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

Mi­no­ryx and Sper­o­genix ink an ex­clu­sive li­cense agree­ment to de­vel­op and com­mer­cial­ize lerigli­ta­zone in Chi­na

September 23, 2020 – Hong Kong, Beijing, Shanghai (China) and Mataró, Barcelona (Spain)  

Minoryx will receive an upfront and milestone payments of up to $78 million, as well as double digit royalties on annual net sales 

Sperogenix will receive exclusive rights to develop and commercialize leriglitazone for the treatment of X-linked adrenoleukodystrophy (X-ALD), a rare life-threatening neurological condition

FDA commissioner Stephen Hahn at the White House (AP Images)

Un­der fire, FDA to is­sue stricter guid­ance for Covid-19 vac­cine EUA this week — re­port

The FDA has been insisting for months that a Covid-19 vaccine had to be at least 50% effective – a measure of transparency meant to shore public trust in the agency and in a vaccine that had been brought forward at record speed and record political pressure. But now, with concerns of a Trump-driven authorization arriving before the election, the agency may be raising the bar.

The FDA is set to release new guidance that would raise safety and efficacy requirements for a vaccine EUA above earlier guidance and above the criteria used for convalescent plasma or hydroxychloroquine, The Washington Post reported. Experts say this significantly lowers the odds of an approval before the election on November 3, which Trump has promised despite vocal concerns from public health officials, and could help shore up public trust in the agency and any eventual vaccine.

Secretary of health and human services Alex Azar speaking in the Rose Garden at the White House (Photo: AFP)

Trump’s HHS claims ab­solute au­thor­i­ty over the FDA, clear­ing path to a vac­cine EUA

The top career staff at the FDA has vowed not to let politics overrule science when looking at vaccine data this fall. But Alex Azar, who happens to be their boss’s boss, apparently won’t even give them a chance to stand in the way.

In a new memorandum issued Tuesday last week, the HHS chief stripped the FDA and other health agencies under his purview of their rule making ability, asserting all such power “is reserved to the Secretary.” Sheila Kaplan of the New York Times first obtained and reported the details of the September 15 bulletin.

Vas Narasimhan (AP Images)

UP­DAT­ED: Still held down by clin­i­cal hold, No­var­tis' Zol­gens­ma falls fur­ther be­hind Bio­gen and Roche as FDA asks for a new piv­otal study

Last October, the FDA slowed down Novartis’ quest to extend its gene therapy to older spinal muscular atrophy patients by slapping a partial hold on intrathecal administration. Almost a year later, the hold is still there, and regulators are adding another hurdle required for regulatory submission: a new pivotal confirmatory study.

The new requirement — which departs significantly from Novartis’ prior expectations — will likely stretch the path to registration beyond 2021, when analysts were expecting a BLA submission. That could mean more time for Biogen to reap Spinraza revenues and Roche to ramp up sales of Evrysdi in the absence of a rival.

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Scoop: ARCH’s Bob Nelsen is back­ing an mR­NA up­start that promis­es to up­end the en­tire man­u­fac­tur­ing side of the glob­al busi­ness

For the past 2 years, serial entrepreneur Igor Khandros relied on a small network of friends and close insiders to supply the first millions he needed to fund a secretive project to master a new approach to manufacturing mRNA therapies.

Right now, he says, he has a working “GMP-in-a-box” prototype for a new company he’s building — after launching 3 public companies — which plans to spread this contained, precise manufacturing tech around the world with a set of partners. He’s raised $60 million, recruited some prominent experts. And not coincidentally, he’s going semi-public with this just as a small group of pioneers appears to be on the threshold of ushering in the world’s first mRNA vaccines to fight a worldwide pandemic.

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Isaac Veinbergs, Libra CEO

With $29M in Se­ries A, Boehringer-backed Li­bra looks to tack­le neu­rode­gen­er­a­tion through cel­lu­lar clean­ing

Can the natural process by which cells clean out toxic proteins be harnessed to create potential treatments for neurodegenerative disorders?

That’s the question Libra Therapeutics will be trying to answer, as the new biotech officially launched Wednesday morning with $29 million in Series A financing. The company has three preclinical programs at the ready, with its lead candidate targeting ALS and frontotemporal dementia. But CEO Isaac Veinbergs said he hopes to develop therapies for a wide range of diseases, including Parkinson’s, Alzheimer’s and Huntington’s.

Patrick Enright, Longitude co-founder (Longitude)

As its biotechs hit the pan­dem­ic ex­it, Lon­gi­tude rais­es $585M for new neu­ro, can­cer, ag­ing and or­phan-fo­cused fund

The years have been kind to Longitude Capital. This year, too.

A 2006 spinout of Pequot Capital, its founders started their new firm just four years before the parent company would go under amid insider trading allegations. Their first life sciences fund raised $325 million amid the financial crisis, they added a second for $385 million and then in, 2016, a third for $525 million. In the last few months, the pandemic biotech IPO boom netted several high-value exits from those funds, as Checkmate, Vaxcyte, Inozyme and Poseida all went public.

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Gene Wang, Immetas co-founder and CEO (file photo)

Im­metas Ther­a­peu­tics nabs $11M Se­ries A to nar­row their bis­pe­cif­ic work tar­get­ing in­flam­ma­tion in age-re­lat­ed dis­eases

How does a biotech celebrate its two-year anniversary? For Immetas Therapeutics, it’s with an $11 million Series A round and a game plan to fight age-related disease.

Co-founders Gene Wang and David Sinclair came together years ago around the idea that inflammation is the ultimate process driving age-related illnesses, including cancer. The duo launched Immetas in 2018 and packed the staff with industry experts. Wang, who says he’s always had an entrepreneurial spirit, has held lead roles at Novartis, GSK, Bristol Myers Squibb and Merck. He’s worked on blockbuster drugs like Humira, Gardasil, Varubi and Zolinza. And now, he’s channeling that spirit as CEO.

Samit Hirawat (Bristol Myers Squibb)

Af­ter bruis­ing re­jec­tion, blue­bird and Bris­tol My­ers Squibb land ide-cel pri­or­i­ty re­view. But will it mat­ter for the CVR?

With the clock all but up, the FDA accepted and handed priority review to Bristol Myers Squibb and bluebird bio’s BCMA CAR-T, keeping a narrow window open for Celgene investors to still cash in on the $9 CVR from the $63 billion Celgene merger.

The acceptance comes five months after the two companies weres slammed with a surprise refuse-to-file that threatened to foreclose the CVR entirely. Today’s acceptance sets the FDA decision date for March 27, 2021 – or precisely 4 days before the CVR deadline of March 31. Given the breakthrough designation and strong pivotal data — 81.5% response rate, 35.2% complete response rate — priority review was largely expected.

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