'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.

5AM Ven­tures: Fu­el­ing the Next Gen­er­a­tion of In­no­va­tors

By RBC Capital Markets
With Andy Schwab, Co-Founder and Managing Partner at 5AM Ventures

Key Points

Prescription Digital Therapeutics, cell therapy technologies, and in silico medicines will be a vital part of future treatment modalities.
Unlocking the potential of the microbiome could be the missing link to better disease diagnosis.
Growing links between academia, industry, and venture capital are spinning out more innovative biotech companies.
Biotech is now seen by investors as a growth space as well as a safe haven, fuelling the recent IPO boom.

Biohaven CEO Vlad Coric (Photo Credit: Andrew Venditti)

Pssst: That big Bio­haven Alzheimer's study? It was a bust. Even the sub­group analy­sis ex­ecs tout­ed was a flop

You know it’s bad when a biopharma player plucks out a subgroup analysis for a positive take — even though it was way off the statistical mark for success, like everything else.

So it was for Biohaven $BHVN on MLK Monday, as the biotech reported on the holiday that their Phase II/III Alzheimer’s study for troriluzole flunked both co-primary endpoints as well as a key biomarker analysis.

The drug — a revised version of the ALS drug riluzole designed to regulate glutamate — did not “statistically differentiate” from placebo on the Alzheimer’s Disease Assessment Scale-Cognitive Subscale 11 (ADAS-cog) and the Clinical Dementia Rating Scale Sum of Boxes (CDR-SB).  The “hippocampal volume” assessment by MRI also failed to distinguish itself from placebo for all patients fitting the mild-to-moderate disease profile they had established for the study.

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News brief­ing: Ve­rastem CMO ex­its two weeks af­ter join­ing com­pa­ny; Ther­mo Fish­er inks $550M M&A deal

Two weeks after joining Verastem Oncology as chief medical officer, Frank Neumann is leaving the company for another job.

Neumann had joined Verastem after leaving bluebird bio, which surprisingly split into two companies last week, one in oncology and one in rare diseases. It’s not yet clear to where Neumann is headed next, but he noted in a statement that Verastem’s data and strategy were “truly exciting.”

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A month after filing the IND application for its human extracellular matrix designed to regenerate knee cartilage, Histogen has hit a roadblock.

The FDA on Tuesday verbally notified the San Diego-based biotech that it was placing a clinical hold on the planned Phase I/II clinical trial of HST-003 due to pending CMC information and additional questions needed to complete their review.

Histogen had planned to test the safety and efficacy of implanting hECM within microfracture interstices and related cartilage defects to regenerate that cartilage in conjunction with a microfracture procedure. The company said in a press release that it expects to receive written notice of the clinical hold from the FDA by Feb 12.

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Grit­stone con­tin­ues Covid-19 push with deal to de­vel­op 'self-am­pli­fy­ing RNA' vac­cines, as shares con­tin­ue bal­loon­ing

Gritstone Oncology has had a big week, and it’s only Wednesday.

On Tuesday, the biotech revealed plans to start clinical testing of an experimental Covid-19 vaccine — in tandem with NIAID — that can also target other coronaviruses, with the goal of preventing future pandemics should SARS-CoV-2 prove difficult to cure with current vaccines. Then, on Wednesday morning, Gritstone licensed lipid nanoparticle technology from Genevant Sciences to develop what it’s calling “self-amplifying RNA vaccines” against Covid-19.

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Glax­o­SmithK­line's $4B bis­pe­cif­ic can­cer drug al­liance with Mer­ck KGaA hit by big set­back with a PhI­II fail­ure on NSCLC

Close to 2 years ago, GSK’s R&D team eagerly agreed to pay up to $4 billion-plus to ally itself with Merck KGaA on a mid-stage bispecific called bintrafusp alfa, which intrigued them with the combination of a TGF-β trap with the anti-PD-L1 mechanism in one fusion protein.

But today the German pharma company says that their lead study on lung cancer was a bust, as independent monitors said there was no reason to believe that the experimental drug — targeting PD-L1/TGF-Beta — could beat Keytruda.

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Janet Woodcock and Joshua Sharfstein (AP, Images)

Poll: Should Joshua Sharf­stein or Janet Wood­cock lead the FDA from here?

It’s time for a new FDA commissioner to come on board, a rite of passage for Joe Biden’s administration that should help seal the new president’s rep on seeking out the experts to lead the government over the next 4 years.

As of now, the competition for the top job appears to have narrowed down to 2 people: The longtime CDER chief Janet Woodcock and Joshua Sharfstein, the former principal deputy at the FDA under Peggy Hamburg. Both were appointed by Barack Obama.

Bris­tol My­ers Squibb gets re­view date for Op­di­vo com­bo in gas­tric can­cer, look­ing to over­turn Keytru­da's 3-year lead

The past two months have been tough for Bristol Myers Squibb and its checkpoint inhibitor Opdivo after setbacks in lung and brain cancers. But in the battle against Merck’s Keytruda, any success matters — and now Bristol could be looking at a quick approval for Opdivo in an unmatched indication.

The FDA will launch a speedy review of a combination of Bristol Myers Squibb’s Opdivo and chemotherapy to treat first-line patients with advanced or metastatic gastric cancer, gastroesophageal junction cancer or esophageal adenocarcinoma, the drugmaker said Wednesday. The agency set an action date of May 25 for the application.

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Bristol Myers Squibb isn’t the only pharma giant that’s been standing in the FDA’s waiting line for site inspections.

GlaxoSmithKline is telling us today that their H2 2020 PDUFA deadline for the PD-1 drug dostarlimab — picked up in its Tesaro buyout — was pushed back due to a delay in the manufacturing site inspection needed for a regulatory decision. And that is forcing the company to revise its timeline.

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