Shehnaaz Suli­man dives back in­to Alzheimer's at Alec­tor; Pyx­is re­cruits Spring­Works founder Lara Sul­li­van as CEO

Shehnaaz Suli­man

Amid Shehnaaz Suli­man’s lengthy re­sume it could be easy to miss her stint lead­ing ear­ly-stage Alzheimer’s R&D at Genen­tech, where she over­saw a pro­gram for the ill-fat­ed crenezum­ab and ini­ti­at­ed one of the first pre­ven­tion stud­ies around the dev­as­tat­ing neu­rode­gen­er­a­tive dis­ease. But it is this ex­pe­ri­ence that she — af­ter think­ing long and hard about her next ca­reer move over the past months — will be lean­ing heav­i­ly on as the first pres­i­dent and COO of Alec­tor.

Re­turn­ing to the dis­ease area af­ter spend­ing some years ad­vis­ing and work­ing for sev­er­al com­pa­nies on oth­ers, most re­cent­ly as SVP of cor­po­rate de­vel­op­ment and strat­e­gy at Ther­a­vance, Suli­man sees rea­son to be com­pelled by Alec­tor’s pi­o­neer­ing work in im­muno-neu­rol­o­gy, which is fast ap­proach­ing a piv­otal test loom­ing next year.

“The field has evolved in terms of the so­phis­ti­ca­tion with which we are now able to both iden­ti­fy as well as cor­re­late bio­mark­ers with clin­i­cal out­comes,” she told End­points News.

That in­cludes the work that some of her old col­leagues from Genen­tech are now do­ing at De­nali, just down the road on Oys­ter Point Boule­vard in South San Fran­cis­co. At Alec­tor, their big idea is that ge­net­ic mu­ta­tions and the ag­ing process ac­cel­er­ate senes­cence or de­te­ri­o­ra­tion of the brain im­mune cells. Restor­ing a healthy im­mune sys­tem can ad­dress those is­sues — and with her ex­pe­ri­ence lead­ing clin­i­cal tri­als in mild-to-mod­er­ate Alzheimer’s “I al­most in­tu­itive­ly un­der­stood how this ap­proach could be a game-chang­er.”

In her new role Shehnaaz has broad re­spon­si­bil­i­ty over day-to-day op­er­a­tions in every­thing rang­ing from pre­clin­i­cal de­vel­op­ment to po­ten­tial com­mer­cial­iza­tion strat­e­gy. A key at­trac­tion for the job is to part­ner with Arnon Rosen­thal, founder and CEO, in fig­ur­ing out how to scale the or­ga­ni­za­tion while pre­serv­ing the agili­ty through which the biotech has cre­at­ed 14 can­di­dates and ush­ered four of them in­to the clin­ic with­in five years.

“Arnon is a tow­er­ing leader in the field of neu­rode­gen­er­a­tion and he has built an in­cred­i­ble team,” she said.

She now plans to help grow that team from 117 to be­tween 120 and 140 by the end of the year. And they have got­ten more ex­perts on board for the scale-up: Alec­tor an­nounced this morn­ing that Genen­tech vet Richard Scheller and Stan­ford pro­fes­sor Thomas Süd­hof, renowned neu­ro­sci­en­tists, will co-chair their strate­gic port­fo­lio ad­vice and re­view com­mit­tee. — by Am­ber Tong


Lara Sul­li­van

Lara Sul­li­van was deep in­to seed stage on­col­o­gy op­por­tu­ni­ties, just wrap­ping up a round for a stealth pre­clin­i­cal play­er when she came across the team at Pyx­is On­col­o­gy this sum­mer.

“I im­me­di­ate­ly rec­og­nized the trans­for­ma­tive po­ten­tial of Pyx­is’s nov­el bi­o­log­i­cal ap­proach­es built on the tech­nol­o­gy out of Tom Gajew­s­ki’s lab at Uni­ver­si­ty of Chica­go,” she told End­points News. “The en­thu­si­asm in the sci­en­tif­ic com­mu­ni­ty for Tom’s work com­bined with the horse­pow­er that was al­ready in place through the Se­ries A syn­di­cate of Long­wood, Leaps by Bay­er, Agent Cap­i­tal and Ipsen made it a no-brain­er to jump on board.”

