Col­in Fre­und takes new CEO job at Mod­ra Phar­ma; Com­pass re­cruits Pfiz­er, Bio­gen vets to C-suite

Col­in Fre­und

→ Am­s­ter­dam-based Mod­ra Phar­ma­ceu­ti­cals has tapped a per­ma­nent CEO to guide its pipeline of oral chemother­a­pies as it wraps up a Phase Ib/IIa study for the lead pro­gram — a tablet for­mu­la­tion of do­c­etax­el. Col­in Fre­und comes with fresh CEO ex­pe­ri­ence at Que On­col­o­gy as well as a pre­vi­ous stints at Trangene and GPC Biotech. Er­ic van der Put­ten, the Agla­ia Bio­med­ical Ven­tures part­ner who was fill­ing the role ad in­ter­im, will re­cede to a board di­rec­tor role. Mean­while Ed­win De Wit has al­so joined the com­pa­ny as head of on­col­o­gy de­vel­op­ment.

No­var­tis’ in­sis­tence on cen­tral­iz­ing top ex­ecs in its Swiss head­quar­ters has cost the phar­ma gi­ant a key leader: Liz Bar­rett has put in her no­tice just 10 months af­ter tak­ing on the on­col­o­gy chief role.

“Af­ter much per­son­al re­flec­tion, it be­came clear that my fam­i­ly would be un­able to re­lo­cate to Basel where the on­col­o­gy head­quar­ters is based,” Bar­rett said in a state­ment.

Su­sanne Schaf­fert, pres­i­dent of No­var­tis sub­sidiary Ad­vanced Ac­cel­er­a­tor Ap­pli­ca­tions, is re­plac­ing Bar­rett as CEO of the on­col­o­gy busi­ness unit. Bar­rett is mov­ing to the helm of a US-based biotech, though she told End­points she can’t say which just yet.

Or­biMed– and Thiel-backed Com­pass Ther­a­peu­tics has scooped Pfiz­er’s head of ear­ly clin­i­cal de­vel­op­ment, Yu Liu, to over­see the slate of pro­grams gen­er­at­ed from its an­ti­body dis­cov­ery plat­form. The new CMO will have a chance to work on tar­gets in can­cer, in­flam­ma­tion and au­toim­mune dis­ease. lever­ag­ing a di­verse range of ex­pe­ri­ence ac­crued over the years at Bio­gen, Bris­tol-My­ers Squibb, Es­sen­tialis Ther­a­peu­tics and Am­gen. Fel­low Bio­gen vet Lynne Sul­li­van — who al­so han­dled tax­es for Mer­ck KGaA is com­ing on board as CFO.

No­var­tis may still have big plans for CAR-T, but the phar­ma gi­ant con­tin­ues to bleed top tal­ent from the group ex­pect­ed to car­ry out the work. Cam­bridge, MA-based Sem­ma Ther­a­peu­tics — which is de­vel­op­ing a hoped-for stem cell cure for Type 1 di­a­betes — said that they have re­cruit­ed No­var­tis CAR-T chief David Leb­wohl as their new chief med­ical of­fi­cer. Sem­ma has al­so re­cruit­ed David DiGius­to as chief tech­nol­o­gy of­fi­cer and Ann Dar­da as head of hu­man re­sources. Last fall in­vestors put up $114 mil­lion to fund a pi­o­neer­ing hu­man study that will put a new de­liv­ery tech to the test in di­a­betes.

Daphne Qui­mi just got a pro­mo­tion at Am­i­cus Ther­a­peu­tics $FOLD, where she will be­come CFO in the be­gin­ning of next year as Chip Baird leaves for a new job. The hand­off caps the first year Am­i­cus be­came a com­mer­cial com­pa­ny with a con­tro­ver­sial OK for its Fab­ry dis­ease drug Galafold. Sev­er­al oth­er ex­ecs are get­ting new roles: Al­iba­ba alum­nus David Clark has been ap­point­ed chief peo­ple of­fi­cer; Ellen Rosen­berg has been pro­mot­ed to chief le­gal of­fi­cer; An­drew Mul­berg is now SVP, glob­al reg­u­la­to­ry af­fairs; and An­tho­ny Sileno will be SVP, clin­i­cal op­er­a­tions and trans­la­tion­al sci­ences.

