Tetraphase deal done, La Jol­la Phar­ma­ceu­ti­cal taps Lar­ry Ed­wards as CEO; Long­time Eli Lil­ly ex­ec Michael Over­dorf heads to An­nex­on as CBO

Lar­ry Ed­wards

→ As La Jol­la Phar­ma­ceu­ti­cal closed on their ac­qui­si­tion of Tetraphase on Wednes­day, the San Diego biotech al­so an­nounced that they’re tak­ing the pres­i­dent and CEO right along with them as Lar­ry Ed­wards steps in. Ed­wards, who had a 15-year run at Mer­ck and was a glob­al mar­ket­ing di­rec­tor for the phar­ma gi­ant, spent the last year at the helm at Tetraphase and 5 years over­all in oth­er roles.

Last No­vem­ber, George Tid­marsh walked away as La Jol­la’s top ex­ec “to pur­sue oth­er in­ter­ests” af­ter their drug LJPC-401 flamed out for be­ta tha­lassemia pa­tients and the study (LJ401-BT01) was sum­mar­i­ly scrapped.

An­nex­on, Dou­glas Love’s Bay Area biotech that joined the IPO craze this month with a $100 mil­lion raise, has a new CBO in Eli Lil­ly vet Michael Over­dorf. Leav­ing Lil­ly af­ter more than 19 years, Over­dorf had been the phar­ma gi­ant’s VP, cor­po­rate busi­ness de­vel­op­ment the last 2 years, and be­fore tak­ing that on, he was their VP, cor­po­rate strat­e­gy & busi­ness trans­for­ma­tion. He al­so co-found­ed and was the chair­man and CEO of In­nosight be­fore mov­ing on to Lil­ly.

→ Dutch clin­i­cal on­col­o­gy biotech Merus, which changed CEOs in De­cem­ber, has wel­comed Big Phar­ma vet An­drew Joe as their CMO. Joe helped co-de­vel­op Lib­tayo with Re­gen­eron while he led Sanofi’s im­muno-on­col­o­gy pro­gram, and he al­so led the new in­di­ca­tions de­vel­op­ment team at Mer­ck for Keytru­da, help­ing nab ap­provals for Mi­crosatel­lite In­sta­bil­i­ty-High (MSI-H) can­cer and cer­vi­cal can­cer. Joe al­so spent time as med­ical di­rec­tor for No­var­tis and Roche.

Patrick Bur­nett

Patrick Bur­nett has been tapped as CMO of Fra­zier-backed im­muno-der­ma­tol­ogy bio­phar­ma Ar­cutis Ther­a­peu­tics, which se­cured an up­sized $159 mil­lion IPO in Jan­u­ary. Bur­nett jumps to Ar­cutis from Ver­ri­ca Phar­ma­ceu­ti­cals, where he was CMO the last 2 years. A for­mer glob­al pro­gram med­ical di­rec­tor at No­var­tis, Bur­nett was as­so­ciate VP of clin­i­cal de­vel­op­ment, der­ma­tol­ogy and rheuma­tol­ogy at Sun Phar­ma­ceu­ti­cal, shep­herd­ing the BLA for Ilumya in pa­tients with pso­ri­a­sis in the US and Eu­rope.

→ Top­ping up their IPO at $298 mil­lion in June, Avid­i­ty Bio­sciences has se­lect­ed Jae Kim as CMO. Be­fore mov­ing to Avid­i­ty, a play­er in oligonu­cleotide-based ther­a­pies to fight mus­cle dis­or­ders, Kim spent 4 years at Al­ny­lam as VP of clin­i­cal de­vel­op­ment and was al­so clin­i­cal re­search head and chair of the clin­i­cal tri­al re­view board. Pri­or to Al­ny­lam, he was ex­ec­u­tive di­rec­tor, clin­i­cal re­search at MyoKar­dia and glob­al de­vel­op­ment leader at Am­gen.