As the new CEO of the com­pa­ny, suc­ceed­ing Long­wood part­ner David Stein­berg, she will keep the team laser-fo­cused on the ear­ly pipeline while bring­ing in the right part­ners for the plat­form, which iden­ti­fies new tar­gets for can­cer im­munother­a­py from the tu­mor mi­croen­vi­ron­ment. CSO Ronald Herb­st, who joined in Oc­to­ber, has helped “set our sci­en­tif­ic strate­gies and rapid­ly at­tract tal­ent,” Sul­li­van said, and their biggest chal­lenge right now re­mains the tech­ni­cal one of pick­ing the right drugs for the right pa­tient pop­u­la­tions.

It has been a year since Sul­li­van left Spring­Works, the biotech she helped spin out of Pfiz­er with mid- to late-stage can­di­dates that didn’t make the cut for in­ter­nal de­vel­op­ment.

“I’ve al­ways felt strong­ly that great sci­ence de­serves the op­por­tu­ni­ty to de­clare it­self, and that at­tri­tion of great sci­ence (whether at dis­cov­ery or clin­i­cal stage) dri­ven by in­suf­fi­cient bud­get or in­ef­fi­cient op­er­a­tions is in­ex­cus­able,” she said.

With $22 mil­lion in Se­ries A fund­ing from deep pock­et­ed in­vestors and an ex­pe­ri­enced team in place, she is count­ing on Pyx­is to tack­le the chal­lenge head on. — by Am­ber Tong


→ More changes at com­ing at Bris­tol-My­ers Squibb. Just a day af­ter con­firm­ing BD chief Paul Bion­di’s de­par­ture, the phar­ma gi­ant said John Elick­er, EVP of cor­po­rate af­fairs and in­vestor re­la­tions, is set to re­tire by the end of March next year. His role will be split in­to two: Kathryn Met­calfe, the chief com­mu­ni­ca­tions of­fi­cer of CVS Health, has been poached to take on the lead in cor­po­rate af­fairs; 13-year vet­er­an Tim Pow­er is be­ing pro­mot­ed to head of in­vestor re­la­tions.

→ Fol­low­ing an FDA OK for its be­ta-tha­lassemia drug Re­blozyl, Ac­celeron Phar­ma has wooed Jay Back­strom, the CMO of its part­ner Cel­gene, to the new­ly cre­at­ed role of head of R&D. Back­strom moves as Cel­gene is be­ing in­te­grat­ed in­to Bris­tol-My­ers Squibb af­ter a $74 bil­lion ac­qui­si­tion. Back­strom’s pre­vi­ous stints span Pharmion, Mar­i­on Mer­rell Dow and Quin­tiles

James Burns

→  San-Diego-based Lo­cana — which launched ear­li­er this year based on ge­net­ic re­search from UC San Diego pro­fes­sor Gene Yeo’s lab — has tapped James Burns to run the com­pa­ny as CEO. Burns suc­ceeds Jef­frey Os­trove, who will con­tin­ue to serve as a board di­rec­tor. Burns joins af­ter a stint as CEO of Case­bia, lead­ing the team in de­vel­op­ing new CRISPR/Cas9 ther­a­peu­tics to treat blood dis­or­ders. Burns al­so brings ex­pe­ri­ence from his time at Sanofi-Gen­zyme to the role.

Leila Al­land

PMV Phar­ma has wel­comed Leila Al­land to the fold as CMO, help­ing push the p53 drug it re­ceived $74 mil­lion back in 2017 to test in hu­mans. Most re­cent­ly, Al­land served in the same role at Af­fimed and has pre­vi­ous­ly held stints at Tarve­da Ther­a­peu­tics, As­traZeneca, Bris­tol-My­ers Squibb, No­var­tis and Scher­ing-Plough

Eli Wal­lace

→ Af­ter drop­ping their bid to re­claim Ei­dos af­ter three of­fer re­jec­tions, Neil Ku­mar-led Bridge­Bio Phar­ma has ap­point­ed Eli Wal­lace as the com­pa­ny’s CSO in res­i­dence for on­col­o­gy. Wal­lace joins the com­pa­ny af­ter a stint as CSO at Pelo­ton Ther­a­peu­tics, the can­cer biotech Mer­ck snapped up for $2.2 bil­lion. Pri­or to Pelo­ton, Wal­lace served in the med­i­c­i­nal chem­istry de­part­ment at Ar­ray Bio­Phar­ma — where he led re­search that pro­duced eight chem­i­cal en­ti­ties for the treat­ment of can­cer, in­clud­ing Mek­tovi.

