Ex-DARPA di­rec­tor pur­sues all-in-one can­cer pill as NED CEO; Karyopharm los­es com­mer­cial chief ahead of drug roll­out

“Why not try?”

That’s what Ge­of­frey Ling told me over the phone when asked about what led him to his jour­ney to the po­si­tion of CEO at NED Bio­sciences — a com­pa­ny with a lofty goal of cre­at­ing an all-in-one oral drug to treat all types of can­cer and mak­ing this drug avail­able to not on­ly de­vel­oped na­tions, but al­so the de­vel­op­ing world. 

Ling comes from an ex­ten­sive back­ground in med­i­cine and the gov­ern­ment. He is the co-leader of The Brain Health Pro­ject, a pro­fes­sor of neu­rol­o­gy and an at­tend­ing neu­r­o­crit­i­cal care physi­cian at John Hop­kins Uni­ver­si­ty and Hos­pi­tal, as well as the as­sis­tant di­rec­tor for Med­ical In­no­va­tion of the Sci­ence Di­vi­sion in pres­i­dent Oba­ma’s White House Of­fice of Sci­ence and Tech­nol­o­gy Pol­i­cy (OSTP). 

Ling, a re­tired colonel, served for 27 years in the US mil­i­tary where he toured Iraq and Afghanistan. Af­ter his time serv­ing his coun­try, Ling joined as a pro­gram man­ag­er at the De­fense Ad­vanced Re­search Pro­jects Agency (DARPA) of the US De­part­ment of De­fense — re­spon­si­ble for fund­ing the de­vel­op­ment of mil­i­tary tech­nol­o­gy — where he be­came a found­ing di­rec­tor of the DARPA Bi­o­log­i­cal Tech­nolo­gies Of­fice. Af­ter wit­ness­ing young Amer­i­cans bad­ly in­jured, and hav­ing lost their arms, Ling want­ed to find a way to give back to his fel­low sol­diers and cre­ate a pros­thet­ic arm con­trolled by thought. And in the face of skep­ti­cism, six months lat­er, Ling and his team were able to cre­ate FDA-ap­proved, thought-con­trolled pros­thet­ics.

It was dur­ing his time at DARPA that Ling came in­to con­tact with NED when they came to the or­ga­ni­za­tion to ask for fund­ing. 

“I thought their ap­proach was very straight­for­ward, re­al­ly made a lot of sense to me,” he said. “When they came to me with this drug cock­tail of theirs, I looked at it and I re­al­ly ad­mired the phar­ma­col­o­gy be­hind it. I un­der­stood the sci­ence. Can we find a straight­for­ward way of treat­ing mul­ti­ple can­cer types, in­ex­pen­sive­ly and with low tox­i­c­i­ty? And I looked at it and I said ‘this is re­al­ly cool.’ And I said we got­ta find a way to make it work.”

He was pas­sion­ate about NED’s mis­sion and once he left DARPA, he hopped on­to NED’s board of di­rec­tors. When the com­pa­ny de­cid­ed to take their drug in­to hu­man clin­i­cal tri­als and start rais­ing funds, Ling stepped up to the chal­lenge. He said that the chal­lenges he per­ceives that he’ll have in this role will be sim­i­lar to the one he had at DARPA: dis­mis­sive­ness from oth­er peo­ple.

At DARPA we would al­ways take on ideas that were con­sid­ered to be im­pos­si­ble to do, hereti­cal to the cur­rent way that peo­ple are do­ing things and it’s so out of the box that peo­ple who think tra­di­tion­al­ly, they want to be dis­mis­sive even though its a cool thing. Like an in­vis­i­ble air­plane, they want to dis­miss it and you say, why are you dis­miss­ing it? If it worked wouldn’t it be great? But that’s not the way peo­ple think. Peo­ple think ‘oh, it’s too hard. It’s too ex­pen­sive. It’ll nev­er work.’ They’re dis­mis­sive. And that’s the prob­lem the NED folks are hav­ing. Peo­ple are say­ing ‘oh, this is not a new bi­o­log­i­cal. It is not us­ing a sin­gle drug ap­proach. It is not a brand spank­ing new drug. In fact, it’s bor­ing.’ And be­cause of that peo­ple are dis­miss­ing them out of hand with­out giv­ing them a fair shake.

In ad­di­tion to Ling’s ap­point­ment, Pe­ter D’Erri­co — cur­rent­ly the CFO of NED — will add COO to his ti­tle. 