Paul Liz­zul has signed on at San Diego-based Anap­tys Bio as their CMO. Be­fore he joined the drug de­vel­op­er, whose an­ti-IL-33 an­ti­body etokimab struck out for eczema in No­vem­ber, Liz­zul had been glob­al de­vel­op­ment lead for in­flam­ma­tion at Am­gen, and be­fore that, the CMO of Si­en­na Bio­phar­ma­ceu­ti­cals and se­nior med­ical di­rec­tor at Kythera Bio­phar­ma­ceu­ti­cals.

Gad Berdugo

Part­nered with Al­ler­gan on the BRIL­LIANCE tri­al that treat­ed its first pa­tient for a rare ge­net­ic mu­ta­tion that caus­es blind­ness with in vi­vo CRISPR, gene edit­ing pi­o­neer Ed­i­tas Med­i­cine has brought on Gad Berdugo as CBO. Berdugo had been co-founder, CEO and a board mem­ber at Epi­Vax On­col­o­gy be­fore join­ing the CRISPR biotech, which saw a slew of de­par­tures that cul­mi­nat­ed in CEO Ka­trine Bosley sud­den­ly part­ing ways in Jan­u­ary 2019. Berdugo was al­so EVP and CFO at Im­mune Phar­ma­ceu­ti­cals.

→ Stock­holm-based Moberg Phar­ma, putting an em­pha­sis on their nail fun­gus treat­ment MOB-015 with Phase III stud­ies un­der­way, has called up­on Cindy Wong to be CMO. Wong comes from Merz Phar­ma­ceu­ti­cals GmbH, where she was VP and head of glob­al clin­i­cal de­vel­op­ment. She al­so has pre­vi­ous CMO ex­pe­ri­ence at Q-Med/Gal­der­ma.

Bri­an Dow has been named CFO of breast can­cer-fo­cused Agen­dia. Pri­or to join­ing the Cal­i­for­nia pre­ci­sion on­col­o­gy play­er, Dow held the CFO post for 4 years at Pulse Bio­sciences, steer­ing the com­pa­ny through its ear­ly-stage IPO, and was briefly the CFO at Prog­y­ny. He al­so had a 5-year tenure as VP and prin­ci­pal ac­count­ing of­fi­cer at Pa­cif­ic Bio­sciences.

Ivan Zhu

→ Scor­ing $104 mil­lion in Jan­u­ary as the first Chi­nese biotech since Zai Lab to hit Nas­daq, and now search­ing for a US part­ner, Shang­hai-based I-Mab has made Ivan Yifei Zhu their chief com­mer­cial of­fi­cer. Zhu, the ex-CCO of BeiGene, was pre­vi­ous­ly Qilu Phar­ma­ceu­ti­cal Group’s VP and GM of the sales di­vi­sion. He al­so spent more than 20 years at Chi­nese J&J sub­sidiary Xi’an Janssen.

→ Ex-Helsinn pres­i­dent and CEO William Mann has a new gig as chief op­er­at­ing of­fi­cer at Pitts­burgh-based NeuBase Ther­a­peu­tics, a next-gen­er­a­tion an­ti­sense oligonu­cleotide (ASO) play­er us­ing its PA­TrOL plat­form to tar­get rare ge­net­ic dis­eases. Mann, who kicked off his ca­reer at No­var­tis and was their di­rec­tor of glob­al busi­ness de­vel­op­ment and li­cens­ing, was at the helm at Helsinn from 2009-18. Be­fore Helsinn, he was a busi­ness de­vel­op­ment ex­ec at Sap­phire Ther­a­peu­tics.

Kim­ber­ly Vanover

En­grail Ther­a­peu­tics, which launched in mid-June with a $32 mil­lion Se­ries A thanks to Nan Fung Life Sci­ences, is fill­ing out its team with Kim­ber­ly Vanover as CSO and Eve Tay­lor as VP, clin­i­cal de­vel­op­ment. Vanover and Tay­lor both hail from In­tra-Cel­lu­lar Ther­a­pies: Vanover was SVP, ear­ly stage clin­i­cal de­vel­op­ment and trans­la­tion­al med­i­cine among oth­er roles over 13 years, and Tay­lor was a se­nior di­rec­tor in clin­i­cal de­vel­op­ment. Stephen Cun­ning­ham, Vanover’s pre­de­ces­sor who was al­so EVP, de­vel­op­ment, will tran­si­tion to the role of chief de­vel­op­ment of­fi­cer.

