Af­ter sev­en months of search­ing, Lan­dos hires a CEO; Mar­ty Du­vall re-emerges from ill-fat­ed On­copep­tides tenure

Gre­go­ry Oakes

Lan­dos Bio­phar­ma has land­ed a new CEO af­ter sev­en months of be­ing led by an in­ter­im chief ex­ec­u­tive.

Gre­go­ry Oakes took the helm of the au­toim­mune biotech this month, bring­ing with him near­ly 30 years of in­dus­try chops, most re­cent­ly as pres­i­dent of Vi­for Phar­ma’s North Amer­i­ca di­vi­sion and, be­fore that, VP at Cel­gene. Oakes al­so spent a bet­ter part of the 2010s at No­var­tis, mak­ing his way up to head of bio­phar­ma­ceu­ti­cals for gener­ics di­vi­sion San­doz.

He as­sumes the top post as Lan­dos fig­ures out its fu­ture path, about 18 months af­ter land­ing on Nas­daq. A “com­plete re­view of clin­i­cal de­vel­op­ment plans” will oc­cur by year’s end, the biotech said this week. Tim Mayleben, the ex-Es­pe­ri­on CEO, had been in­ter­im chief since Josep Bas­saganya-Ri­era’s de­par­ture in No­vem­ber 2021.

“We are ex­cit­ed to lever­age Greg’s strong back­ground in in­flam­ma­tion and im­munol­o­gy as we re­fine and fi­nal­ize de­vel­op­ments plans for our three clin­i­cal-stage prod­uct can­di­dates – omi­lan­cor, NX-13 and LABP-104,” chair­man Chris Garabe­di­an said in a state­ment.

Lan­dos has eval­u­at­ed omi­lan­cor and NX-13 in the clin­ic for ul­cer­a­tive col­i­tis and Crohn’s dis­ease. LABP-104 has al­so been test­ed in the clin­ic for lu­pus and rheuma­toid arthri­tis.

Oakes will al­so be tasked with turn­ing around a com­pa­ny with lit­tle stock $LABP val­ue re­main­ing — go­ing from a peak of $15 last Sep­tem­ber to un­der $1 to­day — and rel­a­tive­ly few funds in the bank. Lan­dos had $73.8 mil­lion at the end of March, just enough to keep the lights on in­to the sec­ond half of 2023, as of a May up­date.

Kyle LaHu­cik


Mar­ty Du­vall

→ We see it all the time in sports: Just be­cause a head coach hits a snag with one team doesn’t mean that coach isn’t be­ing court­ed else­where. So it is with Mar­ty Du­vall, the ex-Toca­gen CEO who has signed on to be chief ex­ec­u­tive at lit­tle-known ADC biotech Ang­iex. Du­vall presided over On­copep­tides when the Swedish biotech de­cid­ed to yank its mul­ti­ple myelo­ma drug Pepax­to from the US mar­ket in Oc­to­ber 2021, send­ing the com­pa­ny in­to a tail­spin. Du­vall left On­copep­tides more than a year in­to the job in No­vem­ber, lead­ing to the re­turn of Jakob Lind­berg as CEO — and the pos­si­ble state­side re­turn of Pepax­to it­self af­ter an un­ex­plained change of heart about the with­draw­al in Jan­u­ary. On Thurs­day, CHMP de­liv­ered a unan­i­mous­ly pos­i­tive opin­ion on Pepax­ti in the EU, set­ting the stage for the EMA’s fi­nal de­ci­sion. Chaired by Iain Dukes, Ang­iex fo­cus­es on nu­clear-de­liv­ered an­ti­body-drug con­ju­gates, or ND-AD­Cs.

Arati Prab­hakar

→ The White House has nom­i­nat­ed Arati Prab­hakar as the next di­rec­tor of the Of­fice of Sci­ence and Tech­nol­o­gy Pol­i­cy (OSTP), the first woman and woman of col­or to be so nom­i­nat­ed. The po­si­tion, which re­quires Sen­ate con­fir­ma­tion, was pre­vi­ous­ly filled by Er­ic Lan­der, the found­ing di­rec­tor of the Broad In­sti­tute who re­signed his post in Feb­ru­ary short­ly af­ter nu­mer­ous ac­counts piled up re­gard­ing his pat­tern of bul­ly­ing and dis­parag­ing staff. The White House bridged the gap by coax­ing Fran­cis Collins out of re­tire­ment be­fore nom­i­nat­ing Prab­hakar, the head of DARPA from 2012-17 and the Na­tion­al In­sti­tute of Stan­dards and Tech­nol­o­gy from 1993-97.

