'Ris­ing star' CEO re­counts path from pre-med to break­through meds; Den­dreon taps Big Phar­ma vet Ja­son O'Neill as CEO

Fresh­man year was a trans­for­ma­tive one for Aet­na Wun Tromb­ley.

Aet­na Wun Tromb­ley

Hav­ing en­rolled at the Uni­ver­si­ty of Cal­i­for­nia, San Diego think­ing she would be­come a pe­di­a­tri­cian some day, she got in­trigued by the chem­istry re­search projects she was in­tro­duced to in her first un­der­grad­u­ate chem­istry course. She joined the lab of the lec­tur­er, paving the way for her to drop pre-med and even­tu­al­ly com­plete a PhD at MIT.

But there was al­so a rea­son why the re­search — which fo­cused on in­or­gan­ic chem­istry more in the ma­te­r­i­al space — ul­ti­mate­ly wasn’t sat­is­fy­ing enough. Af­ter her first year in col­lege, her fa­ther quite abrupt­ly passed away from liv­er can­cer.

“The most dif­fi­cult thing for me to un­der­stand — and I think it’s still true to­day — was that there were no good treat­ments for some­one like him,” Tromb­ley, the new­ly in­stalled CEO at Ly­cia Ther­a­peu­tics, told End­points News. “It was metasta­t­ic at the time, but even — I mean, where are we now? Many years lat­er, decades lat­er, we still don’t have re­al­ly good treat­ments for he­pa­to­cel­lu­lar car­ci­no­ma.”

The de­sire to ap­ply her prob­lem solv­ing an­a­lyt­i­cal skills to biotech led her to the Pa­lo Al­to of­fice of McK­in­sey, where she got ac­quaint­ed with both Big Phar­ma and small biotechs on the West Coast. It was al­so there that she met col­leagues who would go on to take up roles at Ver­sant Ven­tures.

“We knew from that time that she was a ris­ing star,” Clare Oza­wa, a Ver­sant man­ag­ing di­rec­tor who’s al­so on Ly­cia’s board, said. “To be hon­est, she’s been on our radar screen for some time. As soon as she seemed to be in the right place for her­self, per­son­al­ly and pro­fes­sion­al­ly, to make a move to CEO, we want­ed to try to grab her.”

Not that Tromb­ley has ever re­al­ly want­ed to take the helm com­pa­ny — es­pe­cial­ly af­ter serv­ing as chief of staff to Joe Jimenez at No­var­tis’ Basel head­quar­ters.

“See­ing what a CEO does, and what they bear, in terms of all the re­spon­si­bil­i­ty and ac­count­abil­i­ty, at the time it seemed so daunt­ing,” she said. “There’s fires that we would have to deal with.”

If there’s one thing that stood out, though, it might be the hu­man el­e­ment to the role.

Find­ing great peo­ple to work with and dri­ve sci­ence for­ward, she not­ed, is rare. So just as she grasped the op­por­tu­ni­ty to join Bill Rieflin — a for­mer boss and ear­ly men­tor — to build NGM nine years ago, she jumped at the chance to re­al­ize Car­olyn Bertozzi’s ideas about next-gen de­graders that can send ex­tra­cel­lu­lar pro­teins to the lyso­some for dis­pos­al.

“She’s amaz­ing,” Tromb­ley said, re­call­ing her first meet­ing with the Stan­ford pro­fes­sor. “That was ev­i­dent in the first minute of the con­ver­sa­tion.”

Ly­cia cur­rent­ly leans on Ver­sant’s In­cep­tion Dis­cov­ery En­gine as its R&D mus­cle. One of Tromb­ley’s pri­or­i­ties now as the first and on­ly em­ploy­ee is to re­cruit a full-time team and cre­ate a cul­ture where they would want to stay. Set­ting ag­gres­sive goals is al­so im­por­tant, she added.

