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.

Brian Kaspar. AveXis via Twitter

AveX­is sci­en­tif­ic founder fires back at No­var­tis CEO Vas Narasimhan, 'cat­e­gor­i­cal­ly de­nies any wrong­do­ing'

Brian Kaspar’s head was among the first to roll at Novartis after company execs became aware of the fact that manipulated data had been included in its application for Zolgensma, now the world’s most expensive therapy.

But in his first public response, the scientific founder at AveXis — acquired by Novartis for $8.7 billion — is firing back. And he says that not only was he not involved in any wrongdoing, he’s ready to defend his name as needed.

I reached out to Brian Kaspar after Novartis put out word that he and his brother Allen had been axed in mid-May, two months after the company became aware of the allegations related to manipulated data. His response came back through his attorneys.

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Novartis CEO Vas Narasimhan [via Bloomberg/Getty]

I’m not per­fect: No­var­tis chief Vas Narasimhan al­most apol­o­gizes in the wake of a new cri­sis

Vas Narasimhan has warily stepped up with what might pass as something close to a borderline apology for the latest scandal to engulf Novartis.

But he couldn’t quite get there.

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FDA to Sarep­ta: Your wide­ly an­tic­i­pat­ed fol­lowup to Ex­ondys 51 is not get­ting an ac­cel­er­at­ed OK for Duchenne MD

In one of the least anticipated moves of the year, the FDA has rejected Sarepta’s application for an accelerated approval of its Duchenne MD drug golodirsen after fretting over safety issues.

In a statement that arrived after the bell on Monday, Sarepta explained the CRL, saying:

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Levi Garraway. Broad Institute via Youtube

Roche raids Eli Lil­ly for its next chief med­ical of­fi­cer as San­dra Horn­ing plans to step down

We found out Monday morning where Levi Garraway was headed after he left Eli Lilly as head of oncology R&D a few days ago. Roche named Garraway as their new chief medical officer, replacing Sandra Horning, who they say is retiring from the company.

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Af­ter a posse of Wall Street an­a­lysts pre­dict a like­ly new win for Sarep­ta, we're down to the wire on a crit­i­cal FDA de­ci­sion

As Bloomberg notes, most of the Wall Street analysts that cover Sarepta $SRPT are an upbeat bunch, ready to cheer on the team when it comes to their Duchenne MD drugs, or offer explanations when an odd setback occurs — as happened recently with a safety signal that was ‘erroneously’ reported last week.

Ritu Baral Cowen
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UP­DAT­ED: No­var­tis spin­off Nabri­va fi­nal­ly scores its first an­tibi­ot­ic ap­proval

In May, Nabriva Therapeutics suffered a setback after the FDA rejected its antibiotic for complicated urinary tract infections — the Novartis spinoff has now had some better luck with the US agency, which on Monday approved its other drug for community-acquired bacterial pneumonia.

The drug, lefamulin, has been developed as an intravenous and oral formulation and been tested in two late-stage clinical trials. The semi-synthetic compound, whose dosing can be switched between the two formulations, is engineered to inhibit the synthesis of bacterial protein by binding to a part of the bacterial ribosome.

Saqib Islam. CheckRare via YouTube

Spring­Works seeks $115M to push Pfiz­er drugs across fin­ish line while Sat­suma sells mi­graine play in $86M IPO

SpringWorks and Satsuma — both biotech spinouts that have closed B rounds in April — are loading up with IPO cash to boost their respective late-stage plans.
SpringWorks

Bain-backed SpringWorks is the better-known company of the two, and it’s gunning for a larger windfall of $115 million to add to $228 million from previous financings. In the process, the Stamford, CT-based team is also drawing the curtains on the partnerships it has in mind for the pair of assets it had initially licensed from Pfizer.

Mi­nor­i­ty racial groups con­tin­ue to be dis­mal­ly rep­re­sent­ed in can­cer tri­als — study

Data reveal that different racial and ethnic groups — by nature and/or nurture — can respond differently in terms of pharmacokinetics, efficacy, or safety to therapeutics, but this disparity is not necessarily accounted for in clinical trials. A fresh analysis of the last decade of US cancer drug approvals suggests the trend continues, cementing previous research that suggests oncology trials are woefully under-representative of the racial makeup of the real world.

Van­da shares slide af­ter FDA spurns their big end­point and re­jects a pitch on jet lag re­lief

Back in the spring of last year, Vanda Pharmaceuticals $VNDA served up a hot stew of mixed data for a slate of endpoints related to what they called clear evidence that their melatonin sleep drug Hetlioz (tasimelteon) could help millions of travelers suffering from jet lag.

Never mind that they couldn’t get a planned 90 people in the study, settling for 25 instead; Vanda CEO Mihael H. Polymeropoulos said they were building on a body of data to prove it would help jet-lagged patients looking for added sleep benefits. And that, they added, would be worth a major upgrade from the agency as they sought to tackle a big market.