Stephen Gould

→ It didn’t es­cape the litany of biotechs scal­ing back their work­forces, but an­ti­body-fo­cused Atre­ca has shored up its se­nior lead­er­ship with Stephen Gould as CSO. Gould capped a 16-year ca­reer with Genen­tech by spend­ing the last year as ex­ec­u­tive di­rec­tor, trans­la­tion­al on­col­o­gy be­fore ven­tur­ing off to Cal­i­for­nia-based Atre­ca, which de­cid­ed to chop 25% of its staff ear­li­er this month in a re­struc­tur­ing that is ex­pect­ed to keep the train on the tracks through 2023. Phase Ib da­ta are ex­pect­ed for its lead mon­o­clon­al an­ti­body can­di­date ATRC-101 — both as a monother­a­py and in com­bi­na­tion with Mer­ck’s Keytru­da — by year’s end.

John Stuben­rauch

→ Al­ready do­ing a trepak dance over its $167 mil­lion Se­ries C round from March, Bob Nelsen-backed mR­NA play­er Nut­crack­er Ther­a­peu­tics has wel­comed a trio of lead­ers to the stage. John Stuben­rauch, who had a long ca­reer in Mer­ck’s man­u­fac­tur­ing di­vi­sion from 1996-2015, climbs aboard as COO af­ter spend­ing a year at Gilead as VP of bi­o­log­ics com­mer­cial op­er­a­tions (he had been SVP of man­u­fac­tur­ing for Im­munomedics be­fore the buy­out).

Ge­off Nos­rati, now Nut­crack­er’s CBO, had filled the same po­si­tion at Im­munoScape and was SVP of strat­e­gy and cor­po­rate de­vel­op­ment with Aduro Biotech. Fi­nal­ly, Ian Wiener has been named gen­er­al coun­sel, end­ing a near­ly 30-year as­so­ci­a­tion with Los An­ge­les-based Irell & Manel­la.

Tanya Hay­den

→ Ham­pered by a CRL this week for its urea cy­cle dis­or­der drug AC­ER-001 “be­cause the fa­cil­i­ty was not ready for in­spec­tion,” Ac­er Ther­a­peu­tics has nonethe­less pro­mot­ed Tanya Hay­den to COO. Be­fore leap­ing to Ac­er in June 2021 as VP of pro­gram and strate­gic al­liance man­age­ment, Hay­den was head of op­er­a­tional ex­cel­lence at Lon­za’s Bend, OR cam­pus, which the CD­MO gi­ant pur­chased through its ac­qui­si­tion of Bend Re­search in 2017. Hay­den’s pre­de­ces­sor, Har­ry Palmin, will fo­cus sole­ly on his CFO du­ties.

Fil­ip­po Pet­ti

Fil­ip­po Pet­ti is turn­ing in his keys as CEO and CFO of Bel­gium com­pa­ny Celyad On­col­o­gy to pur­sue oth­er op­por­tu­ni­ties. Celyad’s chair­man and co-founder Michel Lussier will serve as in­ter­im CEO un­til the com­pa­ny can find a per­ma­nent re­place­ment. Tak­ing over for Lussier will be Hilde Windels, who has been named chair of the com­pa­ny’s board.

Pet­ti’s de­par­ture fol­lows the re­cent rough patch Celyad faced in Feb­ru­ary af­ter two pa­tients died in a tri­al for its lead can­di­date for col­orec­tal can­cer.

Michael Kauff­man

Michael Kauff­man is mak­ing his way over to Is­rael-based SIRT­Lab Cor­po­ra­tion. The co-founder and for­mer CEO of Karyopharm is tak­ing up the man­tle of CMO and will al­so co-chair the com­pa­ny’s board of di­rec­tors. Pri­or to his stint at Karyopharm, Kauff­man was CMO of Onyx Phar­ma­ceu­ti­cals, CEO of EPIC Phar­ma­ceu­ti­cals and held a va­ri­ety of roles at Mil­len­ni­um Phar­ma­ceu­ti­cals and Bio­gen.

