Ex-Al­tim­mune chief Bill En­right lands CEO role at Vac­citech; Rea­ta poach­es Al­ny­lam CFO Man­meet Soni

Bill En­right

→ Af­ter a stint con­sult­ing for Avidea Tech­nolo­gies, Bill En­right is back at the CEO game Vac­citech’s new chief. Like Al­tim­mune — which En­right led for 11 years — Vac­citech has a dual fo­cus on can­cer and in­fec­tious dis­eases. The ap­point­ment brings him from Bal­ti­more to Ox­ford, UK, where he will over­see piv­otal da­ta read­out from its lead in­fluen­za pro­gram. Mean­while, Tom Evans will tran­si­tion to the CSO post, steer­ing the sci­ence and R&D “that un­der­pin Vac­citech’s tech in­duc­ing CD8+ and CD4+ T cell re­spons­es against for­eign pathogens and tu­mors.

Ul­rich Thienel

Re­Al­ta Life Sci­ences — a young biotech cre­ation of pe­di­a­tri­cians and med­ical school re­searchers in Nor­folk, Vir­ginia— has tapped bio­phar­ma vet Ul­rich Thienel as CEO. Thienel’s in­volve­ment with the com­pa­ny dat­ed back to his stint at the con­tract re­search or­ga­ni­za­tion RRD In­ter­na­tion­al, where his team “helped Re­Al­ta choose the best ini­tial in­di­ca­tions for the com­pa­ny to de­vel­op. Ul­rich then joined the Re­Al­ta Board fol­low­ing its for­ma­tion in 2018,” re­called chair­man John Hard­ing. Thienel has since moved to a CMO role at Finch Ther­a­peu­tics, the lat­est in a string of sim­i­lar po­si­tions span­ning J&J, Bris­tol-My­ers Squibb and Take­da.

He­len Ljung­dahl Round

→ With an eye to com­mer­cial­iza­tion, stem cell play­er Am­ni­cell has re­cruit­ed He­len Ljung­dahl to the helm. The Mer­ck vet, who jumps from the lead glob­al mar­ket­ing and busi­ness de­vel­op­ment role at GN Hear­ing, brings a blend of ex­pe­ri­ence in phar­ma and medtech. She is now charged with re­al­iz­ing the po­ten­tial of Am­ni­cell’s re­search on am­ni­ot­ic flu­id stem cells, which the com­pa­ny be­lieves can ac­cel­er­ate heal­ing, re­duce scar­ring in non-heal­ing wounds, and even treat end-stage lung dis­ease and di­a­betes.

Man­meet Soni

→ Once Ab­b­Vie-al­lied Rea­ta Phar­ma­ceu­ti­cals — fo­cused on tar­get­ing mol­e­c­u­lar path­ways in­volved in the reg­u­la­tion of cel­lu­lar me­tab­o­lism and in­flam­ma­tion — has wel­comed Man­meet Soni on board to suc­ceed Ja­son Wil­son as CFO, while Wil­son tran­si­tions to a new role as ex­ec­u­tive vice pres­i­dent of op­er­a­tions. Soni served in the same role at Al­ny­lam Phar­ma­ceu­ti­cals, se­cur­ing more than $2 bil­lion in new cap­i­tal and col­lab­o­ra­tion agree­ments; ARI­AD Phar­ma­ceu­ti­cals, help­ing with their $5.2 bil­lion ac­qui­si­tion by Take­da; and Phar­ma­cyclics, as­sist­ing in their $21 bil­lion ac­qui­si­tion by Ab­b­Vie

Priya Chaturve­di

→ A few months af­ter Ei­sai mapped out plans to test a com­bi­na­tion of their Bio­gen-part­nered BACE drug elen­be­ce­s­tat with BAN2401 as a pre­ven­ta­tive Alzheimer’s ther­a­py, the com­pa­ny has poached Priya Chaturve­di from Mer­ck Re­search Labs to over­see glob­al clin­i­cal qual­i­ty as­sur­ance. The new VP hops from a sim­i­lar role as ex­ec­u­tive di­rec­tor, clin­i­cal qual­i­ty as­sur­ance, head of glob­al GCP for in­fec­tious dis­ease and vac­cines at Mer­ck. Her re­sume in­cludes var­i­ous roles at Pfiz­er and GSK