→ The ex­o­dus from As­traZeneca fol­low­ing its big R&D re­or­ga­ni­za­tion con­tin­ues. Boaz Hir­sh­berg, VP and head of car­dio­vas­cu­lar, meta­bol­ic and re­nal dis­ease at Med­Im­mune, has joined BOL Phar­ma as CMO. The Is­raeli com­pa­ny prides it­self for be­ing an ear­ly play­er in the med­ical cannabis in­dus­try and as­pires to be a lead­ing sup­pli­er of cannabi­noid-based APIs to phar­ma, uni­ver­si­ties and oth­er in­sti­tu­tions.

Anand Varadan

→ On the same day Karyopharm bagged a con­tro­ver­sial FDA OK for its mul­ti­ple myelo­ma drug se­linex­or (Xpovio), the com­pa­ny qui­et­ly dis­closed that its chief com­mer­cial of­fi­cer has re­signed. Anand Varadan’s tenure last on­ly one year, dur­ing which he was cred­it­ed for lay­ing the ground­work for a prod­uct launch. Per­ry Mona­co, the cur­rent VP of sales, will take up more re­spon­si­bil­i­ty with some help from CEO Michael Kauff­man. 

→ Cam­bridge, MA-based Tia­ki Ther­a­peu­tics has re­cruit­ed Suzanne Bruhn as its new CEO. She takes over from in­ter­im CEO Bar­bara Tate, the chief strat­e­gy of­fi­cer of the De­men­tia Dis­cov­ery Fund. Her last post was as CEO of Proclara, which op­er­at­ed in a sim­i­lar field: neu­rode­gen­er­a­tion. Tia­ki has tar­get­ed im­mune cells of the brain — mi­croglia — in an at­tempt to ad­dress in­flam­ma­to­ry-dri­ven CNS dis­or­ders and pro­tect cog­ni­tive func­tion.

Kim Bran­son

GSK R&D chief Hal Bar­ron is aim­ing high for the phar­ma gi­ant’s crew for ar­ti­fi­cial in­tel­li­gence and ma­chine learn­ing. The phar­ma gi­ant poached their new chief of the AI/ML group from Genen­tech, tap­ping that tal­ent-rich tech zone in South San Fran­cis­co which Bar­ron — long based in the Bay Area — al­ways in­tend­ed to re­cruit from. Kim Bran­son — who was head of AI, ear­ly clin­i­cal de­vel­op­ment at Genen­tech — adds to Bar­ron’s list of lo­cal re­cruits, which in­cludes BD chief Kevin Sin. Bran­son’s glob­al team in­cludes Je­re­my Eng­land, a for­mer as­so­ciate pro­fes­sor at MIT fo­cused on the cross­roads of bi­ol­o­gy and physics. 

→ For the lat­est in his se­ries of biotech start­up gigs, Jay Mohr has opt­ed for the COO and CBO role at AZTher­a­pies as the com­pa­ny en­ters the fi­nal clin­i­cal stretch with a treat­ment for ear­ly Alzheimer’s dis­ease. Mohr, a found­ing mem­ber and part­ner emer­i­tus at Lo­cust Walk, had re­cent­ly left a pres­i­dent and CEO po­si­tion at Diri­go Ther­a­peu­tics. His ex­pe­ri­ence with part­ner­ships and prod­uct com­mer­cial­iza­tion, CEO David El­maleh said, is es­pe­cial­ly help­ful at a time reg­u­la­to­ry fil­ings loom large. AZTher­a­pies’ idea is to slow the pro­gres­sion of Alzheimer’s — an ail­ment that’s de­feat­ed vir­tu­al­ly every at­tempt to rein it in  — by tamp­ing down the neu­roin­flam­ma­tion that leads to neu­ronal death.

→ Ahead of a piv­otal read­out, NASH play­er Madri­gal Phar­ma is pro­mot­ing Re­bec­ca Taub to pres­i­dent of R&D, a new po­si­tion that gives her more over­sight over the pipeline. Taub, a founder and for­mer CEO of Madri­gal pri­or to its merg­er with Syn­ta, has been steer­ing resme­tirom (MG-3196) in the clin­ic as CMO.

San­jay Keswani

An­nex­on Bio­sciences has made sev­er­al re­cruit­ments to ex­pand its se­nior lead­er­ship team to help ad­vance its two mon­o­clon­al an­ti­body prod­uct can­di­dates, ANX005 and ANX007 — used for the treat­ment of au­toim­mune and neu­rode­gen­er­a­tive dis­or­ders. The com­pa­ny wel­comed San­jay Keswani as CMO, Jen­nifer Lew as CFO and Les­ley Stolz as CBO. 

