Lau­ra Shawver on why she came back af­ter an $88M wind­fall; Mor­phoSys taps Am­gen vet as CCO

Lau­ra Shawver

Lau­ra Shawver didn’t quite un­der­stand can­cer un­til she had it.

By that point, in 2006, she had al­ready been mak­ing on­col­o­gy drugs for over 15 years, a dyed-in-the-wool re­searcher who had ob­tained a PhD in phar­ma­col­o­gy be­fore re­train­ing her­self as a mol­e­c­u­lar bi­ol­o­gist in the heady pre-Dol­ly days of cloning. She knew all about tu­mors. She knew the genes that drove them and the drugs that halt­ed them. Her pre­vi­ous com­pa­ny, Sug­en, had se­quenced can­cers to de­vel­op suni­tinib, one of the first ki­nase in­hibitors.

”So I thought, oh, I’ll just go to get my tu­mor pro­filed,” Shawver told End­points News in an in­ter­view this week. “What I found out was that Lau­ra Shawver could get oth­er peo­ple’s tu­mors se­quenced, but Lau­ra Shawver the pa­tient — I couldn’t get my tu­mor pro­filed to save my soul. And that pissed me off.”

There was al­so a sec­ond rev­e­la­tion, one marked per­haps less by anger than by a sort of trag­ic clar­i­ty: Sud­den­ly, the year or so you could buy some­one with the drugs biotech was de­vel­op­ing didn’t seem as great a gift.

“I start­ed look­ing quite dif­fer­ent­ly at this, and said, ‘Wait a minute, these tar­get­ed agents — they don’t last that long,’” she said. “We don’t want to treat peo­ple for just 6 to 12 months, we want to pro­vide them cures.”

The can­cer would go — treat­ed with surgery and chemother­a­py, which she took while rais­ing a Se­ries C for her sec­ond ma­jor com­pa­ny, Phe­nomix — but the im­print would stay. Af­ter fi­nal­ly get­ting her tu­mor se­quenced by Ven­tana founder Thomas Gro­gan, Shawver found­ed Clear­i­ty, an or­ga­ni­za­tion ded­i­cat­ed to get­ting women ac­cess to tu­mor pro­fil­ing that can point to­ward treat­ments. And she be­came ob­sessed with im­muno-on­col­o­gy, a field that seemed to hold the promise to bring­ing pa­tients the clos­est thing to a cure.

Now, Shawver will get her first chance to run a biotech fo­cused square­ly on im­muno-on­col­o­gy. This week, af­ter the briefest of hia­tus­es from biotech, she was named CEO of Sil­ver­back Ther­a­peu­tics, the long-stealthy Or­biMed-found­ed Seat­tle can­cer start­up.

It’s a re­union of sorts for Shawver, who worked with Sil­ver­back founder and Or­biMed part­ner Pe­ter Thomp­son at her two pre­vi­ous com­pa­nies, Cleave Ther­a­peu­tics and Syn­thorx. The two had al­ready de­cid­ed, over din­ner one night while she was still at Syn­thorx, that they didn’t want this to be their last project to­geth­er. And sure enough, in Feb­ru­ary, less than 3 months af­ter Shawver ex­e­cut­ed a $2.5 bil­lion sale of Syn­thorx to Sanofi — a deal that land­ed her an $88 mil­lion wind­fall — she was land­ing in Seat­tle to meet the team Thomp­son had amassed.

Thomp­son, who served as CEO since found­ing the com­pa­ny in 2016, told End­points he want­ed some­one who could “push the en­ve­lope of sci­ence” for pa­tients while stick­ing to the facts. She praised Shawver as “frank and hon­est,” both as a men­tor and with the board.

“I know very suc­cess­ful folks in this in­dus­try who are very com­pelling sales peo­ple,” Thomp­son said. “And Lau­ra is a sci­en­tist. She is go­ing to tell you ex­act­ly what the da­ta shows and she won’t shy away from telling you what isn’t well known.”

Shawver is as fas­ci­nat­ed by the sci­ence as she is by any­thing else. “When has that been done be­fore? Oh not since the be­gin­ning of life,” she said of her days at Syn­thorx, a biotech built around the in­ven­tion of a new DNA base pair. Thomp­son point­ed out both of them had lived through the en­tire de­vel­op­ment of mod­ern can­cer ther­a­py, from high dose chemother­a­py to CAR-T. So she was par­tic­u­lar­ly in­ter­est­ed in Sil­ver­back, which is try­ing to take an­ti­body drug con­ju­gates — an idea first con­ceived in the ear­ly 2000s to de­liv­er chemother­a­py di­rect­ly to tu­mors — and use it to send the im­mune sys­tem di­rect­ly af­ter tu­mors.

