Scor­pi­on snags a Sanofi vet to lead the way to the clin­ic; All eyes on eli-cel as blue­bird seeks a fi­nance leader — again

Michael Stre­it

Up­on tak­ing the helm at pre­ci­sion on­col­o­gy-fo­cused Scor­pi­on Ther­a­peu­tics last sum­mer, Ax­el Hoos told End­points News that he had a clear vi­sion of the type of lead­ers he want­ed to hire.

It ap­pears that for­mer Sanofi project head Michael Stre­it, one of Hoos’ old col­leagues from GSK, fits the bill.

Stre­it has been tapped to lead Scor­pi­on’s first two ex­per­i­men­tal drugs in­to the clin­ic, the com­pa­ny an­nounced on Mon­day. When Hoos ap­proached him about the open CMO po­si­tion, Stre­it said he was “keen about the op­por­tu­ni­ty” to work to­geth­er again.

“It was the unique com­bi­na­tion of a fo­cused strat­e­gy and the right peo­ple to ex­e­cute this strat­e­gy that at­tract­ed me to Scor­pi­on,” he said in an email to End­points News. He was most re­cent­ly at Sanofi, where he served as VP and se­nior glob­al project head on SAR444245, the com­pa­ny’s PE­Gy­lat­ed, not-al­pha in­ter­leukin-2 can­di­date.

His re­sume al­so in­cludes stops at GSK, where he rose to VP of de­vel­op­ment, and Janssen, where he led ear­ly de­vel­op­ment for the com­pa­ny’s prostate can­cer and hema­tol­ogy pro­grams.

When it comes to Scor­pi­on, Stre­it’s first pri­or­i­ty is steer­ing STX-478 and STX-721 in­to the clin­ic. The for­mer is de­signed to in­hib­it mu­tant forms of phos­pho­inosi­tide 3-ki­nase al­pha (PI3Kα), one of the most com­mon dri­vers across sol­id tu­mors, Stre­it said, while the lat­ter tar­gets the Ex­on 20 in­ser­tion mu­ta­tion in epi­der­mal growth fac­tor re­cep­tor (EGFR) in pa­tients with non-small cell lung can­cer. IND fil­ings are ex­pect­ed next year, ac­cord­ing to Hoos, though Scor­pi­on has more than 15 oth­er less-ad­vanced pro­grams.

“Crit­i­cal for me as a CEO is that you’re de­ci­sive, you’re a good lis­ten­er so you get all the in­for­ma­tion you need to make de­ci­sions and then you car­ry that for­ward with con­vic­tion,” Hoos told End­points last Ju­ly. “Con­vic­tion is a big thing, es­pe­cial­ly in biotech. You can­not be suc­cess­ful if you don’t be­lieve in what you’re do­ing.” — Nicole De­Feud­is


Ja­son Cole

→ The PDU­FA date is up­on us for eli-cel, and with its gene ther­a­py Zyn­te­glo now ap­proved by the FDA and steeply priced, blue­bird bio is look­ing for its third CFO this year, as chief strat­e­gy and fi­nan­cial of­fi­cer Ja­son Cole walks out the door Oct. 14 “to pur­sue new ca­reer op­por­tu­ni­ties.” Cole orig­i­nal­ly rolled in­to blue­bird eight and a half years ago as gen­er­al coun­sel, then be­came chief le­gal of­fi­cer, chief op­er­at­ing & le­gal of­fi­cer and chief busi­ness of­fi­cer. He re­placed Gi­na Con­syl­man as fi­nance chief in March when she bolt­ed for Vedere Bio II af­ter eight months, and the job is open again in short or­der as Dan­forth Ad­vi­sors ex­ec Kather­ine Breed­is pinch-hits on an in­ter­im ba­sis. This marks the lat­est de­par­ture from blue­bird af­ter chief reg­u­la­to­ry of­fi­cer Anne-Vir­ginie Eggi­mann left for the same post at Flag­ship’s Tessera Ther­a­peu­tics in Au­gust.

