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.

Pi­o­neer­ing Click Chem­istry in Hu­mans

Reimagining cancer treatments

Cancer is a leading cause of death worldwide, accounting for nearly 10 million deaths in 2020, which is nearly one in six deaths. Recently, we have seen incredible advances in novel cancer therapies such as immune checkpoint inhibitors, cell therapies, and antibody-drug conjugates that have revamped cancer care and improved survival rates for patients.

Despite this significant progress in therapeutic targeting, why are we still seeing such a high mortality rate? The reason is that promising therapies are often limited by their therapeutic index, which is a measure of the effective dose of a drug, relative to its safety. If we could broaden the therapeutic indices of currently available medicines, it would revolutionize cancer treatments. We are still on the quest to find the ultimate cancer medicine – highly effective in several cancer types, safe, and precisely targeted to the tumor site.

Justin Klee (L) and Joshua Cohen, Amylyx co-CEOs (Cody O'Loughlin/The New York Times; courtesy Amylyx)

Ad­vo­cates, ex­perts cry foul over Amy­lyx's new ALS drug, cit­ing is­sues with price, PhI­II com­mit­ment

Not 24 hours after earning the first ALS drug approval in five years, Amylyx Pharmaceuticals’ Relyvrio is already drawing scrutiny. And it’s coming from multiple fronts.

In an investor call Friday morning, Amylyx revealed that it would charge about $158,000 per year, a price point that immediately drew backlash from ALS advocates and some outside observers. The cost reveal had been highly anticipated in the immediate hours after Thursday evening’s approval, though Amylyx only teased Relyvrio would cost less than previously approved drugs.

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Land­mark Amy­lyx OK spurs de­bate; Some... pos­i­tive? Alzheimer's da­ta; Can­cer tri­al bot­tle­neck; Sanofi's CRISPR bet; 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.

After brief stops in Paris and Boston, John Carroll and the Endpoints crew are staying on the road in October with their return for a live/streaming EUBIO22 in London. The hybrid event fireside chats and panels on mRNA, oncology and the crazy public market. We hope you can join him there.

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Joshua Cohen (L) and Justin Klee, Amylyx co-CEOs

Up­dat­ed: Af­ter long and wind­ing road, FDA ap­proves Amy­lyx's ALS drug in vic­to­ry for pa­tients and ad­vo­ca­cy groups

For just the third time in its 116-year history, the FDA has approved a new treatment for Lou Gehrig’s disease, or ALS.

US regulators gave the thumbs-up to the drug, known as Relyvrio, in a massive win for patients and their families. The approval, given to Boston-area biotech Amylyx Pharmaceuticals, comes after two years of long and contentious debates over the drug’s effectiveness between advocacy groups and FDA scientists, following the readout of a mid-stage clinical trial in September 2020.

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Up­dat­ed: Al­ny­lam re­in­forces APOL­LO-B patisir­an da­ta be­fore head­ing to the FDA

Weeks after uncorking some mostly positive data for patisiran in transthyretin-mediated (ATTR) amyloidosis with cardiomyopathy, Alnylam is bolstering its package with new exploratory and subgroup data before shipping it off to regulators.

The RNAi drug maintained “generally consistent” benefits in efficacy and quality of life across several prespecified subgroups at month 12, Alnylam announced on Friday afternoon, including age, baseline tafamidis use, ATTR amyloidosis type, baseline six-minute walk test score and others.

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Nooman Haque, head of life sciences and healthcare at Silicon Valley Bank, and John Carroll

I’m head­ed to Lon­don soon for #EU­BIO22. Care to join me?

It was great getting back to a live ESMO conference/webinar in Paris followed by a live pop-up event for the Endpoints 11 in Boston. We’re staying on the road in October with our return for a live/streaming EUBIO22 in London.

Silicon Valley Bank’s Nooman Haque and I are once again jumping back into the thick of it with a slate of virtual and live events on October 12. I’ll get the ball rolling with a virtual fireside chat with Novo Nordisk R&D chief Marcus Schindler, covering their pipeline plans and BD work.

#AAO22: J&J’s first look at com­mon eye dis­ease port­fo­lio pads the case for PhII of gene ther­a­py

CHICAGO — While the later-stage drug developers in the geographic atrophy field are near the finish line, Johnson & Johnson’s Janssen is taking a more deliberate route, with a treatment that it hopes to be a one-time fix.

The Big Pharma will take its Hemera Biosciences-acquired gene therapy into a Phase II study later this year in patients with GA, a common form of age-related macular degeneration that impacts about five million people worldwide. To get there, Janssen touted early-stage safety data at the American Academy of Ophthalmology annual conference Saturday morning, half a day after competitors Apellis and Iveric Bio revealed their own more-detailed Phase III analyses.

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Jerome Durso, Intercept Pharmaceuticals CEO

In­ter­cep­t's OCA fails a PhI­II NASH tri­al, rais­ing fresh doubts about its years­long quest for an OK

Intercept Pharmaceuticals has run into another big setback in its yearslong quest to win an approval for OCA in NASH. The biotech put out word Friday morning that its Phase III REVERSE study failed the primary endpoint for the liver disease, sending its share price into a tailspin.

There was no significant improvement in fibrosis among the patients suffering from cirrhosis who were treated with obeticholic acid, with investigators hunting for a minimum 1-stage histological improvement in the disease after 18 months of therapy.

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Bo Cumbo, new Solid Bio CEO

Sol­id Bio gets a new CEO, $75M cash and drops lead drug as big in­vestors ju­ry-rig a merg­er deal

Three months after Endpoints News broke the story that gene therapy outfit AavantiBio had gutted its CMC group in a reorganization, the biotech’s CEO has helped engineer a merger with struggling penny stock player Solid Bio. And he’s going to remain in charge of the combined operation, as Solid founder Ilan Ganot steps aside.

The merger news this morning features some high-profile investors.

Perceptive Advisors, RA Capital Management and Bain Capital Life Sciences are leading a $75 million raise to add to the pool of cash Solid will have after the tie-up. That will leave Solid $215 million in cash as Bain’s Adam Koppel jumps on the board — enough to pay for ops and get through some key data milestones on their way into 2025.

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