Bill Lund­berg takes over the reins at Merus; For­mer Akcea COO Jef­frey Gold­berg takes the helm of Im­mu­ni­tas

Bill Lund­berg

→ Dutch biotech Merus, who struck up a $200 mil­lion bis­pe­cif­ic de­vel­op­ment deal with In­cyte in 2016,  is los­ing their CEO Ton Logten­berg. Mean­while, the com­pa­ny has nom­i­nat­ed Sven (Bill) Ante Lund­berg to be Logten­berg’s suc­ces­sor. Lund­berg, most re­cent­ly served as CSO at CRISPR Ther­a­peu­tics — help­ing es­tab­lish the com­pa­ny in Cam­bridge, MA and lead­ing the de­vel­op­ment of the com­pa­ny’s first clin­i­cal tri­al ap­pli­ca­tion. Pri­or to CRISPR, Lund­berg was the head of trans­la­tion­al med­i­cine at Alex­ion Phar­ma­ceu­ti­cals and CMO of Tal­i­gen Ther­a­peu­tics. His oth­er stints in­clude roles at Xan­thus/Anth­so­ma, Wyeth and Gen­zyme.

→ Ear­li­er this year, Hep B vac­cine mak­er Dy­navax Tech­nolo­gies was look­ing to un­load its im­muno-on­col­o­gy pro­gram, slash­ing jobs and de­vot­ing its re­sources to its vac­cine Hep­lisav-B. Now, the com­pa­ny has an­nounced the pro­mo­tion of Ryan Spencer to the role of CEO and David No­vack to the po­si­tion of pres­i­dent and COO. Spencer hopped aboard the com­pa­ny in 2006, and most re­cent­ly served as com­mer­cial vice pres­i­dent and since May 2019 has served as in­ter­im co-pres­i­dent with No­vack. No­vack joined Dy­navax in 2013. He pre­vi­ous­ly served in var­i­ous roles at No­var­tis

Jef­frey Gold­berg

→ Af­ter be­ing swept out with two oth­er top ex­ecs at Akcea, Jef­frey Gold­berg has found a new home at the helm of Im­mu­ni­tas Ther­a­peu­tics, where he will serve as the com­pa­ny’s CEO and di­rec­tor. Gold­berg will suc­ceed found­ing CEO, Christoph West­phal, who is mov­ing to the role of chair­man of the board of di­rec­tors. Dur­ing his time at Akcea, Gold­berg served as COO. Pri­or to that, he was the VP of busi­ness op­er­a­tions at Pro­teosta­sis Ther­a­peu­tics. His oth­er roles in­clude stints at Sanofi and Gen­zyme.

Ac­cel­er­a­tor Life Sci­ences start­up Lo­do Ther­a­peu­tics has tapped Dale Pfost to head the com­pa­ny as CEO and chair­man. Pfost draws from his ex­pe­ri­ence of pre­vi­ous­ly run­ning five biotech com­pa­nies — Mi­cro­Bio­me Ther­a­peu­tics, Acu­ity Phar­ma­ceu­ti­cals (lat­er merged to form OP­KO Health), Ox­ford Gly­co­Sciences, Or­chid Bio­Sciences and Re­cep­tor Bi­oLogix (lat­er ac­quired by Sym­phogen). Pfost was al­so a gen­er­al part­ner at VC firm Ad­vent Life Sci­ences. In ad­di­tion to Pfost’s ap­point­ment, Lo­do wel­comed Mer­ck vet Steve Col­let­ti as SVP of R&D, co-founder of Bloom Sci­ence An­tho­ny Co­lasin as SVP of busi­ness de­vel­op­ment, prin­ci­pal at BLL Part­ners Bar­bara Lind­heim as con­sult­ing vice pres­i­dent of strate­gic com­mu­ni­ca­tions and in­vestor re­la­tions and pres­i­dent of The Macken­zie Con­sult­ing Group Sara­jane Macken­zie as con­sult­ing vice pres­i­dent of hu­man re­sources and or­ga­ni­za­tion de­vel­op­ment.

