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.

Karyopharm lines up $150 mil­lion cash in­jec­tion to back con­tro­ver­sial drug launch

Karyopharm has entered into a royalty agreement worth up to $150 million to back the launch of their multiple myeloma drug — recently approved by the FDA over the objections of a majority of the agency’s outside experts.

The deal with HealthCare Royalty Partners, worth $75 million now and $75 million once certain regulatory and commercial milestones have been reached, will fund the commercialization of Karyopharm’s oral SINE compound Xpovio (selinexor) for patients with multiple myeloma who have already had at least four prior therapies. The money will help Karyopharm as it markets its newly approved drug and pushes through clinical trials testing the drug on refractory multiple myeloma patients with one to three therapies and patients with treatment-resistant diffuse large B-cell lymphoma. It will give Karyopharm a cushion through mid-2021.

Deborah Dunsire. Lundbeck

UP­DAT­ED: Deb­o­rah Dun­sire is pay­ing $2B for a chance to leap di­rect­ly in­to a block­buster show­down with a few of the world's biggest phar­ma gi­ants

A year after taking the reins as CEO of Lundbeck, Deborah Dunsire is making a bold bid to beef up the Danish biotech’s portfolio of drugs in what will likely be a direct leap into an intense rivalry with a group of giants now carving up a growing market for new migraine drugs.

Bright and early European time Monday morning the company announced that it will pay up to about $2 billion to buy Alder, a little biotech that is far along the path in developing a quarterly IV formulation of a CGRP drug aimed at cutting back the number of crippling migraines patients experience each month. In a followup call, Dunsire also noted that the company will likely need 200 to 250 reps for this marketing task on both sides of the Atlantic. And analysts were quick to note that the dealmaking at Lundbeck isn’t done, with another $2 billion to $3 billion available for more deals to beef up the pipeline.

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Af­ter a run of CT­LA-4 com­bo fail­ures, sci­en­tists spot­light a way to make it work — in se­lect pa­tients

CTLA-4/PD-(L)1 combinations have been one of the El Dorados of oncology, its promise forever behind that next hill but apparently unattainable after a series of pivotal clinical failures. But researchers at New York’s Memorial Sloan Kettering Cancer Center and the Technical University of Munich think they may know how to fix what’s wrong and boost the drive to next-gen cancer combos.

In a preclinical animal research program, researchers found that within a cell, checkpoints rely on a specific molecule — RNA-sensing molecule RIG-I — to work. If that sounds familiar, it’s because it has already been identified as a target for boosting immune responses and was subject to at least one Phase I/II trial. Pfizer in December allied itself with Kineta with $15 million upfront and $505 million in potential milestones to develop RIG-I immunotherapies, and three years ago Merck purchased German upstart Rigontec for $137 million upfront and over $400 million in potential milestones for the same purpose.

Pur­due Phar­ma files for bank­rupt­cy as first step in $10B opi­oid set­tle­ment

It’s settled. Purdue Pharma has filed for bankruptcy as part of a deal that would see the OxyContin maker hand over $10 billion in cash and other contributions to mitigate the opioid crisis — without acknowledging any wrongdoing in the protracted epidemic that’s resulted in hundreds of thousands of deaths.

The announcement came two weeks after news of a proposed settlement surfaced and largely confirm what’s already been reported.

It’s fi­nal­ly over: Bio­gen, Ei­sai scrap big Alzheimer’s PhI­I­Is af­ter a pre­dictable BACE cat­a­stro­phe rais­es safe­ty fears

Months after analysts and investors called on Biogen and Eisai to scrap their BACE drug for Alzheimer’s and move on in the wake of a string of late-stage failures and rising safety fears, the partners have called it quits. And they said they were dropping the drug — elenbecestat — after the independent monitoring board raised concerns about…safety.

We don’t know exactly what researchers found in this latest catastrophe, but the companies noted in their release that investigators had determined that the drug was flunking the risk/benefit analysis.

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Lisa M. DeAngelis, MSKCC

MSK picks brain can­cer ex­pert Lisa DeAn­ge­lis as its next CMO — fol­low­ing José Basel­ga’s con­tro­ver­sial ex­it

It’s official. Memorial Sloan Kettering has picked a brain cancer expert as its new physician-in-chief and CMO, replacing José Baselga, who left under a cloud after being singled out by The New York Times and ProPublica for failing to properly air his lucrative industry ties.

His replacement, who now will be in charge of MSK’s cutting-edge research work as well as the cancer care delivered by hundreds of practitioners, is Lisa M. DeAngelis. DeAngelis had been chair of the neurology department and co-founder of MSK’s brain tumor center and was moved in to the acting CMO role in the wake of Baselga’s departure.

Penn team adapts CAR-T tech, reengi­neer­ing mouse cells to treat car­diac fi­bro­sis

After establishing itself as one of the pioneer research centers in the world for CAR-T cancer therapies, creating new attack vehicles to eradicate cancer cells, a team at Penn Medicine has begun the tricky transition of using the basic technology for heart repair work.

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Tal Zaks. Moderna

The mR­NA uni­corn Mod­er­na has more ear­ly-stage hu­man da­ta it wants to show off — reach­ing new peaks in prov­ing the po­ten­tial

The whole messenger RNA field has attracted billions of dollars in public and private investor cash gambled on the prospect of getting in on the ground floor. And this morning Boston-based Moderna, one of the leaders in the field, wants to show off a few more of the cards it has to play to prove to you that they’re really in the game.

The whole hand, of course, has yet to be dealt. And there’s no telling who gets to walk with a share of the pot. But any cards on display at this point — especially after being accused of keeping its deck under lock and key — will attract plenty of attention from some very wary, and wired, observers.

“In terms of the complexity and unmet need,” says Tal Zaks, the chief medical officer, “this is peak for what we’ve accomplished.”

Moderna has two Phase I studies it wants to talk about now.

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It's not per­fect, but it's a good start: FDA pan­elists large­ly en­dorse Aim­mune's peanut al­ler­gy ther­a­py

Two days after a fairly benign review from FDA staff, an independent panel of experts largely endorsed the efficacy and safety of Aimmune’s peanut allergy therapy, laying the groundwork for approval with a risk evaluation and mitigation strategy (REMS).

Traditionally, peanut allergies are managed by avoidance, but the threat of accidental exposure cannot be nullified. Some allergists have devised a way to dose patients off-label with peanut protein derived from supermarket products to wean them off their allergies. But the idea behind Aimmune’s product was to standardize the peanut protein, and track the process of desensitization — so when accidental exposure in the real world invariably occurs, patients are less likely to experience a life-threatening allergic reaction.

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