Rob Schott

→ It may be too ear­ly to lis­ten to “Dance of the Sug­ar Plum Fairy” or “Waltz of the Flow­ers,” but RNA drug de­vel­op­er Nut­crack­er Ther­a­peu­tics is ready to bring in Rob Schott as CMO. Pre­vi­ous­ly the head of ther­a­peu­tics at Sang­amo, Schott is an Eli Lil­ly alum who was med­ical chief at the In­di­anapo­lis phar­ma’s sub­sidiary Cho­rus. ARCH-backed Nut­crack­er pulled in a sub­stan­tial chunk of change in March with a $167 mil­lion Se­ries C, and the Cal­i­for­nia biotech fleshed out its lead­er­ship this sum­mer with COO John Stuben­rauch, CBO Ge­off Nos­rati and gen­er­al coun­sel Ian Wiener.

Ruben Tomas­si

Pearl Huang’s pro­tein degra­da­tion up­start Dunad Ther­a­peu­tics has pegged Ruben Tom­masi as chief R&D of­fi­cer. Tom­masi logged 17 years at No­var­tis and left NI­BR to be­come head of in­fec­tious dis­ease chem­istry at As­traZeneca in 2011. Since 2015, he had been CSO of As­traZeneca spin­out En­ta­sis Ther­a­peu­tics, the $113 mil­lion an­ti­body de­vel­op­er that was sold to In­no­vi­va in May. Flag­ship stitched to­geth­er Inzen and Huang’s old com­pa­ny Cyg­nal to form Sonata Ther­a­peu­tics that same month, and then Huang took the helm at Cam­bridge, UK-based Dunad in late June.

Paul Daruwala

Cellics Ther­a­peu­tics, a San Diego biotech that got the go-ahead on an IND ap­pli­ca­tion for its red blood cell nanosponge CTI-005, has tapped Bris­tol My­ers Squibb vet­er­an Paul Daruwala as pres­i­dent and CEO. Daruwala split his eight years at Cidara Ther­a­peu­tics be­tween serv­ing as chief com­mer­cial of­fi­cer (2014-18) and COO (since 2018), and at Bris­tol My­ers he was VP of US mar­ket­ing for the he­pa­tol­ogy fran­chise. Ear­li­er, he spent 18 years at Mer­ck and then piv­ot­ed to Ver­tex in 2010 as VP, com­mer­cial & strate­gic man­age­ment.

Gail Far­fel

→ On Sept. 19, Pfiz­er and No­var­tis vet Gail Far­fel will take over for Gene Williams as CEO of Toron­to-head­quar­tered ProMIS Neu­ro­sciences, which is go­ing af­ter such dis­eases as Alzheimer’s, ALS and mul­ti­ple sys­tem at­ro­phy. Far­fel just had a sev­en-year run as chief de­vel­op­ment of­fi­cer of Zo­genix and is a board mem­ber at Avro­bio and Durect Cor­po­ra­tion.

Nal­lakkan Arvin­dan

Nal­lakkan Arvin­dan has signed on as chief tech­nol­o­gy of­fi­cer of Spot­light Ther­a­peu­tics, a San Fran­cis­co CRISPR gene edit­ing shop that chalked up a $36.5 mil­lion Se­ries B in March and added En­her­tu whis­per­er An­toine Yver as a board mem­ber in Ju­ly. In his long ca­reer at Five Prime be­fore the $2 bil­lion Am­gen buy­out of March 2021, Arvin­dan was VP, strate­gic tech­nol­o­gy op­er­a­tions and would get pro­mot­ed to SVP in 2018.

→ Be­set by a flail­ing stock price $TXMD and an M&A move that was called off in Ju­ly by po­ten­tial buy­er EW Health­care Part­ners, for­mer No­var­tis ex­ec Hugh O’Dowd’s tenure at Bo­ca Ra­ton, FL women’s health biotech Ther­a­peu­tic­sMD hasn’t panned out, so co-founder Bri­an Ber­nick and ex-Es­pe­ri­on chief com­mer­cial of­fi­cer Mark Glick­man have thus been named in­ter­im co-CEOs. Ber­nick had filled the role of chief sci­en­tif­ic and med­ical of­fi­cer, while Glick­man had been CBO since June 2021 at Ther­a­peu­tic­sMD, chaired by for­mer HHS Sec­re­tary Tom­my Thomp­son.