Keswani brings over 20 years of ex­pe­ri­ence to the po­si­tion, hop­ping over to the com­pa­ny af­ter a brief, 10-month stint as CEO of Rheos Med­i­cines. Ear­li­er he had done a stint at Roche as their SVP and glob­al head of neu­ro­science, oph­thal­mol­o­gy and rare dis­eases re­search & de­vel­op­ment. Pri­or to Roche, he served in se­nior roles at Bris­tol-My­ers Squibb and Eli Lil­ly.

Jen­nifer Lew

Lew, who served as trou­bled Aduro Biotech’s CFO, is cred­it­ed with play­ing a lead role in the prepa­ra­tion and ex­e­cu­tion of their IPO which raised $119 mil­lion in 2015. Stolz hopped over from J&J In­no­va­tion where she helped run their West Coast JLABS busi­ness.

→ Ex-Genen­tech star and 23andMe vet Richard Scheller jumped over to join Neil Ku­mar’s new com­pa­ny, Bridge­Bio, as their chair­man in R&D. Bridge­Bio re­cent­ly fin­ished off a stel­lar IPO, which has left the com­pa­ny with a $3.3 bil­lion mar­ket cap. Scheller com­mit­ted to stay­ing with 23andMe for 4 years and now leaves his po­si­tion in the hands of Ken­neth Hillan, the for­mer CEO of Achao­gen, which went bank­rupt and liq­ui­dat­ed in a fire sale 

Les­ley Stolz

IDEAYA Bio­sciences strength­ens its lead­er­ship team with the ap­point­ments of Paul Stone as CFO, An­dres Ruiz Briseno as vice pres­i­dent, fi­nance and ten year Genen­tech vet Mick O’Quigley as vice pres­i­dent, de­vel­op­ment op­er­a­tions. Stone pre­vi­ous­ly served as the com­pa­ny’s SVP, gen­er­al coun­sel and head of op­er­a­tions. He will con­tin­ue his du­ties as the prin­ci­pal fi­nan­cial ac­count­ing of­fi­cer and over­see the le­gal func­tion as gen­er­al coun­sel. Stone joined the com­pa­ny from 5AMVen­tures. Ruiz Briseno re­cent­ly served as the com­pa­ny’s se­nior di­rec­tor, fi­nance and con­troller. He joined the com­pa­ny from Phar­ma­cyclics as their di­rec­tor of fi­nan­cial plan­ning and analy­sis. He was cred­it­ed with help­ing lead Phar­ma­cyclics’ fi­nance and op­er­a­tions ef­forts in sup­port of the suc­cess­ful launch of Im­bru­vi­ca through to its ac­qui­si­tion by Ab­b­Vie. O’Quigley has sup­port­ed the com­pa­ny in var­i­ous clin­i­cal op­er­a­tions. Pre­vi­ous­ly, he held var­i­ous clin­i­cal op­er­a­tion roles at Am­gen for twelve years.

Oc­u­lar Ther­a­peu­tix — a com­pa­ny fo­cused on the de­vel­op­ment of treat­ments for eye con­di­tions and dis­eases — wel­comed Christo­pher White as the com­pa­ny’s SVP, head of busi­ness and cor­po­rate de­vel­op­ment. Be­fore hop­ping on­board to Oc­u­lar, White was the COO at Sil­ver Creek Phar­ma­ceu­ti­cals — a pri­vate Bay Area biotech­nol­o­gy com­pa­ny fo­cused on the de­vel­op­ment of nov­el re­gen­er­a­tive med­i­cines. He’s al­so held roles as CBO of both En­ta­sis Ther­a­peu­tics and AM­AG Phar­ma­ceu­ti­cals. Be­fore join­ing the biotech in­dus­try, White worked as a part­ner at man­age­ment con­sult­ing firms Ac­cen­ture and A.T. Kear­ney

NeoPhore — a com­pa­ny de­vel­op­ing small mol­e­cule treat­ments for can­cer — wel­comed Matthew Bak­er to the ranks of its man­age­ment team as VP im­munol­o­gy. Cur­rent­ly, Bak­er serves as the non-ex­ec­u­tive di­rec­tor at Ox­ford Ge­net­ics. Pri­or to join­ing NeoPhore, Bak­er was the co-founder, CEO and CSO of An­ti­tope. Oth­er po­si­tions that he has served in­clude CSO of Abzena and co-founder and CSO of Den­cep­tor Ther­a­peu­tics. Be­fore co-found­ing, An­ti­tope in 2004, Bak­er held stints at Bio­va­tion, Cel­lu­lar Tech­nolo­gies and What­man Bio­Sciences