Of course Shawver didn’t know when she vis­it­ed Seat­tle in Feb­ru­ary that the city was about to be­come the first US hotspot for Covid-19, and that soon af­ter, trav­el any­where would be­come un­ten­able and she would take over as CEO in dig­i­tal ab­sen­tia. But she said it’s been large­ly seam­less. The on­ly kinks were hav­ing to do a cou­ple in­tro­duc­tions and a cou­ple hires via Zoom. Much of the staff is now re­mote, al­though some lab work­ers still go in.

”It’s like be­ing a sci­en­tist,” Shawver said. “You do what you have to do.”

Even­tu­al­ly, though, Shawver will move up to Seat­tle. It will be the fifth time run­ning a biotech and it’ll be a choice. The $2.5 bil­lion Syn­thorx land­ed her a huge per­son­al for­tune. She could’ve tak­en it and lived out re­tire­ment on a beach in San Diego, where she’s spent much of her ca­reer.

In­stead, she’ll work to get their lead HER2-tar­get­ing drug in­to the clin­ic by year’s end. The goal is to treat sol­id tu­mors that have been re­sis­tant to im­munother­a­py thus far. Shawver said it wasn’t even a choice.

“For­get the wind­fall,” she said. “I just want­ed to do it again.” — Ja­son Mast


→ With the FDA giv­ing pri­or­i­ty re­view to its an­ti­body taf­a­sita­m­ab, Mor­phoSys has found a new chief com­mer­cial of­fi­cer. Roland Wan­del­er will step in­to the role ef­fec­tive May 5 and will be re­spon­si­ble for all com­mer­cial­iza­tion ac­tiv­i­ties world­wide. Be­fore Mor­phoSys, Wan­del­er held var­i­ous po­si­tions at Am­gen for al­most 15 years, most re­cent­ly as cor­po­rate VP and GM of Am­gen’s US Bone Health and Car­di­ol­o­gy Busi­ness Unit.

Rus­sell El­li­son

Rus­sell El­li­son has re­ceived the ba­ton at Rock­well Med­ical as pres­i­dent and CEO. El­li­son has sim­i­lar ex­pe­ri­ence at Prome­dior (CEO) and Bond Bio­sciences (pres­i­dent and CEO), and al­so spent time at Sanofi and Roche, both as CMO and VP, med­ical af­fairs. El­li­son suc­ceeds Stu­art Paul, who re­signed from the metro De­troit biotech af­ter re­plac­ing Robert Chioi­ni, who tried to un­fire him­self in 2018 be­fore reach­ing a set­tle­ment.

Jen­nifer Creel has left Cel­gene to be­come CFO of ADC Ther­a­peu­tics as the Swiss on­col­o­gy biotech works to­ward sub­mit­ting a BLA for its lead drug, lon­cas­tux­imab tesirine. Creel was at Cel­gene for more than a decade, most re­cent­ly as fran­chise CFO and cor­po­rate VP, glob­al fi­nance & busi­ness plan­ning. Oth­er stops where she held fi­nance po­si­tions in­clude Wat­son Phar­ma­ceu­ti­cals and Pfiz­er.

→ Fo­cused on the treat­ment of di­a­bet­ic and oth­er pe­riph­er­al neu­ropathies, Re­ge­na­cy Phar­ma­ceu­ti­cals has en­list­ed for­mer Mer­ck ex­ec David Michel­son as CMO. Pri­or to his new post, Michel­son served as CMO of Proclara Bio­sciences. Dur­ing his 11 year stint at Mer­ck, Michel­son was the neu­ro­science ther­a­peu­tic area head and VP for clin­i­cal de­vel­op­ment. Michel­son jump­start­ed his ca­reer at Eli Lil­ly.

Greg Guy­er

Bio­Marin, whose he­mo­phil­ia A gene ther­a­py val­rox has ob­tained pri­or­i­ty re­view al­beit with a steep price, has ap­point­ed Greg Guy­er to be chief tech­ni­cal of­fi­cer, EVP of glob­al man­u­fac­tur­ing and tech­ni­cal op­er­a­tions, ef­fec­tive May 4. He suc­ceeds Robert Baf­fi, who stays on full-time as a spe­cial ad­vi­sor to the chair­man and CEO for the rest of the year as he heads to­ward re­tire­ment. Pri­or to join­ing Bio­Marin, Guy­er had been SVP, op­er­a­tions at Bris­tol My­ers Squibb.