Liq­uidia, which has been in an on­go­ing tus­sle with Unit­ed Ther­a­peu­tics over its com­pet­ing pul­monary ar­te­r­i­al hy­per­ten­sion drugs, has lined up Ra­jeev Sag­gar as CMO, tak­ing over for Tushar Shah on Ju­ly 18. Sag­gar, the for­mer in­ter­im chief of the pul­monary crit­i­cal care di­vi­sion of The Uni­ver­si­ty of Ari­zona Col­lege of Med­i­cine — Phoenix, was re­cent­ly VP of clin­i­cal de­vel­op­ment for Ther­a­vance Bio­phar­ma. In No­vem­ber 2021, Liq­uidia re­ceived a “ten­ta­tive ap­proval” with its in­hala­tion pow­der for PAH, named Yutrepia, and then its stock tum­bled when Unit­ed nabbed an ac­tu­al ap­proval for Ty­va­so DPI in May, all while get­ting en­tan­gled in a patent dis­pute that Unit­ed lost in March.

Ben Yerxa

Ben Yerxa has been named per­ma­nent CEO of Opus Ge­net­ics, a gene ther­a­py play from Lux­tur­na ar­chi­tect Jean Ben­nett that kicked things off with $19 mil­lion in seed fund­ing last Sep­tem­ber. Yerxa, the act­ing CEO at the reti­nal dis­ease biotech since its de­but, has al­so been CEO of The Foun­da­tion Fight­ing Blind­ness and the Reti­nal De­gen­er­a­tion Fund. He al­so co-found­ed En­visia Ther­a­peu­tics and has board seats at such com­pa­nies as Spar­ingVi­sion and Nacu­ity Phar­ma­ceu­ti­cals.

With this move, The Foun­da­tion Fight­ing Blind­ness el­e­vat­ed Ja­son Men­zo to CEO and Rus­sell Kel­ley to man­ag­ing di­rec­tor of the RD Fund.

EMD Serono tells Peer Re­view that Dan Zol­nierz has been named glob­al brand lead for Mer­ck KGaA’s mul­ti­ple scle­ro­sis drug evo­bru­ti­nib, a Bru­ton’s ty­ro­sine ki­nase (BTK) in­hibitor. In 2016, Zol­nierz start­ed out as a mem­ber of the Maven­clad launch team, and two years ago, EMD Serono pro­mot­ed him to neu­rol­o­gy & im­munol­o­gy (N&I) busi­ness unit di­rec­tor for the UK and Ire­land.

Eu­an Men­zies

Jim Datin has re­tired af­ter nine years as chief ex­ec­u­tive of Durham, NC-based CRO BioAg­i­lytix and has been suc­ceed­ed by Eu­an Men­zies, who will al­so be chair­man. Men­zies has al­so been chair­man and CEO of Bio­clin­i­ca (which merged with ERT to form Clario) and the CEO of Vertafore. His ap­point­ment comes af­ter BioAg­i­lytix ap­point­ed two sci­en­tif­ic of­fi­cers — ex-Genen­tech sci­en­tist Lynn Ka­men and Michelle Miller — and added for­mer Lab­corp CEO David King to the board of di­rec­tors.

Ni­na De­Loren­zo

→ Trav­el­ing down a new road af­ter run­ning in­to trou­ble with the De­part­ment of Jus­tice over its opi­oid ad­dic­tion drug — lead­ing to jail time for ex-CEO Shaun Thax­terIn­di­v­ior has se­lect­ed Big Phar­ma vet Ni­na De­Loren­zo as chief glob­al im­pact of­fi­cer. De­Loren­zo comes from a place that’s had its own share of tri­als and tribu­la­tions, Emer­gent BioSo­lu­tions, where she was SVP of glob­al com­mu­ni­ca­tions and pub­lic af­fairs. Ear­li­er, she held pub­lic af­fairs roles at Mer­ck and Pfiz­er; was VP, in­ter­na­tion­al gov­ern­ment af­fairs for Ab­b­Vie; and was chief of staff, ex­ter­nal af­fairs for Sanofi.

