Roche Chi­na CEO preps for a move to Mer­ck KGaA while US Mer­ck adds to C-suite; Suc­ces­sion plan fi­nal­ized for EVPs re­tir­ing from Sanofi

Hong Chow

→ Be­gin­ning Oct. 1, Roche Chi­na CEO Hong Chow will be head of Chi­na & in­ter­na­tion­al for Mer­ck KGaA’s health­care busi­ness, a po­si­tion that al­so en­com­pass­es Japan, Eu­rope, Latin Amer­i­ca, Asia-Pa­cif­ic, the Mid­dle East, Africa and Rus­sia. The mul­ti-pronged po­si­tion al­so has Chow lead­ing the car­dio­vas­cu­lar me­tab­o­lism & en­docrinol­o­gy fran­chise and the Glob­al Busi­ness In­no­va­tion (GBI) unit. A Bay­er alum, Chow has helmed Roche Chi­na since 2015.

“My years with Roche have been just in­cred­i­ble and I am for­ev­er grate­ful for the op­por­tu­ni­ty to work with so many amaz­ing peo­ple in Chi­na and around the world to de­liv­er so many more in­no­v­a­tive drugs to Chi­nese pa­tients in an unimag­in­able speed,” Chow said on LinkedIn. “At the same time, I am very ex­cit­ed to start the new chap­ter in Oc­to­ber with Mer­ck to make a broad­er im­pact to pa­tients and so­ci­ety in Chi­na and in­ter­na­tion­al­ly.”

Cristal Down­ing

→ As for the oth­er Mer­ck, Cristal Down­ing will be­come chief com­mu­ni­ca­tions & pub­lic af­fairs of­fi­cer for new CEO Rob Davis’ team, ef­fec­tive Aug. 16. Down­ing jumps from an­oth­er Big Phar­ma, J&J, where she spent six years in mul­ti­ple com­mu­ni­ca­tions ca­pac­i­ties, end­ing her run there as VP, com­mu­ni­ca­tion & pub­lic af­fairs, med­ical de­vices. Mer­ck’s lead­er­ship re­vamp has ex­tend­ed be­yond the CEO slot, with Car­o­line Litch­field suc­ceed­ing Davis as CFO, for­mer chief mar­ket­ing of­fi­cer Mike Nal­ly leav­ing for Flag­ship’s Gen­er­ate Bio­med­i­cines, and Dean Li tak­ing over R&D for Roger Perl­mut­ter, who’s get­ting a fresh start as CEO of Eikon Ther­a­peu­tics.

Karen Line­han

→ Long­time ex­ecs Karen Line­han (EVP, gen­er­al coun­sel and head of le­gal, ethics & busi­ness in­tegri­ty) and Philippe Lus­can (EVP, glob­al head of in­dus­tri­al af­fairs) are re­tir­ing from Sanofi, with Roy Pa­p­atheodor­ou and Bren­dan O’Callaghan slat­ed to re­place them. Pa­p­atheodor­ou has been gen­er­al coun­sel at No­var­tis since 2017 and joined the Swiss phar­ma in 2014. O’Callaghan scores a pro­mo­tion from his cur­rent po­si­tion as glob­al head of Sanofi’s bi­o­log­ics plat­form that will take ef­fect af­ter Lus­can’s re­tire­ment some­time in 2022. Their pre­de­ces­sors share an im­pres­sive run: Lus­can’s Sanofi ca­reer be­gan in 1990, while Line­han, who re­tires on Dec. 31, joined soon af­ter in 1991.

Lu­ciana Bo­rio has quite the dec­o­rat­ed ré­sumé and she’s adding a new gig as a ven­ture part­ner at Bob Nelsen’s ARCH to the list. Bo­rio, who was once vet­ted by Pres­i­dent Biden’s team to lead the FDA as com­mis­sion­er, for­mer­ly served as the ad­min­is­tra­tion’s act­ing chief sci­en­tist. In ad­di­tion, she’s held roles as VP at non­prof­it in­vest­ment firm In-Q-Tel, serves as a se­nior fel­low for glob­al health at the Coun­cil on For­eign Re­la­tions, and is a mem­ber of CEPI’s sci­en­tif­ic ad­vi­so­ry com­mit­tee.