→ With their lead mon­o­clon­al an­ti­body cirm­tuzum­ab in a Phase I/II clin­i­cal tri­al in com­bi­na­tion with ibru­ti­nib for the treat­ment of chron­ic lym­pho­cyt­ic leukemia (CLL) and man­tle cell lym­phoma (MCL), Onc­ter­nal Ther­a­peu­tics has made some new ad­di­tions to its lead­er­ship team with the ap­point­ments of Frank Hsu as CMO and Ra­jesh Kr­ish­nan as SVP, chem­istry, man­u­fac­tur­ing and con­trols (CMC) and man­u­fac­tur­ing. Hsu most re­cent­ly served as vice pres­i­dent and head of on­col­o­gy at Im­mune De­sign be­fore its ac­qui­si­tion by Mer­ck. He has al­so served as CMO at Zyn­ge­nia, com­plet­ed a stint at Gen­zyme and taught as a fac­ul­ty mem­ber at Yale Uni­ver­si­ty. Kr­ish­nan hops over to the com­pa­ny af­ter serv­ing as vice pres­i­dent, process de­vel­op­ment and man­u­fac­tur­ing sci­ences at Dy­navax Tech­nolo­gies. Kr­ish­nan has held roles at Gilead Sci­ences, Mer­ck, Am­gen and Pfiz­er.

Rhon­da Chicko

Schol­ar Rock — fo­cused on the de­vel­op­ment of med­i­cines in which sig­nal­ing pro­tein growth fac­tors plays a key role to treat dis­eases, such as neu­ro­mus­cu­lar dis­or­ders, can­cer, fi­bro­sis and ane­mia — an­nounced that their CFO, Rhon­da Chicko, will soon be hit­ting the ex­it “to pur­sue oth­er op­por­tu­ni­ties.” Pri­or to her time at the com­pa­ny, Chicko served as vice pres­i­dent fi­nance for Ed­i­tas Med­i­cine and had stints at Iron­wood Phar­ma­ceu­ti­cals and Welling­ton Man­age­ment. The com­pa­ny has ini­ti­at­ed a search for a suc­ces­sor. 

→ Rheumat­ic dis­ease-fo­cused Hori­zon Ther­a­peu­tics CBO, Robert Carey, is step­ping down from his post and the com­pa­ny has tapped Andy Paster­nak as ex­ec­u­tive vice pres­i­dent and his suc­ces­sor. Paster­nak jumps over to Hori­zon af­ter a stint at con­sult­ing firm Bain & Com­pa­ny. Pre­vi­ous­ly, Paster­nak was a found­ing part­ner in the health & life sci­ences prac­tice at Oliv­er Wyman

Ed­ward Cox has left the FDA af­ter a long run as a top of­fi­cial at the reg­u­la­to­ry agency and made the leap to bio­phar­ma. Cox has tak­en a new job as VP of reg­u­la­to­ry af­fairs for Re­gen­eron, a com­pa­ny he has come to know well as it field­ed its block­buster cash cow Eylea and then steered its way to new la­bel ex­ten­sions. Cox — who had been di­rec­tor of the FDA’s of­fice of an­timi­cro­bial prod­ucts (OAP) at CDER — has been reg­u­lar­ly quot­ed as the se­nior FDA of­fi­cial on new reg­u­la­to­ry de­vel­op­ments for Eylea. 

→ Af­ter a string of pipeline deals aimed at re­vi­tal­iz­ing the R&D group, the de­cid­ed­ly pri­vate Ger­man com­pa­ny is un­der­go­ing a high-lev­el makeover of the top team. Boehringer re­port­ed that their phar­ma and bio­phar­ma busi­ness chief Al­lan Hill­grove has stepped down from their board of man­ag­ing di­rec­tors and will soon re­tire from the com­pa­ny af­ter a 37-year stint that start­ed with his po­si­tion as a sales rep. He’s be­ing re­placed by Carine Brouil­lon, who joined the com­pa­ny a lit­tle more than a year ago af­ter leav­ing J&J, where she was in charge of com­mer­cial strate­gies for neu­ro­sciences. And that’s not all. Joachim Hasen­maier, head of an­i­mal health, will al­so leave Boehringer at the end of the year. He’ll be re­placed by 32-year com­pa­ny vet­er­an Jean Scheft­sik de Szol­nok.

