'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.

Regeneron CEO Leonard Schleifer speaks at a meeting with President Donald Trump, members of the Coronavirus Task Force, and pharmaceutical executives in the Cabinet Room of the White House (AP Photo/Andrew Harnik)

OWS shifts spot­light to drugs to fight Covid-19, hand­ing Re­gen­eron $450M to be­gin large scale man­u­fac­tur­ing in the US

The US government is on a spending spree. And after committing billions to vaccines defense operations are now doling out more of the big bucks through Operation Warp Speed to back a rapid flip of a drug into the market to stop Covid-19 from ravaging patients — possibly inside of 2 months.

The beneficiary this morning is Regeneron, the big biotech engaged in a frenzied race to develop an antibody cocktail called REGN-COV2 that just started a late-stage program to prove its worth in fighting the virus. BARDA and the Department of Defense are awarding Regeneron a $450 million contract to cover bulk delivery of the cocktail starting as early as late summer, with money added for fill/finish and storage activities.

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Daniel O'Day, Gilead CEO (Kevin Dietsch/UPI/Bloomberg via Getty Images)

A new study points to $6.5B in pub­lic sup­port build­ing the sci­en­tif­ic foun­da­tion of Gilead­'s remde­sivir. Should that be re­flect­ed in the price?

By drug R&D standards, Gilead’s move to repurpose remdesivir for Covid-19 and grab an emergency use authorization was a remarkably easy, low-cost layup that required modest efficacy and a clean safety profile from just a small group of patients.

The drug OK also arrived after Gilead had paid much of the freight on getting it positioned to move fast.

In a study by Fred Ledley, director of the Center for Integration of Science and Industry at Bentley University in Waltham, MA, researchers concluded that the NIH had invested only $46.5 million in the research devoted to the drug ahead of the pandemic, a small sum compared to the more than $1 billion Gilead expected to spend getting it out this year, all on top of what it had already cost in R&D expenses.

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UP­DAT­ED: Bio­gen shares spike as ex­ecs com­plete a de­layed pitch for their con­tro­ver­sial Alzheimer's drug — the next move be­longs to the FDA

Biogen is stepping out onto the high wire today, reporting that the team working on the controversial Alzheimer’s drug aducanumab has now completed their submission to the FDA. And they want the agency to bless it with a priority review that would cut the agency’s decision-making time to a mere 6 months.

The news drove a 10% spike in Biogen’s stock $BIIB ahead of the bell.

Part of that spike can be attributed to a relief rally. Biogen execs rattled backers and a host of analysts earlier in the year when they unexpectedly delayed their filing to the third quarter. That delay provoked all manner of speculation after CEO Michel Vounatsos and R&D chief Al Sandrock failed to persuade influential observers that the pandemic and other factors had slowed the timeline for filing. Actually making the pitch at least satisfies skeptics that the FDA was not likely pushing back as Biogen was pushing in. From the start, Biogen execs claimed that they were doing everything in cooperation with the FDA, saying that regulators had signaled their interest in reviewing the submission.

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FDA bars the door — for now — against Mer­ck’s star can­cer drug af­ter Roche beat them to the punch

Merck has been handed a rare setback at the FDA.

After filing for the accelerated approval of a combination of their star PD-1 drug Keytruda with Eisai’s Lenvima as a first-line treatment for unresectable hepatocellular carcinoma, the FDA nixed the move, handing out a CRL because Roche beat them to the punch on the same indication by a matter of weeks.

According to Merck:

Ahead of the Prescription Drug User Fee Act action dates of Merck’s and Eisai’s applications, another combination therapy was approved based on a randomized, controlled trial that demonstrated overall survival. Consequently, the CRL stated that Merck’s and Eisai’s applications do not provide evidence that Keytruda in combination with Lenvima represents a meaningful advantage over available therapies for the treatment of unresectable or metastatic HCC with no prior systemic therapy for advanced disease. Since the applications for KEYNOTE-524/Study 116 no longer meet the criteria for accelerated approval, both companies plan to work with the FDA to take appropriate next steps, which include conducting a well-controlled clinical trial that demonstrates substantial evidence of effectiveness and the clinical benefit of the combination.

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Covid-19 roundup: Mod­er­na sticks to Ju­ly for its Phase III as ru­mors swirl; Fol­low­ing US lead, EU buys up Covid-19 treat­ments

The Phase III might be delayed from its original early July goal, but Moderna says it will still kick off the pivotal study for what could ultimately be the first Covid-19 vaccine before the end of the month.

A day after Reuters reported that squabbling between the Cambridge biotech and government regulators had held up the trial by about two weeks, Moderna released a statement saying that they had completed enrollment of their 650-person Phase II trial and were on track to begin Phase III by the end of the month. The protocol for that study, which is meant to prove whether or not the vaccine can prevent people from becoming sick, has been finalized, they said.

Stephen Hahn, AP

Trump and Navar­ro press again for hy­drox­y­chloro­quine. Can the FDA stay in­de­pen­dent?

Tuesday morning, economist and Trump advisor Peter Navarro walked onto the White House driveway and promptly brought a political cloud back onto the FDA.

Speaking to a White House pool reporter, Navarro said that four Detroit doctors were, based on a single disputed study, filing for the FDA to again issue an emergency authorization for hydroxychloroquine, the anti-malarial pill that President Trump hyped for months as a Covid-19 treatment over the objections of his own scientists. Then, while avoiding directly calling for the FDA to OK the drug, blasted the agency. He said its decision to pull an earlier authorization “was based on bad science” and “had a tremendously negative effect” on doctors and patients.

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Zai Lab inks Chi­na deal with Turn­ing Point with $25M up­front; Xen­cor, Atre­ca team up on bis­pecifics

Zai Lab is paying out a $25 million upfront for the rights to sell Turning Point Therapeutics’ lead drug repotrectinib in Greater China. The San Diego-based biotech is also in line for up to $151 million in milestones, along with mid-to-high teen royalties. Zai plans to add sites to the Phase II trial of the drug, which is designed to treat ROS1-positive advanced NSCLC in patients who were not previously treated with a TKI.

Sin­gu­lar fo­cus on ROR1 earns Velos­Bio $137M to fund PhI ADC and oth­er pro­grams

Years after selling Acerta to AstraZeneca for $7 billion, largely on the promise of its BTK inhibitor, Dave Johnson has once again gathered hefty financial support behind a new cancer target.

Matrix Capital Management and Surveyor Capital are leading a $137 million round for VelosBio, which has recently begun a Phase I study for its lead antibody-drug conjugate targeted against ROR1. Johnson took up the CEO post in October 2018.

Roger Tung, Concert Pharmaceuticals CEO (Concert)

Con­cert gets BTD for alope­cia drug, set­ting up a late-stage show­down with gi­ant ri­val Pfiz­er

Concert Pharmaceuticals’ path to developing a drug that treats alopecia areata has been bumpy, but the pharma company scored a win Wednesday.

The FDA granted Concert a Breakthrough Therapy Designation (BTD) for its oral Janus kinase inhibitor, named CTP-543, paving the way for a Phase III study of the drug to begin in the fourth quarter of 2020. The news follows positive Phase II results from last September, which saw the drug meet its primary endpoint in both 8 mg and 12 mg twice-daily doses.