Con­cur­rent with those ap­point­ments, Tony Ho has been elect­ed to En­grail’s board of di­rec­tors, bring­ing the to­tal on their board to 5. He has been EVP of R&D at CRISPR Ther­a­peu­tics the last 3 years.

An­toine Awad

→ Cam­bridge, MA-based Syn­log­ic has pro­mot­ed An­toine Awad to chief op­er­at­ing of­fi­cer af­ter join­ing the com­pa­ny in 2018 as head of tech­ni­cal op­er­a­tions. Be­fore Syn­log­ic, Awad was SVP of CMC and op­er­a­tions at Abpro Ther­a­peu­tics and L.E.A.F. Phar­ma­ceu­ti­cals. On an­oth­er Syn­log­ic note, An­drew Marsh has been named head of de­vel­op­ment op­er­a­tions af­ter lead­ing clin­i­cal de­vel­op­ment at Ra Phar­ma­ceu­ti­cals. Marsh has al­so worked in clin­i­cal de­vel­op­ment at Tetraphase and Zio­pharm On­col­o­gy.

David Binga­man is on board as VP, glob­al clin­i­cal de­vel­op­ment at Swiss eye drop de­vel­op­er Oculis af­ter 9 years at PanOp­ti­ca, where he was se­nior di­rec­tor and head of reti­na de­vel­op­ment. From 1998-2011, Binga­man had a se­ries of roles at Al­con Re­search, the for­mer eye-care di­vi­sion of No­var­tis, among them as­so­ciate di­rec­tor of reti­na R&D.

→ As not­ed last week, the Park­er In­sti­tute for Can­cer Im­munother­a­py has tapped John Con­nol­ly as CSO. Con­nol­ly hops aboard af­ter a stint at Tes­sa Ther­a­peu­tics as its CSO.

Kel­lie Mal­loy Fo­ert­er

On­coSec Med­ical — who faced a full-on class ac­tion com­plaint from Al­pha Hold­ings last No­vem­ber — has pro­mot­ed Kel­lie Mal­loy Fo­ert­er to the role of COO. Mal­loy Fo­ert­er pre­vi­ous­ly served as chief clin­i­cal de­vel­op­ment of­fi­cer and joined the mi­cro­cap biotech in 2018. Pri­or to On­coSec, Mal­loy Fo­ert­er was at Sy­neos Health.

→ San Diego nov­el RNA biotech DTx Phar­ma has cho­sen Bryan Laf­fitte as VP, bi­ol­o­gy. Laf­fitte makes the leap to DTx from In­cep­tion Ther­a­peu­tics, where he served in the same ca­pac­i­ty. Start­ing out as an in­ves­ti­ga­tor in high through­put bi­ol­o­gy for GSK, Laf­fitte logged 13 years at the Ge­nomics In­sti­tute of the No­var­tis Re­search Foun­da­tion, most re­cent­ly as their di­rec­tor, re­gen­er­a­tive med­i­cine.

Joseph Shul­man

→ Not long af­ter grab­bing David Meek­er as their new CEO, Rhythm Phar­ma­ceu­ti­cals has re­cruit­ed Joseph Shul­man as SVP of tech­ni­cal op­er­a­tions. Shul­man was just at Ra Phar­ma­ceu­ti­cals, re­cent­ly ac­quired by UCB, in the same ca­pac­i­ty and has con­sid­er­able tech­ni­cal op­er­a­tions ex­pe­ri­ence at such com­pa­nies as Nov­e­l­ion Ther­a­peu­tics, Zio­pharm On­col­o­gy and Dyax.

