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.

Regeneron CEO Leonard Schleifer speaks at a meeting with President Donald Trump, members of the Coronavirus Task Force, and pharmaceutical executives in the Cabinet Room of the White House (AP Photo/Andrew Harnik)

OWS shifts spot­light to drugs to fight Covid-19, hand­ing Re­gen­eron $450M to be­gin large scale man­u­fac­tur­ing in the US

The US government is on a spending spree. And after committing billions to vaccines defense operations are now doling out more of the big bucks through Operation Warp Speed to back a rapid flip of a drug into the market to stop Covid-19 from ravaging patients — possibly inside of 2 months.

The beneficiary this morning is Regeneron, the big biotech engaged in a frenzied race to develop an antibody cocktail called REGN-COV2 that just started a late-stage program to prove its worth in fighting the virus. BARDA and the Department of Defense are awarding Regeneron a $450 million contract to cover bulk delivery of the cocktail starting as early as late summer, with money added for fill/finish and storage activities.

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Noubar Afeyan, Flagship CEO and Tessera chairman (Victor Boyko/Getty Images)

Flag­ship ex­ecs take a les­son from na­ture to mas­ter ‘gene writ­ing,’ launch­ing a star-stud­ded biotech with big am­bi­tions to cure dis­ease

Flagship Pioneering has opened up its deep pockets to fund a biotech upstart out to revolutionize the whole gene therapy/gene editing field — before gene editing has even made it to the market. And they’ve surrounded themselves with some marquee scientists and execs who have crowded around to help shepherd the technology ahead.

The lead player here is Flagship general partner Geoff von Maltzahn, an MIT-trained synthetic biologist who set out in 2018 to do CRISPR — a widely used gene editing tool — and other rival technologies one or two better. Von Maltzahn has been working with Sana co-founder Jake Rubens, another synthetic biology player out of MIT who he describes as his “superstar,” who’s taken the CSO role.

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Covid-19 roundup: Squab­bles with gov­ern­ment de­lay Mod­er­na’s PhI­II — re­ports; No­vavax se­cures largest Warp Speed deal yet: $1.6B

A much-anticipated Phase III trial for Moderna’s Covid-19 vaccine is being held up as the company delayed submitting trial protocols and sparred with government scientists on how to run the study and even what the benchmark for success should be, Reuters reported.

Moderna, the first US company to put their vaccine into human testing, was supposed to enter a 30,000-person study this month in partnership with the NIH to determine whether it can prevent infection. STAT reported last week that the trial was facing delays over the protocol, but that a July start was still possible. Neither the NIH nor Moderna ever disclosed a specific date the trial should start, but Reuters reported that the agency had hoped to begin on July 10.

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Donald and Melania Trump watch the smoke of fireworks from the South Lawn of the White House on July 4, 2020 (via Getty)

Which drug de­vel­op­ers of­fer Trump a quick, game-chang­ing ‘so­lu­tion’ as the pan­dem­ic roars back? Eli Lil­ly and Ab­Cellera look to break out of the pack

We are unleashing our nation’s scientific brilliance and will likely have a therapeutic and/or vaccine solution long before the end of the year.

— Donald Trump, July 4

Next week administration officials plan to promote a new study they say shows promising results on therapeutics, the officials said. They wouldn’t describe the study in any further detail because, they said, its disclosure would be “market-moving.”

— NBC News, July 3

Something’s cooking. And it’s not just July 4 leftovers involving stale buns and uneaten hot dogs.

Over the long weekend observers picked up signs that the focus in the Trump administration may swiftly shift from the bright spotlight on vaccines being promised this fall, around the time of the election, to include drugs that could possibly keep patients out of the hospital and take the political sting out of the soaring Covid-19 numbers causing embarrassment in states that swiftly reopened — as Trump cheered along.