Ryan Arnold

BioCryst has hand­ed out two pro­mo­tions as en­roll­ment picks up again on clin­i­cal tri­als for BCX9930, its lead drug that had re­ceived a par­tial hold from the FDA in May. Bill Sheri­dan has been el­e­vat­ed to chief de­vel­op­ment of­fi­cer, and Ryan Arnold has suc­ceed­ed Sheri­dan as CMO of the rare dis­ease biotech. In 2008, Sheri­dan moved on to BioCryst from Am­gen, where he capped off his 14 years with the phar­ma gi­ant as VP, North Amer­i­can med­ical af­fairs. Arnold was brought on board six months ago as SVP of glob­al med­ical af­fairs, a po­si­tion that the Sanofi/Gen­zyme alum al­so held at Sage Ther­a­peu­tics and An­nex­on Bio­sciences.

Ryan May­nard

→ While look­ing to broad­en the hori­zons for its FDA-ap­proved pru­ri­tus drug Ko­r­su­va with an oral for­mu­la­tion in Phase III, Cara Ther­a­peu­tics has en­list­ed Ryan May­nard as chief fi­nan­cial of­fi­cer. May­nard, the CFO for 10 of his 16 years with Rigel Phar­ma­ceu­ti­cals, would lat­er hold the same ti­tle at Blade Ther­a­peu­tics and health­care so­lu­tions out­fit Lets­GetChecked. He’s al­so on the board of di­rec­tors at Io­vance along­side such mem­bers as chair­man Iain Dukes and Athena Coun­tou­ri­o­tis, the new chair­per­son at Re­cludix Phar­ma who ran Turn­ing Point un­til Bris­tol My­ers snapped it up for $4.1 bil­lion last year.

→ While we’re think­ing of it, Turn­ing Point’s for­mer in­ter­im CSO Gavin Hirst has a new gig as chief sci­en­tist at Atom­wise, part of Sanofi’s AI full-court press that al­so in­cludes Ex­sci­en­tia. Be­fore the Take­da vet was with Turn­ing Point, Hirst was Janssen’s se­nior di­rec­tor and head of im­m­munol­o­gy med­i­c­i­nal chem­istry. In a deal cen­tered on small mol­e­cules, Sanofi paid Atom­wise $20 mil­lion up­front in Au­gust with mile­stones in the neigh­bor­hood of $1 bil­lion.

John Maraganore

→ There’s move­ment on the Maraganore Me­ter again as ex-Al­ny­lam chief John Maraganore tacks on an­oth­er strate­gic ad­vi­so­ry role with Xilio Ther­a­peu­tics. The I/O biotech has bol­stered its board of di­rec­tors with Tom Hey­man, who re­tired in 2019 af­ter 37 years at J&J, and has plugged in Myles Clous­ton as VP of in­vestor re­la­tions. Clous­ton worked at Nas­daq for more than eight years and had led US in­vestor re­la­tions at Mor­phoSys.

Michael Ship­ton

Sci­ence 37 pulled off a $235 mil­lion SPAC deal last year, then trimmed its work­force by “just un­der 25” peo­ple this sum­mer as the bear mar­ket put many oth­er com­pa­nies in a sim­i­lar bind. The de­cen­tral­ized clin­i­cal tri­als provider out of the Re­search Tri­an­gle in North Car­oli­na has since re­cruit­ed Quin­tiles vet Michael Ship­ton as chief com­mer­cial of­fi­cer. Ship­ton took on the role of SVP, cus­tomer so­lu­tions & strat­e­gy to con­clude his four years with Sy­neos Health.