Lau­ra Edger­ly-Pflug

Lyra Ther­a­peu­tics — fo­cused on de­vel­op­ing treat­ments for ear, nose and throat (ENT) dis­eases — has added Lau­ra Edger­ly-Pflug as SVP of tech­ni­cal op­er­a­tions of the com­pa­ny. Edger­ly-Pflug joins right as their lead drug can­di­date, LYR-210 is en­ter­ing a Phase II clin­i­cal tri­al for the treat­ment of rhi­nos­i­nusi­tis. Edger­ly-Pflug joins from her pre­vi­ous post as vice pres­i­dent of tech­ni­cal op­er­a­tions at Adgero Bio­phar­ma­ceu­ti­cals. She brings over 25 years worth of ex­pe­ri­ence from sev­er­al biotech and phar­ma­ceu­ti­cal com­pa­nies, such as In­smed, Ova­tion Phar­ma­ceu­ti­cals (cur­rent­ly Recor­dati Rare Dis­eases), Bio­mi­ra (cur­rent­ly Seat­tle Ge­net­ics) and The Li­po­some Com­pa­ny

Start Codon, the start­up ac­cel­er­a­tor with a mis­sion to nur­ture ear­ly-stage health­care star­tups in the Gold­en Tri­an­gle, has added two ex­ecs to their sup­port team. Daniel Rooke, part­ner and head of op­er­a­tions, brings le­gal ex­per­tise and some re­cent in­sights gleaned at Cy­cle Phar­ma. Saku­ra Hol­loway leaps from a BD role at Mer­ck KGaA to be­come part­ner and head of dili­gence.

Jim Mel­lon’s ag­ing ven­ture Ju­ve­nes­cence — which in Jan­u­ary raised $46 mil­lion to crack the bi­o­log­i­cal bar­ri­ers of ag­ing to live un­til 150 — has tapped Col­in Watts as CEO of Ju­ve­nes­cence Life, which is fo­cus­ing on the com­mer­cial­iza­tion of health sup­ple­ments, nu­traceu­ti­cals and med­ical foods that can im­prove hu­man longevi­ty and qual­i­ty of life. Watts comes from a back­ground in the health­care, re­tail, con­sumer prod­ucts, food, and well­ness in­dus­tries and most re­cent­ly served as CEO of The Vi­t­a­min Shoppe

With con­tri­bu­tion by Am­ber Tong

Hal Barron and Rick Klausner (GSK, Lyell)

Ex­clu­sive: GSK’s Hal Bar­ron al­lies with Rick Klaus­ner’s $600M cell ther­a­py start­up, look­ing to break new ground blitz­ing sol­id tu­mors

LONDON — Chances are, you’ve heard little or nothing about Rick Klausner’s startup Lyell. But that ends now.

Klausner, the former head of the National Cancer Institute, former executive director for global health at the Gates Foundation, co-founder at Juno and one of the leaders in the booming cell therapy field, has brought together one of the most prominent teams of scientists tackling cell therapy 2.0 — highlighted by a quest to bridge a daunting tech gap that separates some profound advances in blood cancers with solid tumors. And today he’s officially adding Hal Barron and GlaxoSmithKline as a major league collaborator which is pitching in a large portion of the $600 million he’s raised in the past year to make that vision a reality.

“We’ve being staying stealth,” Klausner tells me, then adding with a chuckle: “and going back to stealth after this.”

“Cell therapy has a lot of challenges,” notes Barron, the R&D chief at GSK, ticking off the resistance put up by solid tumors to cell therapies, the vein-to-vein time involved in taking immune cells out of patients, engineering them to attack cancer cells, and getting them back in, and more. “Over the years Rick and I talked about how it would be wonderful to take that on as a mission.”

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Pfizer, South San Francisco — Jeff Rumans for Endpoints News

Pfiz­er takes aim at a flag­ship fran­chise at Sanofi and Re­gen­eron — and scores a few di­rect hits

Count Pfizer in as a top player in the blockbuster game of JAK1 inhibitors.
Over the weekend the pharma giant posted some stellar Phase III efficacy data for their heavyweight contender abrocitinib in atopic dermatitis (eczema) that lines up ahead of a booming Dupixent (dupilumab), a blockbuster in the portfolios of Regeneron and Sanofi. And they put some real distance ahead of Eli Lilly’s trailing Olumiant, which made a delayed initial arrival on the market for rheumatoid arthritis after the FDA hobbled it with some additional hurdles on safety concerns.
JADE-MONO-1 scores well for Pfizer, teeing up what will be an intensely followed breakdown of the JADE MONO-2 data, which the pharma giant recently top-lined as “similar” to the first Phase III when tested against a placebo — a control group that has been easily outclassed by all the drugs in this market niche.
As of now, Pfizer looks to be equipped to run into the review stage — advantaged by a breakthrough therapy designation that is intended to speed up the regulatory process.
Here’s what physicians and patients are likely to be confronted with in the not too distant future, as Pfizer goes about the tricky business of getting a JAK inhibitor past regulators at the FDA and EMA.
Lined up side by side we see:
IGA response rate (clear or nearly clear skin)