Sono­ma Phar­ma­ceu­ti­cals, a spe­cial­ty phar­ma now fo­cused on der­ma­tol­ogy, has hired Fred­er­ick (Bub­ba) Sand­ford to ex­e­cute the com­pa­ny’s turn­around plan. He will take the roles of both CEO Jim Schutz and CFO Bob Miller, who re­signed from the com­pa­ny $SNOA.

→ As Johns Hop­kins spin­out Wind­MIL Ther­a­peu­tics opens a new of­fice to con­sol­i­date its cell ther­a­py work and at­tract tal­ent in Philadel­phia, two ex­ecs are join­ing the out­post. Monil Shah, chief de­vel­op­ment of­fi­cer, comes with a string of roles at Brook­lyn Im­munoTher­a­peu­tics, Ven­trus Bio­sciences, Cel­gene, Fi­bro­Gen, Am­gen and oth­ers on his re­sume. New VP of op­er­a­tions Patrick Dougher­ty was the chief of staff to the SVP of R&D at Glax­o­SmithK­line. Wind­MIL closed a $32.5 mil­lion round ear­li­er this year for its work on mem­o­ry T cells re­sid­ing in the bone mar­row and a “sig­nif­i­cant ex­pan­sion” of its team.

→ The first snap­shot of ef­fi­ca­cy for Avro­bio’s lead gene ther­a­py to treat Fab­ry dis­ease might have spooked in­vestors, but the Cam­bridge, MA-based biotech $AVRO is keen to re­gain their con­fi­dence with four new hires. Bir­gitte Vol­ck, a rare dis­ease ex­pert for­mer­ly of So­bi and GSK, has been tapped as pres­i­dent of R&D; Erik Os­trows­ki joins as CFO from the same role at Sum­mit Ther­a­peu­tics; for­mer FDA staffer Josie Yang is the new head of reg­u­la­to­ry af­fairs; while Bio­gen vet Steven Avruch be­comes gen­er­al coun­sel.

→ Parisian biotech Bio­phytis has pro­mot­ed Jean-Christophe Mon­tigny to COO, from his pre­vi­ous role of su­per­vis­ing all things fi­nan­cial and le­gal for the com­pa­ny. Mean­while, Bio­phytis has al­so named Daniel Schnei­der­man as CFO. Schnei­der­man, who served most re­cent­ly as VP of fi­nance and con­troller at Boston-based pre­ci­sion med­i­cine com­pa­ny Meta­S­tat, will be based at the com­pa­ny’s Cam­bridge of­fice in the Unit­ed States as Bio­phytis ex­pands its op­er­a­tions in the re­gion. “We plan to con­tin­ue build­ing…in­fra­struc­ture in Boston with ad­di­tion­al key hires in 2018 and 2019, as we ex­e­cute the clin­i­cal de­vel­op­ment of SAR­CO­NEOS through our…clin­i­cal phase 2b tri­al for the treat­ment of sar­cope­nia in both the Unit­ed States and Eu­rope, as well as progress SAR­CO­NEOS…in Duchenne mus­cu­lar dy­s­tro­phy (DMD) and MA­CU­NEOS…in dry age-re­lat­ed mac­u­lar de­gen­er­a­tion (AMD), CEO Stanis­las Veil­let said. 

Ed Kaye has re­cruit­ed two for­mer Sarep­ta col­league to his team as he moves Stoke Ther­a­peu­tics in­to a larg­er R&D space in Bed­ford, MA. Shamim Ruff, pre­vi­ous­ly Sarep­ta’s chief reg­u­la­to­ry af­fairs of­fi­cer and SVP, head of qual­i­ty, will have the ti­tle SVP of reg­u­la­to­ry af­fairs and qual­i­ty. Nan­cy Wyant comes on board as VP, head of clin­i­cal op­er­a­tions af­ter con­sult­ing with Stoke for the past few months fol­low­ing stints at Idera and BeiGene.