Bone Ther­a­peu­tics — who saw their shares plum­met 26% af­ter hit­ting the brakes on a Phase III study of their cell ther­a­py for os­teonecro­sis — has snagged Miguel Forte to the helm of the com­pa­ny as CEO, suc­ceed­ing Thomas Lien­ard, who is hit­ting the ex­it. Forte makes the leap to the com­pa­ny af­ter serv­ing as the CEO of Zel­lu­na Im­munother­a­py and is cur­rent­ly serv­ing as CCO and chair of the com­mer­cial­iza­tion com­mit­tee of the In­ter­na­tion­al So­ci­ety of Cel­lu­lar Ther­a­py (ISCT). His pre­vi­ous ex­pe­ri­ence in­cludes roles at the EMA, UCB and Tx­Cell.

→ CRISPR-fo­cused Mam­moth Bio­sciences — co-found­ed by Jen­nifer Doud­na and backed by Tim Cook and Jeff Hu­ber — has ex­pand­ed its lead­er­ship team with the ap­point­ments of Pe­ter Nell to the role of CBO and head of ther­a­peu­tics and Ted Tisch as COO. Nell joins the with ex­pe­ri­ence from his time at Case­bia Ther­a­peu­tics and Bay­er Health­Care. Tisch joins the com­pa­ny af­ter a stint at Syn­thego, where he es­tab­lished the de­vel­op­ment, man­u­fac­tur­ing op­er­a­tions and com­mer­cial pro­gram of two CRISPR-based prod­uct lines.

Lantern Phar­ma — fo­cused on can­cer drug de­vel­op­ment with the help of AI and ge­nomics — has tapped David Mar­grave to the role of CFO and Kishor Gopal­das Bha­tia as CSO. Mar­grave joins the com­pa­ny af­ter serv­ing at BioN­u­merik Phar­ma­ceu­ti­cals, where he spent time in the roles of pres­i­dent, chief ad­min­is­tra­tive of­fi­cer and gen­er­al coun­sel. Bha­tia, whose re­search fo­cus­es on lym­phoma and EBV makes the hop over to Lantern from the di­rec­tor’s chair at Na­tion­al Can­cer In­sti­tute’s AIDS Ma­lig­nan­cy Pro­gram. 

Flag­ship-backed Cyg­nal Ther­a­peu­tics — which is fo­cused on ex­oneur­al bi­ol­o­gy — has ap­point­ed Elaine Caugh­ey to the role of CBO. Caugh­ey joins the com­pa­ny af­ter a stint as a con­sul­tant at The Black­stone Group. Her pre­vi­ous roles in­clude serv­ing as se­nior di­rec­tor of busi­ness de­vel­op­ment at Bio­gen and a role in busi­ness de­vel­op­ment and cor­po­rate ven­ture at CY­TYC Cor­po­ra­tion, lat­er ac­quired by Ho­log­ic

Joanne Beck Boston

Nim­bus Ther­a­peu­tics — who, back in Ju­ly, had Cel­gene, ahead of $74 bil­lion Bris­tol-My­ers buy­out, bag an op­tion for the com­pa­ny’s HPK1 in­hibitor pro­gram — has pro­mot­ed CMO An­nie Chen to be pres­i­dent of the com­pa­ny’s Tyk2 sub­sidiary, Nim­bus Lak­sh­mi. Along with her new role, Chen will still con­tin­ue her re­spon­si­bil­i­ties as CMO to the com­pa­ny. Chen has served in the role of CMO since 2015 and pri­or to her time at Nim­bus, was ex­ec­u­tive di­rec­tor of clin­i­cal re­search and sec­tion head of vac­cines at Mer­ck. Be­fore that, Chen held stints at Genen­tech and Cel­era Ge­nomics.

