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. 

BiTE® Plat­form and the Evo­lu­tion To­ward Off-The-Shelf Im­muno-On­col­o­gy Ap­proach­es

Despite rapid advances in the field of immuno-oncology that have transformed the cancer treatment landscape, many cancer patients are still left behind.1,2 Not every person has access to innovative therapies designed specifically to treat his or her disease. Many currently available immuno-oncology-based approaches and chemotherapies have brought long-term benefits to some patients — but many patients still need other therapeutic options.3

Fangliang Zhang (Imaginechina via AP Images)

The big mon­ey: Poised to make drug R&D his­to­ry, a Chi­na biotech un­veils uni­corn rac­ing am­bi­tions in a bid to raise $350M-plus on Nas­daq

Almost exactly three years after Shanghai-based Legend came out of nowhere to steal the show at ASCO with jaw-dropping data on their BCMA-targeted CAR-T for multiple myeloma, the little player with Big Pharma connections is taking a giant step toward making it big on Wall Street. And this time they want to seal the deal on a global rep after staking out a unicorn valuation in what’s turned out to be a bull market for biotech IPOs — in the middle of a pandemic.

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Gilead re­leas­es an­oth­er round of murky remde­sivir re­sults

A month after the NIH declared the first trial on remdesivir in Covid-19 a success, Gilead is out with new results on their antiviral. But although the study met one of its primary endpoints, the data are likely to only add to a growing debate over how effective the drug actually is.

In a Phase III trial, patients given a 5-day dose of remdesivir were 65% more likely to show “clinical improvement” compared to an arm given standard-of-care. The trial, though, gave little indication for whether the drug had an impact on key endpoints such as survival or time-to-recovery. And in a surprising twist, a 10-day dosing arm of remdesivir didn’t lead to a statistically significant improvement over standard of care.

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Len Schleifer (left) and George Yancopoulos, Regeneron (Vimeo)

Eyes on he­mo­phil­ia prize, Re­gen­eron adds a $100M wa­ger on joint de­vel­op­ment cam­paign with In­tel­lia

When George Yancopoulos first signed up Intellia to be its CRISPR/Cas9 partner on gene editing projects 4 years ago, the upstart smartly ramped up its IPO at the same time. Today, Regeneron $REGN is coming back in, adding $100 million in an upfront fee and equity to significantly boot up a whole roster of new development projects.

And they’re highlighting some clinical hemophilia research plans in the process.

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Covid-19 roundup: Did in­sid­ers cash in on pos­i­tive news re­port about Gilead be­fore pub­li­ca­tion?

A series of bullish trades on Gilead options just before the release of a favorable news story is raising questions among regulatory experts, Reuters reported.

On April 16, just hours before STAT published anecdotes from a Chicago hospital that served as one of the clinical sites to test Gilead’s remdesivir in Covid-19 patients, the California-based company’s shares were trading at around $75. Four large blocks of options were purchased for about $1.5 million each, betting that the stock would rise beyond that to as much as $87.5 by mid-August.

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Federico Mingozzi (Spark)

Spark touts an­i­mal da­ta for a so­lu­tion to AAV gene ther­a­py's an­ti­body prob­lem

Among all the limitations of using an adeno-associated virus as a vector to deliver a gene — still the most established modality in gene therapy given years of trial and error and finally success — the presence of neutralizing antibodies, whether pre-existing or induced, looms large.

“When I think about the immune responses in AAV, I try to sort of layer them,” Federico Mingozzi, the CSO at Spark Therapeutics, told Endpoints News. “The antibody is the first layer. It’s the first block that you find when you’re trying to do gene transfer.”

Iterum's fu­ture looks un­cer­tain, af­ter lead an­tibi­ot­ic fails con­sec­u­tive piv­otal stud­ies

While the market for antibiotics remains in tatters — unlike many of its bankrupt (or at the brink of bankruptcy) peers — Iterum is suffering not because its antibiotic isn’t selling, but because the compound has now failed back-to-back late-stage studies.

The experimental drug, sulopenem, was designed to tackle drug-resistant infections with an outpatient focus (in addition to hospitals), to avert those reimbursement challenges that incentivize hospitals to prescribe cheaper, generic broad-spectrum antibiotics.

Jean-Jacques Bienaimé, BioMarin chairman and CEO

Bio­Marin holds the line on bleeds with 4-year val­rox up­date on he­mo­phil­ia A — but what's this about an­oth­er de­cline in Fac­tor 8 lev­els?

BioMarin has posted some top-line results for their 4-year followup on the most advanced gene therapy for hemophilia A — extending its streak on keeping a handful of patients free of bleeds and off Factor VIII therapy, but likely stirring fresh worries over a continued drop in Factor VIII levels.

We just don’t know how big a drop.

We’ll see more data when the results are presented at the World Federation of Hemophilia in a couple of weeks. But in a statement out Sunday night, BioMarin $BMRN reported that none of the patients required Factor VIII treatment, adding:

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As­traZeneca trum­pets the 'mo­men­tous' da­ta they found for Tagris­so in an ad­ju­vant set­ting for NSCLC — but many of the ex­perts aren’t cheer­ing along

AstraZeneca is rolling out the big guns this evening to provide a salute to their ADAURA data on Tagrisso at ASCO.

Cancer R&D chief José Baselga calls the disease-free survival data for their drug in an adjuvant setting of early stage, epidermal growth factor receptor-mutated NSCLC patients following surgery “momentous.” Roy Herbst, the principal investigator out of Yale, calls it “transformative.”

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