→ Ahead of a Phase III read­out of its NSCLC treat­ment, OSE Im­munother­a­peu­tics has ap­point­ed for­mer Sanofi $SNY ex­ec­u­tive Julien Per­ri­er as chief com­mer­cial of­fi­cer. Per­ri­er most re­cent­ly served as the head of Ab­b­Vie’s $AB­BV im­munol­o­gy di­vi­sion in France, where he was in charge of the com­mer­cial op­er­a­tions for Hu­mi­ra, as well as prep­ping the launch of two oth­er im­munol­o­gy prod­ucts. “Julien’s ex­pe­ri­ence in im­munol­o­gy and bi­o­log­ics will al­so prove es­sen­tial as we plan next steps for FR104, a Phase 2-ready, first-in-class CD28 an­tag­o­nist with ex­cit­ing po­ten­tial to treat au­toim­mune dis­ease,” OSE chief Alex­is Pey­roles said.

Boehringer In­gel­heim’s Hen­ning Ger­schews­ki is head­ing over to an­oth­er Ger­man firm where he will serve as as vice pres­i­dent of man­u­fac­tur­ing, sci­ence and tech­nol­o­gy. The com­pa­ny, Rentschler Bio­phar­ma SE, fo­cus­es on con­tract de­vel­op­ment and man­u­fac­tur­ing for bio­phar­ma­ceu­ti­cal com­pa­nies.  


With con­tri­bu­tion by Na­tal­ie Grover.

ZS Per­spec­tive: 3 Pre­dic­tions on the Fu­ture of Cell & Gene Ther­a­pies

The field of cell and gene therapies (C&GTs) has seen a renaissance, with first generation commercial therapies such as Kymriah, Yescarta, and Luxturna laying the groundwork for an incoming wave of potentially transformative C&GTs that aim to address diverse disease areas. With this renaissance comes several potential opportunities, of which we discuss three predictions below.

Allogenic Natural Killer (NK) Cells have the potential to displace current Cell Therapies in oncology if proven durable.

Despite being early in development, Allogenic NKs are proving to be an attractive new treatment paradigm in oncology. The question of durability of response with allogenic therapies is still an unknown. Fate Therapeutics’ recent phase 1 data for FT516 showed relatively quicker relapses vs already approved autologous CAR-Ts. However, other manufacturers, like Allogene for their allogenic CAR-T therapy ALLO-501A, are exploring novel lymphodepletion approaches to improve persistence of allogenic cells. Nevertheless, allogenic NKs demonstrate a strong value proposition relative to their T cell counterparts due to comparable response rates (so far) combined with the added advantage of a significantly safer AE profile. Specifically, little to no risk of graft versus host disease (GvHD), cytotoxic release syndrome (CRS), and neurotoxicity (NT) have been seen so far with allogenic NK cells (Fig. 1). In addition, being able to harness an allogenic cell source gives way to operational advantages as “off-the-shelf” products provide improved turnaround time (TAT), scalability, and potentially reduced cost. NKs are currently in development for a variety of overlapping hematological indications with chimeric antigen receptor T cells (CAR-Ts) today, and the question remains to what extent they will disrupt the current cell therapy landscape. Click for more details.

Lat­est news on Pfiz­er's $3B+ JAK1 win; Pacts over M&A at #JPM22; 2021 by the num­bers; Bio­gen's Aduhelm reck­on­ing; The sto­ry of sotro­vimab; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

For those of you who attended #JPM22 in any shape or form, we hope you had a fruitful time. Regardless of how you spent the past hectic week, may your weekend be just what you need it to be.

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A $3B+ peak sales win? Pfiz­er thinks so, as FDA of­fers a tardy green light to its JAK1 drug abroc­i­tinib

Back in the fall of 2020, newly crowned Pfizer chief Albert Bourla confidently put their JAK1 inhibitor abrocitinib at the top of the list of blockbuster drugs in the late-stage pipeline with a $3 billion-plus peak sales estimate.

Since then it’s been subjected to serious criticism for the safety warnings associated with the class, held back by a cautious FDA and questioned when researchers rolled out a top-line boast that their heavyweight contender had beaten the champ in the field of atopic dermatitis — Dupixent — in a head-to-head study.

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Robert Califf, FDA commissioner nominee (Graeme Sloan/Sipa USA/Sipa via AP Images)

Rob Califf ad­vances as Biden's FDA nom­i­nee, with a close com­mit­tee vote

Rob Califf’s second confirmation process as FDA commissioner is already much more difficult than his near unanimous confirmation under the Obama administration.