Boston Phar­ma­ceu­ti­cals — who, last Oc­to­ber, inked two big in-li­cens­ing deals with No­var­tis and GSK has wel­comed Joanne Beck as COO. Beck makes the hop over af­ter a stint as EVP of glob­al phar­ma­ceu­ti­cal de­vel­op­ment and op­er­a­tions at Cel­gene. In her new role, Beck will draw from ex­pe­ri­ence dur­ing her time at Shire — serv­ing as SVP of phar­ma­ceu­ti­cal de­vel­op­ment — Ab­bott’s Glob­al Phar­ma­ceu­ti­cal Op­er­a­tions, Ab­bott Vas­cu­lar, Genen­tech and Am­gen

Im­muneer­ing — whose cur­rent pipeline fo­cus­es on dis­eases such as can­cer cachex­ia and metas­ta­sis — has tapped Scott Bar­rett as CMO. Pri­or to join­ing the com­pa­ny, Bar­rett was the glob­al med­ical af­fairs lead for Tar­get­ed Ther­a­peu­tics at In­cyte Phar­ma­ceu­ti­cals. In ad­di­tion, he has al­so held stints at In­fin­i­ty Phar­ma­ceu­ti­cals, Ei­sai Phar­ma­ceu­ti­cals, and at the Janssen di­vi­sion of J&J.

Scott Bar­rett Im­muneer­ing

→ Neu­rode­gen­er­a­tive dis­ease-fo­cused E-Scape Bio has named Tony Ri­mac as CFO and Ann Ka­poun as SVP of R&D. Ri­mac joins the com­pa­ny from Chrono Ther­a­peu­tics, where he served as CFO and CBO. Pri­or to that, he served as CFO of Aldea Phar­ma­ceu­ti­cals, Adamas Phar­ma­ceu­ti­cals — lead­ing the com­pa­ny’s IPO — and Aerovance. Most re­cent­ly, Ka­poun served as SVP of trans­la­tion­al med­i­cine at On­coMed Phar­ma­ceu­ti­cals and has pre­vi­ous­ly held roles at ALZA and Scios, a bio­phar­ma unit of J&J.

→ Cell en­gi­neer­ing ser­vice provider Max­cyte — who re­cent­ly inked a deal with KSQ Ther­a­peu­tics has named Shru­ti Ab­ba­to as EVP of busi­ness de­vel­op­ment as the com­pa­ny con­tin­ues with a Phase I tri­al of its can­cer drug, MCY-M11. Pri­or to his new role at Max­cyte, Ab­ba­to was the VP of busi­ness de­vel­op­ment at treat­ment de­vel­op­er Cel­dara Med­ical and was the own­er of Per­spicere.

→ Not long af­ter seal­ing a li­cens­ing deal with Emory Uni­ver­si­ty, Neu­ro­trau­ma Sci­ences has wel­comed Todd Ver­doorn as VP of re­search and de­vel­op­ment. Ver­doorn, most re­cent­ly, served as CSO of Di­aMed­ica.

→ Months af­ter the FDA lift­ed its par­tial hold on Xen­cor’s CD123 x CD3 bis­pe­cif­ic, XmAb14045 — af­ter the drug caused one of two deaths —  the com­pa­ny has ap­point­ed Allen Yang to the role of SVP and CMO. In his new role, Yang will be re­spon­si­ble for lead­ing clin­i­cal de­vel­op­ment and strat­e­gy and over­see­ing op­er­a­tions for Xen­cor’s port­fo­lio of XmAb an­ti­body drug can­di­dates. Yang joins the com­pa­ny from Jazz Phar­ma­ceu­ti­cals, where he served as VP, head of clin­i­cal de­vel­op­ment and act­ing CMO. Be­fore Jazz, Yang held roles at Spec­trum Phar­ma­ceu­ti­cals and Am­gen — where he was the glob­al de­vel­op­ment leader for Arane­sp in on­col­o­gy and clin­i­cal re­search med­ical di­rec­tor for Blin­cy­to.

