­e­gy & con­tract­ing for OneOn­col­o­gy.

Dar­lene Dep­tu­la-Hicks has notched her sec­ond board ap­point­ment in as many months, this time with Aera­mi Ther­a­peu­tics out of Durham, NC. In Oc­to­ber, the F-star CFO picked up a seat on the board of di­rec­tors at Abcuro.

Ar­bu­tus Bio­phar­ma has pulled in Tram Tran to its board of di­rec­tors. Tran cur­rent­ly serves as the CMO of Glympse Bio and has pre­vi­ous­ly served as VP of med­ical af­fairs, glob­al head, liv­er dis­eases, fi­bro­sis and Covid-19 at Gilead.

→ Van­cou­ver-based De­fence Ther­a­peu­tics has re­cruit­ed Ri­am Sham­maa to its board of di­rec­tors. Sham­maa is the founder of Pal­lian­era Phar­ma and In­tel­lis­tem Tech­nolo­gies and is a man­ag­ing di­rec­tor of Re­gen Cap­i­tal.

Derek Graf al­so con­tributed to this edi­tion.

Alexander Lefterov/Endpoints News

A new can­cer im­munother­a­py brings cau­tious hope for a field long await­ing the next big break­through

Bob Seibert sat silent across from his daughter at their favorite Spanish restaurant near his home in Charleston County, SC, their paella growing cold as he read through all the places in his body doctors found tumors.

He had texted his wife, a pediatric intensive care nurse, when he got the alert that his online chart was ready. Although he saw immediately it was bad, many of the terms — peritoneal, right iliac — were inscrutable. But she was five hours downstate, at a loud group dinner the night before another daughter’s cheer competition.

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Dominic Borie, Kyverna Therapeutics CEO

Well-con­nect­ed, Gilead-backed biotech gets an­oth­er stack of cash to pur­sue CAR-Ts for au­toim­mune dis­ease

Almost exactly two years after its debut at the 2020 JP Morgan confab — and on the heels of a new partnership with the gene editing experts at Intellia — a Gilead-backed, autoimmune disease-focused startup has returned to the well with a clearer outline of just what it plans to do with its CAR-T platform.

Kyverna brought in $85 million in its oversubscribed Series B, the company announced Wednesday. Northpond Ventures led the round, and Westlake Village BioPartners, Vida Ventures, Gilead and Intellia all contributed as well.

Days af­ter Gilead yanks PI3K drug, In­cyte with­draws NDA for its own PI3K — say­ing con­fir­ma­to­ry tri­als would take too long

The FDA’s intensifying scrutiny on accelerated approvals isn’t just putting pressure on drugmakers with marketed products. It is also subtly reshaping the regulatory dynamics.

Case in point: Incyte announced late Tuesday that it has made the “business decision” to withdraw an NDA for parsaclisib, its oral PI3Kδ inhibitor, after deciding that running the confirmatory studies the agency was asking for to support an accelerated approval wouldn’t be worth it.

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Dan O'Day (Getty Images)

In a set­back, FDA or­ders Gilead to hit the brakes on their late-stage, $5B can­cer play

Gilead’s $5 billion drug magrolimab has run into a serious setback.

The FDA ordered Gilead to halt enrollment on their studies of the drug in combination with azacitidine after investigators reports revealed an “apparent imbalance” in the suspected unexpected serious adverse reactions between study arms. And the halt is raising questions about Gilead’s plans for a quick pitch to regulators.

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Graphic: Alexander Lefterov for Endpoints News

Small biotechs with big drug am­bi­tions threat­en to up­end the tra­di­tion­al drug launch play­book

Of the countless decisions Vlad Coric had to make as Biohaven’s CEO over the past seven years, there was one that felt particularly nerve-wracking: Instead of selling to a Big Pharma, the company decided it would commercialize its migraine drug itself.

“I remember some investors yelling and pounding on the table like, you can’t do this. What are you thinking? You’re going to get crushed by AbbVie,” he recalled.

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Mar­ket­ingRx roundup: Pfiz­er de­buts Pre­vnar 20 TV ads; Lil­ly gets first FDA 2022 pro­mo slap down let­ter

Pfizer debuted its first TV ad for its Prevnar 20 next-generation pneumococcal pneumonia vaccine. In the 60-second spot, several people (actor portrayals) with their ages listed as 65 or older are shown walking into a clinic as they turn to say they’re getting vaccinated with Prevnar 20 because they’re at risk.

The update to Pfizer’s blockbuster Prevnar 13 vaccine was approved in June, and as its name suggests is a vaccine for 20 serotypes — the original 13 plus seven more that cause pneumococcal disease. Pfizer used to spend heavily on TV ads to promote Prevnar 13 in 2018 and 2019 but cut back its TV budgets in the past two fall and winter seasonal spending cycles. Prevnar had been Pfizer’s top-selling drug, notching sales of just under $6 billion in 2020, and was the world’s top-selling vaccine before the Covid-19 vaccines came to market last year.

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Roy Baynes, Merck

FDA bats back Mer­ck’s ‘pipeline in a prod­uct,’ de­mands more ef­fi­ca­cy da­ta

Despite some heavy blowback from analysts, Merck execs maintained an upbeat attitude about the market potential of its chronic cough drug gefapixant. But the confidence may be fading somewhat today as Merck puts out news that the FDA is handing back its application with a CRL.

Dubbed by Merck’s development chief Roy Baynes as a “pipeline in a product” with a variety of potential uses, Merck had fielded positive late-stage data demonstrating the drug’s ability to combat chronic cough. The drug dramatically reduced chronic cough in Phase III, but so did placebo, leaving Merck’s research team with a marginal success on the p-value side of the equation.

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Albert Bourla (Photo by Steven Ferdman/Getty Images)

UP­DAT­ED: Pfiz­er fields a CRL for a $295M rare dis­ease play, giv­ing ri­val a big head start

Pfizer won’t be adding a new rare disease drug to the franchise club — for now, anyway.

The pharma giant put out word that their FDA application for the growth hormone therapy somatrogon got the regulatory heave-ho, though they didn’t even hint at a reason for the CRL. Following standard operating procedure, Pfizer said in a terse missive that they would be working with regulators on a followup.

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Florida Gov. Ron DeSantis (AP Photo/Wilfredo Lee, File)

Opin­ion: Flori­da is so mAb crazy, Ron De­San­tis wants to use mAbs that don't work

Florida Gov. Ron DeSantis is trying so hard to politicize the FDA and demonize the federal government that he entered into an alternate universe on Monday evening in describing a recent FDA action to restrict the use of two monoclonal antibody, or mAb, treatments for Covid-19 that don’t work against Omicron.

Without further ado, let’s break down his statement from last night, line by line, adjective by adjective.