Peer Re­view: Don Hay­den com­mits to CEO role at Wind­MIL; X4 nabs new CMO Lynne Kel­ley from His­to­gen­ics ex­ile

→ Since leav­ing a 25-year ca­reer and the pres­i­dent of glob­al phar­ma­ceu­ti­cals ti­tle at Bris­tol-My­ers Squibb in 2005, Don Hay­den has kept him­self busy as a con­sul­tant and ad­vis­er to bio­phar­ma com­pa­nies, some­times jug­gling sev­en or eight board ap­point­ments. But af­ter a few months as in­ter­im CEO of Wind­MIL Ther­a­peu­tics, he’s ready to “sub­stan­tial­ly pull back” on all those com­mit­ments as he tran­si­tions to a full-time role.

Don Hay­den

“Every now and then in one’s ca­reer you come across a com­bi­na­tion of cir­cum­stances that con­vince you you just want to be a part of it, and that’s re­al­ly what hap­pened at Wind­MIL,” he told me.

The Bal­ti­more-based start­up was spun out of Johns Hop­kins and got its name, in part, from mar­row in­fil­trat­ing lym­pho­cytes, or MILs. These mem­o­ry T cells re­sid­ing in the bone mar­row have an in­nate abil­i­ty to rec­og­nize tu­mors, ren­der­ing them a po­tent can­cer killing agent both on its own and as a “base” for oth­er treat­ments like CAR-T.

His fo­cus now, Hay­den said, is to po­si­tion the com­pa­ny for a “very big year” in 2020, when the first da­ta read­out from a mul­ti­ple myelo­ma tri­al is due. Wind­MIL al­so plans to delve deep­er in­to sol­id tu­mor, fol­low­ing a non-small cell lung can­cer tri­al (in PD-1 re­frac­to­ry/re­lapsed pa­tients) it hopes to start this year.

Gra­ham Kel­ly

→ In prepa­ra­tion for a Nas­daq list­ing, Aus­tralian drug­mak­er Nox­opharm has re­as­signed some hats in top lead­er­ship. Founder Gra­ham Kel­ly is mov­ing up to the ex­ec­u­tive chair­man role, tap­ping Greg van Wyk — the cur­rent CMO — to dou­ble as chief ex­ec­u­tive. This way, the com­pa­ny says, Kel­ly can spend more time “look­ing to raise the com­pa­ny’s pro­file in the US cap­i­tal mar­kets,” where he’s led two IPOs al­most two decades ago.

No­var­tis’ Vas Narasimhan has raid­ed Glaso­SmithK­line’s se­nior ex­ec­u­tive crew for his new San­doz chief. Richard Saynor is mak­ing the leap from his last post as SVP clas­sic & es­tab­lished prod­ucts, com­mer­cial & dig­i­tal plat­forms at a time spec­u­la­tion about the fu­ture of San­doz has been ram­pant. But he may have some ideas on what can be done bet­ter. Ac­cord­ing to his LinkedIn page, he’s been at GSK for close to 9 years — af­ter jump­ing over from San­doz.

Jim Robin­son

→ Af­ter a stint at Alk­er­mes $ALKS that took him to Boston area for a lit­tle over a year, Jim Robin­son is mov­ing home. Re­port­ing at Paragon Bio­sciences’ Chica­go of­fice this week, Robin­son keeps the same ti­tle: pres­i­dent and chief op­er­at­ing of­fi­cer. But in­stead of over­see­ing one en­ti­ty, he will run a host of func­tion­al ser­vices to sup­port Paragon’s six and count­ing port­fo­lio com­pa­nies.

X4 Phar­ma­ceu­ti­cals $XFOR has re­cruit­ed Lynne Kel­ley to steer a Phase III pro­gram for a rare ge­net­ic, pri­ma­ry im­mun­od­e­fi­cien­cy dis­ease known as WHIM syn­drome. The new CMO is one of the His­to­gen­ics ex­ecs who were dis­band­ed af­ter the mi­cro­cap es­sen­tial­ly sold its shell to Ocu­gen in a re­verse merg­er.