→ Af­ter woo­ing Al­ny­lam ex­ec Em­manuel Du­lac to the post of CEO in April, Zealand Phar­ma has fi­nal­ly found a suc­ces­sor in Matthew Dal­las for their CFO Mats Blom — who an­nounced his de­par­ture in Jan­u­ary. Dal­las has served in the same role at Aveo Phar­ma­ceu­ti­cals and CoLu­cid Phar­ma­ceu­ti­cals (ac­quired by Eli Lil­ly). Dal­las has al­so held stints at Gen­zyme, NEN Life Sci­ence Prod­ucts and Kim­ber­ly Clark. Ivan Møller, who has been serv­ing as in­ter­im CFO, will re­sume his role as SVP of tech­ni­cal de­vel­op­ment & op­er­a­tions.

→ Uni­ver­si­ty of Leeds, UK spin­out Tis­sue Re­genix Group, a re­gen­er­a­tive med­ical de­vices com­pa­ny, has named Mike Bark­er as CFO and as an ex­ec­u­tive di­rec­tor of the board — af­ter serv­ing the com­pa­ny as in­ter­im fi­nance di­rec­tor since the be­gin­ning of the year. Bark­er has years of ex­pe­ri­ence as a char­tered ac­coun­tant for both AIM list­ed and pri­vate busi­ness­es and spent time in a role with De­loitte, as well as set­ting up his own con­sul­tan­cy busi­ness.  

→ Med­ical cannabis com­pa­ny Verdemed — which is try­ing to make a big­ger pres­ence for it­self in Latin Amer­i­ca — has named Alexan­dre Pen­ha CFO and ap­point­ed David Beat­ty to its board of di­rec­tors. Pen­ha has served as VP, cor­po­rate de­vel­op­ment and mem­ber of the board of di­rec­tors of Aus­tralian-list­ed fer­til­iz­er com­pa­ny Fer­toz Lim­it­ed. He’s al­so han­dled cor­po­rate de­vel­op­ment for a min­er­als com­pa­ny. Beat­ty is cur­rent­ly man­ag­ing di­rec­tor, In­dus­tri­al Al­liance Se­cu­ri­ties

→ Med­ical de­vice and dig­i­tal health com­pa­ny Genete­sis wel­comed Pe­ter Do­na­to on board as CBO. Do­na­to tran­si­tioned from a role as an in­de­pen­dent di­rec­tor and au­dit com­mit­tee chair­man for Genete­sis. He joins the crew with ex­pe­ri­ence as CFO from his pre­vi­ous stints at Neu­ro­net­ics and As­surex Health.

Ryan Tarzy has joined StartX spin­out Car­di­nal An­a­lytx So­lu­tions as their CMO. Pri­or to join­ing the Pa­lo Al­to, Cal­i­for­nia-based com­pa­ny, Tarzy served in a va­ri­ety of roles at Cov­erMyMeds (ac­quired by McKesson in 2017). Pre­vi­ous­ly, he served as the SVP of busi­ness de­vel­op­ment for Pok­it­Dok and co-found Play­ful Bee, and ear­ly child­hood de­vel­op­ment start­up.

Fi­bro­Gen founder and CEO Thomas Neff died “un­ex­pect­ed­ly” over the week­end, says the biotech com­pa­ny. He was 64 years old, ac­cord­ing to the com­pa­ny’s lat­est proxy state­ment. Neff’s death comes as the biotech’s lead drug rox­adu­s­tat — which is part­nered with As­traZeneca — is draw­ing block­buster pro­jec­tions from an­a­lysts as it nears NDA re­view sta­tus, 25 years af­ter Neff found­ed the com­pa­ny. Board mem­ber James A. Schoe­neck has been named in­ter­im CEO. The com­pa­ny did not pro­vide a cause of death in its state­ment Mon­day morn­ing. Fi­bro­Gen has be­gun a search for a per­ma­nent re­place­ment.

Mark Schoenebaum, one of the best known and most liked biotech an­a­lysts in the busi­ness, died over the week­end. Umer Raf­fat, who was men­tored by Schoenebaum and stepped in­to his role at Ever­core ISI, put out the word on Sun­day, not­ing:

We’ve all looked up to him as the very best eq­ui­ty re­search an­a­lyst there has ever been on Wall Street.  But that was on­ly part of who he was: he was an ab­solute stand­out in­di­vid­ual who touched so many lives, and whose strength of char­ac­ter showed in his sheer hu­mil­i­ty de­spite his ab­solute­ly un­prece­dent­ed suc­cess.

He had ev­i­dent­ly been mak­ing the rounds again in re­cent months, drop­ping emails about his in­ter­est in get­ting go­ing again.

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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