→ Af­ter snag­ging a $75.2 mil­lion IPO ear­ly last month, NEA-found­ed Imara has an­nounced that their CMO Willem Scheele will be hit­ting the ex­it. Scheele joined the com­pa­ny in March 2019. In ad­di­tion, SVP and CMO of Au­dentes Ther­a­peu­tics Ed­ward Con­ner has joined the com­pa­ny’s board of di­rec­tors.

Megan Bai­ley

Megan Bai­ley has been pro­mot­ed to CEO of Per­son­al Genome Di­ag­nos­tics (PGDx), suc­ceed­ing Dou­glas Ward. Bai­ley start­ed at PGDx, which fo­cus­es on can­cer ge­nomics, in 2018 as VP of mar­ket­ing and was even­tu­al­ly pro­mot­ed to chief com­mer­cial of­fi­cer. Be­fore her time at the Bal­ti­more-based PGDx, she had var­i­ous roles at Roche for more than 14 years.

Karen Smith

Emer­gent BioSo­lu­tions, called up­on by J&J to help pro­duce 1 bil­lion vac­cine dos­es by 2021 to com­bat Covid-19, has wel­comed Karen Smith as its CMO. She had pre­vi­ous­ly been CMO at Jazz Phar­ma­ceu­ti­cals and has most re­cent­ly been CEO of Mede­or Ther­a­peu­tics. Smith has made the rounds at nu­mer­ous play­ers, in­clud­ing Al­ler­gan, As­traZeneca and Bris­tol My­ers Squibb.

→ In­fec­tious dis­ease spe­cial­ist Yoav Golan is mov­ing his way up to Ap­pili Ther­a­peu­tics as CMO. Golan has been an at­tend­ing physi­cian in the Di­vi­sion of Ge­o­graph­ic Med­i­cine and In­fec­tious Dis­eases at Tufts Med­ical Cen­ter since 2002 and an as­so­ciate pro­fes­sor at Tufts Uni­ver­si­ty School of Med­i­cine. In oth­er ex­ec­u­tive roles, Golan was CEO of ExAr­ca Phar­ma­ceu­ti­cals and CSO of Pro­fil­i­ty.

Ser­e­na Hung

Arku­da Ther­a­peu­tics, which launched in No­vem­ber with a $44 mil­lion Se­ries A round, has ex­pand­ed its man­age­ment team with two new faces. Ser­e­na Hung has been named head of clin­i­cal de­vel­op­ment and Ray­mond Hurst will be VP of phar­ma­col­o­gy for Arku­da, which tar­gets neu­rode­gen­er­a­tive dis­eases. Hung makes the tran­si­tion to the Cam­bridge, MA-based start­up from WAVE Life Sci­ences, where she led clin­i­cal de­vel­op­ment for CNS pro­grams. Hurst heads to Arku­da from Con­cert Phar­ma­ceu­ti­cals, where he served as di­rec­tor of bi­ol­o­gy and phar­ma­col­o­gy.

Im­vax, the Philadel­phia biotech de­vel­op­ing IGV-001 to treat new­ly-di­ag­nosed glioblas­toma mul­ti­forme, has re­cruit­ed Mark Ex­ley as CSO af­ter bring­ing on John Furey as CEO last fall. Ex­ley comes to Im­vax from Agen­Tus Ther­a­peu­tics, where he was VP, cel­lu­lar im­munol­o­gy.

→ Cam­bridge, MA-based Reper­toire Im­mune Med­i­cines, a T cell-fo­cused Flag­ship Pi­o­neer­ing com­pa­ny, has added new mem­bers to the team. An­drea Di­Fabio joins Reper­toire as EVP, chief le­gal and cor­po­rate ad­min­is­tra­tion of­fi­cer; Tim Har­ris takes on the role of EVP, cor­po­rate de­vel­op­ment; and Lu­cia Celona is now EVP, chief hu­man re­sources of­fi­cer.

Gen­prex, an Austin-based gene ther­a­py biotech, has brought in Shan­non In­man as VP of glob­al clin­i­cal op­er­a­tions. No stranger to Texas, In­man comes to Gen­prex af­ter be­ing VP of glob­al clin­i­cal op­er­a­tions at Cell Med­ica (now Ku­ur Ther­a­peu­tics). She al­so was as­so­ciate di­rec­tor of clin­i­cal op­er­a­tions at Opexa Ther­a­peu­tics out of The Wood­lands, Texas.