Ig­or Ma­tushan­sky

→ There are changes aplen­ty at are­navi­ral im­munother­a­py play­er Hookipa Phar­ma, a month re­moved from Chris­tine Bak­er’s pro­mo­tion to COO. Ig­or Ma­tushan­sky, Hookipa’s CMO and glob­al head of R&D since 2017, will step away from these po­si­tions on June 30, but he’ll main­tain a pres­ence at the biotech as chair­man of the sci­en­tif­ic ad­vi­so­ry board.

Ad­di­tion­al­ly, head of im­muno-on­col­o­gy Ka­tia Schlienger has earned a pro­mo­tion to EVP, clin­i­cal de­vel­op­ment. In her most re­cent stop at Mer­ck, Schlienger was se­nior di­rec­tor, clin­i­cal re­search, late de­vel­op­ment on­col­o­gy (GI tu­mors). And Ro­man Neci­na, who took on the role of chief tech­nol­o­gy of­fi­cer at Hookipa in 2019 af­ter a short stay at Take­da, has now shift­ed to chief de­vel­op­ment of­fi­cer.

Mark Strobeck

→ Iron de­fi­cien­cy out­fit Rock­well Med­ical is cy­cling through an­oth­er CEO as Rus­sell El­li­son ex­its stage left on June 30. He’ll be re­placed on Ju­ly 1 by Aqui­lo Part­ners man­ag­ing di­rec­tor Mark Strobeck, the ex-COO of Zy­la Life Sci­ences and then As­ser­tio Ther­a­peu­tics af­ter the two com­pa­nies merged in 2020. El­li­son be­came chief ex­ec­u­tive in April 2020 af­ter the de­par­ture of Stu­art Paul, and the Paul era fol­lowed the ac­ri­mo­nious fir­ing of Rock­well Med­ical founder Robert Chioi­ni, who re­fused to step down and then sued the com­pa­ny. Chioi­ni would be­come CEO of SQI Di­ag­nos­tics in the sum­mer of 2020, but he was gone with­in nine months.

→ Swedish kid­ney can­cer biotech On­core­na has tapped one of its founders, Bör­je Har­alds­son, as CEO. A long­time pro­fes­sor with the Sahlgren­s­ka Acad­e­my at the Uni­ver­si­ty of Gothen­burg, Har­alds­son led glob­al pro­gram teams at No­var­tis for is­cal­imab — a com­pound that CEO Vas Narasimhan played up, on­ly to see it land with a thud in the kid­ney trans­plant in­di­ca­tion — and ianalum­ab.

Cori Bargmann

Cori Bargmann is step­ping away from her role as head of sci­ence at the Chan Zucker­berg Ini­tia­tive (CZI) to re­turn to her lab at The Rock­e­feller Uni­ver­si­ty. Bargmann is hand­ing the reins over to Stephen Quake, a pro­fes­sor of bio­engi­neer­ing and pro­fes­sor of ap­plied physics at Stan­ford. Quake for­mer­ly served as co-pres­i­dent of the Chan Zucker­berg Bio­hub in San Fran­cis­co and most re­cent­ly served as pres­i­dent of the CZ Bio­hub Net­work.

Bargmann will stay on as a dis­tin­guished fel­low and head of sci­ence emeri­ta at CZI un­til the end of the year be­fore join­ing CZI’s sci­en­tif­ic ad­vi­so­ry board.

Car­rie Melvin

Car­rie Melvin has been named the first COO at Virid­i­an Ther­a­peu­tics, which re­brand­ed from mi­Ra­gen last year and is tack­ling thy­roid eye dis­ease with its lead pro­gram VRDN-001. Melvin had been SVP of clin­i­cal de­vel­op­ment op­er­a­tions at X4 Phar­ma­ceu­ti­cals since Au­gust 2020. She was al­so VP of glob­al clin­i­cal sci­ences and de­liv­ery, on­col­o­gy at GSK af­ter its ac­qui­si­tion of Tesaro, where she was VP of clin­i­cal op­er­a­tions.

