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.

A fa­vorite in Alex­ion’s C-suite is leav­ing, and some mighty sur­prised an­a­lysts aren’t the least bit hap­py about it

Analysts hate to lose a biotech CFO they’ve come to trust and admire — especially if they’re being blindsided by a surprise exit.

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While No­var­tis ban­ish­es Zol­gens­ma scan­dal scars — Bio­gen goes on a Spin­raza 'of­fen­sive'

While Novartis painstakingly works to mop up the stench of the data manipulation scandal associated with its expensive gene therapy for spinal muscular atrophy (SMA) Zolgensma— rival Biogen is attempting to expand the use of its SMA therapy, Spinraza. 

The US drugmaker $BIIB secured US approval for Spinraza for use in the often fatal genetic disease in 2016. The approval covered a broad range of patients with infantile-onset (most likely to develop Type 1) SMA. 

Jason Kelly. Mike Blake/Reuters via Adobe

Eye­ing big ther­a­peu­tic push, Gink­go bags $290M to build a cell pro­gram­ming em­pire

Ginkgo Bioworks is on a roll. Days after publicizing a plan to nurture new startups via partnerships with accelerators Y Combinator and Petri, the Boston biotech says it has raised another $290 million for its cell programming platform to reach further and wider.

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UP­DAT­ED: Speak­er Nan­cy Pelosi to un­veil bill for fed­er­al­ly ne­go­ti­at­ed drug prices

After months of buzz from both sides of the aisle, Speaker Nancy Pelosi will today introduce her plan to allow the federal government to negotiate prices for 250 prescription drugs, setting up a showdown with a pharmaceutical industry working overtime to prevent it.

The need to limit drug prices is a rare point of agreement between President Trump and Democrats, although the president has yet to comment on the proposal and will likely face pressure to back a more conservative option or no bill at all. Republican Senator Chuck Grassley is reportedly lobbying his fellow party members on a more modest proposal he negotiated with Democratic Senator Ron Wyden in July.

David Grainger [file photo]

'Dis­con­nect the bas­tard­s' — one biotech's plan to break can­cer cell­s' uni­fied de­fens­es

Chemotherapy and radiotherapy are the current gladiators of cancer treatment, but they come with well-known limitations and side-effects. The emergence of immunotherapy — a ferocious new titan in oncologist’s toolbox — takes the brakes off the immune system to kill cancer cells with remarkable success in some cases, but the approach is not always effective. What makes certain forms of cancer so resilient? Scientists may have finally pieced together a tantalizing piece of the puzzle, and a new biotech is banking on a new approach to fill the gap.

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Jeff Kindler's Cen­trex­ion re­news bid to make pub­lic de­but

Jeffrey Kindler’s plan to take his biotech — which is developing a slate of non-opioid painkillers — public, is back on.

The Boston based company, led by former Pfizer $PFE chief Kindler, originally contemplated a $70 million to $80 million IPO last year— but eventually postponed that strategy. On Wednesday, the company revived its bid to make a public debut in a filing with the SEC — although no pricing details were disclosed.

Zachary Hornby. Boundless

'A fourth rev­o­lu­tion in can­cer ther­a­pies': ARCH-backed Bound­less Bio flash­es big check, makes big­ger promis­es in de­but

It was the cellular equivalent of opening your car door and finding an active, roaring engine in the driver seat.

Scientists learned strands of DNA could occasionally appear outside of its traditional home in the nucleus in the 1970s, when they appeared as little, innocuous circles on microscopes; inexplicable but apparently innate. But not until UC San Diego’s Paul Mischel published his first study in Science in 2014 did researchers realize these circles were not only active but potentially overactive and driving some cancer tumors’ superhuman growth.

It’s fi­nal­ly over: Bio­gen, Ei­sai scrap big Alzheimer’s PhI­I­Is af­ter a pre­dictable BACE cat­a­stro­phe rais­es safe­ty fears

Months after analysts and investors called on Biogen and Eisai to scrap their BACE drug for Alzheimer’s and move on in the wake of a string of late-stage failures and rising safety fears, the partners have called it quits. And they said they were dropping the drug — elenbecestat — after the independent monitoring board raised concerns about…safety.

We don’t know exactly what researchers found in this latest catastrophe, but the companies noted in their release that investigators had determined that the drug was flunking the risk/benefit analysis.

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Mer­ck helps bankroll new part­ner Themis' game plan to fin­ish the chikun­gun­ya race and be­gin on­colyt­ic virus quest

As Themis gears up for a Phase III trial of its chikungunya vaccine, the Vienna-based biotech has closed out €40 million ($44 million) to foot the clinical and manufacturing bills.

Its heavyweight partners at Merck — which signed a pact around a mysterious “blockbuster indication” last month — jumped into the Series D, led by new investors Farallon Capital and Hadean Ventures. Adjuvant Capital also joined, as did current investors Global Health Investment Fund, aws Gruenderfonds, Omnes Capital, Ventech and Wellington Partners Life Sciences.