'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.

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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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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Anap­tys­Bio's etokimab pro­vides more dis­ap­point­ing re­sults, rais­ing ques­tions about com­pound's fu­ture

The lead program for AnaptysBio’s in-house pipeline has hit another setback.

Etokimab, an IL-33 inhibitor, did not achieve statistically significant improvement in a Phase II trial for patients suffering from chronic rhinosinusitis with nasal polyps. Researchers measured the individuals’ bilateral nasal polyps score and sino-nasal outcome test, finding that neither improved upon a placebo after both four- and eight-week time markers, though they did demonstrate improvement over baseline levels of the examinations.

Gallia Levy, Spark CMO (Roche)

Spark Ther­a­peu­tics nabs new CMO from Genen­tech, fill­ing a ma­jor post-merg­er de­par­ture

Spark Therapeutics is getting a new CMO from their new owners.

The gene therapy company-turned-subsidiary has named Gallia Levy, who had been running rare blood disorders — including clinical development for their blockbuster-potential hemophilia antibody Hemlibra for Roche’s big biotech sub Genentech — to run medical affairs.

The appointment is a fitting one. Roche spent $4.8 billion to acquire Spark last year in large part to get their hands on their hemophilia gene therapy, SPK-8011, and expand the toe-hold Hemlibra gave them in an crowded hemophilia space.  It’s also a somewhat ironic appointment: The FTC held up the Spark acquistions for nearly a year, reportedly over concerns about the anti-trust implications of Roche owning both a top chronic treatment in Hemlibra and a top one-time treatment in Spark’s gene therapy.

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