Alek­san­dra Ri­zo

→ With Faye Feller tak­ing over as CMO of Geron Cor­po­ra­tion on Ju­ly 9, cur­rent CMO Alek­san­dra Ri­zo will take on a con­sul­tant role as se­nior med­ical and reg­u­la­to­ry ad­vi­sor. Feller has been with Geron since 2019, serv­ing as the ime­tel­stat mak­er’s VP of clin­i­cal de­vel­op­ment. Pri­or to join­ing Geron, Feller was a med­ical leader in the hema­tol­ogy pro­gram at Janssen.

→ Fac­ing reg­u­la­to­ry bar­ri­cades in the PI3K class with its Ky­owa Kirin-part­nered drug zan­delis­ib, MEI Phar­ma has se­lect­ed Anne Frese as chief peo­ple of­fi­cer. The ex-VP of hu­man re­sources at Bel­licum and Arti­va Ther­a­peu­tics, Frese just com­plet­ed a brief stay as chief hu­man re­sources of­fi­cer with Vy­ripharm En­ter­pris­es.

Shaw­na Wolver­ton

→ San Fran­cis­co-based Bench­ling, which last year pulled in a $200 mil­lion Se­ries E in April and a $100 mil­lion Se­ries F in No­vem­ber for its R&D cloud plat­form, has ap­point­ed Shaw­na Wolver­ton as chief prod­uct of­fi­cer and Stu­art Kerst as head of rev­enue op­er­a­tions. Wolver­ton brings ex­pe­ri­ence from Zen­desk and Sales­force, while Kerst most re­cent­ly served as VP of glob­al field op­er­a­tions at Work­day.

Aditya Khosla

→ De­vel­op­ing AI-based ther­a­pies for GI dis­eases, specif­i­cal­ly in­flam­ma­to­ry bow­el dis­ease, It­er­a­tive Scopes has ap­point­ed Aditya Khosla as chief tech­nol­o­gy of­fi­cer. Khosla co-found­ed and was CTO of PathAI, which just teamed up with GSK in April on a NASH/on­col­o­gy drug dis­cov­ery al­liance.

Robert Deni­son

→ Dig­i­tal health com­pa­ny Con­geni­ca is lock­ing in Robert Deni­son as CEO. Deni­son joined the com­pa­ny in Sep­tem­ber 2019 as chief in­for­ma­tion of­fi­cer. Pri­or to join­ing the Cam­bridge, UK-based com­pa­ny, Deni­son was VP of tech­nol­o­gy at Ab­cam and chief tech­nol­o­gy of­fi­cer at Sum­mit Me­dia.

Herve Berdou

→ In­di­an drug man­u­fac­tur­er Pi­ra­mal Phar­ma So­lu­tions — which has been busy open­ing and up­dat­ing its fa­cil­i­ties across the globe — has tapped Herve Berdou as COO. Berdou makes his way to the Mum­bai-based com­pa­ny from Lon­za, where he served as glob­al head of op­er­a­tions, cell and gene tech­nolo­gies. Pri­or to that, Berdou was with As­traZeneca, Med­Im­mune and No­var­tis.

Maryam Ab­dul-Ka­reem

→ Un­spool­ing da­ta at this month’s AS­CO for a BC­MA CAR-T that’s pit­ting it­self against J&J/Leg­end’s Carvyk­ti in mul­ti­ple myelo­ma, Ar­cel­lx has brought on Maryam Ab­dul-Ka­reem as gen­er­al coun­sel. Ab­dul-Ka­reem had been deputy gen­er­al coun­sel at Kin­nate Bio­phar­ma af­ter sev­en years of le­gal roles with As­traZeneca, in­clud­ing as­sis­tant gen­er­al coun­sel, cor­po­rate.

Frank Scholz is up­ping his role at ra­dio­phar­ma­ceu­ti­cals-fo­cused North­Star Med­ical Tech­nolo­gies, be­ing pro­mot­ed to the po­si­tion of pres­i­dent and COO. When Scholz hopped aboard last June, he start­ed as SVP and COO. Scholz came to the com­pa­ny from Al­ix­Part­ners, where he served as man­ag­ing di­rec­tor. Be­fore that, Scholz had a six-year gig with Mallinck­rodt.

