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.

Bris­tol My­ers is clean­ing up the post-Cel­gene merg­er pipeline, and they’re sweep­ing out an ex­per­i­men­tal check­point in the process

Back during the lead up to the $74 billion buyout of Celgene, the big biotech’s leadership did a little housecleaning with a major pact it had forged with Jounce. Out went the $2.6 billion deal and a collaboration on ICOS and PD-1.

Celgene, though, also added a $530 million deal — $50 million up front — to get the worldwide rights to JTX-8064, a drug that targets the LILRB2 receptor on macrophages.

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Fangliang Zhang, AP Images

UP­DAT­ED: Leg­end fetch­es $424 mil­lion, emerges as biggest win­ner yet in pan­dem­ic IPO boom as shares soar

Amid a flurry of splashy pandemic IPOs, a J&J-partnered Chinese biotech has emerged with one of the largest public raises in biotech history.

Legend Biotech, the Nanjing-based CAR-T developer, has raised $424 million on NASDAQ. The biotech had originally filed for a still-hefty $350 million, based on a range of $18-$20, but managed to fetch $23 per share, allowing them to well-eclipse the massive raises from companies like Allogene, Juno, Galapagos, though they’ll still fall a few dollars short of Moderna’s record-setting $600 million raise from 2018.

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As it hap­pened: A bid­ding war for an an­tibi­ot­ic mak­er in a mar­ket that has rav­aged its peers

In a bewildering twist to the long-suffering market for antibiotics — there has actually been a bidding war for an antibiotic company: Tetraphase.

It all started back in March, when the maker of Xerava (an FDA approved therapy for complicated intra-abdominal infections) said it had received an offer from AcelRx for an all-stock deal valued at $14.4 million.

The offer was well-timed. Xerava was approved in 2018, four years after Tetraphase posted its first batch of pivotal trial data, and sales were nowhere near where they needed to be in order for the company to keep its head above water.

Drug man­u­fac­tur­ing gi­ant Lon­za taps Roche/phar­ma ‘rein­ven­tion’ vet as its new CEO

Lonza chairman Albert Baehny took his time headhunting a new CEO for the company, making it absolutely clear he wanted a Big Pharma or biotech CEO with a good long track record in the business for the top spot. In the end, he went with the gold standard, turning to Roche’s ranks to recruit Pierre-Alain Ruffieux for the job.

Ruffieux, a member of the pharma leadership team at Roche, spent close to 5 years at the company. But like a small army of manufacturing execs, he gained much of his experience at the other Big Pharma in Basel, remaining at Novartis for 12 years before expanding his horizons.

Covid-19 roundup: Ab­b­Vie jumps in­to Covid-19 an­ti­body hunt; As­traZeneca shoots for 2B dos­es of Ox­ford vac­cine — with $750M from CEPI, Gavi

Another Big Pharma is entering the Covid-19 antibody hunt.

AbbVie has announced a collaboration with the Netherlands’ Utrecht University and Erasmus Medical Center and the Chinese-Dutch biotech Harbour Biomed to develop a neutralizing antibody that can treat Covid-19. The antibody, called 47D11, was discovered by AbbVie’s three partners, and AbbVie will support early preclinical work, while preparing for later preclinical and clinical development. Researchers described the antibody in Nature Communications last month.

Is a pow­er­house Mer­ck team prepar­ing to leap past Roche — and leave Gilead and Bris­tol My­ers be­hind — in the race to TIG­IT dom­i­na­tion?

Roche caused quite a stir at ASCO with its first look at some positive — but not so impressive — data for their combination of Tecentriq with their anti-TIGIT drug tiragolumab. But some analysts believe that Merck is positioned to make a bid — soon — for the lead in the race to a second-wave combo immuno-oncology approach with its own ambitious early-stage program tied to a dominant Keytruda.

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Pfiz­er’s Doug Gior­dano has $500M — and some ad­vice — to of­fer a cer­tain breed of 'break­through' biotech

So let’s say you’re running a cutting-edge, clinical-stage biotech, probably public, but not necessarily so, which could see some big advantages teaming up with some marquee researchers, picking up say $50 million to $75 million dollars in a non-threatening minority equity investment that could take you to the next level.

Doug Giordano might have some thoughts on how that could work out.

The SVP of business development at the pharma giant has helped forge a new fund called the Pfizer Breakthrough Growth Initiative. And he has $500 million of Pfizer’s money to put behind 7 to 10 — or so — biotech stocks that fit that general description.

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Leen Kawas, Athira CEO (Athira)

Can a small biotech suc­cess­ful­ly tack­le an Ever­est climb like Alzheimer’s? Athi­ra has $85M and some in­flu­en­tial back­ers ready to give it a shot

There haven’t been a lot of big venture rounds for biotech companies looking to run a Phase II study in Alzheimer’s.

The field has been a disaster over the past decade. Amyloid didn’t pan out as a target — going down in a litany of Phase III failures — and is now making its last stand at Biogen. Tau is a comer, but when you look around and all you see is destruction, the idea of backing a startup trying to find complex cocktails to swing the course of this devilishly complicated memory-wasting disease would daunt the pluckiest investors.

GSK presents case to ex­pand use of its lu­pus drug in pa­tients with kid­ney dis­ease, but the field is evolv­ing. How long will the mo­nop­oly last?

In 2011, GlaxoSmithKline’s Benlysta became the first biologic to win approval for lupus patients. Nine years on, the British drugmaker has unveiled detailed positive results from a study testing the drug in lupus patients with associated kidney disease — a post-marketing requirement from the initial FDA approval.

Lupus is a drug developer’s nightmare. In the last six decades, there has been just one FDA approval (Benlysta), with the field resembling a graveyard in recent years with a string of failures including UCB and Biogen’s late-stage flop, as well as defeats in Xencor and Sanofi’s programs. One of the main reasons the success has eluded researchers is because lupus, akin to cancer, is not just one disease — it really is a disease of many diseases, noted Al Roy, executive director of Lupus Clinical Investigators Network, an initiative of New York-based Lupus Research Alliance that claims it is the world’s leading private funder of lupus research, in an interview.