Atara brings on No­var­tis vet to re­place founder Ciechanover as chief

Isaac Ciechanover Atara

Af­ter found­ing T-cell im­munother­a­py com­pa­ny Atara Bio­ther­a­peu­tics us­ing Am­gen $AMGN drug as­sets in 2012, Isaac Ciechanover made a sur­prise de­ci­sion to leave the com­pa­ny this Jan­u­ary. No­var­tis vet­er­an Pas­cal Tou­chon is set to re­place him as chief, the South San Fran­cis­co biotech said on Tues­day.

Ex­ist­ing CAR-T ther­a­pies — No­var­tis’ $GILD Kym­ri­ah and Gilead’s $GILD Yescar­ta — tar­get a sin­gle anti­gen called CD19. Atara — akin to oth­er play­ers in pur­suit of next-gen CAR-T drugs — is work­ing on en­gi­neer­ing T cells (a type of white blood cell) to tack­le mul­ti­ple tar­gets for ad­dress­ing can­cers with di­verse cell types that of­ten be­come re­sis­tant to treat­ment, such as acute myel­oge­nous leukemia and B cell ma­lig­nan­cies.

Pas­cal Tou­chon Co­gen

Kym­ri­ah was the first CAR-T drug to win ap­proval in the Unit­ed States and Eu­rope. The ther­a­py — an au­tol­o­gous prod­uct made from pa­tients’ own T cells — was ex­pect­ed to notch block­buster rev­enue, but sales have suf­fered due to man­u­fac­tur­ing wob­bles. Atara’s tech­nol­o­gy, mean­while, is pow­ered to cre­ate an al­lo­gene­ic, off-the-shelf CAR-T ther­a­py, com­pris­ing cells bio­engi­neered from donors with healthy im­mune func­tion.

Tou­chon is well versed in No­var­tis’ Kym­ri­ah woes. Most re­cent­ly, he worked with­in No­var­tis On­col­o­gy as glob­al head, cell & gene and as a mem­ber of the on­col­o­gy ex­ec­u­tive com­mit­tee, where he was in charge of glob­al roll­out of Kym­ri­ah — se­cur­ing reg­u­la­to­ry ap­proval and re­im­burse­ment in ma­jor mar­kets, ex­pand­ing glob­al CAR T man­u­fac­tur­ing and tech­ni­cal op­er­a­tions and over­see­ing mul­ti­ple new clin­i­cal stud­ies. Be­fore tak­ing on that role, Tou­chon served as glob­al head, strat­e­gy, busi­ness de­vel­op­ment of on­col­o­gy at No­var­tis. Tou­chon has al­so pre­vi­ous­ly worked at Servi­er, Sanofi and Glaxo.

Tou­chon of­fi­cial­ly joins Atara $ATRA on June 24.

Di­et­mar Berg­er Atara

Di­et­mar Berg­er, who joined Atara last year as head of R&D to steer the com­pa­ny’s al­lo­gene­ic T cell im­munother­a­pies through the clin­ic, both in CAR-T and oth­er ap­pli­ca­tions, is step­ping down from his po­si­tion to pur­sue oth­er op­por­tu­ni­ties, Atara added.

Atara’s lead ex­per­i­men­tal drug, tab­ele­cleu­cel, is in late-stage de­vel­op­ment for pa­tients with Ep­stein-Barr virus-as­so­ci­at­ed post-trans­plant lym­pho­pro­lif­er­a­tive dis­or­der, and is in ear­li­er stage de­vel­op­ment for oth­er EBV-as­so­ci­at­ed hema­to­log­ic ma­lig­nan­cies and sol­id tu­mors.

Novartis CEO Vas Narasimhan [via Bloomberg/Getty]

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Vas Narasimhan has warily stepped up with what might pass as something close to a borderline apology for the latest scandal to engulf Novartis.

But he couldn’t quite get there.

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Mi­nor­i­ty racial groups con­tin­ue to be dis­mal­ly rep­re­sent­ed in can­cer tri­als — study

Data reveal that different racial and ethnic groups — by nature and/or nurture — can respond differently in terms of pharmacokinetics, efficacy, or safety to therapeutics, but this disparity is not necessarily accounted for in clinical trials. A fresh analysis of the last decade of US cancer drug approvals suggests the trend continues, cementing previous research that suggests oncology trials are woefully under-representative of the racial makeup of the real world.