Bi­cy­cle Ther­a­peu­tics, which an­nounced a $1.7 bil­lion im­muno-on­col­o­gy col­lab­o­ra­tion with Genen­tech in Feb­ru­ary, has se­lect­ed Za­far Qadir as its gen­er­al coun­sel. Be­fore join­ing Bi­cy­cle, Qadir was at UK’s Cell and Gene Ther­a­py Cat­a­pult as le­gal and busi­ness ad­vis­er. He al­so spent near­ly five years at Cell Med­ica and was their VP, le­gal coun­sel & com­pa­ny sec­re­tary.

Ra­jiv De Sil­va has been named chair­man of Co­vis Phar­ma‘s board of di­rec­tors. De Sil­va, the man­ag­ing part­ner of Asiri Ad­vi­sors, was the pres­i­dent, CEO and di­rec­tor at En­do In­ter­na­tion­al and the pres­i­dent of Valeant Phar­ma­ceu­ti­cals. Pri­or to that, he held sev­er­al po­si­tions at No­var­tis.

James McArthur

James McArthur, step­ping down from Imara’s board of di­rec­tors, has joined the board of di­rec­tors at T-Cure Bio­science, an im­muno-on­col­o­gy com­pa­ny in the Los An­ge­les area. The founder and one-time CEO of Imara, McArthur has al­so found­ed Cy­dan and rare dis­ease biotech Vtesse. The lat­est com­pa­ny McArthur has found­ed is Tibu­rio, which fo­cus­es on rare neu­roen­docrine dis­or­ders.

→ Buoyed by en­cour­ag­ing Phase III da­ta with its lead drug vo­closporin for the treat­ment of lu­pus nephri­tis, Au­rinia has ap­point­ed Tim Wal­bert to its board of di­rec­tors. Wal­bert has been pres­i­dent and CEO of Hori­zon Ther­a­peu­tics since 2008. He has al­so been pres­i­dent, CEO and di­rec­tor of IDM Phar­ma, which was ac­quired by Take­da, and the EVP of com­mer­cial op­er­a­tions at NeoPharm.

Ro­mesh Sub­ra­man­ian’s new biotech start­up, Dyne Ther­a­peu­tics, which is us­ing oligonu­cleotides to de­grade RNA re­spon­si­ble for dis­ease, has ap­point­ed David Lub­n­er to its board of di­rec­tors. Lub­n­er serves as the EVP and CFO of Ra Phar­ma (ac­quired by UCB).

Julie Ham­ble­ton

→ Cal­i­for­nia biotech Arch On­col­o­gy, fo­cused on an­ti-CD47 an­ti­body ther­a­pies with its lead can­di­date AO-176, has named Julie Ham­ble­ton to its board of di­rec­tors. Ham­ble­ton is the CMO at Ideaya Bio­sciences, and be­fore that, she was at Bris­tol My­ers Squibb as VP, head of US med­ical. She has al­so been EVP and CMO at Five Prime Ther­a­peu­tics.

At the In­flec­tion Point for the Next Gen­er­a­tion of Can­cer Im­munother­a­py

While oncology researchers have long pursued the potential of cellular immunotherapies for the treatment of cancer, it was unclear whether these therapies would ever reach patients due to the complexity of manufacturing and costs of development. Fortunately, the recent successful development and regulatory approval of chimeric antigen receptor-engineered T (CAR-T) cells have demonstrated the significant benefit of these therapies to patients.

Stéphane Bancel, Moderna CEO

'This is not go­ing to be good': Mod­er­na CEO Ban­cel warns of a 'ma­te­r­i­al drop' in vac­cine ef­fi­ca­cy as Omi­cron spreads

Even as public health officials remain guarded about their comments on the likelihood Omicron will escape the reach of the currently approved Covid-19 vaccines, there’s growing scientific consensus that we’re facing a variant that threatens to overwhelm the vaccine barricades that have been erected.

Stéphane Bancel, the CEO of Moderna, one of the leading mRNA players whose quick vault into the markets with a highly effective vaccine created an instant multibillion-dollar market, added his voice to the rising chorus early Tuesday. According to Bancel, there will be a significant drop in efficacy when the average immune system is confronted by Omicron. The only question now is: How much?