“Even if you don’t hit all of those goals — be­cause that’s just how sci­ence works some­times — but be­cause you re­al­ly fo­cused every­one on try­ing to achieve them, any progress that they would have made to such ag­gres­sive goals would be tremen­dous val­ue cre­ation for the com­pa­ny,” she said.

Am­ber Tong


Ja­son O’Neill

Den­dreon Phar­ma­ceu­ti­cals, de­vel­op­ers of the pi­o­neer­ing drug Provenge used by men with ad­vanced prostate can­cer, has tapped Ja­son O’Neill as CEO. You name it, O’Neill’s been there: Start­ing out at Pfiz­er, he then moved to Scher­ing-Plough and Bris­tol My­ers Squibb in the 1990s. O’Neill spent nine-and-a-half years in a hand­ful of roles at Sanofi, was briefly at Genen­tech and was the glob­al ther­a­peu­tic area head, im­munol­o­gy & oph­thal­mol­o­gy at Roche. O’Neill was the gen­er­al man­ag­er, rheuma­tol­ogy unit at Mallinck­rodt be­fore be­com­ing the CEO of Irid­i­um Ther­a­peu­tics in 2017.

Pre­ston Klassen will now helm Metacrine — co-found­ed by Rich Hey­man and in the clin­ic with po­ten­tial treat­ments for NASH — as pres­i­dent and CEO. Klassen, an Am­gen vet, was for­mer­ly the EVP, head of R&D for Are­na Phar­ma­ceu­ti­cals and the CMO at Lab­o­ra­toris San­i­fit SL. Ad­di­tion­al­ly, Metacrine an­nounced that As­sem­bly Bio­sciences pres­i­dent and CEO John McHutchi­son will lend his ex­per­tise to the San Diego bio­phar­ma’s board of di­rec­tors.

Franck Brinkhaus

→ Adding to his list of ti­tles at im­muno-on­col­o­gy biotech Epi­cen­tRx, which raised $35 mil­lion last sum­mer in a Se­ries D round, Franck Brinkhaus has been named pres­i­dent of the com­pa­ny. Brinkhaus had been CFO at Epi­cen­tRx, lo­cat­ed in the Tor­rey Pines area of San Diego, since De­cem­ber. Be­fore his ar­rival, Brinkhaus found­ed and was the CEO of Biotech Al­liances In­ter­na­tion­al.

→ UK-based an­ti-ag­ing biotech Ju­ve­nes­cence has wel­comed Ellen Don­nel­ly to the fray as CEO of the epi­ge­net­ics di­vi­sion of the com­pa­ny while al­so helm­ing its port­fo­lio com­pa­ny Sou­vien Bio. Don­nel­ly most re­cent­ly served as CEO of Modus Ther­a­peu­tics AB and has pre­vi­ous­ly held posts at Pfiz­er.

Jef­frey Humphrey is re­plac­ing Adri­an Senderow­icz as CMO of Cam­bridge, MA epi­ge­net­ics play­er Con­stel­la­tion Phar­ma­ceu­ti­cals. Senderow­icz will tran­si­tion to se­nior ad­vi­sor, which will go in­to ef­fect June 22. Be­fore his ar­rival at Con­stel­la­tion, Humphrey was the chief de­vel­op­ment of­fi­cer at Ky­owa Kirin. He’s al­so held se­nior man­age­ment po­si­tions at Pfiz­er, Bay­er and Bris­tol My­ers Squibb.

Yael Hay­on

Pro­tal­ix Bio­Ther­a­peu­tics, which filed a BLA in May for their Fab­ry Dis­ease treat­ment, pe­gu­ni­gal­si­dase al­fa, is bring­ing on Yael Hay­on as VP of R&D. Hay­on will get the ball rolling at Pro­tal­ix af­ter be­ing VP of clin­i­cal af­fairs at Syqe Med­ical in Tel Aviv. Pri­or to that  she led Log­icBio‘s Is­raeli-based R&D fa­cil­i­ty.

