Atom­wise, On­coStatyx launch JV to tar­get triple-neg­a­tive breast can­cer; Can­cer biotech woos for­mer Spark COO John Furey

Celyad is team­ing up with Be The Match Bio­Ther­a­pies, a cell and gene ther­a­py so­lu­tions provider, on a clin­i­cal tri­al of its non-gene edit­ed al­lo­gene­ic CAR-T ther­a­pies. Be The Match Bio­Ther­a­pies will pro­vide the biotech with over 20 mil­lion vol­un­teer donors from their reg­istry of po­ten­tial blood stem cell donors, the source of start­ing ma­te­r­i­al for hematopoi­et­ic stem cell trans­plant and cel­lu­lar ther­a­py.

→ AI-fo­cused Atom­wise is launch­ing a joint ven­ture with Ohio-based On­coStatyx to dis­cov­er and de­vel­op small mol­e­cule com­pounds that in­hib­it KDM5B — a key epi­ge­net­ic mod­u­la­tor pro­tein — as an an­ti-can­cer agent, es­pe­cial­ly for triple-neg­a­tive breast can­cer (TNBC). “In­hi­bi­tion of KDM5B will re­ac­ti­vate ex­pres­sion of the tu­mor sup­pres­sor pro­tein HEX­IM1, which plays an im­por­tant role in turn­ing off the can­cer­ous state in mul­ti­ple types of sol­id tu­mor can­cers, in­clud­ing TNBC,” the part­ners not­ed.

John Furey

Im­vax has wooed John Furey, for­mer COO of Spark Ther­a­peu­tics, to the helm as CEO and to its board of di­rec­tors. Furey suc­ceeds in­ter­im CEO David An­drews, the com­pa­ny’s co-founder and CMO. Dur­ing his time at Spark, Furey led the US launch of pi­o­neer­ing gene ther­a­py Lux­tur­na. Pri­or to Spark, Furey served as SCP and head of glob­al op­er­a­tions at Bax­al­ta. He al­so held a stint at Pfiz­er, where he ini­ti­at­ed the re­struc­tur­ing and di­vesti­ture of Bax­ter In­ter­na­tion­al’s vac­cines fran­chise to Pfiz­er.

In his new role Furey will steer Philadel­phia-based Im­vax through a Phase II for its au­tol­o­gous tu­mor cell vac­cine for glioblas­toma mul­ti­forme, a no­to­ri­ous­ly hard-to-treat can­cer.

Flex­ion Ther­a­peu­tics $FLXN — which in 2017 scored FDA ap­proval for in­jectable treat­ment for os­teoarthri­tis-re­lat­ed knee pain — has inked a deal to de­vel­op Xenon Phar­ma­ceu­ti­cals$XENE NaV1.7 in­hibitor — XEN402 —to man­age post-op­er­a­tive pain. Flex­ion will use an ex­tend­ed re­lease for­mu­la­tion of XEN402 for its pre­clin­i­cal pro­gram, FX301. FX301 is ex­pect­ed to hit the clin­ic by 2021. Un­der the deal, Xenon gets an up­front $3 mil­lion, and up to about $125 mil­lion in mile­stone pay­ments, in ad­di­tion to po­ten­tial roy­al­ties.

Scott Gottlieb, AP Images

Scott Got­tlieb is once again join­ing a team that en­joyed good times at the FDA un­der his high-en­er­gy stint at the helm

Right after jumping on Michael Milken’s FasterCures board on Monday, the newly departed FDA commissioner is back today with news about another life sciences board post that gives him a ringside chair to cheer on a lead player in the real-world evidence movement — one with very close ties to the FDA.

Aetion is reporting this morning that Gottlieb is joining their board, a group that includes Mohamad Makhzoumi, a general partner at New Enterprise Associates, where Gottlieb returned after stepping out of his role at the FDA 2 years after he started.

Gottlieb — one of the best connected execs in biopharma — knows this company well. As head of FDA he championed the use of real-world evidence to help guide drug developers and the agency in gaining greater efficiencies, which helped set up Aetion as a high-profile player in the game.

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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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San Diego cou­ple charged with steal­ing trade se­crets, open­ing Chi­nese biotech as DOJ crack­down con­tin­ues

A San Diego couple has been charged with stealing trade secrets from a US hospital and opening a business based off those secrets in China as the controversial industry-wide crackdown on alleged corporate espionage continues. On the same day, the Department of Justice announced they had arrested Beijing representative Zhongsan Liu for allegedly trying to obtain research visas for government recruiters.

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UP­DAT­ED: Bio­gen pulls the plug on prized IPF drug from $562M+ Stromedix buy­out

One of Biogen’s attempts to branch out has flopped as the biotech scraps a mid-stage program for idiopathic pulmonary fibrosis.

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Warts for the win: Aclar­is' lead drug clears piv­otal study

Aclaris Therapeutics has found a way to get rid of the warts and all.

The company — which earlier this month decided to focus on its arsenal of kinase inhibitors — on Monday unveiled positive data from a pivotal study testing its lead experimental drug for use in common warts.

The drug, A-101, was tested in a 502-patient study called THWART-2 — patients enrolled had one to six warts before qualifying for the trial. Patients either self-administered A-101 topical solution or a vehicle twice a week over a two-month period. A higher proportion of patients on the drug (a potent hydrogen peroxide topical solution) saw their warts disappear at day 60, versus the vehicle (p<0.0001) — meeting the main goal of the study.  Each secondary endpoint also emerged in favor of A-101, the company said.

Charles Nichols, LSU School of Medicine

Could psy­che­delics tack­le the obe­si­ty cri­sis? A long­time re­searcher in the field says his lat­est mouse study sug­gests po­ten­tial

Psychedelics have experienced a renaissance in recent years amid a torrent of preclinical and clinical research suggesting it might provide a path to treat mood disorders conventional remedies have only scraped at. Now a preclinical trial from a young biotech suggests at least one psychedelic compound has effects beyond the mind, and — if you believe the still very, very early hype — could provide the first single remedy for some of the main complications of obesity.

Tower Bridge in London [Shutterstock]

#UK­BIO19: Join GSK’s Hal Bar­ron and a group of top biotech ex­ecs for our 2nd an­nu­al biotech sum­mit in Lon­don

Over the past 10 years I’ve made a point of getting to know the Golden Triangle and the special role the UK biopharma industry plays there in drug development. The concentration of world class research institutes, some of the most accomplished scientists I’ve ever seen at work and a rising tide of global investment cash leaves an impression that there’s much, much more to come as biotech hubs are birthed and nurtured.

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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Ac­celeron drops a de­vel­op­ment pro­gram as #2 drug fails to spark func­tion­al ben­e­fits in pa­tients with a rare neu­ro­mus­cu­lar ail­ment

Acceleron is scrapping a muscular dystrophy development program underway for its number 2 drug in the pipeline after pouring over some failed mid-stage secondary data.

Gone is the ACE-083 project in patients with facioscapulohumeral muscular dystrophy. Their drug hit the primary endpoint on building muscle but flopped on key secondaries for functional improvements in patients, which execs felt was vital to the drug’s success.