Bruce Eaton

Jim Mullen is fill­ing an­oth­er C-suite va­can­cy at Ed­i­tas Med­i­cine by pro­mot­ing Bruce Eaton to CBO af­ter choos­ing Mark Shear­man to re­place Charles Al­bright as CSO. Eaton’s as­so­ci­a­tion with Ed­i­tas dates back to 2015 when he start­ed con­sult­ing for the genome edit­ing play­er, then be­came a re­search col­lab­o­ra­tor be­fore ul­ti­mate­ly gain­ing the ti­tle of SVP, chem­istry, and site head in Boul­der, CO. Eaton al­so co-found­ed and was CEO of i2 Phar­ma­ceu­ti­cals and fleet­ing­ly served as COO of So­ma­Log­ic.

On a re­lat­ed Ed­i­tas note, for­mer CEO Cyn­thia Collins has been elect­ed to the board of di­rec­tors at Po­sei­da Ther­a­peu­tics.

→ Or­chard Ther­a­peu­tics’ for­mer chief tech­ni­cal of­fi­cer, Ran Zheng, is tak­ing over the wheel at Land­mark Bio — a new cen­ter for ad­vanced cell man­u­fac­tur­ing once known as the Cen­ter for Ad­vanced Bi­o­log­i­cal In­no­va­tion and Man­u­fac­tur­ing (CABIM). Dur­ing her time at Or­chard, Zheng was ad­vanc­ing the com­pa­ny’s prod­uct pipeline with the ap­proval of Lib­meldy for metachro­mat­ic leukody­s­tro­phy. Be­sides her stint at Or­chard, Zheng held lead­er­ship po­si­tions at Gen­zyme and Am­gen.

Medicxi-backed Syn­Ox Ther­a­peu­tics launched in No­vem­ber 2020 with a $44 mil­lion Se­ries A round, aim­ing to de­vel­op an an­ti­body to treat tenosyn­ovial gi­ant cell tu­mors (TGCT) named emac­tuzum­ab that John Reed once had on his radar while he was with Roche. This week Ray Bar­low takes over as CEO of Syn­Ox, while Ton Logten­berg has been named chair­man. Bar­low was CBO of Kiadis Phar­ma, the Dutch biotech which was sold to Sanofi — where Reed now leads R&D — for $357 mil­lion. He took on a num­ber of busi­ness de­vel­op­ment roles at As­traZeneca and was Am­gen’s ex­ec­u­tive di­rec­tor of cor­po­rate de­vel­op­ment from 2012-17. In ad­di­tion to start­ing Cru­cell (ac­quired by J&J), Logten­berg found­ed Merus and stepped down as the com­pa­ny’s pres­i­dent, CEO and prin­ci­pal fi­nan­cial of­fi­cer at the end of 2019.

Kris­ten Al­bright

→ Lon­don-based mi­cro­bial im­munother­a­py out­fit Prokar­i­um has pro­mot­ed Kris­ten Al­bright to CEO. Al­bright, who set her ca­reer in mo­tion as a post­doc­tor­al fel­low at J&J, first turned up at Prokar­i­um in 2018 as VP, busi­ness de­vel­op­ment & trans­la­tion­al re­search, then got the bump to COO last sum­mer. Al­bright has al­so been a busi­ness de­vel­op­ment and li­cens­ing man­ag­er with Emer­gent BioSo­lu­tions. That isn’t the on­ly C-suite news here: Prokar­i­um has en­list­ed Uz Stamm­berg­er as CMO, for­mer­ly the trans­la­tion­al clin­i­cal on­col­o­gy pro­gram leader at the No­var­tis In­sti­tutes for Bio­Med­ical Re­search and the clin­i­cal lead for tepo­tinib at Mer­ck KGaA.

Jude Samul­s­ki

→ It’s go big or go home with the re­in­force­ments at Se­lec­ta Bio­sciences, ap­point­ing AAV trail­blaz­er Jude Samul­s­ki as a gene ther­a­py spe­cial ad­vi­sor. What’s the con­nec­tion here? Play­ing a quick Six De­grees of Jude Samul­s­ki game, he co-found­ed and is CSO at AskBio, which made a splash by bring­ing in pres­i­dent of ther­a­peu­tics Kathy High, who co-found­ed Spark, which has col­lab­o­rat­ed on gene ther­a­pies with … Se­lec­ta Bio­sciences.