→ It hasn’t been all peach­es and cream be­tween the FDA and Agenus with its BLA for bal­stil­imab get­ting pulled last year, and the biotech hopes to get back on track with Pa­tri­cia Car­los as chief reg­u­la­to­ry, qual­i­ty, and safe­ty of­fi­cer. Car­los jumps to Agenus from Ar­cus, where she was SVP of reg­u­la­to­ry and qual­i­ty. Agenus has al­so wel­comed Todd Yancey as se­nior glob­al clin­i­cal de­vel­op­ment, med­ical af­fairs and com­mer­cial ad­vi­sor af­ter his time as BeiGene’s SVP, glob­al med­ical af­fairs and new mar­ket de­vel­op­ment. Car­los al­so has BeiGene ties from her days as di­rec­tor (and then se­nior di­rec­tor) of reg­u­la­to­ry af­fairs.

Jonathan Ben­jamin

→ Since its $111 mil­lion Se­ries B in Jan­u­ary, CAR-T de­vel­op­er Imm­PACT Bio has me­thod­i­cal­ly formed its lead­er­ship team with a new chief tech­nol­o­gy of­fi­cer, COO, CFO and the ar­rival of Jonathan Ben­jamin this week as CMO. The ex-med­ical di­rec­tor at Am­gen was SVP for clin­i­cal re­search with Atre­ca, which had to give it­self some breath­ing room by scal­ing back the work­force in June.

→ Pum­meled by a dras­tic 75% staff re­duc­tion and a CRL with its cU­TI drug tebipen­em HBr, Spero Ther­a­peu­tics has se­lect­ed Ka­mal Hamed as CMO. Hamed, a for­mer med­ical di­rec­tor with Bay­er, Bris­tol My­ers and No­var­tis, just had a six-month run as the med­ical chief at Lyso­vant; he’s al­so led clin­i­cal de­vel­op­ment and med­ical af­fairs for Basilea Phar­ma­ceu­ti­ca.

Ronald Herb­st

→ Ef­fec­tive Oct. 3, Ronald Herb­st will get start­ed as CSO at Bi­olo­jic De­sign, the AI-based an­ti­body shop that start­ed Au­los Bio­science with ATP’s Michael Ehlers in Jan­u­ary 2021. A for­mer Med­Im­mune R&D ex­ec, Herb­st was chief sci­en­tist at Pyx­is On­col­o­gy, which pulled the plug on PYX-202 and paused de­vel­op­ment on PYX-203 and PYX-102 in an Au­gust pipeline shake­up.

Robyn Hunter

→ Go­ing af­ter IL-15 with SOT101 and ink­ing a Keytru­da com­bo deal with Mer­ck af­ter rais­ing more than $300 mil­lion in De­cem­ber 2021, Czech can­cer play­er So­tio Biotech has ap­point­ed Robyn Hunter as CFO and Mar­tin Steeg­maier as CSO. Hunter had been with Fortress Biotech since its Coro­n­a­do Bio­sciences days, first as VP & cor­po­rate con­troller and lat­er as CFO, and she’s on the board of di­rec­tors at Tenax Ther­a­peu­tics. Steeg­maier, the for­mer head of dis­cov­ery for large mol­e­cule re­search at Roche, wraps up his two years as head of re­search at Mor­phoSys.

Maria Arce-Tomas

→ Swiss I/O biotech Nous­com has pro­mot­ed No­var­tis can­cer vet Sven Gogov to CMO and picked up Maria Arce-Tomas as VP, head of reg­u­la­to­ry af­fairs. Gogov joined the Janssen part­ner as VP, clin­i­cal de­vel­op­ment last Oc­to­ber af­ter his stint as In­cyte’s ex­ec­u­tive di­rec­tor, glob­al im­muno-on­col­o­gy. Arce-Tomas has held reg­u­la­to­ry po­si­tions at GSK, Ab­bott, Take­da and No­vo Nordisk, and since 2019 she had been glob­al head of reg­u­la­to­ry af­fairs with Phar­ma­Mar.