→ Af­ter re­cent­ly bag­ging an $85 mil­lion round, Zen­tal­is Phar­ma­ceu­ti­cals has tapped Melis­sa Ep­per­ly as CFO. Ep­per­ly makes the jump to Zen­tal­is af­ter a stint in the same role at PsiOxus Ther­a­peu­tics. Pri­or to that, she was the CFO and head of busi­ness de­vel­op­ment at R-Pharm US. Pre­vi­ous­ly, Ep­per­ly has held stints at An­chor­age Cap­i­tal Group, Gold­man Sachs, Bain & Com­pa­ny and Mor­gan Stan­ley

Michael Hef­fer­nan In­da­lo

Pfiz­er and My­lan an­nounced that for­mer CEO and pres­i­dent of Pfiz­er Ian Read and for­mer chair­man and CEO of The Gillette Com­pa­ny James Kilts will join the Vi­a­tris board of di­rec­tors up­on the com­ple­tion of the planned merg­er of My­lan and Up­john — which is ex­pect­ed to oc­cur mid-2020. 

Jen­nifer Cook — who was the CEO of can­cer test­ing start­up Grail, but stepped down for fam­i­ly health rea­sons — has joined the board of di­rec­tors of Neil Ku­mar-led Bridge­Bio.

Mil­len­do Ther­a­peu­tics — who, last Au­gust, merged with strug­gling fer­til­i­ty com­pa­ny Ova­Sciencehas wel­comed cur­rent CMO of Bio­Marin Ge­off Nichol to the com­pa­ny’s board of di­rec­tors. 

In­da­lo Ther­a­peu­tics — fo­cused on the de­vel­op­ment of in­te­grin an­tag­o­nists for pa­tients suf­fer­ing from se­ri­ous fi­brot­ic dis­eases such as id­io­path­ic pul­monary fi­bro­sis (IPF) and non­al­co­holic steato­hep­ati­tis (NASH) — has ap­point­ed for­mer CEO of Col­legium Phar­ma­ceu­ti­cal Michael Hef­fer­nan as chair­man to the board of di­rec­tors.

→ Life sci­ences in­dus­try group RI Bio has ap­point­ed cur­rent CEO, pres­i­dent and co-founder of Med­ley Ge­nomics Patrice Mi­los as chair­man of the board of di­rec­tors. In ad­di­tion, the board ap­point­ed two new mem­bers, Bank of Amer­i­ca SVP and pri­vate client ad­vi­sor with Guy Asado­ri­an and VP of busi­ness de­vel­op­ment for The Al­lied Group Bri­an But­ler.

Patrice Mi­los Ri Bio

Pathios’ search for small mol­e­cule drugs that hit “or­phan” GCPR has been backed by Canaan. The com­pa­ny bagged $8.8 mil­lion in Se­ries A fi­nanc­ing and brought on Stu­art Hugh­es as the com­pa­ny’s CEO. Pri­or to join­ing Pathios, Hugh­es served as a se­nior di­rec­tor at Ver­tex and be­fore that held a stint at Eli Lil­ly

David Meeks has hand­ed in his res­ig­na­tion as CEO to Ipsen and is mak­ing the leap across the At­lantic to head start­up Fer­Gene. The 30-year bio­phar­ma vet­er­an has trav­eled the world through­out his ca­reer. He spent a lit­tle more than 3 years at the helm of Paris-based Ipsen, ar­riv­ing af­ter a stint run­ning the on­col­o­gy di­vi­sion at Bax­al­ta be­fore it was snapped up by Shire (which was lat­er bought by Take­da). Be­fore that, he was the top com­mer­cial of­fi­cer at En­do­cyte and ear­li­er he com­plet­ed a glob­al stint at No­var­tis.