Take­dapart­nered I/O play­er Shat­tuck Labs has ap­point­ed Casi DeY­oung as CBO. DeY­oung hops aboard af­ter serv­ing as COO at Im­mune­Sen­sor Ther­a­peu­tics. Pri­or to Im­mune­Sen­sor, DeY­oung was CBO of Mir­na Ther­a­peu­tics and had var­i­ous ex­ec roles at Rea­ta Phar­ma­ceu­ti­cals, EMD Phar­ma­ceu­ti­cals and Mer­ck KGaA

Julie Grant

Julie Grant and Bren­dan Dick­in­son have been pro­mot­ed to gen­er­al part­ner at Canaan Part­ners, the Sil­i­con Val­ley-based VC firm known for jump­ing in ear­ly. Grant joined in 2013 as an as­so­ciate, af­ter a stint at Genen­tech, while Dick­in­son start­ed in 2010. Grant is the fourth woman in the com­pa­ny to be­come GP.

Roche has a slew of up­com­ing changes to its board of di­rec­tors and cor­po­rate ex­ec­u­tive com­mit­tee. As an­nounced in Ju­ly 2018, An­dreas Oeri will re­tire from the board along with John Bell — their pro­posed suc­ces­sors are Jörg Duschmalé and CEO of Swiss Life Group Patrick Frost re­spec­tive­ly. In ad­di­tion, Clau­dia Böck­stiegel, the cur­rent head of le­gal of the di­ag­nos­tics di­vi­sion, will suc­ceed gen­er­al coun­sel Got­tlieb Keller, who is step­ping out and in­to re­tire­ment. An­nette Luther, cur­rent­ly gen­er­al man­ag­er of Roche Di­ag­nos­tics In­ter­na­tion­al, will take over for Keller as sec­re­tary to the board of di­rec­tors. 

→ Af­ter se­cur­ing FDA ap­proval for its con­tro­ver­sial lead drug El­zon­ris in use for blas­tic plas­ma­cy­toid den­drit­ic cell neo­plasm (BPD­CN), on­col­o­gy-fo­cused drug de­vel­op­er Stem­line Ther­a­peu­tics has pro­mot­ed Robert Fran­co­mano from the role of SVP, glob­al head of com­mer­cial med­ical af­fairs to that of CCO. Fran­co­mano has held po­si­tions at Bax­al­ta, Pfiz­er, GSK and As­traZeneca — where he played a role with­in the com­pa­ny’s breast can­cer fran­chise.  

→ Af­ter mak­ing its de­but on the Hong Kong Stock Ex­change with a $285 mil­lion IPO in Feb­ru­ary, CStone Phar­ma­ceu­ti­cals has brought on Shirley Zhao as gen­er­al man­ag­er for Greater Chi­na and head of com­mer­cial. Pre­vi­ous­ly, Zhao was the coun­try GM for Bris­tol-My­ers Squibb, where she spear­head­ed the launch for Op­di­vo, the first PD-1 in­hibitor to en­ter the Chi­nese mar­ket. Be­fore that, Zhao had the same job at Gen­zyme and Al­ler­gan

Fresh off a $114 mil­lion round led by Sam­sara and with big plans for its CAR-NK plat­form, Nkar­ta Ther­a­peu­tics has re­cruit­ed On­coMed vet Yvonne Li as SVP, fi­nance and for­mer On­cBio­Mune Phar­ma­ceu­ti­cals CMO Bri­an Bar­nett as SVP, clin­i­cal de­vel­op­ment.