Chris Hor­vath

→ To the Cross­roads of Amer­i­ca we go, and with the ra­dio­phar­ma fren­zy show­ing no signs of abat­ing, In­di­anapo­lis-based Point Bio­phar­ma has en­list­ed Chris Hor­vath as EVP, com­mer­cial. Hor­vath brings ex­pe­ri­ence in the space from No­var­tis’ Ad­vanced Ac­cel­er­a­tor Ap­pli­ca­tions, where he was VP, head of US sales and mar­ket­ing, prostate can­cer fran­chise, ra­di­oli­gand ther­a­py. He’s al­so held mar­ket­ing po­si­tions at Janssen, Mer­ck (with Keytru­da), Den­dreon (with Provenge) and Bay­er (with daro­lu­tamide and the ra­dio­phar­ma drug Xofi­go).

Kevin Litwiler

→ Led by Ar­ray Bio­phar­ma co-founder Tony Pis­co­pio, Boul­der, CO can­cer play­er OnKure Ther­a­peu­tics has re­cruit­ed a for­mer Ar­ray col­league, Kevin Litwiler, as SVP of DMPK and clin­i­cal phar­ma­col­o­gy. Litwiler spent 19 years at Ar­ray be­fore Pfiz­er’s $11.4 bil­lion ac­qui­si­tion in 2019, and af­ter the buy­out, he was the phar­ma gi­ant’s ex­ec­u­tive di­rec­tor, clin­i­cal phar­ma­col­o­gy glob­al prod­uct de­vel­op­ment.

Amer­i­can Gene Tech­nolo­gies has named Jeff Boyle as CSO. Boyle joins the com­pa­ny from El­lume USA, where he helped or­ga­nize the con­struc­tion of the com­pa­ny’s au­to­mat­ed man­u­fac­tur­ing fa­cil­i­ty for Covid-19 home tests in part­ner­ship with the De­part­ment of De­fense. Pri­or to that, Boyle was with Qi­a­gen.

→ San Diego-based Tryp Ther­a­peu­tics has added on Sid Tauben­feld as COO. Tauben­feld most re­cent­ly served as CEO of Tikun Olam Phar­ma and has served as a health­care an­a­lyst at com­pa­nies like Scopia Cap­i­tal, RH Cap­i­tal and Paw Part­ners.

Saman­tha Truex

→ DNA dam­age spe­cial­ist and No­var­tis part­ner Ar­tios has added Saman­tha Truex to the board of di­rec­tors. The for­mer chief ex­ec­u­tive at Quench Bio, Truex is now CEO of Up­stream Bio, which set sail with $200 mil­lion in fi­nanc­ing ear­li­er this month. Up­stream’s lead mon­o­clon­al an­ti­body is an Astel­las castoff named UPB-101.

→ For­mer GSK and Sanofi ex­ec Anne Whitak­er has been named chair of the board at ALS biotech QurAlis. Whitak­er, who led the US car­dio­vas­cu­lar, meta­bol­ic and urol­o­gy busi­ness to con­clude her 19 years at GSK, still chairs the board of Aera­mi Ther­a­peu­tics, the com­pa­ny she helmed from 2018-20.

Vik Ba­jaj

Ver­i­ly co-founder and ex-CSO Vik Ba­jaj is slid­ing in­to the board of di­rec­tors at Quan­tum-Si. Ba­jaj cur­rent­ly serves as man­ag­ing di­rec­tor at Fore­site Cap­i­tal and pre­vi­ous­ly served as CSO of Grail.

Doug Fam­brough has clinched his spot on the board of di­rec­tors at On­corus, led by Mod­er­na on­col­o­gy vet Ted Ash­burn. Fam­brough was CEO of Dicer­na from 2010 un­til No­vo Nordisk pur­chased the RNAi biotech for $3.3 bil­lion in late 2021.

Don­na Am­brosi­no

Don­na Am­brosi­no and Big Phar­ma alum Ralf Clemens are walk­ing over to Clover Bio­phar­ma­ceu­ti­cals, join­ing the com­pa­ny’s board of di­rec­tors. Am­brosi­no is on Clover’s vac­cine sci­en­tif­ic ad­vi­so­ry board and she had pre­vi­ous­ly served as CEO of Noso­co­mi­al Vac­cine Cor­po­ra­tion. Clemens, the chair of Val­ne­va’s SAB and a mem­ber of the SAB at Cure­Vac, joins the board as a vet­er­an ex­ec­u­tive from GSK, No­var­tis Vac­cines, and Take­da.