James Cas­sidy

Pfiz­er spin­out Spring­Works Ther­a­peu­tics adds to its long line of new ex­ecs with CMO James Cas­sidy. While he was with Len Schleifer’s squad at Re­gen­eron, Cas­sidy was VP of on­col­o­gy/strate­gic pro­gram di­rec­tion, and he’s al­so been VP of on­col­o­gy at Bris­tol My­ers Squibb. In De­cem­ber 2020, Spring­Works pro­mot­ed Badred­din Edris to COO and Mary Smith to chief de­vel­op­ment of­fi­cer, then plucked chief com­mer­cial of­fi­cer Bhavesh Ashar from Bay­er in March. Spring­Works sub­se­quent­ly brought in R&D chief Mike Burgess from Turn­stone Bi­o­log­ics in May.

Pe­ter Buh­ler

→ French vac­cine biotech Val­ne­va has fi­nal­ly found a re­place­ment for CFO David Lawrence, but they’re stretch­ing out the tran­si­tion by in­di­cat­ing that Pe­ter Buh­ler’s first day will be some­time “with­in the six months.” This odyssey to­ward a new CFO be­gan when Lawrence ini­tial­ly re­tired from Val­ne­va in Sep­tem­ber 2020, on­ly to be named act­ing CFO sev­er­al months lat­er. Now he’ll “con­tin­ue sup­port­ing Val­ne­va un­til late 2021” in a change to the orig­i­nal plan up­on re­tire­ment to stick around as an ad­vi­sor un­til ear­ly 2021. Buh­ler, the cur­rent CFO of Quo­tient, has a num­ber of fi­nan­cial roles on his ré­sumé, in­clud­ing head of fi­nance, Eu­rope at Mer­ck Serono.

→ The next wave of new lead­er­ship at Pe­ter Thiel-backed Pep­ti­log­ics fea­tures a quin­tet of ex­ecs, with CBO Nik Bhide lead­ing off. A No­var­tis and Al­ler­gan vet in fi­nance and cor­po­rate de­vel­op­ment, Bhide joins the pep­tide drug de­vel­op­er af­ter a stint as the ex­ec­u­tive di­rec­tor, busi­ness de­vel­op­ment & li­cens­ing for Mer­ck Re­search Lab­o­ra­to­ries.

Marc Lesnick (SVP, reg­u­la­to­ry and qual­i­ty) co-found­ed and was chief de­vel­op­ment of­fi­cer at Park Ther­a­peu­tics, and his reg­u­la­to­ry knowhow has tak­en him to such com­pa­nies as Sh­iono­gi, Cas­ca­di­an Ther­a­peu­tics and Spruce Ther­a­peu­tics. Jodie Gillon (SVP, cor­po­rate af­fairs and pa­tient ad­vo­ca­cy) is a Big Phar­ma alum who was re­cent­ly Abeona’s chief pa­tient of­fi­cer and head of cor­po­rate and med­ical af­fairs. Al­so new to Pitts­burgh-based Pep­ti­log­ics is Al­bert Fonti­ciel­la (VP of peo­ple), who has worked in the Steel City as VP of cor­po­rate ser­vices for Ed­wards Marc Brands, the choco­lati­er which al­so has The Milk Shake Fac­to­ry and Snap­pers pret­zel snacks with­in its um­brel­la. And Shire vet Steve Kulp (VP of op­er­a­tions) moves on from his cor­po­rate op­er­a­tions gig at Idera Phar­ma­ceu­ti­cals.

Thiel con­tributed to the $35.4 mil­lion Se­ries B that Pep­ti­log­ics an­nounced this past De­cem­ber be­fore Christ­mas.

Lisa Danzig

→ The pieces to the lead­er­ship puz­zle at CRISPR play­er Ex­ci­sion Bio­Ther­a­peu­tics — built around the work of Kamel Khalili — con­tin­ue to fit in­to place with Lisa Danzig tak­ing the CMO reins. Danzig’s lead­er­ship on Ch­i­ron’s clin­i­cal meningo­coc­cal fran­chise team laid the ground­work for her ca­reer; she has held the CMO po­si­tion at Pax­Vax and was glob­al head of med­ical & sci­en­tif­ic af­fairs at No­var­tis. Since its Se­ries A, Ex­ci­sion has al­so ap­point­ed an SVP of clin­i­cal de­vel­op­ment, a CFO and a head of trans­la­tion­al med­i­cine.