→ Waltham, MA CRO and bio­phar­ma ser­vice provider Parex­el has re­in­forced its glob­al reg­u­la­to­ry & ac­cess con­sult­ing team with three new staffers that will be des­ig­nat­ed as tech­ni­cal VPs. Ya­jie Li has been se­nior clin­i­cal re­view­er with the Cen­ter for Drug Eval­u­a­tion (CDE) in Bei­jing and was al­so Janssen’s reg­u­la­to­ry af­fairs ther­a­peu­tic area di­rec­tor for in­fec­tious dis­eases & vac­cines. Jorge Ca­marero is a for­mer al­ter­nate mem­ber of the Com­mit­tee for Med­i­c­i­nal Prod­ucts for Hu­man Use (CHMP) at the EMA, and pri­or to that, led the on­col­o­gy area at the Span­ish Agency for Med­i­cines and Med­ical De­vices. Fi­nal­ly, FDA vet Lu­cas Kempf has held sev­er­al roles at the Cen­ter for Drug Eval­u­a­tion and Re­search and the NIH, in­clud­ing the CDER’s act­ing as­so­ciate di­rec­tor, rare dis­eases pro­gram.

Jens Hol­stein

→ Ge­nom­ic di­ag­nos­tics com­pa­ny Ve­r­a­cyte has nabbed Jim Er­linger as their EVP, gen­er­al coun­sel and sec­re­tary. Er­linger was a part­ner for 27 years at Bryan Cave Leighton Pais­ner be­fore be­com­ing EVP and gen­er­al coun­sel at IQVIA from 2012-18. Fur­ther, Ve­r­a­cyte has added Jens Hol­stein, the CFO at Mor­phoSys since 2011, to their board of di­rec­tors.

Heather Adams has joined Turn­ing Point Ther­a­peu­tics as VP of hu­man re­sources, a cou­ple weeks af­ter the San Diego on­col­o­gy com­pa­ny named An­drew Par­tridge EVP and chief com­mer­cial of­fi­cer. Be­fore head­ing to Turn­ing Point, which signed a deal ear­li­er in the month with Zai Lab to sell re­potrec­tinib in Greater Chi­na, Adams filled HR roles at Bio­nano Ge­nomics be­fore be­com­ing their chief ad­min­is­tra­tion of­fi­cer.

De­r­i­ca Rice

De­r­i­ca Rice and Paula Price have been elect­ed as in­de­pen­dent di­rec­tors at Bris­tol My­ers Squibb, ef­fec­tive Sept. 1. Cur­rent­ly a board mem­ber at the Walt Dis­ney Com­pa­ny, Rice’s tenure at Eli Lil­ly spanned more than 25 years, a good por­tion of that as EVP of glob­al ser­vices and CFO. Price is a for­mer EVP and CFO at Ma­cy’s, where she’s still an ad­vi­sor.

Hematopoi­et­ic stem cell-fo­cused Vor con­tin­ues to ex­pand its board of di­rec­tors, let­ting in David Lub­n­er af­ter Daniel­la Beck­man joined a cou­ple weeks ago. Lub­n­er had been EVP and CFO of Ra Phar­ma­ceu­ti­cals and pri­or to that, he spent near­ly 10 years as SVP and CFO of Tetraphase.

Paula Brown Stafford

Paula Brown Stafford has ex­pand­ed her role at Mor­risville, NC biotech No­van and is now chair of the board in ad­di­tion to lead­ing the com­pa­ny as pres­i­dent and CEO since Feb­ru­ary. Stafford has sat on the board the last 3 years. Along­side this an­nounce­ment, Robert In­gram is re­tir­ing as No­van’s ex­ec­u­tive chair­man, but will stay on as a board mem­ber.

In­cyte EVP and GM, North Amer­i­ca Bar­ry Flan­nel­ly has made his way to the board of di­rec­tors at Pro­tara Ther­a­peu­tics, which got the FDA seal of ap­proval in May with IV choline chlo­ride for in­testi­nal fail­ure-as­so­ci­at­ed liv­er dis­ease (IFALD). Scott Braun­stein re­signed from Pro­tara’s board to con­cen­trate on his role as CEO at Mar­i­nus Phar­ma­ceu­ti­cals, leav­ing the door open for Flan­nel­ly to re­place him.