William Kaelin has joined the board of di­rec­tors at IconOVir Bio, which just brought in John Huynh as chief tech­nol­o­gy of­fi­cer a cou­ple weeks ago. The 2019 No­bel Prize re­cip­i­ent is a pro­fes­sor in the De­part­ment of Med­i­cine at Dana-Far­ber and at Brigham and Women’s Hos­pi­tal.

Jill Quigley has been elect­ed to the board of di­rec­tors at Chemomab Ther­a­peu­tics, the Pe­ter Thiel-backed Is­raeli biotech study­ing CM-101 in mul­ti­ple in­di­ca­tions, in­clud­ing pri­ma­ry scle­ros­ing cholan­gi­tis. Quigley left Pas­sage Bio in Jan­u­ary af­ter three years as COO and is a board mem­ber at Terns Phar­ma­ceu­ti­cals.

Derek Graf con­tributed to this edi­tion.

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FDA commissioner Rob Califf (Tom Williams/CQ Roll Call via AP Images)

With drug pric­ing al­most done, Con­gress looks to wrap up FDA user fee leg­is­la­tion

The Senate won’t return from its summer recess until Sept. 6, but when it does, it officially has 18 business days to finalize the reauthorization of the FDA user fee programs for the next 5 years, or else thousands of drug and biologics reviewers will be laid off and PDUFA dates will vanish in the interim.

FDA commissioner Rob Califf recently sent agency staff a memo explaining how, “Our latest estimates are that we have carryover for PDUFA [Prescription Drug User Fee Act], the user fee funding program that will run out of funding first, to cover only about 5 weeks into the next fiscal year.”

Pascal Soriot, AstraZeneca CEO (David Zorrakino/Europa Press via AP Images)

As­traZeneca and Dai­ichi Sankyo sprint to mar­ket af­ter FDA clears En­her­tu in just two weeks

Regulators didn’t keep AstraZeneca and Daiichi Sankyo waiting long at all for their latest Enhertu approval.

The partners pulled a win on Friday in HER2-low breast cancer patients who’ve already failed on chemotherapy, just two weeks after submitting a supplemental BLA. While this isn’t the FDA’s fastest approval — Bristol Myers Squibb won an OK for its blockbuster checkpoint inhibitor Opdivo in just five days back in March — it comes well ahead of Enhertu’s original Q4 PDUFA date.

Ted Love, Global Blood Therapeutics CEO

Up­dat­ed: Pfiz­er scoops up Glob­al Blood Ther­a­peu­tics and its sick­le cell ther­a­pies for $5.4B

Pfizer is dropping $5.4 billion to acquire Global Blood Therapeutics.

Just ahead of the weekend, word got out that Pfizer was close to clinching a $5 billion buyout — albeit with other potential buyers still at the table. The pharma giant, flush with cash from Covid-19 vaccine sales, apparently got out on top.

The deal immediately swells Pfizer’s previously tiny sickle cell disease portfolio from just a Phase I program to one with an approved drug, Oxbryta, plus a whole pipeline that, if all approved, the company believes could make for a $3 billion franchise at peak.

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GSK and IQVIA launch plat­form of US vac­ci­na­tion da­ta, show­ing drop in adult rates

Throughout the Covid-19 pandemic, the issue of vaccine uptake has been a point of contention, but a new platform from GSK and IQVIA is hoping to shed more light on vaccine data, via new transparency and general awareness.

The two companies have launched Vaccine Track, a platform intended to be used by public health officials, medical professionals and others to strengthen data transparency and display vaccination trends. According to the companies, the platform is intended to aid in increasing vaccine rates and will provide data on trends to assist public health efforts.

Ab­b­Vie sur­veys emo­tion­al im­pact of chron­ic leukemia con­di­tion, finds 'roller coast­er' of emo­tions

Rare diseases often have more than just physical effects on patients — especially when it comes to chronic conditions. In the case of the rare slow-growing blood cancer chronic lymphocytic leukemia (CLL), AbbVie wanted to try to assess the mental and emotional toll on patients.