Van­da shares slide af­ter FDA spurns their big end­point and re­jects a pitch on jet lag re­lief

Back in the spring of last year, Vanda Pharmaceuticals $VNDA served up a hot stew of mixed data for a slate of endpoints related to what they called clear evidence that their melatonin sleep drug Hetlioz (tasimelteon) could help millions of travelers suffering from jet lag.

Never mind that they couldn’t get a planned 90 people in the study, settling for 25 instead; Vanda CEO Mihael H. Polymeropoulos said they were building on a body of data to prove it would help jet-lagged patients looking for added sleep benefits. And that, they added, would be worth a major upgrade from the agency as they sought to tackle a big market.

Jim Mellon [via YouTube]

Health­i­er, longer lifes­pans will be a re­al­i­ty soon­er than you think, Ju­ve­nes­cence promis­es as it clos­es $100M round

Earlier this year, an executive from Juvenescence-backed AgeX predicted the field of longevity will eventually “dwarf the dotcom boom.” Greg Bailey, the UK-based anti-aging biotech’s CEO, certainly hopes so.

On Monday, Juvenescence completed its $100 million Series B round of financing. The company is backed by British billionaire Jim Mellon — who wrote his 400-page guide to investing in the field of longevity shortly after launching the company in 2017. Bailey, who served as a board director for seven years at Medivation before Pfizer swallowed the biotech for $14 billion, is joined by Declan Doogan, an industry veteran with stints at Pfizer $PFE and Amarin $AMRN.

UP­DAT­ED: AveX­is sci­en­tif­ic founder was axed — and No­var­tis names a new CSO in wake of an ethics scan­dal

Now at the center of a storm of controversy over its decision to keep its knowledge of manipulated data hidden from regulators during an FDA review, Novartis CEO Vas Narasimhan has found a longtime veteran in the ranks to head the scientific work underway at AveXis, where the incident occurred. And the scientific founder has hit the exit.

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Ab­b­Vie gets its FDA OK for JAK in­hibitor upadac­i­tinib, but don’t look for this one to hit ex­ecs’ lofty ex­pec­ta­tions

Another big drug approval came through on Friday afternoon as the FDA OK’d AbbVie’s upadacitinib — an oral JAK1 inhibitor that is hitting the rheumatoid arthritis market with a black box warning of serious malignancies, infections and thrombosis reflecting fears associated with the class.

It will be sold as Rinvoq — at a wholesale price of $59,000 a year — and will likely soon face competition from a drug that AbbVie once controlled, and spurned. Reuters reports that a 4-week supply of Humira, by comparison, is $5,174, adding up to about $67,000 a year.

John Hood [file photo]

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Six years after Sanofi gave it up for dead, the FDA has approved the myelofibrosis drug fedratinib, now owned by Celgene.

The drug will be sold as Inrebic, and will soon land in the portfolio at Bristol-Myers Squibb, which is finalizing a deal to acquire Celgene.

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The top 10 fran­chise drugs in bio­phar­ma his­to­ry will earn a to­tal of $1.4T (tril­lion) by 2024 — what does that tell us?

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UP­DAT­ED: Sci­en­tist-CEO ac­cused of im­prop­er­ly us­ing con­fi­den­tial in­fo from uni­corn Alec­tor

The executive team at Alector $ALEC has a bone to pick with scientific co-founder Asa Abeliovich. Their latest quarterly rundown has this brief note buried inside:

On June 18, 2019, we initiated a confidential arbitration proceeding against Dr. Asa Abeliovich, our former consulting co-founder, related to alleged breaches of his consulting agreement and the improper use of our confidential information that he learned during the course of rendering services to us as our consulting Chief Scientific Officer/Chief Innovation Officer. We are in the early stage of this arbitration proceeding and are unable to assess or provide any assurances regarding its possible outcome.

There’s no explicit word in the filing on what kind of confidential info was involved, but the proceeding got started 2 days ahead of Abeliovich’s IPO.

Abeliovich, formerly a tenured associate professor at Columbia, is a top scientist in the field of neurodegeneration, which is where Alector is targeted. More recently, he’s also helped start up Prevail Therapeutics as the CEO, which raised $125 million in an IPO. And there he’s planning on working on new gene therapies that target genetically defined subpopulations of Parkinson’s disease. Followup programs target Gaucher disease, frontotemporal dementia and synucleinopathies.

But this time Abeliovich is the CEO rather than a founding scientist. And some of their pipeline overlaps with Alector’s.

Abeliovich and Prevail, though, aren’t taking this one lying down.

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