→ An­ti-ag­ing play­er Alka­h­est, now a Gri­fols sub­sidiary af­ter a $146 mil­lion deal in Sep­tem­ber 2020, has pegged Am­gen vet César Cere­zo as CMO. Cere­zo piv­ots to Alka­h­est af­ter four years with the phar­ma gi­ant, which just chan­neled Mon­ty Hall again this week and made a deal to ac­quire Teneo­bio for $2.5 bil­lion. For the last year, Cere­zo was Am­gen’s VP, ther­a­peu­tic area head of glob­al af­fairs, gen­er­al med­i­cine in the fol­low­ing ther­a­peu­tic ar­eas: car­dio­vas­cu­lar/meta­bol­ic, bone, nephrol­o­gy, neu­ro­science, in­flam­ma­tion and biosim­i­lars.

Dan­nielle Ap­pel­hans

Dan­nielle Ap­pel­hans has been named COO at Pablo Cagnoni’s Ru­bius Ther­a­peu­tics, which saw its stock soar due to the mid-March re­lease of hu­man da­ta for its red blood cell-de­rived can­cer drug. Ap­pel­hans, an ex-team leader in phar­ma­ceu­ti­cal man­u­fac­tur­ing at Eli Lil­ly, was pre­vi­ous­ly SVP of tech­ni­cal op­er­a­tions and chief tech­ni­cal of­fi­cer for No­var­tis Gene Ther­a­pies. Ru­bius’ shares have since lev­eled off and the biotech is pin­ning its hopes on RTX-240 af­ter “de­pri­or­i­tiz­ing” its lead drug RTX-134 in March 2020.

RARE-X has tapped Char­lene Son Rig­by to helm its com­pa­ny as CEO of the rare dis­ease tech­nol­o­gy non­prof­it. Son Rig­by pre­vi­ous­ly served in po­si­tions at Or­a­cle and Dou­bletwist be­fore hop­ping over to the CBO role at Fab­ric Ge­nomics. Ad­di­tion­al­ly, Nicole Boice, RARE-X’s founder and cur­rent ex­ec­u­tive di­rec­tor, will shift over to the role of chief en­gage­ment of­fi­cer.

→ Fresh off its $40 mil­lion Se­ries A, Stephen Squin­to-led Gen­nao Bio has brought on Clau­dine Prowse as CFO af­ter the biotech an­nounced the ad­di­tion of COO Chris Duke a cou­ple weeks ago. Prowse wraps up her time at Rock­et Phar­ma­ceu­ti­cals (which pre­dates the In­otek merg­er) as SVP, strat­e­gy and cor­po­rate de­vel­op­ment, and she’s been an in­vestor re­la­tions ex­ec with Bio­gen and Hu­man Genome Sci­ences.

Sung You

→ Our Max Gel­man pro­filed Sali­o­Gen when it an­nounced its Se­ries A fi­nanc­ing in March, look­ing to play an in­te­gral part in gene ther­a­py 3.0 by us­ing mam­malian-de­rived en­zymes as its de­liv­ery sys­tem. This week Sali­o­Gen is as­sem­bling more mem­bers of the team with Sung You, chief busi­ness and strat­e­gy of­fi­cer; Nan­cy Craig, SVP of ge­net­ic en­gi­neer­ing and mo­bile el­e­ments; and Sandeep Ne­ma, SVP of tech­ni­cal op­er­a­tions. Be­fore be­com­ing a man­ag­ing part­ner with PBM Cap­i­tal, You was a health­care in­vest­ment bank­ing ex­ec with Mor­gan Stan­ley; Craig’s work in mo­bile ge­net­ic el­e­ments is the dri­ving force be­hind Sali­o­Gen’s gene cod­ing plat­form called ED­IT; and Ne­ma ends a 24-year as­so­ci­a­tion with Pfiz­er, mak­ing his ex­it as ex­ec­u­tive di­rec­tor of bio­ther­a­peu­tics phar­ma­ceu­ti­cal sci­ence.

→ When mi­Ra­gen bought out Virid­i­an last fall — tak­ing the Virid­i­an name with it — Jonathan Vi­o­lin was cho­sen to con­duct the Boul­der, CO biotech or­ches­tra and Bar­rett Katz land­ed the CMO slot. This week Virid­i­an has an­oth­er prin­ci­pal mu­si­cian to add with CFO and CBO Kris­t­ian Humer com­ing on board. Humer had been with Cit­i­group for 11 years, and since 2016 he was man­ag­ing di­rec­tor of bank­ing, cap­i­tal mar­kets & ad­vi­so­ry for Citi’s glob­al health­care team.