John Cur­nutte

John Cur­nutte is hang­ing up his R&D boots at Por­to­la Phar­ma­ceu­ti­cals $PT­LA, trad­ing a lead role for a con­sul­tant po­si­tion. His re­tire­ment comes al­most a year af­ter that of ex-CEO William Lis, which put Cur­nutte in charge briefly as a co-pres­i­dent. In their time, the two ex­ecs shep­herd­ed Beyvexxa — an an­ti­co­ag­u­lant — and An­dexxa — an an­ti-an­ti­co­ag­u­lant — to FDA ap­provals, de­spite some hic­cups along the way. Pamela Con­ley, a 15-year vet­er­an of the com­pa­ny and cur­rent SVP of re­search, will take over the re­search team while Jeff My­ers serves as in­ter­im CMO.

→ Af­ter kick­ing off its Phase III pro­gram, En­ta­sis Ther­a­peu­tics, the biotech spun out from As­traZeneca to house its an­tibi­otics group, is plan­ning for its com­mer­cial fu­ture — and hir­ing an ex­pe­ri­enced hand. Er­ic Kim­ble joins the biotech $ET­TX as the field is still rat­tling from Achao­gen’s bank­rupt­cy, yet an­oth­er stark re­minder of the grim con­di­tions that face an­tibi­otics de­vel­op­ers even when they man­age to bring their drugs to the mar­ket. Kim­ble, a Cu­bist Phar­ma alum who’s spent the past five years con­sult­ing for an­tibi­otics star­tups, said he wel­comes the chal­lenge.

→ A trou­bled Aduro has re­cruit­ed Pfiz­er can­cer R&D ex­ec to take the chief med­ical of­fi­cer’s job. Dim­it­ry Nuyten is mov­ing from his job as vice pres­i­dent and im­muno-on­col­o­gy clin­i­cal de­vel­op­ment leader to the biotech. His stint at Pfiz­er put Nuyten in charge of its Baven­cio work, part­nered with Mer­ck KGaA. “We are ex­treme­ly pleased to wel­come Dim­it­ry as we pre­pare to broad­en our de­vel­op­ment plans for STING ag­o­nist ADU-S100 and ini­ti­ate our first in hu­man study of an­ti-APRIL an­ti­body BION-1301 in IgA nephropa­thy,” not­ed CEO Stephen Isaacs in a state­ment.

→ The crew at Ju­ve­nes­cence has brought on David El­lam on their an­ti-ag­ing cru­sade. El­lam jumps from the same role at Lon­don-based Si­lence Ther­a­peu­tics, which he joined af­ter stints at Bio­Marin and Ark Ther­a­peu­tics. With over $110 mil­lion to spend on ex­ist­ing and fu­ture port­fo­lio com­pa­nies, El­lam will work along­side CEO Greg Bai­ley to build up Ju­ve­nes­cence’s in­fra­struc­ture and cor­po­rate gov­er­nance as it ex­plores “a list­ing on an in­ter­na­tion­al ex­change.”

Thomas Le­ung is the new CFO at Men­lo Park, CA-based Ad­verum Biotech­nolo­gies $AD­VM, play­ing a big role in shap­ing the com­pa­ny as it charts a clin­i­cal path for its gene ther­a­py for the eye. A for­mer VP at TPG Cap­i­tal, Le­ung’s most re­cent job was in busi­ness op­er­a­tions at a women’s health ge­net­ic test­ing com­pa­ny.

→ Keen on get­ting its wet age-re­lat­ed mac­u­lar de­gen­er­a­tion drug ap­proved around the world next year, Out­look Ther­a­peu­tics $OTLK has ap­point­ed Jen­nifer Kiss­ner as SVP clin­i­cal de­vel­op­ment. As CMO Ken­neth Bahrt heads out the door (with no re­place­ment planned), Kiss­ner will ef­fec­tive­ly take up the re­spon­si­bil­i­ty to work with con­tract­ed ser­vices to dri­ve ONS-5010 for­ward, lever­ag­ing lessons she learned at Al­con, Acucela and most re­cent­ly Clear­side Bio­med­ical.