So it surveyed more than 300 CLL patients, caregivers and physicians. While each group differed in how they felt — caregivers overwhelmingly (81%) felt positive about their role, for instance — patients described a “roller coaster” of emotions traversing diagnosis to treatment to remission and even relapse for some.

David Reese, Amgen R&D chief

UP­DAT­ED: In a fresh dis­ap­point­ment, Am­gen spot­lights a ma­jor safe­ty is­sue with KRAS com­bo

Amgen had hoped that its latest study matching its landmark KRAS G12C drug Lumakras with checkpoint inhibitors would open up its treatment horizons and expand its commercial potential. Instead, the combo spurred safety issues that blunted efficacy and forced the pharma giant to alter course on its treatment strategy, once again disappointing analysts who have been tracking the drug’s faltering sales and limited therapeutic reach.

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FDA's vac­cine ad­comm to re­view first fe­cal trans­plant to treat C. dif­fi­cile in­fec­tions

Back in 2018, Swiss drugmaker Ferring Pharmaceuticals made a big bet on Minnesota-based Rebiotix, buying up the company for its experimental poop-based drug implant to treat an infection caused by C. difficile, a potentially dangerous bacteria, in a new way.

Four years later, Ferring’s fecal microbiota transplant, dubbed RBX2660 or Rebyota, will face the FDA’s adcomm of outside vaccine experts on Sept. 22, debating whether the agency should license the transplant as a treatment for adults following antibiotic treatment for recurrent C. difficile infection.

Bernhardt Zeiher, outgoing Astellas CMO (Astellas)

Q&A: Astel­las' re­tir­ing head of de­vel­op­ment re­flects on gene ther­a­py deaths

For anyone who’s been following discussions about the safety alarms surrounding the adeno-associated viruses (AAV) commonly used to deliver gene therapy, Astellas should be a familiar name.

The Japanese pharma — which bought out Audentes Therapeutics near the end of 2019 and later built a gene therapy unit around the acquisition — rocked the field when it reported three patient deaths in a trial testing AT132, the lead program from Audentes designed to treat a rare muscle disease called X-linked myotubular myopathy (XLMTM).

When the company restarted the trial, it adjusted the dose and instituted a battery of other measures to try to prevent the same thing from happening again. But tragically, the first patient to receive the new regimen died just weeks after administration. The therapy remains under clinical hold, and just weeks ago, Astellas flagged another safety-related hold for a separate gene therapy candidate. In the process of investigating the deaths, the company has also taken flak about the way it disclosed information.

Big questions remain — questions that can have big implications about the future of AAV gene therapies.

Bernhardt Zeiher did not imagine any of it when he first joined Astellas as the therapeutic area leader in inflammation, immunology and infectious diseases. But his ascent to chief medical officer and head of development coincided almost exactly with Astellas’ big move into gene therapy, putting him often in the driver’s seat to grapple with the setbacks.

As Zeiher prepares to retire next month after a 12-year tenure — leaving the unfinished tasks to his successor, a seasoned cancer drug developer — he chatted with Endpoints News, in part, to discuss the effort to understand what happened, lessons learned and the criticism along the way.

The transcript has been lightly edited for length and clarity.

Endpoints: I want to also ask you a bit about the gene therapy efforts you’ve been working on. Astellas has really been at the forefront of discovering the safety concerns associated with AAV gene therapy. What’s that been like for you?

Zeiher: Well, I have to admit, it’s been a bit of a roller coaster. We acquired Audentes. Huge amount of enthusiasm. What we saw with AT132 — that was the lead program in XLMTM — was just remarkable efficacy. I mean, kids who went from being on ventilators, not able to eat for themselves, sit up, do things like that, to off ventilators, walking, you know, really — one investigator called it this Lazarus-like effect. It was just really dramatic efficacy. And then to have the safety events that occurred. So they actually occurred within that first year of the acquisition. So we had the three patient deaths. Me and my organization became very, very much involved. In fact, Ed Conner, who had been the chief medical officer, he left after some of the deaths, but I stepped in as the kind of acting chief medical officer, we had another chief medical officer who was involved, and then we had a fourth death, and I became acting again for a period of time.

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