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.

Illustration: Assistant Editor Kathy Wong for Endpoints News

How Pur­due's $272M ad­dic­tion pay­out fund­ed a new home for its dis­card­ed non-opi­oid re­search

Don Kyle spent more than 20 years working for Purdue Pharma, right through the US opioid epidemic that led to the company’s rise and eventual infamy. But contrary to Purdue’s focus on OxyContin, Kyle was researching non-opioid painkillers — that is, until the company shelved his research.

As the company’s legal troubles mounted, Kyle found an unlikely way to reboot the project. In 2019, he took his work to an Oklahoma State University center that’s slated to receive more than two-thirds of the state’s $272 million settlement with Purdue over claims that the drugmaker’s behavior ignited the epidemic of opioid use and abuse.

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President Joe Biden at the State of the Union address with Vice President Kamala Harris and House Speaker Kevin McCarthy (Patrick Semansky/AP Images)

The drug pric­ing pres­i­dent: Biden warns of ve­to for any IRA re­peal at­tempts

President Joe Biden made clear in his “finish the job” State of the Union address last night that one of those jobs to be finished is insulin prices.

Biden’s push again to tackle insulin prices, after Republicans rebuffed the idea last summer and just after Biden won Medicare drug price negotiations/caps via the Inflation Reduction Act, shows how heavily he’s leaning into this work.

Rupert Vessey, Bristol Myers Squibb head of research and early development

Up­dat­ed: R&D tur­bu­lence at Bris­tol My­ers now in­cludes the end of a $650M al­liance and the de­par­ture of a top re­search cham­pi­on

This morning biotech Dragonfly put out word that Bristol Myers Squibb has handed back all rights to its IL-12 clinical-stage drug after spending $650 million to advance it into the clinic.

The news arrives amid a turbulent R&D stage for the pharma giant, which late last week highlighted Rupert Vessey’s decision to depart this summer as head of early-stage R&D following a crucial three-year stretch after he jumped to Bristol Myers in the big Celgene buyout. During that time he struck a series of deals for Bristol Myers, and also shepherded a number of Celgene programs down the pipeline, playing a major role for a lineup of biotechs which depended on him to champion their drugs.

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Bill Haney, Dragonfly CEO (Dave Pedley/Getty Images for SXSW)

Drag­on­fly chief: Bris­tol My­ers shouldn’t blame IL-12’s clin­i­cal per­for­mance for de­ci­sion to scrap the deal — eco­nom­ics played a key role

Bristol Myers Squibb says the IL-12 drug they were developing out of Dragonfly Therapeutics was scrubbed from the pipeline for a simple reason: It didn’t measure up on clinical performance.

But Bill Haney, the CEO of Dragonfly, is taking issue with that.

The early-stage drug, still in Phase I development, has passed muster with Bristol Myers’ general clinical expectations, advancing successfully while still in Phase I, he says.

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Utpal Koppikar, new Verily CFO

Ex­clu­sive: Ver­i­ly wel­comes Atara Bio­ther­a­peu­tics vet­er­an as new CFO

Verily, Alphabet’s life sciences outfit, has plucked a new CFO from the ranks of Atara Biotherapeutics, the company announced on Wednesday.

Utpal Koppikar joins Verily after a nearly five-year stint as CFO and senior VP at Atara, though his résumé also boasts roles at Gilead and Amgen.

The news follows a major reshuffling at Verily, including several senior departures earlier this year and a round of layoffs.

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Singer Nick Jonas is back at work for Dexcom, this time for its new G7 glucose monitor.

Dex­com's spokescelebri­ty Nick Jonas re­turns to Su­per Bowl in new glu­cose mon­i­tor com­mer­cial

Dexcom is going back to the Super Bowl with its pop singer and patient spokesperson Nick Jonas. Jonas takes center stage as the lone figure in the 30-second commercial showcasing Dexcom’s next-generation G7 continuous glucose monitoring (CGM) device.

Jonas’ sleight-of-hand tricks populate the commercial — he pinches his empty fingers together and pops them open to reveal the small CGM — even as he ends the ad, saying, “It’s not magic. It just feels that way.” Jonas then disappears in a puff of smoke.

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Richard Francis, newly-appointed Teva CEO (Novartis via Facebook)

New Te­va CEO Richard Fran­cis repri­or­i­tizes to 'get back to growth'

Six weeks into his new role at the helm of Teva Pharmaceutical, Richard Francis said it’s time to “get back to growth,” starting with a good look at the company’s priorities.

The chief executive has kicked off a strategic review, he announced during Teva’s quarterly call, which will continue over the next several months and produce results sometime in the middle of 2023. That means some pipeline cuts may be in store, he told Endpoints News, while declining to offer much more detail.

FDA Commissioner Robert Califf on Capitol Hill, Feb. 8, 2023 (Drew Angerer/Getty Images)

FDA com­mis­sion­er floats ideas on how to bet­ter han­dle the pan­dem­ic

FDA Commissioner Rob Califf joined the heads of the CDC and NIH in the hot seat today before a key House subcommittee, explaining that there needs to be a much faster, more coordinated way to oversee vaccine safety, and that foreign biopharma inspections, halted for years due to the pandemic, are slowly ramping up again.

Califf, who stressed to the House Energy and Commerce’s Subcommittee on Health that the CDC also needs better data, made clear that the FDA’s ability to monitor the safety of vaccines “would also benefit greatly by a coordinated federal public health data reporting authority.”

Sanofi is renewing its #VaccinesForDreams campaign with more stories, such as Juan's in Argentina (Sanofi)

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Sanofi is highlighting people’s dreams — both big and small — to make the point that vaccines make them possible.

The renewed “Dream Big” global social media campaign’s newest dreamer is Juan, a teacher in the Misiones rainforest in Argentina whose story is told through videos on Instagram and Sanofi’s website with the hashtag #VaccinesForDreams.

The campaign ties to Sanofi’s broader umbrella initiative “Vaccine Stories” to promote the value of vaccines and drive awareness of the need for improved vaccination coverage.

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