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First place fin­ish: Eli Lil­ly just moved to fran­chise leader with their sec­ond mi­graine drug OK in 1 year

In a rare twist for Eli Lilly’s historically slow-moving R&D group, the pharma giant has seized bragging rights to a first-in-class new drug approval. And all signs point to an aggressive marketing followup as they look to outclass some major franchise rivals hobbled by internal dissension.

The FDA came through with an OK for lasmiditan on Friday evening, branding it as Reyvow and lining it up — once a substance classification comes through from the DEA — for a major market release. The oral drug binds to 5-HT1F receptors and is designed to stop an acute migraine after it starts. That makes it a complementary therapy to their CGRP drug Emgality, which has a statistically significant impact on preventing attacks.

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Allogene HQ Open House on September 17, 2019 in South San Francisco. (Jeff Rumans, Endpoints News)

The next 10 years: Where is biotech head­ed?

The last 10 years have seen a revolution in drug development. Timelines have shortened, particularly in oncology. Regulators have opened up. Investment has skyrocketed. China became a player. Biotechs have multiplied as gene and cell therapy has exploded — offering major new advances in the way diseases are treated, and sometimes cured.

So where are we headed from here? I journeyed out to San Francisco in September to discuss the answer to that question at Allogene’s open house. If the last 10 years have been an eye-opener, what does the next decade hold in store?

Patrick Mahaffy, Getty Images

Court green-lights Clo­vis case af­ter de­tail­ing ev­i­dence the board ‘ig­nored red flags’ on false safe­ty and ef­fi­ca­cy da­ta

Clovis investors have cleared a major hurdle in their long-running case against the board of directors, with a Delaware court making a rare finding that they had a strong enough case against the board to proceed with the action.

In a detailed ruling at the beginning of the month that’s been getting careful scrutiny at firms specializing in biotech and corporate governance, the Delaware Court of Chancery found that the attorneys for the investors had made a careful case that the board — a collection of experts that includes high-profile biotech entrepreneurs, a Harvard professor and well-known investigator as well as Clovis CEO Patrick Mahaffy — repeatedly ignored obvious warnings that Mahaffy’s executive crew was touting inflated, unconfirmed data for their big drug Roci. Serious safety issues were also reportedly overlooked while the company continued a fundraising campaign that brought in more than a half-billion dollars. And that leaves the board open to claims related to their role in the fiasco.

The bottom line:

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Bill Gates backs Gink­go Biowork­s' $350M raise to fu­el the buzzy syn­thet­ic bi­ol­o­gy 'rev­o­lu­tion'

If you want to understand Ginkgo Bioworks, the name should suffice: Bioworks, a spin off “ironworks,” that old industrial linchpin devoted to leveraging scale as a wellspring for vast new industries capable of remaking society. Ginkgo wants to be the ironworks for the revolution it’s heralded with as much fanfare as they can, playing off of one of the buzziest technologies in biotech.

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UCB bags a ri­val to Soliris in $2.1B buy­out deal — but will an in­creas­ing­ly vig­i­lant FTC sign off?

UCB is buying out Ra Pharma $RARX, announcing an acquisition deal that rings up at $48 a share, or $2.1 billion net of cash, and puts them toe-to-toe with Alexion on a clinical showdown.

Ra shares closed at $22.70 on Wednesday.

There’s a small pipeline in play at Ra, but UCB is going for the lead drug — a C5 inhibitor called zilucoplan in Phase III for myasthenia gravis (MG) looking to play rival to Alexion’s Soliris. Soliris has the market advantage, though, with a much earlier approval in MG in late 2017 that UCB feels confident in challenging.

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A new play­er is tak­ing the field in a push for a he­mo­phil­ia A gene ther­a­py, and it’s a big one

BioMarin, the execs at Spark (and buyer-to-be Roche) as well as the Sangamo/Pfizer team have a new rival striding onto the hemophilia block. And it’s a big one.

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Stuck with a PhI­II gene ther­a­py fail­ure at 96 weeks, Gen­Sight prefers the up­beat as­sess­ment

Two years after treatment, the best thing that GenSight Biologics $SIGHT can say about their gene therapy for vision-destroying cases of Leber Hereditary Optic Neuropathy is that it’s just a bit better than a placebo — just maybe because one treatment can cover both eyes.

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