Tracey Lodie

→ Treg-fo­cused Quell Ther­a­peu­tics has pulled in Tracey Lodie as CSO, fol­low­ing a stint at Gami­da Cell where she served in the same role. Pri­or to that, she was SVP, tran­si­tion­al im­munol­o­gy at Blue­Rock Ther­a­peu­tics and VP of im­munol­o­gy at Sy­ros Phar­ma­ceu­ti­cals. Lodie jump-start­ed her ca­reer at Sanofi Gen­zyme.

→ With first-year CEO An­drin Os­wald at the con­trols, Cen­to­gene has tapped Patrice Denèfle as CSO start­ing Aug. 16. Denèfle picks up the man­tle from Phil Lam­bert, who’s leav­ing the Ger­man rare dis­ease biotech for undis­closed rea­sons af­ter less than two years on the job. Once the gen­er­al man­ag­er of the Roche In­sti­tute for Re­search and Trans­la­tion­al Med­i­cine, Denèfle has been a chief sci­en­tist be­fore with 4P-Phar­ma and Genethon.

Si­mon Harnest

Si­mon Harnest has an­swered the call to be chief in­vest­ment of­fi­cer at Emeryville, CA-based Metageno­mi, the gene edit­ing biotech that de­buted with a Se­ries A that Leaps by Bay­er co-led in No­vem­ber. When he first clocked in at Cel­lec­tis at 2015, Harnest was VP, fi­nance and in­vestor re­la­tions, and he leaves An­dré Chouli­ka’s team af­ter be­ing pro­mot­ed to chief in­vest­ment of­fi­cer this Jan­u­ary.

Bruce Ker­win

→ The cash spig­ot is flow­ing at Peer Re­view main­stay Umo­ja Bio­phar­ma af­ter its $210 mil­lion Se­ries B in June, and the Seat­tle-based com­pa­ny con­tin­ues its tor­rid hir­ing pace with three new ex­ecs. Bruce Ker­win (SVP of process and prod­uct de­vel­op­ment) was VP of drug prod­uct de­sign at Just Bio­ther­a­peu­tics — al­so out of Seat­tle — and served as a sci­en­tif­ic di­rec­tor in pro­tein for­mu­la­tion de­vel­op­ment at Am­gen, where he spent 16 years. Ryan Lar­son (VP and head of trans­la­tion­al sci­ence) co-found­ed the cell ther­a­py prod­uct sci­ences de­part­ment at Bris­tol My­ers and was se­nior di­rec­tor of the cell ther­a­py prod­uct and an­a­lyt­i­cal team. Fi­nal­ly, Mike Fitz­patrick (VP of busi­ness de­vel­op­ment and op­er­a­tions) is al­so a Bris­tol My­ers vet — spend­ing 15 years at Zy­mo­Ge­net­ics be­fore the 2010 buy­out — with re­spon­si­bil­i­ties rang­ing from pro­tein bio­chem­istry and process de­vel­op­ment to cor­po­rate op­er­a­tions.

Metri­on Bio­sciences has re­cruit­ed Nick Fos­ter as CCO and head of glob­al busi­ness de­vel­op­ment. Fos­ter joins with ex­pe­ri­ence from his times at Bio­Fo­cus (now Charles Riv­er Lab­o­ra­to­ries) as as­so­ciate di­rec­tor, busi­ness de­vel­op­ment Eu­rope; Optib­ri­um as head of com­mer­cial op­er­a­tions; and WuXi AppTec as di­rec­tor, busi­ness de­vl­op­ment.

Anand Shah

Mak­ing its plans to go pub­lic last week, Till­man Gern­gross and Ada­gio Ther­a­peu­tics are build­ing a blue-rib­bon group for its board of di­rec­tors, with Tom Hey­man, Anand Shah and Michael Wyz­ga re­serv­ing their seats along­side Ada­gio chair Rene Rus­so. Hey­man, the ex-pres­i­dent of John­son & John­son De­vel­op­ment Cor­po­ra­tion, re­tired in 2019 af­ter 37 years with J&J. Shah was deputy com­mis­sion­er for med­ical and sci­en­tif­ic af­fairs at the FDA for a year un­til he stepped aside in Jan­u­ary. And Wyz­ga, who was with Gen­zyme from 1993-2011 and was pres­i­dent and CEO of Ra­dius Health, is pres­i­dent of MSW Con­sult­ing, Inc.