→ Hav­ing learned the ins and outs of can­cer di­ag­nos­tics at Foun­da­tion Med­i­cine, Al­fred “Fred­di” Bowie is bring­ing his busi­ness skillset to Ve­r­a­cyte $VCYT. As VP, cor­po­rate and busi­ness de­vel­op­ment, Bowie is tasked with as­sess­ing and man­ag­ing part­ner­ships, li­cens­ing and ac­qui­si­tions. One of them will be a lung can­cer de­tec­tion project al­lied with J&J in an al­liance an­nounced this Jan­u­ary.

→ Rare dis­ease-fo­cused Log­icBio Ther­a­peu­tics $LOGC has hired five se­nior ex­ecs to help man­age its ex­pand­ed lab op­er­a­tions, from CMC and tech­nol­o­gy de­vel­op­ment to pro­gram and clin­i­cal man­age­ment. They in­clude Matthias Hebben, VP of tech­nol­o­gy de­vel­op­ment, jump­ing from Genethon; Marie Pay­ton, VP of clin­i­cal op­er­a­tions, for­mer­ly of Mil­len­ni­um; Sanofi Gen­zyme vet Car­ol Sher­ako, se­nior di­rec­tor, pro­gram man­age­ment; Sven Loe­brich, a CMC ex­pert with ex­pe­ri­ence at Im­muno­Gen; and Voy­ager’s Lau­ren Drouin, who will fo­cus on an­a­lyt­i­cal de­vel­op­ment. To­geth­er, they will push Log­icBio’s first drug in­to clin­i­cal de­vel­op­ment while re­fin­ing its gene edit­ing plat­form.

Yposke­si, a French CD­MO spe­cial­iz­ing in gene ther­a­py vi­ral vec­tor man­u­fac­tur­ing, has ap­point­ed Morad El Gued­dari as pro­duc­tion di­rec­tor of its core op­er­a­tion. A vet­er­an of Cell­for­Cure — now a No­var­tis sub­sidiary — El Gued­dari joins as the com­pa­ny is dou­bling its glob­al foot­print.

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.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 94,200+ biopharma pros reading Endpoints daily — and it's free.

Pascal Soriot (AP Images)

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.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 94,200+ biopharma pros reading Endpoints daily — and it's free.

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.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 94,200+ biopharma pros reading Endpoints daily — and it's free.

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.

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.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

John Maraganore, Alnylam CEO (Scott Eisen/Bloomberg via Getty Images)

UP­DAT­ED: Al­ny­lam gets the green light from the FDA for drug #3 — and CEO John Maraganore is ready to roll

Score another early win at the FDA for Alnylam.

The FDA put out word today that the agency has approved its third drug, lumasiran, for primary hyperoxaluria type 1, better known as PH1. The news comes just 4 days after the European Commission took the lead in offering a green light.

An ultra rare genetic condition, Alnylam CEO John Maraganore says there are only some 1,000 to 1,700 patients in the US and Europe at any particular point. The patients, mostly kids, suffer from an overproduction of oxalate in the liver that spurs the development of kidney stones, right through to end stage kidney disease.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 94,200+ biopharma pros reading Endpoints daily — and it's free.

Bob Nelsen (Photo by Michael Kovac/Getty Images)

Bob Nelsen rais­es $800M and re­cruits a star-stud­ded board to build the 'Fox­con­n' of biotech

Bob Nelsen spent his pandemic spring in his Seattle home, talking on the phone with Luciana Borio, the scientist who used to run pandemic preparedness on the National Security Council, and fuming with her about the dire state of American manufacturing.

Companies were rushing to develop vaccines and antibodies for the new virus, but even if they succeeded, there was no immediate supply chain or infrastructure to mass-produce them in a way that could make a dent in the outbreak.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 94,200+ biopharma pros reading Endpoints daily — and it's free.

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.