→ Cam­bridge, Mass­a­chu­setts-based X4 Phar­ma­ceu­ti­cals — run­ning a Phase III tri­al for its lead drug ma­vorix­afor for the treat­ment of WHIM syn­drome, has pro­mot­ed Re­na­to Skerlj to CSO. Skerlj is one of the sci­en­tif­ic founders of X4. Skerlj hopped aboard the com­pa­ny last Sep­tem­ber as SVP, re­search and de­vel­op­ment. Pri­or to join­ing the com­pa­ny, Skerlj held posts at Lyso­so­mal Ther­a­peu­tics and was head of small mol­e­cule dis­cov­ery at Gen­zyme.

→ Top­ping $90 mil­lion with its Se­ries C round in May, San Diego bio­phar­ma Am­plyx Phar­ma­ceu­ti­cals is adding to its lead­er­ship team with the ap­point­ments of Chris LeMas­ters as chief op­er­at­ing of­fi­cer and Car­los Sat­tler as se­nior vice pres­i­dent, clin­i­cal de­vel­op­ment. LeMas­ters had been EVP and CBO at Mi­rati Ther­a­peu­tics and was al­so the CEO at Pro­mo­some. Sat­tler was pre­vi­ous­ly VP, glob­al med­ical and sci­en­tif­ic af­fairs at Halosyme, and be­fore that, he was at San­doz from 2013-19.

Jo Ellen Schwein­le

→ New Jer­sey-based de­vel­op­er of au­tol­o­gous stem cell ther­a­pies Ren­o­vaCare has gained its first CMO with the ap­point­ment of Jo Ellen Schwein­le. Schwein­le comes with ex­pe­ri­ence from her time as for­mer se­nior med­ical of­fi­cer at the US De­part­ment of Health and Hu­man Ser­vices as well as ex­ec po­si­tions at Bay­er, GSK, and Ch­i­ron/No­var­tis, among oth­ers.

→ There are lead­er­ship moves aplen­ty at iTeos, which fo­cus­es on im­muno-on­col­o­gy and snapped up $125 mil­lion in Se­ries B2 fi­nanc­ing. Cel­gene and Gilead vet Matthew Gall is the new CFO, jump­ing to iTeos from Sarep­ta, where he was SVP of cor­po­rate de­vel­op­ment and trea­sur­er. Yvonne Mc­Grath is now VP of R&D and was pre­vi­ous­ly the chief sci­en­tif­ic of­fi­cer at Com­plix N.V. as well as the head of de­vel­op­ment at Im­muno­core. Mean­while, Philippe Bran­tegem, whose work in biotech be­gan at Sanofi Pas­teur, has signed on as VP of hu­man re­sources.

Justin Renz

Justin Renz has stepped in as CFO of Cal­i­for­nia-based Arde­lyx, which se­cured FDA ap­proval for IBS with Ib­srela in Sep­tem­ber. Renz was pre­vi­ous­ly pres­i­dent and CFO of Cor­re­vio Phar­ma, lead­ing the sale of the com­pa­ny to Ad­vanz Phar­ma in May. Be­fore he helmed Cor­re­vio, he was EVP, CFO and trea­sur­er of Karyopharm Phar­ma­ceu­ti­cals.

→ Ger­man biotech Af­fimed, al­lied with Genen­tech and en­rolling for stud­ies of can­cer drug can­di­dates AFM13 and AFM24, has reeled in An­gus Smith as CFO. Smith had been CFO at Rock­well Med­ical since No­vem­ber 2018, when he left Pernix Ther­a­peu­tics as their SVP, CBO and prin­ci­pal fi­nan­cial of­fi­cer.

TriSalus just in­tro­duced a new CFO in Ra­jesh Mis­try. Now the Den­ver com­pa­ny has a new chief tech­nol­o­gy of­fi­cer in Scott Davie, who will be the site lead for TriSalus’ fa­cil­i­ty in West­min­ster, CO and will over­see re­search and de­vel­op­ment of in­travas­cu­lar in­fu­sion sys­tems. Davie was a long­time pres­ence at Medtron­ic, leav­ing as the se­nior di­rec­tor of R&D.