Amy Garabe­di­an

→ Not shy­ing away from the IPO vol­cano that has erupt­ed the past cou­ple years, La­va Ther­a­peu­tics ex­ceed­ed $100 mil­lion with its raise in March and has wel­comed Amy Garabe­di­an this week as gen­er­al coun­sel and cor­po­rate sec­re­tary. Garabe­di­an had pre­vi­ous­ly been as­so­ciate gen­er­al coun­sel at Spark, where she had been lend­ing her le­gal ex­per­tise since 2015.

SPT Labtech has some changes in its lead­er­ship team. David New­ble, who has been serv­ing as man­ag­ing di­rec­tor has been tapped as the com­pa­ny’s CEO — tak­ing over for Patrick Ben­nett who will as­sume the role of chair­man of the board. Ad­di­tion­al­ly, Paul Ven­tu­ra has been named VP of sales and Jo­by Jenk­ins joins as VP of busi­ness de­vel­op­ment.

At­tralus has brought on Jake Bauer as an in­de­pen­dent di­rec­tor on its board of di­rec­tors. Bauer was most re­cent­ly CBO of MyoKar­dia and VP, busi­ness op­er­a­tions and head of cor­po­rate de­vel­op­ment at Ablex­is.

Adri­an Woolf­son

→ Af­ter Sang­amo’s R&D split last sum­mer, Adri­an Woolf­son has resur­faced as a board mem­ber at Im­munoScape, which ze­roes in on tech­nol­o­gy “that al­lows for im­mune pro­fil­ing and char­ac­ter­i­za­tion of the hu­man im­mune re­sponse at ex­treme­ly high res­o­lu­tion.” Ja­son Fontenot, the act­ing head of re­search af­ter Woolf­son’s de­par­ture, has since been pro­mot­ed to CSO, while Rob Schott came in to lead de­vel­op­ment at Sang­amo ear­li­er this year.

→ Siz­ing things up for an IPO ac­cord­ing to Bloomberg, Sin­ga­pore’s Hum­ming­bird Bio­science has beefed up its board of di­rec­tors with Fred Hutch pres­i­dent Tom Lynch. In May, Hum­ming­bird raised $125 mil­lion for its pre­ci­sion on­col­o­gy pipeline in a Se­ries C led by No­vo Hold­ings.

He­len Collins

Troy Wil­son-led Ku­ra On­col­o­gy has made He­len Collins a mem­ber of its board of di­rec­tors. The CMO at Five Prime un­til the Am­gen pur­chase, Collins has al­so been Gilead’s glob­al lead of on­col­o­gy biosim­i­lars.

→ Cam­bridge, MA im­muno-on­col­o­gy biotech On­corus has opened up a seat for Bar­bara Yan­ni on a board of di­rec­tors that has ex­pand­ed in the last year af­ter the ap­point­ments of Scott Canute and fel­low Mer­ck vet Er­ic Ru­bin. Yan­ni re­tired from Mer­ck in 2014 as VP and chief li­cens­ing of­fi­cer

Karimah Es Sabar

Lin­da Mar­bán and the folks at Capri­cor Ther­a­peu­tics are bring­ing in Karimah Es Sabar as a mem­ber of their board of di­rec­tors. Es Sabar is CEO and part­ner at Van­cou­ver-based Quark Ven­ture and she chairs the Health & Bio­sciences Eco­nom­ic Strat­e­gy Table for the gov­ern­ment of Cana­da.

→ Cell and gene ther­a­py biotech In­cep­tor Bio has named Mark Gilbert as chair of its sci­en­tif­ic ad­vi­so­ry board. Gilbert was the for­mer CMO of Juno Ther­a­peu­tics and was a fac­ul­ty mem­ber at Fred Hutch and the Uni­ver­si­ty of Wash­ing­ton in Seat­tle.

Janssen vet Mark Bach has gained a seat on the clin­i­cal sci­en­tif­ic ad­vi­so­ry board at Lu­mos Phar­ma. Bach is cur­rent­ly CMO for ShouTi, hav­ing joined the com­pa­ny from As­cendis Phar­ma.

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

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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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