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.

2019 Trin­i­ty Drug In­dex Eval­u­ates Ac­tu­al Com­mer­cial Per­for­mance of Nov­el Drugs Ap­proved in 2016

Fewer Approvals, but Neurology Rivals Oncology and Sees Major Innovations

This report, the fourth in our Trinity Drug Index series, outlines key themes and emerging trends in the industry as we progress towards a new world of targeted and innovative products. It provides a comprehensive evaluation of the performance of novel drugs approved by the FDA in 2016, scoring each on its commercial performance, therapeutic value, and R&D investment (Table 1: Drug ranking – Ratings on a 1-5 scale).

How to cap­i­talise on a lean launch

For start-up biotechnology companies and resource stretched pharmaceutical organisations, launching a novel product can be challenging. Lean teams can make setting a launch strategy and achieving your commercial goals seem like a colossal undertaking, but can these barriers be transformed into opportunities that work to your brand’s advantage?
We spoke to Managing Consultant Frances Hendry to find out how Blue Latitude Health partnered with a fledgling subsidiary of a pharmaceutical organisation to launch an innovative product in a
complex market.
What does the launch environment look like for this product?
FH: We started working on the product at Phase II and now we’re going into Phase III trials. There is a significant unmet need in this disease area, and everyone is excited about the launch. However, the organisation is still evolving and the team is quite small – naturally this causes a little turbulence.

UP­DAT­ED: FDA’s golodirsen CRL: Sarep­ta’s Duchenne drugs are dan­ger­ous to pa­tients, of­fer­ing on­ly a small ben­e­fit. And where's that con­fir­ma­to­ry tri­al?

Back last summer, Sarepta CEO Doug Ingram told Duchenne MD families and investors that the FDA’s shock rejection of their second Duchenne MD drug golodirsen was due to some concerns regulators raised about the risk of infection and the possibility of kidney toxicity. But when pressed to release the letter for all to see, he declined, according to a report from BioPharmaDive, saying that kind of move “might not look like we’re being as respectful as we’d like to be.”

He went on to assure everyone that he hadn’t misrepresented the CRL.

But Ingram’s public remarks didn’t include everything in the letter, which — following the FDA’s surprise about-face and unexplained approval — has now been posted on the FDA’s website and broadly circulated on Twitter early Wednesday.

The CRL raises plenty of fresh questions about why the FDA abruptly decided to reverse itself and hand out an OK for a drug a senior regulator at the FDA believed — 5 months ago, when he wrote the letter — is dangerous to patients. It also puts the spotlight back on Sarepta $SRPT, which failed to launch a confirmatory study of eteplirsen, which was only approved after a heated internal controversy at the FDA. Ellis Unger, director of CDER’s Office of Drug Evaluation I, notes that study could have clarified quite a lot about the benefit and risks associated with their drugs — which can cost as much as a million dollars per patient per year, depending on weight.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 70,400+ biopharma pros reading Endpoints daily — and it's free.

UP­DAT­ED: Eli Lil­ly’s $1.6B can­cer drug failed to spark even the slight­est pos­i­tive gain for pa­tients in its 1st PhI­II

Eli Lilly had high hopes for its pegylated IL-10 drug pegilodecakin when it bought Armo last year for $1.6 billion in cash. But after reporting a few months ago that it had failed a Phase III in pancreatic cancer, without the data, its likely value has plunged. And now we’re getting some exact data that underscore just how little positive effect it had.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 70,400+ biopharma pros reading Endpoints daily — and it's free.

Stephen Hahn, AP

The FDA has de­val­ued the gold stan­dard on R&D. And that threat­ens every­one in drug de­vel­op­ment

Bioregnum Opinion Column by John Carroll

A few weeks ago, when Stephen Hahn was being lightly queried by Senators in his confirmation hearing as the new commissioner of the FDA, he made the usual vow to maintain the gold standard in drug development.

Neatly summarized, that standard requires the agency to sign off on clinical data — usually from two, well-controlled human studies — that prove a drug’s benefit outweighs any risks.

Over the last few years, biopharma has enjoyed an unprecedented loosening over just what it takes to clear that bar. Regulators are more willing to drop the second trial requirement ahead of an accelerated approval — particularly if they have an unmet medical need where patients are clamoring for a therapy.

That confirmatory trial the FDA demands can wait a few years. And most everyone in biopharma would tell you that’s the right thing for patients. They know its a tonic for everyone in the industry faced with pushing a drug through clinical development. And it’s helped inspire a global biotech boom.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 70,400+ biopharma pros reading Endpoints daily — and it's free.

UP­DAT­ED: New play­ers are jump­ing in­to the scram­ble to de­vel­op a vac­cine as pan­dem­ic pan­ic spreads fast

When the CNN news crew in Wuhan caught wind of the Chinese government’s plan to quarantine the city of 11 million people, they made a run for one of the last trains out — their Atlanta colleagues urging them on. On the way to the train station, they were forced to skirt the local seafood market, where the coronavirus at the heart of a brewing outbreak may have taken root.

And they breathlessly reported every moment of the early morning dash.

In shuttering the city, triggering an exodus of masked residents who caught wind of the quarantine ahead of time, China signaled that they were prepared to take extreme actions to stop the spread of a virus that has claimed 17 lives, sickened many more and panicked people around the globe.

CNN helped illustrate how hard all that can be.

The early reaction in the biotech industry has been classic, with small-cap companies scrambling to headline efforts to step in fast. But there are also new players in the field with new tech that has been introduced since the last of a series of pandemic panics that could change the usual storylines. And they’re volunteering for a crash course in speeding up vaccine development — a field where overnight solutions have been impossible to prove.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 70,400+ biopharma pros reading Endpoints daily — and it's free.

Wuhan virus out­break trig­gers in­evitable small-biotech ral­ly

Every few years, a public health crisis (think Ebola, Zika) spurred by a rogue pathogen triggers a small-biotech rally, as drugmakers emerge from the woodwork with ambitious plans to treat the mounting outbreak. In most cases, that enthusiasm never quite delivers.

Things are no different, as the coronavirus outbreak in Wuhan, China takes hold. There have been close to 300 confirmed human infections in China, and at least four deaths. Coronaviruses are a large family of viruses, which include MERS and SARS. On Tuesday, the CDC reported the virus was detected in a US traveler returning from Wuhan.

Mer­ck KGaA spin­out gets first fund­ing to bring dual-act­ing can­cer mol­e­cules in­to the clin­ic

Two and a half years after launch, Merck KGaA spinout iOnctura is getting its first major round of funding.

The oncology startup raised €15 million ($16.6 million) to put its lead drug into the clinic and get its second drug past IND-enabling tests. INKEF Capital and VI Partners co-led the round and were joined by the biotech’s longtime backer M Ventures, an arm of Merck KGaA, and Schroder Adveq.

Am­gen aug­ments Asia foothold by tak­ing over Astel­las joint ven­ture in Japan

California-based Amgen, which does the bulk of its business in the United States, made its ambition to reinvigorate its growth prospects by expanding its presence in Asia clear at the sidelines of the JP Morgan healthcare conference in San Francisco earlier this month.

The Thousand Oaks-based company on Thursday executed its plan to dissolve the joint venture with Astellas — created in 2013 — to operate the unit independently in Japan. With its rapidly aging population, the region represents an appealing market for Amgen’s osteoporosis treatments Prolia and Evenity as well as a cholesterol-lowering injection Repatha.