Last year Sue Dil­lon and Karyn O’Neil left J&J to launch fledg­ling Aro Bio­ther­a­peu­tics, and now the com­pa­ny has wel­comed Scott Green­berg as VP, busi­ness de­vel­op­ment and al­liance man­age­ment. Green­berg joins Aro af­ter a stint as VP, head of op­er­a­tions at Roivant Sci­ences. Pri­or to that, Green­berg spent more than a decade at Cel­gene — now swal­lowed by Bris­tol-My­ers in a $74 bil­lion deal — and Gold­man Sachs.

Sean Khozin

→ Ex-FDA of­fi­cial Sean Khozin has made the leap to join Janssen R&D as their glob­al head of da­ta strat­e­gy. Khozin was the for­mer as­so­ciate di­rec­tor for the FDA On­col­o­gy Cen­ter of Ex­cel­lence and found­ing di­rec­tor of the agency’s In­for­ma­tion Ex­change and Da­ta Trans­for­ma­tion (IN­FORMED). Khozin al­so found­ed SKMD, where he was CMO, and Hel­loHealth

Parex­el — which re­cent­ly part­nered up with Vivek Ra­maswamy’s Roivant-spawned Data­vant to em­brace re­al world ev­i­dence — has snatched up some reg­u­la­to­ry pros from the US and UK to join its team. All four will serve as tech­ni­cal vice pres­i­dents. The ad­di­tions in­clude: Mark Birse, for­mer MHRA deputy di­rec­tor of in­spec­tion, en­force­ment and stan­dards di­vi­sion; Philip Crook­er, drug de­vel­op­ment at­tor­ney; Lynne En­sor, who served as FDA act­ing deputy di­rec­tor of the of­fice of process and fa­cil­i­ties; and Yuex­ia Li, most re­cent­ly the FDA deputy di­rec­tor of the of­fice of pro­gram and reg­u­la­to­ry op­er­a­tions.

→ San Fran­cis­co start­up Verge Ge­nomics has ap­point­ed Thomas Large, the cur­rent CEO and co-founder of Blue Oak Phar­ma­ceu­ti­cals, and James Sum­mers, for­mer VP of neu­ro­science re­search at Ab­b­Vie, to its sci­en­tif­ic ad­vi­so­ry board. 

Biogen CEO Michel Vounatsos (via Getty Images)

With ad­u­canum­ab caught on a cliff, Bio­gen’s Michel Vounatsos bets bil­lions on an­oth­er high-risk neu­ro play

With its FDA pitch on the Alzheimer’s drug aducanumab hanging perilously close to disaster, Biogen is rolling the dice on a $3.1 billion deal that brings in commercial rights to one of the other spotlight neuro drugs in late-stage development — after it already failed its first Phase III.

The big biotech has turned to Sage Therapeutics for its latest deal, close to a year after the crushing failure of Sage-217, now dubbed zuranolone, in the MOUNTAIN study.

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Jason Kelly, Ginkgo Bioworks CEO (Kyle Grillot/Bloomberg via Getty Images)

Af­ter Ko­dak de­ba­cle, US lends $1.1B to a syn­thet­ic bi­ol­o­gy com­pa­ny and their big Covid-19, mR­NA plans

In mid-August, as Kodak’s $765 million government-backed push into drug manufacturing slowly fell apart in national headlines, Ginkgo Bioworks CEO Jason Kelly got a message from his company’s government liaison: HHS wanted to know if they, too, might want a loan.

The government’s decision to lend Kodak three quarters of a billion dollars raised eyebrows because Kodak had never made drugs before. But Ginkgo, while not a manufacturing company, had spent the last decade refining new ways to produce materials inside cells and building automated facilities across Boston.

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Jef­frey Hat­field takes over from Diego Mi­ralles as CEO of Vi­vid­ion; Drag­on­fly scores a new ex­ec with COO Alex Lu­gov­skoy

→ San Diego protein degradation startup Vividion Therapeutics has made a change at the top with Jeffrey Hatfield taking the helm as CEO, replacing Diego Miralles six months after Roche forked over $135 million to collaborate with Vividion on their small molecule degraders. Hatfield is chairman of the board at miRagen Therapeutics and previously held the CEO job at Zafgen and Vitae Pharmaceuticals. He also had a series of leadership roles at Bristol Myers Squibb from 1996-2004, including SVP, immunology and virology divisions.