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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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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Af­ter putting aside a bit­ter le­gal feud, Al­ny­lam and Dicer­na chiefs make nice with an RNAi col­lab­o­ra­tion

John Maraganore and Douglas Fambrough used to be at each other’s throats as Alnylam pursued claims that its RNAi rivals at Dicerna had improperly purloined the IP it had picked up from Merck in a bargain basement fire sale.

But that was all settled up close to 2 years ago with a settlement from Dicerna’s Fambrough. And now the two are moving ahead in a close R&D partnership that makes them collaborators on a couple of key disease targets.

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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Covid-19 roundup: In­ovio gets FDA green­light to en­ter hu­man tri­als; Trump push­es untest­ed malar­ia drugs again

Inovio, one of the clutch of companies working on a Covid-19 vaccine, has been cleared the FDA to kick off in-human studies of its experimental vaccine candidate. The Pennsylvania company secured funding from the Coalition for Epidemic Preparedness Innovations (CEPI) and the Bill and Melinda Gates Foundation to support its effort.

The trial testing the DNA vaccine, INO-4800, in up to 40 healthy volunteers is set to begin this week, and the first dose is planned to be administered today. Each participant will receive two doses of INO-4800 a month apart, and the initial immune responses and safety data from the study are expected by late summer, the company said. Shares of Inovio — which in four decades of existence has not successfully developed a product — $INO jumped about 11% to $8.60 in premarket trading.

Ax­some cel­e­brates mi­graine PhI­II win, shift­ing eyes to­ward a pair of Q4 sub­mis­sions

One week after reporting a late-stage failure for its lead drug, Axsome is back with positive news: In the 302-person Phase III INTERCEPT trial, its experimental migraine drug hit both primary endpoints: Stopping migraine pain entirely and preventing pain from progressing beyond ”mild intensity.”

The trial win sets up a big fourth quarter for the 8-year-old company and keeps them on track to file for approval for the migraine drug, known as AXS-05. And despite the late-stage failure, they plan to file for approval on their lead depression drug, known as AXS-07, citing secondary endpoints and the high placebo rates that have long clouded depression trial results.

Bris­tol My­ers Squibb, Ac­celeron rack up sec­ond OK for Re­blozyl, on­to block­buster sta­tus

Reblozyl, the anemia drug Celgene paid a modest $25 million upfront to partner on 9 years ago, brought Bristol Myers Squibb one of only two new drug approvals in 2019. Merely five months later, it’s taking home another supplemental OK expected to catapult sales into blockbuster territory.

The FDA has approved Reblozyl (luspatercept) as a treatment for anemia in a subset of adults with lower-risk myelodysplastic syndromes. Specifically, it’s limited to patients who have failed an erythropoiesis stimulating agent and require 2 or more red blood cell units over 8 weeks. These MDS patients are further characterized by ring sideroblasts, where iron accumulates in the mitochondria of red blood cells, rendering them dysfunctional.

Gilead CEO Daniel O'Day attends a meeting with the President and other biopharma leaders at the White House on March 2, 2020 (AP Photo)

Ramp­ing up glob­al pro­duc­tion of remde­sivir, Gilead CEO Dan O’Day de­tails plans to dis­trib­ute 1.5M dos­es to fight Covid-19 — for free

Gilead is still some days away from turning the card on its first round of data on remdesivir’s ability to fight severe cases of Covid-19, but the big biotech is ramping up an emergency supply of a million courses of therapy as it starts free distribution of the drug to tens of thousands of patients under their compassionate use and expanded access program as well as clinical trials.

In his latest open letter posted over the weekend, Gilead CEO Dan O’Day outlined how the company has been successful in cutting production time on remdesivir while repurposing some of their own facilities and turning to contract manufacturers to build a near-term supply of 1.5 million doses. They are still working on efficacy and dosing, but that supply could cover 140,000 courses of treatment. That supply, he added, would be more widely available following a potential approval.

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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