→ Philadel­phia-based Xy­lo­Cor Ther­a­peu­tics, fo­cused on gene ther­a­py for car­dio­vas­cu­lar dis­ease, has snagged Alexan­der Gaidama­ka as SVP of tech­nol­o­gy, man­u­fac­tur­ing & qual­i­ty. His pre­vi­ous lead­er­ship role came at Am­pliPhi Bio­sciences as VP of chem­istry, man­u­fac­tur­ing & con­trols. He al­so served as CEO and CSO at Per­son­al­ized On­coTher­a­peu­tics.

Alexan­der Gaidama­ka

Ro­mesh Sub­ra­man­ian’s biotech start­up Dyne Ther­a­peu­tics, which is backed by At­las, has re­cruit­ed Daniel Wil­son as VP, head of in­tel­lec­tu­al prop­er­ty. Wil­son joins the Mass­a­chu­setts-based com­pa­ny from Cel­gene, where he served as se­nior cor­po­rate coun­sel. Pri­or to that, he was in­tel­lec­tu­al prop­er­ty coun­sel at Sunovion Phar­ma­ceu­ti­cals.

Af­ter emerg­ing as the biggest win­ner yet dur­ing the pan­dem­ic IPO boom — fetch­ing $424 mil­lion — Leg­end Biotech has wel­comed some new faces to its board of di­rec­tors. The J&J-part­nered CAR-T de­vel­op­er has ap­point­ed ex Juno ex­ec Cora­zon Dat­ing Sanders, cur­rent CEO of Elpi­science Bio­phar­ma­ceu­ti­cals Dar­ren Ji and for­mer AMTD Group ex­ec Philip Yau.

Ca­r­ole Ho

→ Not long af­ter nam­ing Siob­han Nolan Mangi­ni as CFO, NGM Bio is strength­en­ing its board of di­rec­tors. Ca­r­ole Ho, the CMO and head of de­vel­op­ment at De­nali Ther­a­peu­tics since 2015, is jump­ing on to the board. Pri­or to her lead­er­ship roles at De­nali, Ho was VP of ear­ly clin­i­cal de­vel­op­ment at Genen­tech.

→ Af­ter pric­ing a $75 mil­lion IPO in April, ORIC Phar­ma­ceu­ti­cals has wooed Lori Kunkel to its board of di­rec­tors. Kunkel joins the San-Fran­cis­co-based can­cer biotech with ex­pe­ri­ence as act­ing CMO at Loxo On­col­o­gy and CMO at Phar­ma­cyclics and Pro­te­olix.

→ AAV biotech Affinia Ther­a­peu­tics, which raised a $60 mil­lion Se­ries A round that was an­nounced at the end of March, has wel­comed El­liott Si­gal to their board of di­rec­tors. The for­mer CSO and pres­i­dent of R&D at Bris­tol My­ers Squibb, Si­gal had al­so been on the board at Spark Ther­a­peu­tics.

Richard Bag­ger

→ Tiny Tonix Phar­ma­ceu­ti­cals, which has had its share of ups and downs, has en­list­ed Pfiz­er vet Richard Bag­ger to its board of di­rec­tors, re­plac­ing John Rhodes, who stepped down from the po­si­tion of com­pa­ny di­rec­tor. Along with his 16-year stint at Pfiz­er, Bag­ger served as EVP of cor­po­rate af­fairs and mar­ket ac­cess at Cel­gene un­til its ac­qui­si­tion by Bris­tol My­ers Squibb.

Rock­well Med­ical — whose for­mer CEO, Robert Chioi­ni, tried to un­fire him­self in 2018 be­fore reach­ing a set­tle­ment — has ap­point­ed kid­ney dis­ease ex­pert and UCLA emer­i­tus pro­fes­sor of med­i­cine Allen Nis­senson to its board of di­rec­tors. Nis­senson is emer­i­tus CMO of DaVi­ta Kid­ney Care and mem­ber of the board at An­gion Bio­med­ica.