Ja­cob Hes­ter­man

→ Ra­dio­phar­ma­ceu­ti­cals are a hot com­mod­i­ty, and Ja­cob Hes­ter­man is en­ter­ing that world with Ra­tio Ther­a­peu­tics as chief da­ta of­fi­cer. Hes­ter­man was chief tech­nol­o­gy of­fi­cer at Realm IDx and In­vi­cro be­fore this new­ly-cre­at­ed post at Ra­tio, a Bay­er and Lan­theus part­ner that launched from stealth in June with a $20+ mil­lion seed round and will be lo­cat­ed in the Sea­port Dis­trict in Boston.

Julie Dav­es has made her way to Min­neapo­lis-based Di­aMed­ica Ther­a­peu­tics has SVP, clin­i­cal de­vel­op­ment op­er­a­tions. Dav­es had been glob­al head of clin­i­cal op­er­a­tions for San­i­fit, a Span­ish biotech that was bought by Vi­for Phar­ma, which was bought by CSL in a Ma­tryosh­ka doll M&A sce­nario. The FDA is­sued a clin­i­cal hold on Di­aMed­ica’s acute is­chemic stroke and chron­ic kid­ney dis­ease drug, DM199, in Ju­ly.

Pey­ton How­ell

→ Glob­al CRO Parex­el has a pair of pro­mo­tions on its lead­er­ship team with Pey­ton How­ell be­ing el­e­vat­ed to the new­ly-cre­at­ed role of chief op­er­at­ing and growth of­fi­cer and Amy Mc­K­ee mov­ing up to CMO and glob­al head, On­col­o­gy Cen­ter of Ex­cel­lence. How­ell joined the com­pa­ny in May 2018 as its chief com­mer­cial and strat­e­gy of­fi­cer. Be­fore mak­ing her way to Parex­el, How­ell was pres­i­dent for health sys­tems and spe­cial­ty care so­lu­tions at Amerisource­Ber­gen. Mean­while, Mc­K­ee has been with Parex­el since 2019, where she start­ed as SVP and head of reg­u­la­to­ry con­sult­ing ser­vices. Mc­K­ee for­mer­ly held an 11-year stint at the FDA, cul­mi­nat­ing in her role as deputy cen­ter di­rec­tor, On­col­o­gy Cen­ter of Ex­cel­lence (OCE) and su­per­vi­so­ry as­so­ciate di­rec­tor, OHOP, CDER.

End­point Health, not af­fil­i­at­ed with End­points News, has plucked up Ran­si So­maratne as CMO. This isn’t So­maratne’s first time wear­ing the CMO hat, hav­ing served in the same role pre­vi­ous­ly at Spring Dis­cov­ery. So­maratne al­so brings with him ex­pe­ri­ence from his times at Bio­Marin and Am­gen.

Christoph Nowak

→ Not long af­ter Di­amyd Med­ical kicked off its Phase III tri­al of its drug in an HLA-de­fined ge­net­ic sub­pop­u­la­tion of type 1 di­a­betes pa­tients, the Swedish com­pa­ny has pro­mot­ed Christoph Nowak to the po­si­tion of CMO. Nowak joined the au­toim­mune di­a­betes biotech last March af­ter a five-year stint as an as­sis­tant pro­fes­sor at the Karolin­s­ka In­sti­tutet.

Kate Hogg Call

Phos­platin Ther­a­peu­tics changed its name to Promon­to­ry Ther­a­peu­tics in May, but not its fo­cus on de­vel­op­ing small mol­e­cule can­cer drugs. This week, the biotech has wel­comed He­lene Shea as VP of CMC and Kate Hogg Call as VP of clin­i­cal op­er­a­tions. Shea was pre­vi­ous­ly the head of CMC at San­iona and al­so held CMC posts at AM­AG Phar­ma­ceu­ti­cals and Ari­ad Phar­ma­ceu­ti­cals, while Hogg Call had been the se­nior di­rec­tor of clin­i­cal op­er­a­tions at Check­mate Phar­ma­ceu­ti­cals for near­ly two years. Promon­to­ry is part­ner­ing with Pfiz­er and Mer­ck KGaA on a com­bo ther­a­py in­volv­ing Baven­cio and its lead as­set, PT-112.