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Philip Dormitzer

Glax­o­SmithK­line poach­es Pfiz­er's vi­ral vac­cines lead in rush to cap­i­tal­ize on fu­ture of mR­NA

GlaxoSmithKline has appointed Philip Dormitzer, formerly chief scientific officer of Pfizer’s viral vaccines unit, as its newest global head of vaccines R&D, looking to leverage one of the leading minds behind Pfizer and BioNTech’s RNA collaboration that led to Covid-19 jab Comirnaty, the British drug giant said Tuesday.

Dormitzer had been with Pfizer for a little more than six years, joining up after a seven-year stint with Novartis, where he reached the role of US head of research and head of global virology for the company’s vaccines and diagnostics unit.

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In­tro­duc­ing End­points Stu­dio, a new way to ad­ver­tise with End­points-craft­ed brand­ing cam­paigns

Since our start in 2016, Endpoints has grown fast while executing our mission to cover biopharma’s most critical developments for industry pros worldwide. As readership has grown, our advertising business has too. Endpoints advertising partners support the mission and engage their desired audiences through announcements on our email and web platforms, brand recognition in our event coverage and sponsorships of Endpoints daily and weekly reports.

Tillman Gerngross (Adagio)

Till­man Gern­gross on Omi­cron: 'It is a grim sit­u­a­tion...we’re go­ing to see a sig­nif­i­cant drop in vac­cine ef­fi­ca­cy'

Tillman Gerngross, the rarely shy Dartmouth professor, biotech entrepreneur and antibody expert, has been warning for over a year that the virus behind Covid-19 would likely continue to mutate, potentially in ways that avoid immunity from infection and the best defenses scientists developed. He spun out a company, Adagio, to build a universal antibody, one that could snuff out any potential mutation.

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In­cor­po­rat­ing Ex­ter­nal Da­ta in­to Clin­i­cal Tri­als: Com­par­ing Dig­i­tal Twins to Ex­ter­nal Con­trol Arms

Most drug development professionals are familiar with the nerve-racking wait for the read-out of a large trial. If it’s negative, is the investigational therapy ineffective? Or could the failure result from an unforeseen flaw in the design or execution of the protocol, rather than a lack of efficacy? The team could spend weeks analyzing data, but a definitive answer may be elusive due to insufficient power for such analyses in the already completed trial. These problems are only made worse if the trial had lower enrollment, or higher dropout than expected due to an unanticipated event like COVID-19. And if a trial is negative, the next one is likely to be larger and more costly — if it happens at all.

Mar­ket­ingRx roundup: Ab­b­Vie’s Hu­mi­ra TV turns fo­cus to HS skin con­di­tion; Sanofi amps par­ent­ing pol­i­cy

After years as the top spending pharma TV advertiser, AbbVie’s Humira brand finally downshifted earlier this year, ceding much of its marketing budget to up-and-coming sibling meds Skyrizi and Rinvoq. However, now Humira is back on TV with ads for another condition — Hidradenitis suppurativa (HS).

The chronic and painful skin condition results in lumps and abscesses caused by inflammation or infection of sweat glands, most often in the armpits or groin. Humira was first approved to treat HS in 2015 and remains the only FDA-approved drug for the condition. Two TV ads both note more than 30,000 people with HS have been prescribed Humira.

As lead drug runs in­to a wall, De­ci­phera slims down its pipeline, puts 140 jobs on the chop­ping block

Barely a month after disappointing data shattered hopes for a major label expansion for the GI tumor drug Qinlock, Deciphera is making a major pivot — scrapping development plans for that drug and discarding another while it hunkers down and focuses on two remaining drugs in the pipeline.

As a result, 140 of its staffers will be laid off.

The restructuring, which claims the equivalent of 35% of its total workforce, will take place across all departments including commercial, R&D as well as general and administrative support functions, Deciphera said, as it looks to streamline Qinlock-related commercial operations in the US while concentrating only on a “select number of key European markets.”

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FDA can­cels ODAC meet­ing this week to re­view two more dan­gling ac­cel­er­at­ed ap­provals — but won't ex­plain why

The FDA’s Oncologic Drugs Advisory Committee has decided to cancel a planned meeting on Thursday to discuss two cancer drugs that previously won accelerated approvals but failed to confirm clinical benefit in required follow-up trials or have taken a long time to finish those trials.

The FDA said in a statement that the meeting “is no longer needed” but did not offer further detail on why exactly it was canceled, telling Endpoints News to contact the companies. Attempts to contact both Secura Bio and Acrotech went unreturned. The companies may have decided to pull these treatments from the market, or they’ve come to new agreements with the agency on their confirmatory trials.