Amolyt Phar­ma — fo­cused on the de­vel­op­ment of ther­a­peu­tic pep­tides for rare en­docrine and meta­bol­ic dis­eases — has tapped Pierre Legault as di­rec­tor and chair­man of its board of di­rec­tors. Legault comes with ex­pe­ri­ence from his time as chair­man of Bi­cy­cle Ther­a­peu­tics and lead di­rec­tor of Urovant Sci­ences, among oth­ers. Legault joins as the com­pa­ny pre­pares to move its first as­set in­to the clin­ic.

→AI-fo­cused twoXAR Phar­ma­ceu­ti­cals has wel­comed Howard Rosen to its board of di­rec­tors. Rosen’s pre­vi­ous stints in­clude roles at Gilead Sci­ences, Kala Phar­ma­ceu­ti­cals and ALZA Cor­po­ra­tion among oth­ers.

ZS Per­spec­tive: 3 Pre­dic­tions on the Fu­ture of Cell & Gene Ther­a­pies

The field of cell and gene therapies (C&GTs) has seen a renaissance, with first generation commercial therapies such as Kymriah, Yescarta, and Luxturna laying the groundwork for an incoming wave of potentially transformative C&GTs that aim to address diverse disease areas. With this renaissance comes several potential opportunities, of which we discuss three predictions below.

Allogenic Natural Killer (NK) Cells have the potential to displace current Cell Therapies in oncology if proven durable.

Despite being early in development, Allogenic NKs are proving to be an attractive new treatment paradigm in oncology. The question of durability of response with allogenic therapies is still an unknown. Fate Therapeutics’ recent phase 1 data for FT516 showed relatively quicker relapses vs already approved autologous CAR-Ts. However, other manufacturers, like Allogene for their allogenic CAR-T therapy ALLO-501A, are exploring novel lymphodepletion approaches to improve persistence of allogenic cells. Nevertheless, allogenic NKs demonstrate a strong value proposition relative to their T cell counterparts due to comparable response rates (so far) combined with the added advantage of a significantly safer AE profile. Specifically, little to no risk of graft versus host disease (GvHD), cytotoxic release syndrome (CRS), and neurotoxicity (NT) have been seen so far with allogenic NK cells (Fig. 1). In addition, being able to harness an allogenic cell source gives way to operational advantages as “off-the-shelf” products provide improved turnaround time (TAT), scalability, and potentially reduced cost. NKs are currently in development for a variety of overlapping hematological indications with chimeric antigen receptor T cells (CAR-Ts) today, and the question remains to what extent they will disrupt the current cell therapy landscape. Click for more details.

What lured Hal Bar­ron away?; Top FDA minds on ac­cel­er­at­ed ap­proval re­forms; ‘Dead wrong’ Aduhelm ad blitz; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

Nothing can really compete with Hal Barron’s departure from GlaxoSmithKline as the news of the week, but we do have plenty of original reporting and analysis from the Endpoints team in this edition. Enjoy and have a nice weekend.

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Mer­ck wins le­gal bat­tle over in­sur­ance cov­er­age af­ter ran­somware at­tack

Merck has emerged victorious from a years-long legal battle with insurers over the coverage of more than a billion dollars in losses from the malware NotPetya, with a New Jersey Superior Court judge concluding that the responsibility is on insurers to clarify their policies around cyber attacks.

The pharma giant was one of several victims of a global cyber attack back in 2017 that also hit Danish shipping company Maersk, American food company Mondelēz, French construction giant Saint-Gobain and even the systems monitoring the Chernobyl nuclear power stations, Bloomberg reported back in 2019.

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Crit­ics push back on Alzheimer’s As­so­ci­a­tion ad blitz to get Medicare to change its Aduhelm rul­ing: 'Dead wrong'

The latest Alzheimer’s Association advertising campaign encourages people to fight.