The Senate Health Committee on Thursday voted 13-8 in favor of advancing Califf’s nomination to a full Senate vote. Several Democrats voted against Califf, including Sen. Bernie Sanders and Sen. Maggie Hassan. Several other Democrats who aren’t on the committee, like West Virginia’s Joe Manchin and Ed Markey of Massachusetts, also said Thursday that they would not vote for Califf. Markey, Hassan and Manchin all previously expressed reservations about the prospect of Janet Woodcock as an FDA commissioner nominee too.

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Michel Vounatsos, Biogen CEO (World Economic Forum/Ciaran McCrickard)

Bio­gen vows to fight CM­S' draft cov­er­age de­ci­sion for Aduhelm be­fore April fi­nal­iza­tion

Biogen executives made clear in an investor call Thursday they are not preparing to run a new CMS-approved clinical trial for their controversial Alzheimer’s drug anytime soon.

As requested in a draft national coverage decision from CMS earlier this week, Biogen and other anti-amyloid drugs will need to show “a meaningful improvement in health outcomes” for Alzheimer’s patients in a randomized, placebo-controlled trial to get paid for their drugs, rather than just the reduction in amyloid plaques that won Aduhelm its accelerated approval in June.

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CRO own­er pleads guilty to ob­struct­ing FDA in­ves­ti­ga­tion in­to fal­si­fied clin­i­cal tri­al da­ta

The co-owner of a Florida-based clinical research site pleaded guilty to lying to an FDA investigator during a 2017 inspection, revealing that she falsely portrayed part of a GlaxoSmithKline pediatric asthma study as legitimate, when in fact she knew that certain data had been falsified, the Department of Justice said Wednesday.

Three other employees — Yvelice Villaman Bencosme, Lisett Raventos and Maytee Lledo — previously pleaded guilty and were sentenced in connection with falsifying data associated with the trial at the CRO Unlimited Medical Research.

Susan Galbraith, AstraZeneca EVP, Oncology R&D

Can­cer pow­er­house As­traZeneca rolls the dice on a $75M cash bet on a buzzy up­start in the on­col­o­gy field

After establishing itself in the front ranks of cancer drug developers and marketers, AstraZeneca is putting its scientific shoulder — and a significant amount of cash — behind the wheel of a brash new upstart in the biotech world.

The pharma giant trumpeted news this morning that it is handing over $75 million upfront to ally itself with Scorpion Therapeutics, one of those biotechs that was newly birthed by some top scientific, venture and executive talent and bequeathed with a fortune by way of a bankroll to advance an only hazily explained drug platform. And they are still very much in the discovery and preclinical phase.

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‘Skin­ny la­bels’ on gener­ics can save pa­tients mon­ey, re­search shows, but re­cent court de­ci­sions cloud fu­ture

New research shows how generic drug companies can successfully market a limited number of approved indications for a brand name drug, prior to coming to market for all of the indications. But several recent court decisions have created a layer of uncertainty around these so-called “skinny” labels.

While courts have generally allowed generic manufacturers to use their statutorily permitted skinny-label approvals, last summer, a federal circuit court found that Teva Pharmaceuticals was liable for inducing prescribers and patients to infringe GlaxoSmithKline’s patents through advertising and marketing practices that suggested Teva’s generic, with its skinny label, could be employed for the patented uses.

A patient in Alaska receiving an antibody infusion to prevent Covid hospitalizations in September. All but one of these treatments has been rendered useless by Omicron (Rick Bowmer/AP Images)

How a tiny Swiss lab and two old blood sam­ples cre­at­ed one of the on­ly ef­fec­tive drugs against Omi­cron (and why we have so lit­tle of it)

Exactly a decade before a novel coronavirus broke out in Wuhan, Davide Corti — a newly-minted immunologist with frameless glasses and a quick laugh — walked into a cramped lab on the top floor of an office building two hours outside Zurich. He had only enough money for two technicians and the ceiling was so low in parts that short stature was a job requirement, but Corti believed it’d be enough to test an idea he thought could change medicine.

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