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.

Con­quer­ing a silent killer: HDV and Eiger Bio­Phar­ma­ceu­ti­cals

Hepatitis delta, also known as hepatitis D, is a liver infection caused by the hepatitis delta virus (HDV) that results in the most severe form of human viral hepatitis for which there is no approved therapy.

HDV is a single-stranded, circular RNA virus that requires the envelope protein (HBsAg) of the hepatitis B virus (HBV) for its own assembly. As a result, hepatitis delta virus (HDV) infection occurs only as a co-infection in individuals infected with HBV. However, HDV/HBV co-infections lead to more serious liver disease than HBV infection alone. HDV is associated with faster progression to liver fibrosis (progressing to cirrhosis in about 80% of individuals in 5-10 years), increased risk of liver cancer, and early decompensated cirrhosis and liver failure.
HDV is the most severe form of viral hepatitis with no approved treatment.
Approved nucleos(t)ide treatments for HBV only suppress HBV DNA, do not appreciably impact HBsAg and have no impact on HDV. Investigational agents in development for HBV target multiple new mechanisms. Aspirations are high, but a functional cure for HBV has not been achieved nor is one anticipated in the forseeable future. Without clearance of HBsAg, anti-HBV investigational treatments are not expected to impact the deadly course of HDV infection anytime soon.

Am­gen chops 172 more staffers in R&D, op­er­a­tions and sales amid neu­ro­science ex­it, rev­enue down­turn

Neuroscience wasn’t the only unit that’s being hit by a reorganization underway at Amgen. As well as axing 149 employees in its Cambridge office, the company has disclosed that 172 others nationwide, including some from its Thousand Oaks, CA headquarters, are being let go.

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Ahead of strate­gic up­date, new Sanofi CEO mulls op­tions for con­sumer health­care arm — re­ports

Big pharma has made moves to sharpen its focus on developing new medicines, while slow-growing consumer health divisions fall by the wayside. Looks like another large drugmaker is considering a similar move. On Thursday, reports citing sources indicated that Sanofi is reportedly mulling a joint venture, sale, or a public listing of its consumer health arm.

The French group is in discussions for options that could value the division at $30 billion, Bloomberg and Reuters reported, citing sources familiar with the matter.

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The triple crown in biotech: An all-or-noth­ing bet on an FDA ap­proval of 3 drugs over 16 months starts to­day

Bristol-Myers Squibb’s $74 billion Celgene deal closed as expected Wednesday evening. And now a new clock has begun to tick down for Celgene shareholders who came away from the deal with CVRs — contingent value rights — worth $9 or nothing. Those CVRs start trading today as $BMYRT.

The new deadline they have is the end of March 2021, a little more than 16 months from now, when Bristol-Myers will need to gain approvals on 3 late-stage drugs it’s picking up in the buyout: Ozanimod and liso-cel (JCAR017) are due up at the end of 2020, with bb2121 deadlined at the end of Q1 in 2021.

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Genap­sys fi­nal­ly un­veils vaunt­ed se­quencer, but can it dent Il­lu­mi­na?

Hesaam Esfandyarpour holds what looks like a mini-cooler up to the computer screen in his California office.

Esfandyarpour is in his late-30s, with crows feet creeping up against a youthful face. He wears a gray polo and the device in his hand — with its hard plastic-looking shell, blue-and-white pattern, and a white plastic paddle resembling a handle jutting out the front — might contain diced strawberries and peanut-butter sandwiches to meet mom and the kids at a SoCal park. Instead, Esfandyarpour tells me it’s going to change medicine and biopharma research.

Brii Bio backs in­fec­tious dis­ease start­up while ink­ing deal for its lead TB drug, dou­bling down on an­tibi­otics

Almost two years after leaving GSK to launch Brii Bio with a whopping $260 million in funding, Zhi Hong is seeing the trans-Pacific infectious disease specialist he set out to build take shape.

“Our pipeline is coming together,” he told Endpoints News, with 12 partnered assets plus some internal programs.

As its latest partner, AN2 Therapeutics, comes into the limelight for the first time with a $12 million seed round, so is Brii’s plans in the antibiotics space. Brii has obtained China rights to AN2’s antibacterial targeting mycobacterium tuberculosis for multi-drug resistant TB, which it says is in the clinical stage.

UP­DAT­ED: Make that 2 ap­proved RNAi drugs at Al­ny­lam af­ter the FDA of­fers a speedy OK on ul­tra-rare dis­ease drug

Seventeen years into the game, Alnylam’s pivot into commercial operations is picking up speed.
The bellwether biotech $ALNY has nabbed their second FDA OK for an RNAi drug, this time for givosiran, the only therapy now approved for acute hepatic porphyria. This second approval came months ahead of the February deadline — even after winning priority review following their ‘breakthrough’ title earlier.
AHP is an extremely rare disease, with some 3,000 patients in Europe and the US, not all diagnosed, and analysts have projected peak revenue of $600 million to $700 million a year. The drug will be sold as Givlaari.

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David Ricks. Eli Lilly

Eli Lil­ly touts $400M man­u­fac­tur­ing ex­pan­sion, 100 new jobs to much fan­fare in In­di­anapo­lis — even though it's been chop­ping staff

Eli Lilly is pouring in $400 million to beef up manufacturing facilities at its home base of Indianapolis. The investment, which was lauded by the city’s mayor, is expected to create 100 new jobs.

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No­var­tis, Bay­er, Long­wood back ge­nomics start­up to speed search for im­munother­a­py tar­gets

Nearly a century passed between the first proto-immunotherapy attempts in cancer — crude and obscure but nonetheless with some scientific basis — and Jim Allison’s first T cell paper. Thirty-plus years flipped between the discovery of CTLA-4 as an off-switch and the approval of Yervoy. Twenty-two rolled between PD-1’s isolation and Opdiva and Keytruda. 

Longwood co-founder Lea Hachigian is betting she can hasten that. It’s a bet on newly established single-cell genomic analysis tech and the ability to crunch endless troves of data at a rate few others can, and investors including Leaps by Bayer and Novartis Venture Fund just put $39 million behind it. They call it Immunitas.