Matvey Luka­shev

Nerv­Gen has named Matvey Luka­shev as its VP, re­search and pre­clin­i­cal de­vel­op­ment. Luka­shev most re­cent­ly served as VP, trans­la­tion­al sci­ences at the ALS De­vel­op­ment In­sti­tute. Pri­or to that, Luka­shev held a va­ri­ety of roles at Bio­gen.

Adri Os­man is join­ing Azur Group as VP of cor­po­rate qual­i­ty and com­pli­ance. Os­man comes from Te­va Phar­ma­ceu­ti­cals, where he served as head of qual­i­ty strat­e­gy and port­fo­lio man­age­ment.

→ Ex-Pfiz­er On­col­o­gy pres­i­dent Gar­ry Nichol­son has been named chair­man of the board at Day One Bio­phar­ma­ceu­ti­cals, which did the pos­i­tive da­ta-to-pub­lic of­fer­ing two-step in June. Nichol­son chairs the board at G1 Ther­a­peu­tics and had a 28-year run at Eli Lil­ly be­fore join­ing Pfiz­er in 2008.

John Hood

→ South San Fran­cis­co neu­ro biotech Nine Square Ther­a­peu­tics has elect­ed Sa­mumed co-founder and ex-Im­pact Bio­med­i­cines chief John Hood to the board of di­rec­tors. Hood’s new com­pa­ny, En­deav­or Bio­med­i­cines, raised $101 mil­lion in a Se­ries B round back in Feb­ru­ary.

Bri­an Thomas

→ Long non-cod­ing RNA (lncR­NA) up­start Haya Ther­a­peu­tics has locked in Bri­an Thomas as chair­man of the board. Thomas holds the top spot at Metageno­mi, a gene edit­ing play­er that inked a CRISPR deal with Mod­er­na last No­vem­ber.

→ Un­der the new lead­er­ship of CEO Kim Black­well, Zen­tal­is Phar­ma­ceu­ti­cals has re­served space for Jan Skvar­ka on the board of di­rec­tors. The CEO of Tril­li­um un­til it was sold to Pfiz­er for $2.22 bil­lion last year, Skvar­ka chairs the boards of Gen­tiBio and Long­wood’s DEM Bio­Phar­ma, the just-launched CD47 play­er that scored a $70 mil­lion Se­ries A.

Leana Wen

→ Reg­u­lar CNN con­trib­u­tor Leana Wen, who has been un­der the mi­cro­scope for her about-face on Covid man­dates, has joined the board of di­rec­tors at Uro­Gen. The George Wash­ing­ton Uni­ver­si­ty pro­fes­sor is al­so a board mem­ber at Glaukos.

Desney Tan

→ The num­ber of board mem­bers at 1910 Ge­net­ics has grown to four with the se­lec­tion of Desney Tan. The 18-year Mi­crosoft vet and man­ag­ing di­rec­tor of Mi­crosoft Health Fu­tures is join­ing CEO Jen Nwankwo, the NI­BR’s Jen­nifer Leeds and Play­ground Glob­al ven­ture part­ner Phyl­lis White­ley on the board.

Mer­it Cud­kow­icz

Mer­it Cud­kow­icz is tak­ing her tal­ents to South Beach as a mem­ber of the sci­en­tif­ic ad­vi­so­ry board at Mi­a­mi-based neu­ro biotech Pa­sithea Ther­a­peu­tics. Cud­kow­icz, the chief of neu­rol­o­gy at Mass­a­chu­setts Gen­er­al Hos­pi­tal, is a fre­quent re­source for End­points’ ALS cov­er­age.

Ox­ford Bio­ther­a­peu­tics chair­man Bernd Seizinger, the act­ing CEO of Cryp­toMedix, is head­ed to the board of di­rec­tors at Ap­tose. In the 1990s, Seizinger was VP for on­col­o­gy drug dis­cov­ery and VP for cor­po­rate and aca­d­e­m­ic al­liances with Bris­tol My­ers.