Pascal Soriot (AP Images)

UP­DAT­ED: As­traZeneca, Ox­ford on the de­fen­sive as skep­tics dis­miss 70% av­er­age ef­fi­ca­cy for Covid-19 vac­cine

On the third straight Monday that the world wakes up to positive vaccine news, AstraZeneca and Oxford are declaring a new Phase III milestone in the fight against the pandemic. Not everyone is convinced they will play a big part, though.

With an average efficacy of 70%, the headline number struck analysts as less impressive than the 95% and 94.5% protection that Pfizer/BioNTech and Moderna have boasted in the past two weeks, respectively. But the British partners say they have several other bright spots going for their candidate. One of the two dosing regimens tested in Phase III showed a better profile, bringing efficacy up to 90%; the adenovirus vector-based vaccine requires minimal refrigeration, which may mean easier distribution; and AstraZeneca has pledged to sell it at a fraction of the price that the other two vaccine developers are charging.

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Covid-19 roundup: Eu­rope pur­chas­es 80M dos­es of Mod­er­na's vac­cine; CO­V­AXX se­cures $2.8B in emerg­ing mar­ket pre-or­ders

With the announcement of its vaccine efficacy data last week, Moderna is starting to line up customers for its Covid-19 mRNA jabs.

The Massachusetts-based biotech announced Wednesday it has agreed to sell an initial round of 80 million doses to the European Commission, with the option to double the amount to 160 million. Once the member states rubber stamp the approval, the deal will be finalized.

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FDA hands Liq­uidia and Re­vance a CRL and de­fer­ral, re­spec­tive­ly, as Covid-19 cre­ates in­spec­tion chal­lenge

Two biotechs said they got turned away by the FDA on Wednesday, in part due to pandemic-related travel restrictions.

North Carolina-based Liquidia Technologies was handed a CRL for its lead pulmonary arterial hypertension drug, citing the need for more CMC data and on-site pre-approval inspections, which the FDA hasn’t been able to conduct due to travel restrictions. The agency also deferred its decision on Revance Therapeutics’ BLA for its frown line treatment, because it needs to inspect the company’s northern California manufacturing facility. The action, Revance emphasized, was not a CRL.

News brief­ing: FDA re­quests new tri­al for Reata's Friedre­ich's atax­ia pro­gram; J&J's Trem­fya picks up ex­pand­ed la­bel in Eu­rope

Three months after Reata Pharmaceuticals suggested its Friedreich’s ataxia program omaveloxolone could be delayed, the company revealed that is indeed going to be the case.

Reata $RETA shares took a nosedive Wednesday after the biotech revealed that the FDA said supplemental data for its pivotal trial did not strengthen the case for approval. As a result, the drug is likely to need another study before the FDA takes up the case.

Chi­na opens the door for biotech in­vestors in Hong Kong to buy Shang­hai stocks, and vice ver­sa

When Shanghai’s STAR board began opening its doors to biotech, it was considered not just a rival to Nasdaq but also the stock exchange in Hong Kong. Those perceptions may take an amicable turn as China expands a mutual access program with the city.

The changes mean investors in mainland China will be able to own Hong Kong biotech chapter stocks, while those in Hong Kong — a much more internationally connected group — would have access to those listed on STAR. In effect, it turns the Shanghai market into a globally accessible exchange overnight while also broadening a key source of revenue for HKEX.

The ad­u­canum­ab co­nun­drum: The PhI­II failed a clear reg­u­la­to­ry stan­dard, but no one is cer­tain what that means any­more at the FDA

Eighteen days ago, virtually all of the outside experts on an FDA adcomm got together to mug the agency’s Billy Dunn and the Biogen team when they presented their upbeat assessment on aducanumab. But here we are, more than 2 weeks later, and the ongoing debate over that Alzheimer’s drug’s fate continues unabated.

Instead of simply ruling out any chance of an approval, the logical conclusion based on what we heard during that session, a series of questionable approvals that preceded the controversy over the agency’s recent EUA decisions has come back to haunt the FDA, where the power of precedent is leaving an opening some experts believe can still be exploited by the big biotech.

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