So far, Gilead has been the chief beneficiary of the drive on drugs, swiftly offering enough early data to get remdesivir an emergency authorization and into the hands of the US government. But their drug, while helpful in cutting stays, is known for a limited, modest effect. And that won’t tamp down on the hurricane of criticism that’s been tearing at the White House, and buffeting the president’s most stalwart core defenders as the economy suffers.

We’ve had positive early-stage vaccine data, most recently from Pfizer and BioNTech, playing catchup on an mRNA race led by Moderna — where every little sign of potential trouble is magnified into a lethal threat, just as every advance excites a frenzy of support. But that race still has months to play out, with more Phase I data due ahead of the mid-stage numbers looming ahead. A vaccine may not be available in large enough quantities until well into 2021, which is still wildly ambitious.

So what about a drug solution?

Trump’s initial support for a panacea focused on hydroxychloroquine. But that fizzled in the face of data underscoring its ineffectiveness — killing trials that aren’t likely to be restarted because of a recent population-based study offering some support. And there are a number of existing drugs being repurposed to see how they help hospitalized patients.

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Cel­lec­tis slammed af­ter pa­tient dies and FDA slaps a hold on their tri­al for an off-the-shelf CAR-T for mul­ti­ple myelo­ma

Cellectis was slammed after the market close on Monday as the biotech reported that the FDA demanded it hit the brakes on their MELANI-01 trial for their off-the-shelf cell therapy UCARTCS1A after one of the patients in the study died of treatment-related cardiac arrest.

The multiple myeloma patient had previously been treated unsuccessfully with various therapies, noted the biotech, and had been given dose level two (DL2) of their allogeneic CAR-T.

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Shoshanna Shendelman, Applied Therapeutics CEO (Applied Therapeutics)

A lit­tle biotech slaps back at a 'crim­i­nal' short at­tack, vow­ing to pur­sue a pros­e­cu­tion of their case

As short attacks go, Biotech Research Partners’ assault on Applied Therapeutics’ “cherry picked” data and a variety of so-called red flags didn’t cause a whole lot of damage. Ahead of the July 4 holiday, its shares $APLT were dinged and showed signs of quick recovery.

But that didn’t stop an incendiary response, as the biotech swung into action bright and early Monday morning.

Applied Therapeutics accused the authors of the short report of manipulating graphs and figures, misrepresenting data and included factual misrepresentations — all of which added up, in their view, to fraud.

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

A boom­ing Drag­on­fly is tak­ing its TriN­KETs to Copen­hagen as the lat­est Bris­tol My­ers pact spurs ex­pan­sion plans — out­side the US

Bristol Myers Squibb is making a habit out of collaborating with the crew at Dragonfly, adding their 3rd deal in a series that now will take them into newly charted R&D territory. And the fast-growing team at the Cambridge-based biotech is adding a facility in Copenhagen for its next growth spurt, where the government is making it easy to recruit scientists internationally as the U.S. throttles back.

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Covid-19 roundup: Teamed up with NIH, Re­gen­eron launch­es PhI­II pre­ven­tion tri­al for an­ti­body cock­tail

As Regeneron moves its antibody cocktail into Phase II/III trials testing REGN-COV2 as a treatment for both hospitalized and non-hospitalized patients with Covid-19, the biotech is also starting a Phase III in the prevention setting.

The National Institute of Allergy and Infectious Diseases — which orchestrated the large, randomized study for remdesivir that produced positive results — will jointly run the study.

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Douglas Love, Annexon CEO (Annexon)

IPO bound? Ac­tu­al­ly, An­nex­on was al­ready prepped and primed to toss its S-1 to Wall Street as in­vestors ral­lied

The Wall Street IPO shuffle generally calls for a little distance between the crossover ante and the Wall Street double, but with the window on the street wide open and biotech sizzling hot, who’s waiting?

The crew at Annexon didn’t leave anyone in suspense for long about their IPO plans. A day after the Bay Area biotech with clinical plans to target neurodegeneration quietly unveiled a $100 million raise, they were back with an S-1 outlining a pitch to double that — or more.

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