Katharine Kno­bil

Pli­ant Ther­a­peu­tics, an­oth­er biotech that raised a truck­load of cash af­ter pos­i­tive da­ta, has ap­point­ed Ag­i­lent Tech­nolo­gies CMO and long­time GSK ex­ec Katharine Kno­bil to the board of di­rec­tors. She’s al­so been CMO and head of R&D at the now-de­funct Kalei­do Bio­sciences.

→ The folks at hC Bio­science just gained a CSO and chief da­ta sci­ence of­fi­cer last week, and now the tR­NA play­er has waved in Brad Mar­gus to the board of di­rec­tors. The ex-CEO of Cere­vance and En­voy Ther­a­peu­tics al­so has board seats at Arv­inas, Neu­rona Ther­a­peu­tics and the A-T Chil­dren’s Pro­ject.

Philip Kantoff

→ Prostate can­cer biotech ES­SA Phar­ma has added Philip Kantoff to the board of di­rec­tors. The for­mer chair­man of the De­part­ment of Med­i­cine at Memo­r­i­al Sloan Ket­ter­ing, Kantoff co-found­ed and is CEO of an­oth­er biotech that’s tar­get­ing prostate can­cer, Con­ver­gent Ther­a­peu­tics.

→ Tel Aviv-based Ukko has wel­comed aboard Tim Gar­nett to its ad­vi­so­ry board. Gar­nett is the for­mer CMO of Eli Lil­ly, hav­ing served in the role from 2008 to 2021. Gar­nett al­so pre­vi­ous­ly served as the chair of the R&D lead­er­ship fo­rum for PhRMA.

Neogen is pulling out two new seats on its board of di­rec­tors for Jeff Capel­lo and Aashima Gup­ta — who come along af­ter a merg­er agree­ment with 3M. Capel­lo — cur­rent­ly man­ag­ing mem­ber at Monomoy Ad­vi­sors — has had a busy ca­reer, serv­ing as CFO at a num­ber of places in­clud­ing PerkinElmer, Boston Sci­en­tif­ic and Bio­gen. Mean­while, Gup­ta has held a va­ri­ety of roles, in­clud­ing stints at JP Mor­gan Chase, Google Cloud, Apigee and Kaiser Per­ma­nente.

Susan Galbraith, AstraZeneca EVP, oncology R&D, at EUBIO22 (Rachel Kiki for Endpoints News)

Up­dat­ed: As­traZeneca jumps deep­er in­to cell ther­a­py 2.0 space with $320M biotech M&A

Right from the start, the execs at Neogene had some lofty goals in mind when they decided to try their hand at a cell therapy that could tackle solid tumors.

Its founders have helped hone a new approach that would pack in multiple neoantigen targets to create a personalized TCR treatment that would not just make the leap from blood to solid tumors, but do it with durability. And they managed to make their way rapidly to the clinic, unveiling their first Phase I program for advanced tumors just last May.

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Paul Hudson, Sanofi CEO (Romuald Meigneux/Sipa via AP Images)

Sanofi and DN­Di aim to elim­i­nate sleep­ing sick­ness in Africa with promis­ing Ph II/III re­sults for new drug

The Drugs for Neglected Diseases initiative (DNDi) and Sanofi today said that their potential sleeping sickness treatment saw success rates of up to 95% from a Phase II/III study investigating the safety and efficacy of single-dose acoziborole.

The potentially transformative treatment for sleeping sickness would mainly be targeted at African countries, according to data published today in The Lancet Infectious Diseases medical journal. The clinical trial was led by DNDi and its partners in the Democratic Republic of the Congo (DRC) and Guinea, with the authors noting:

Ei­sai’s ex­pand­ed Alzheimer’s da­ta leave open ques­tions about safe­ty and clin­i­cal ben­e­fit

Researchers still have key questions about Eisai’s investigational Alzheimer’s drug lecanemab following the publication of more Phase III data in the New England Journal of Medicine Tuesday night.