→ Aus­tralian drug de­vel­op­er Ki­RA Biotech has ap­point­ed Michael Grissinger as an in­de­pen­dent chair of its board of di­rec­tors. Grissinger spent more than 2 decades at J&J in a num­ber of ex­ec­u­tive posts, the lat­est of which was VP, M&A op­er­a­tions, di­vesti­tures, and im­munol­o­gy busi­ness de­vel­op­ment. It was in that role that he was in­volved in the 2017 Acte­lion buy­out.

Wayne Fred­er­ick

For­ma Ther­a­peu­tics has elect­ed Wayne Fred­er­ick to serve on the com­pa­ny’s board of di­rec­tors. Fred­er­ick comes to the Wa­ter­ton, MA-based biotech from Howard Uni­ver­si­ty, where he cur­rent­ly serves as pres­i­dent.

Michael David­son is now on the board of di­rec­tors at New Jer­sey-based cell ther­a­py play­er Cal­adrius Bio­sciences. David­son found­ed and is the CSO at Cor­vidia Ther­a­peu­tics, which was re­cent­ly sold to No­vo Nordisk for $2.1 bil­lion.

OMass Ther­a­peu­tics, which was spun out of Ox­ford in 2016, has named Nathalie Franchi­mont non-ex­ec­u­tive di­rec­tor. Cur­rent­ly, Franchi­mont serves as VP, head of MS and im­munol­o­gy de­vel­op­ment unit at Bio­gen. Pri­or to her role at Bio­gen, Franchi­mont held var­i­ous po­si­tions at Am­gen.

→ Gene ther­a­py-fo­cused Gene­spire has en­list­ed Jörn Aldag as chair­man of the board. Aldag has been the CEO of HOOKIPA Phar­ma since 2016.

Cell and Gene Con­tract Man­u­fac­tur­ers Must Em­brace Dig­i­ti­za­tion

The Cell and Gene Industry is growing at a staggering 30% CAGR and is estimated to reach $14B by 20251. A number of cell, gene and stem cell therapy sponsors currently have novel drug substances and products and many rely on Contract Development Manufacturing Organizations (CDMO) to produce them with adherence to stringent regulatory cGMP conditions. Cell and gene manufacturing for both autologous (one to one) and allogenic (one to many) treatments face difficult issues such as: a complex supply chain, variability on patient and cellular level, cell expansion count and a tight scheduling of lot disposition process. This complexity affects quality, compliance and accountability in the entire vein-to-vein process for critically ill patients.

Phase III read­outs spell dis­as­ter for Genen­tech’s lead IBD drug

Roche had big plans for etrolizumab. Eyeing a hyper-competitive IBD and Crohn’s market where they have not historically been a player, the company rolled out 8 different Phase III trials, testing the antibody for two different uses across a range of different patient groups.

On Monday, Roche released results for 4 of those studies, and they mark a decided setback for both the Swiss pharma and their biotech sub Genentech, potentially spelling an end to a drug they put over half-a-decade and millions of dollars behind.

DFC CEO Adam Boehler and Kodak CEO Jim Continenza (Kodak)

Covid-19 roundup: Cure­Vac beefs up its uni­corn IPO dreams as bil­lion­aire own­er takes this Covid-19 mR­NA play­er on a forced march to Nas­daq; Ko­dak's $765M deal is put on hold

When CureVac initially jotted down $100 million for its IPO raise a couple of weeks ago, it seemed small. The German mRNA player, after all, had jumped into a Covid-19 race that swelled the sails of Moderna and BioNTech by tens of billions. And after raising $640 million in a slate of deals, $100 million in a hot market like this seemed like a pittance in the bigger scheme of things.

Today, we got a look at a figure that probably comes closer to the game-changing number the top execs probably have in mind. Selling 15.3 million shares at the high end of their $14 to $16 range would net a $243 million bounty. Majority owner Dietmar Hopp is putting in another €100 million, bringing the total to around $350 million. And what are the chances they want to do even better than that?

