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.

The 20 un­der 40: In­side the next gen­er­a­tion of bio­phar­ma lead­ers

“Each generation needs a new music,” Francis Crick wrote in 1988, reflecting back on his landmark discovery. Crick was 35, then, in 1953, when he began working with a 23-year-old named James Watson, and 37 when the pair unveiled the double helix. Rosalind Franklin, whose diffraction work undergirded their metal model, was 32.

The model would become the score for a new era in biology, one devoted to cracking the basic structures turning inside life. Subsequent years would bring new conductors and new rhythms: Robert Swanson, 29 when he convinced a 39-year-old Herb Boyer to build a company off his work and call it Genentech; Phillip Sharp, 29 when he discovered RNA splicing and 34 when he co-founded Biogen; Frances Arnold, 36 when she pioneered directed evolution; Feng Zhang, 31 when he published his CRISPR paper.

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Chart-top­ping ven­ture cash? Strong deal flow? In the month Covid-19 ripped around the globe? Yup

It turns out that even sending everyone from the CEO to rank-and-file staffers home to work in the middle of a Category 5 pandemic wasn’t enough to put a crimp in the flow of venture cash into biopharma. And even dealmaking held its own against the howling winds of misfortune — largely because a group of savvy players was quick to adjust to the new reality.

Our deal expert Chris Dokomajilar ran the numbers for us on a month-to-month basis and found that not only was venture money flowing during the panicky month of March, but it was also hitting home in record sums compared to the last 26 months of deal flow.

Say what?

As you can see in the top chart below, Dokomajilar outlined how the industry racked up $2.41 billion in total for March, just barely ahead of one other topper during the heady days of August 2018.

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FDA Commissioner Stephen Hahn and President Donald Trump at a press briefing on March 19, 2020. (AP Images)

Biotech ex­ecs warn that the FDA is fum­bling their re­sponse to the Covid-19 open-door promise, de­lay­ing progress

A few days ago the FDA touted a procedure for Covid-19 meds that committed the agency to immediate action for developers, formalizing a high-speed response that’s been promised for weeks.

Bioregnum Opinion Column by John Carroll

Decisions that once required months would be measured in hours under the Coronavirus Treatment Acceleration Program. “In many cases” trial protocols could be hammered out in less than a single day. If you had a potential solution to the crisis, the appropriate staffer would be in touch “to get studies underway quickly.”

It would be the ultimate high-speed regulatory pathway from Phase I to approval. Red tape was banished.

But it’s clear that for some — and quite likely many — biopharma execs, the actual agency response has not measured up to the promise. Beyond the front ranks of advanced companies in the field, like Gilead, or for drugs endorsed by President Trump, it may not even come close.

“The first response is this form letter everyone gets,” says one biotech CEO who’s reached out to the FDA on Covid-19. And when you try to cut through that, the ball gets dropped as it is passed from top officials to the frontline staff actually charged with getting things done.

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GSK's Hal Bar­ron buys a $250M stake in George Scan­gos' Vir and makes a bee­line to the clin­ic with Covid-19 an­ti­bod­ies

GlaxoSmithKline is diving straight into the swirling waters of Covid-19 R&D work, and investing $250 million to grab a chunk of equity in one of the emerging stars in infectious disease research to make it official.

GSK put out word this morning that it is partnering with Vir Biotechnology $VIR, the infectious disease startup founded in the Bay Area by former Biogen CEO George Scangos. They’re planning a leap into Phase II studies for 2 preclinical antibody candidates — VIR-7831 and VIR-7832 — that have been engineered to target the SARS-CoV-2 spike protein.

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UP­DAT­ED: A small, ob­scure biotech just won big with their IPO. In this mar­ket. Are you kid­ding me?

How could a small, largely unknown biotech that emerged from stealth mode just months ago with early-stage cancer programs jump onto Wall Street in the middle of a Category 6 financial hurricane and sail through with a $165 million IPO?

And what does that mean for the rest of the industry waiting to see just how much damage global lockdowns will wreak on clinical development?

The biotech is a company called Zentalis. The crew there nabbed an $85 million crossover round late last year — notably waiting 5 years before waving the numbers around to attract attention, according to my read of a FierceBiotech story. Perceptive joined in, but the syndicate was not in general the kind of marquee affair that gets tongues wagging.

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Ready to de­clare a de­fin­i­tive come­back in two months, Im­munomedics stops PhI­II ear­ly, re­cruits new CEO

More than a year ago, hit by a surprise complete response letter from the FDA, Immunomedics bid its then-CEO, Michael Pehl, adieu and began a 15-month quest to resolve the manufacturing issues cited in the CRL and seek a new leader — all the while moving forward with a Phase III study on its lead drug for metastatic triple-negative breast cancer.

Today the biotech said their stars are finally aligning. Not only is Novartis Oncology vet Harout Semerjian coming on board as CEO to steer what they believe will be a smooth sail to a new PDUFA date in June, Immunomedics has also been informed that their late-stage trial can be stopped early due to “compelling evidence of efficacy.”

An­oth­er day, an­oth­er boat­load for biotech. Deer­field adds $840M to rush of ven­ture dol­lars

The biotech dollars just keep rolling in.

Even as the world economy faces an economic contraction unprecedented in nature, biotech venture capital firms are announcing huge new investment pots. The latest? Deerfield Management Co.

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Small mol­e­cules, bi­o­log­ics and now gene ther­a­pies: Ger­many's Evotec adds an­oth­er feath­er to its R&D cap

German drug discovery company Evotec — which has a thriving rolodex of biopharma partners such as Bayer, Boehringer Ingelheim, Novartis, Novo Nordisk, Pfizer, Sanofi, and Takeda — is now venturing into gene therapies.

The company swallowed Seattle-based Just Biotherapeutics, a company focused on reducing the cost of manufacturing protein therapies last year. It is now setting up a dedicated R&D site for gene therapies in Austria, in an effort to achieve a “modality-agnostic” repertoire — small molecules, biologics and now gene therapies.

A pair of PhI­II fail­ures spells last rites for Men­lo’s once-promis­ing Mer­ck drug

Four months after an intercontinental merger, Menlo Therapeutics is counting yet another pair of trial failures — ones with significant consequences for the companies, their shareholders and the drug.

In two pivotal Phase III trials, Menlo’s lead drug serlopitant failed to treat pruritus associated with prurigo nodularis — basically itchiness from a particular skin disease that causes red lesions on a person’s arms or legs. Serlopitant has long been the company’s only drug and as recently as 2018, it looked promising enough to support a stock price of $37. In April of that year, a Phase II failure demolished the stock price overnight: $35 to $9. Other subsequent stumbles trickled the ticker down to just above $2.