Not against the disease or for more research or treatments, but against the Centers for Medicare and Medicaid Services. More specifically, CMS’ recent reimbursement decision to only pay for Biogen and Eisai’s controversial Alzheimer’s drug Aduhelm for patients in clinical trials.

With CMS’ preliminary decision now in a 30-day comment period, patient advocates’ goal is to convince CMS to reverse its decision with a marketing blitz and public pressure.

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Dan O'Day, Gilead CEO (Jim Watson/AFP via Getty Images)

Fail­ing to con­firm clin­i­cal ben­e­fit, Gilead pulls 2 ac­cel­er­at­ed ap­proval in­di­ca­tions for can­cer drug

Gilead recently decided to pull two indications for its cancer drug Zydelig — in relapsed follicular B-cell non-Hodgkin lymphoma (FL) and relapsed small lymphocytic leukemia (SLL) — after failing to complete the confirmatory trials required as part of the accelerated approvals from 2014.

“As the treatment landscape for FL and SLL has evolved, enrollment into the confirmatory study has been an ongoing challenge,” Gilead said in a statement, noting it formally notified the FDA of its decision to voluntarily withdraw these indications.

Richard Pazdur (via AACR)

Time lim­its on ac­cel­er­at­ed ap­provals? FDA's on­col­o­gy chief Rick Paz­dur eyes po­ten­tial re­forms via in­ter­na­tion­al ap­proach­es

The spotlight on the accelerated approval pathway continues to shine bright, with the FDA’s top oncology official writing in an opinion that the pathway may be strengthened with bits and pieces of what other regulators in Europe and elsewhere have done with their expedited approval pathways, such as adding expiration dates for these faster approvals to ensure they confirm clinical benefit in a timely manner.

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Hal Barron, Endpoints UKBIO20 (Jeff Rumans)

'Al­tos was re­al­ly a once-in-a-life­time op­por­tu­ni­ty': Hal Bar­ron re­flects on his big move

By all accounts, Hal Barron had one of the best jobs in Big Pharma R&D. He made more than $11 million in 2020, once again reaping more than his boss, Emma Walmsley, who always championed him at every opportunity. And he oversaw a global R&D effort that struck a variety of big-dollar deals for oncology, neurodegeneration and more.

Sure, the critics never let up about what they saw as a rather uninspiring late-stage pipeline, where the rubber hits the road in the Big Pharma world’s hunt for the next big near-term blockbuster, but the in-house reviews were stellar. And Barron was firmly focused on bringing up the success rate in clinical trials, holding out for the big rewards of moving the dial from an average 10% success rate to 20%.

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Executive Director of the EMA Emer Cooke (AP Photo/Geert Vanden Wijngaert)

Eu­ro­pean Par­lia­ment signs off on strength­en­ing drug reg­u­la­tor's abil­i­ty to tack­le short­ages

The European Parliament on Thursday endorsed a plan to increase the powers of the European Medicines Agency, which will be better equipped to monitor and mitigate shortages of drugs and medical devices.

By a vote of 655 to 31, parliament signed off on a provisional agreement reached with the European Council from last October, in which the EMA will create two shortage steering groups (one for drugs, the other for devices), a new European Shortages Monitoring Platform to facilitate data collection and increase transparency, and on funding for the work of the steering groups, task force, working parties and expert panels that are to be established.

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FDA+ roundup: FDA's neu­ro­science deputy de­parts amid on­go­ing Aduhelm in­ves­ti­ga­tions; Califf on the ropes?

Amid increased scrutiny into the close ties between FDA and Biogen prior to the controversial accelerated approval of Aduhelm, the deputy director of the FDA’s office of neuroscience has called it quits after more than two decades at the agency.

Eric Bastings will now take over as VP of development strategy at Ionis Pharmaceuticals, the company said Wednesday, where he will provide senior clinical and regulatory leadership in support of Ionis’ pipeline.

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