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Eric Shaff (Seres)

UP­DAT­ED: Af­ter a 4-year so­journ, strug­gling mi­cro­bio­me pi­o­neer Seres claims a break­out PhI­II come­back. And shares re­spond in fren­zied spike

Almost exactly 4 years ago, Seres Therapeutics $MCRB experienced one of those soul-crunching failures that can raise big questions about a biotech’s future. Out front in their pursuit of a gut punch to C. difficile infection (CDI), the Phase II test was a flat failure, and investors wiped out a billion dollars of equity value that never returned in the years that followed.

Seres, though, pressed ahead, changing out CEOs a year ago — bidding Merck vet Roger Pomerantz farewell from the C suite — and pushing through a Phase III, hoping that amping up the dosage would make the key difference. And this morning, they unveiled a claim that they had aced the Phase III and positioned themselves for a run at a landmark FDA OK.

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Warren Huff, Reata CEO

Rea­ta sug­gests Friedre­ich's atax­ia pro­gram could be de­layed, send­ing stock plung­ing

Reata Pharmaceuticals $RETA made waves last October when its drug omaveloxolone produced positive trial results in treating a rare neurological disorder, but the candidate’s path forward became much murkier Monday.

In a report of quarterly earnings, the biotech divulged that the FDA is considering delaying omaveloxolone’s NDA pending completion of a second trial. That could push back approval by at least a year given that the target population, individuals with Friedreich’s ataxia, is limited and progression of the hard-to-treat illness is notoriously slow. The Covid-19 pandemic would also hinder Reata’s ability to complete an additional trial.

Michel Vounatsos, Biogen CEO (via YouTube)

UP­DAT­ED: Bio­gen scores a pri­or­i­ty re­view for its Alzheimer's drug ad­u­canum­ab, mov­ing one gi­ant leap for­ward in its con­tro­ver­sial quest

Biogen scored a big win at the FDA today as regulators accepted their application for the controversial Alzheimer’s drug aducanumab and gave it a priority review.

The PDUFA date is March 7, 2021.

Significantly, Biogen says it did not use its priority review voucher to win special treatment at the FDA. The agency handed that out gratis.

That’s the ideal scenario Biogen was looking for as disappointed analysts wondered aloud about the delayed application earlier in the year.

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Vi­da Ven­tures co-leads Dyne's $115M megaround for next-gen oli­go ther­a­pies aimed square­ly at mus­cles

Dyne Therapeutics started out last April with a modest $50 million to mine targeted muscle disease therapies from its in-house conjugate technology. The biotech has now convinced more investors that it’s got gems on its hands, closing $115 million in fresh financing to push its next-gen oligonucleotide drugs into the clinic.

Vida Ventures and Surveyor Capital led the round, joined by a group of other new backers including Wellington Management Company, Logos Capital and Franklin Templeton.

Eli Lil­ly teams with Pieris on HER2+ tu­mors; Op­di­vo + Yer­voy best chemo in mesothe­lioma

Despite the FDA putting a partial clinical hold on its lead program only a few weeks ago, Boston-based Pieris Pharmaceuticals is plowing forward with a new collaboration.

Pieris will work with Eli Lilly to further advance studies on PRS-343, a 4-1BB/HER2 bispecific for HER2-positive tumors, in combination with the latter’s ramucirumab and paclitaxel for the second-line treatment of patients with HER2-positive gastric cancer in a single-arm, Phase II study.

In­novent and Eli Lil­ly chal­lenge Mer­ck­'s mega-block­buster Keytru­da in non-small cell lung can­cer field

China-based Innovent Biologics and its multinational ally Eli Lilly shared Phase III evidence that their PD-1 inhibitor combo can delay the progression of nonsquamous non-small cell lung cancer.

But the drugmakers will face stiff competition in China from Merck’s Keytruda, the ruling PD-1 which is already approved to treat both squamous and nonsquamous NSCLC and boasts positive overall survival rates.

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