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.

Jan Hatzius (Photographer: Christopher Goodney/Bloomberg via Getty Images)

When will it end? Gold­man econ­o­mist gives late-stage vac­cines a good shot at tar­get­ing 'large shares' of the US by mid-2021 — but the down­side is daunt­ing

It took decades for hepatitis B research to deliver a slate of late-stage candidates capable of reining the disease in.

With Covid-19, the same timeline has devoured all of 5 months. And the outcome will influence the lives of billions of people and a multitrillion-dollar world economy.

Count the economists at Goldman Sachs as optimistic that at least one of these leading vaccines will stay on this furiously accelerated pace and get over the regulatory goal line before the end of this year, with a shot at several more near-term OKs. That in turn should lead to the production of billions of doses of vaccines that can create herd immunity in the US by the middle of next year, with Europe following a few months later.

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UP­DAT­ED: No­vavax her­alds the lat­est pos­i­tive snap­shot of ear­ly-stage Covid-19 vac­cine — so why did its stock briefly crater?

High-flying Novavax $NVAX became the latest of the Covid-19 vaccine players to stake out a positive set of biomarker data from its early-stage look at its vaccine in humans.

Their adjuvanted Covid-19 vaccine was “well-tolerated and elicited robust antibody responses numerically superior to that seen in human convalescent sera,” the company noted. According to the biotech:

All subjects developed anti-spike IgG antibodies after a single dose of vaccine, many of them also developing wild-type virus neutralizing antibody responses, and after Dose 2, 100% of participants developed wild-type virus neutralizing antibody responses. Both anti-spike IgG and viral neutralization responses compared favorably to responses from patients with clinically significant COVID‑19 disease. Importantly, the IgG antibody response was highly correlated with neutralization titers, demonstrating that a significant proportion of antibodies were functional.

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Lund­beck sounds taps on an­oth­er CNS drug, re­treat­ing from a mine field still oc­cu­pied by a Mer­ck team

Lundbeck has snipped another clinical-stage branch of its CNS research, dumping a schizophrenia program after determining that their therapy would have no positive influence on the disease.

Designed originally as a 240-patient study, researchers set out in early 2019 to see if a homegrown drug dubbed Lu AF11167 could make it through a proof-of-concept study. The drug is a PDE10Ai inhibitor, targeting an enzyme which it said at the time offered a new pathway to retuning the body’s neurotransmitter dopamine. The big idea was that by hitting their target, the drug would modulate “dopamine D1 and D2 receptor-mediated intraneuronal signaling without binding to these receptors,” influencing negative symptoms of schizophrenia.

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Sean Nolan and RA Session II

Less than 3 months af­ter launch, the AveX­is crew’s Taysha rais­es $95M Se­ries B. Is an IPO next?

The old AveXis team is moving quickly in Dallas.

Three months ago, they launched Taysha with $30 million in Series A funding and a pipeline of gene therapies out of UT Southwestern. Now, they’ve announced an oversubscribed $95 million Series B. And the biotech is declining all interview requests on the news, the kind of broad silence that can indicate an IPO is in the pipeline.

Biotechs, including those relatively fresh off launch, have been going public at a frenzy since the pandemic began. Investors have showed a willingness to put upwards of $200 million to companies that have yet to bring a drug into the clinic. Still, if Taysha were to go public in the near future, it would be perhaps the shortest path from launch to IPO in recent biotech memory.

Stéphane Bancel, Moderna CEO (Steven Ferdman/Getty Images)

Mod­er­na CEO Stéphane Ban­cel out­lines a prospec­tive moth­er­lode of Covid-19 vac­cine rev­enue — will a back­lash fol­low?

Moderna shows no sign of slowing down, or turning charitable when it comes to pricing supplies of its Covid-19 vaccine.

One of the leaders in the Phase III race to get a Covid-19 vaccine across the finish line in record time, Moderna says it’s on track to complete enrollment in one of the most avidly watched studies in the world next month. And the biotech has already banked some $400 million in deposits for vaccine supply as it works through negotiations with countries around the world — as CEO Stéphane Bancel sets out to hire a commercial team.

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Covid-19 roundup: J&J and BAR­DA agree to $1 bil­lion for 100 mil­lion dos­es; Plas­ma re­duces mor­tal­i­ty by 50% — re­ports

J&J has become the latest vaccine developer to agree to supply BARDA with doses of their Covid-19 vaccine, signing an agreement that will give the government 100 million doses in exchange for $1 billion in funding.

The agreement, similar to those signed by Novavax, Sanofi and AstraZeneca-Oxford, provides funding not only for individual doses but to help J&J ramp up manufacturing. Pfizer, by contrast, received $1.95 billion for the doses alone. Still, if one looked at each agreement as purchase amounts, J&J’s deal would be $10 per dose, slotting in between Novavax’s $16 per dose and AstraZeneca’s $4 per dose.

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J&J gets a fresh OK for es­ke­t­a­mine, but is it re­al­ly the game-chang­er for de­pres­sion Trump keeps tweet­ing about?

Backed by an enthusiastic set of tweets from President Trump and a landmark OK for depression, J&J scooped up a new approval from the FDA for Spravato today. But this latest advance will likely bring fresh scrutiny to a drug that’s spurred some serious questions about the data, as well as the price.

First, the approval.

Regulators stamped their OK on the use of Spravato — developed as esketamine, a nasal spray version of the party drug Special K or ketamine — for patients suffering from major depressive disorder with acute suicidal ideation or behavior.

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RA, No­var­tis back Gen­tiBio's seed round, plans to launch de­vel­op­ment of En­gTreg ther­a­pies

Boston, MA-based startup GentiBio landed a $20 million seed fund from three investors to dive into engineered regulatory T cell (EngTreg) development.

Marquee investors OrbiMed, Novartis Venture Fund and RA Capital Management have backed GentiBio’s mission to develop EngTregs for the treatment of autoimmune, alloimmune, autoinflammatory, and allergic diseases. Unlike other companies studying treatments using a patient’s own Tregs, GentiBio plans to make use of CD4+ immune cells, found in the blood.

Paul Laikind, ViaCyte CEO

Stem cell play­er Vi­a­Cyte ex­pands col­lab­o­ra­tion with Gore to de­vel­op sub­cu­ta­neous di­a­betes treat­ment

Longtime stem cell player ViaCyte has teamed up with a materials science company in an effort to solve immunosuppression challenges and advance its type 1 diabetes treatments.

Expanding on an existing collaboration, ViaCyte and W.L. Gore have agreed to combine the biotech’s PEC-Encap candidate with a Gore-produced membrane in what they hope will eliminate the need for immunosuppressive drugs. Such treatments have created foreign body responses in the past, and stamping these reactions out is the main goal, ViaCyte CEO Paul Laikind said.