In the paper, which was released in conjunction with presentations at an Alzheimer’s conference, trial investigators write that a definition of clinical meaningfulness “has not been established.” And the relative lack of new information, following topline data unveiled in September, left experts asking for more — setting up a potential showdown to precisely define how big a difference the drug makes in patients’ lives.

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Lex­i­con slams FDA over hear­ing de­nial fol­low­ing a CRL for its SGLT2 in­hibitor can­di­date

Lexicon Pharmaceutical is not giving up on its Type I diabetes candidate, despite FDA’s repeated rejections. This week the company laid out is argument again for a hearing on sotagliflozin in response to the FDA’s most recent denial.

The issue goes back to March 2019 when the FDA made very clear to Lexicon and its now departed partner Sanofi that it would not approve their application for a potential Type I diabetes drug because it does not appear to be safe.

Digital render of CPI's Medicines Manufacturing Innovation Centre in Glasgow, Scotland (Image: uk-cpi.com)

CPI opens the doors to a new $100M+ man­u­fac­tur­ing fa­cil­i­ty in Scot­land

A manufacturing site that has received interest and investments from large pharma companies and the UK government is opening its doors in Scotland.

The manufacturer CPI (Centre for Process Innovation) has opened a new £88 million ($105 million) “Medicines Manufacturing Innovation Centre” in Glasgow, Scotland, to accelerate the development of manufacturing tech and solve longstanding challenges in medicine development and manufacturing.

Pro­tect­ing its megablock­buster, Janssen chal­lenges Am­gen's Ste­lara biosim­i­lar ahead of planned 2023 launch

Johnson & Johnson unit Janssen on Wednesday sued Amgen over the company’s proposed biosimilar to its megablockbuster Stelara (ustekinumab), after Amgen said it was ready to launch next May or as soon as the FDA signs off on it.

If Amgen carries through with that plan, Janssen told the Delaware district court that the Thousand Oaks, CA-based company will infringe on at least two Janssen patents.

Illustration: Assistant Editor Kathy Wong for Endpoints News

Twit­ter dis­ar­ray con­tin­ues as phar­ma ad­ver­tis­ers ex­tend paus­es and look around for op­tions, but keep tweet­ing

Pharma advertisers on Twitter are done — at least for now. Ad spending among the previous top spenders flattened even further last week, according to the latest data from ad tracker Pathmatics, amid ongoing turmoil after billionaire boss Elon Musk’s takeover now one month ago.

Among 18 top advertisers tracked for Endpoints News, only two are spending: GSK and Bayer. GSK spending for the full week through Sunday was minimal at just under $1,900. Meanwhile, German drugmaker Bayer remains the industry outlier upping its spending to $499,000 last week from $480,000 the previous week. Bayer’s spending also marks a big increase from a month ago and before the Musk takeover, when it spent $16,000 per week.

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Vi­a­tris with­draws ac­cel­er­at­ed ap­proval for top­i­cal an­timi­cro­bial 24 years lat­er

After 24 years without confirming clinical benefit, the FDA announced Tuesday morning that Viatris (formed via Mylan and Pfizer’s Upjohn) has decided to withdraw a topical antimicrobial agent, Sulfamylon (mafenide acetate), after the company said conducting a confirmatory study was not feasible.

Sulfamylon first won FDA’s accelerated nod in 1998 as a topical burn treatment, with the FDA noting that last December, Mylan told the agency that it wasn’t running the trial.

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Mer­ck sues Johns Hop­kins for li­cens­ing Keytru­da patents in se­cret and in con­flict with re­search col­lab­o­ra­tion

Merck filed a lawsuit against Johns Hopkins University in Maryland federal court on Tuesday, arguing that the storied university obtained illegal patents as part of its research collaboration with the company and related to its blockbuster cancer drug Keytruda (pembrolizumab).

Merck alleges that the Baltimore-based university obtained and licensed Keytruda-related patents in secret while claiming that Keytruda was developed before and independent of a 2013 research collaboration between the two organizations. Hopkins also sought “hundreds of millions of dollars” tied to Keytruda sales because of the patents, Merck contends.

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