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.

Ryan Watts, Denali CEO

Bio­gen hands De­nali $1B-plus in cash, $1B-plus in mile­stones to part­ner on late-stage Parkin­son’s drug

Biogen is handing over more than a billion dollars cash to partner with the up-and-coming neurosciences crew at Denali on a new therapy for Parkinson’s. And the big biotech is ready to pile on more than a billion dollars more in milestones — if the alliance is a success.

For Biogen $BIIB, the move on Denali’s small molecule inhibitors of LRRK2 puts them in line to collaborate on a late-stage program for DNL151, which is scheduled to start next year.

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Yvonne Greenstreet, incoming Alnylam president (Alnylam)

Al­ny­lam pres­i­dent Bar­ry Greene leaves af­ter 17 years, hand­ing po­si­tion over to Yvonne Green­street as biotech looks to­ward prof­itabil­i­ty

After 17 years helping Alnylam steer control of buzzy but unproven science they promised could change medicine, president Barry Greene is leaving the RNAi biotech just as that technology is beginning to hit prime time.

Leaving to “pursue outside interests in the biopharmaceutical industry,” the longtime executive will hand over the reins on October 1 to current COO Yvonne Greenstreet. Greenstreet, a former Pfizer and GlaxoSmithKline executive, inherits the high-profile spot at a company that’s proven its tech can work in rare diseases but now faces the daunting task of turning a couple successes and a new mountain of cash into drugs that are broadly applicable and, crucially, profitable.

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President Trump speaks with members of the media before boarding Marine One (AP Images)

'Oc­to­ber is com­ing,' and every­one still wants to know if a Covid-19 vac­cine will be whisked through the FDA ahead of the elec­tion

Right on the heels of a lengthy assurance from FDA commissioner Stephen Hahn that the agency will not rush through a quick approval for a Covid-19 vaccine, the President of the United States has some thoughts on timing he’d like to share.

In an exchange with Fox News’ Geraldo Rivera on Thursday, President Trump allowed that a vaccine could be ready to roll “sooner than the end of the year, could be much sooner.”

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Covid-19 roundup: 34 AGs call for ‘march-in’ rights on remde­sivir; Hahn pleads with pub­lic to trust FDA's vac­cine re­view

A bipartisan group of 34 attorneys general have asked the federal government to bypass Gilead’s patent rights on remdesivir and begin scaling and distributing the Covid-19 antiviral, or to allow the states to do it themselves.

In a letter to HHS secretary Alex Azar, the AGs expressed frustrations over the $3,250 price tag Gilead placed on the the drug, citing the federal funding that went into its developments. And they noted the sustained difficulties hospitals have faced in getting supplies from either the California biotech or their contract manufacturer AmerisourceBergen.

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Douglas Fambrough, Dicerna CEO (Boehringer Ingelheim via YouTube)

Roche-backed Dicer­na push­es in­to the pack rac­ing to­ward the block­buster hep B goal line, armed with PhI da­ta

Dicerna has lined up a set of proof-of-concept data from a small cohort of hepatitis B patients in a match-up against some heavyweight rivals which got out in front of this race. And right in the front row you’ll find a team from Roche, which paid $200 million in cash and offered another $1.5 billion in milestones to partner with Dicerna $DRNA on their RNAi program for hep B.

Right now it’s looking competitive, with lots of big challenges ahead.

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UP­DAT­ED: No­vavax her­alds the lat­est pos­i­tive snap­shot of ear­ly-stage Covid-19 vac­cine — so why did its stock briefly crater?

High-flying Novavax $NVAX became the latest of the Covid-19 vaccine players to stake out a positive set of biomarker data from its early-stage look at its vaccine in humans.

Their adjuvanted Covid-19 vaccine was “well-tolerated and elicited robust antibody responses numerically superior to that seen in human convalescent sera,” the company noted. According to the biotech:

All subjects developed anti-spike IgG antibodies after a single dose of vaccine, many of them also developing wild-type virus neutralizing antibody responses, and after Dose 2, 100% of participants developed wild-type virus neutralizing antibody responses. Both anti-spike IgG and viral neutralization responses compared favorably to responses from patients with clinically significant COVID‑19 disease. Importantly, the IgG antibody response was highly correlated with neutralization titers, demonstrating that a significant proportion of antibodies were functional.

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Jan Hatzius (Photographer: Christopher Goodney/Bloomberg via Getty Images)

When will it end? Gold­man econ­o­mist gives late-stage vac­cines a good shot at tar­get­ing 'large shares' of the US by mid-2021 — but the down­side is daunt­ing

It took decades for hepatitis B research to deliver a slate of late-stage candidates capable of reining the disease in.

With Covid-19, the same timeline has devoured all of 5 months. And the outcome will influence the lives of billions of people and a multitrillion-dollar world economy.

Count the economists at Goldman Sachs as optimistic that at least one of these leading vaccines will stay on this furiously accelerated pace and get over the regulatory goal line before the end of this year, with a shot at several more near-term OKs. That in turn should lead to the production of billions of doses of vaccines that can create herd immunity in the US by the middle of next year, with Europe following a few months later.

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J&J gets a fresh OK for es­ke­t­a­mine, but is it re­al­ly the game-chang­er for de­pres­sion Trump keeps tweet­ing about?

Backed by an enthusiastic set of tweets from President Trump and a landmark OK for depression, J&J scooped up a new approval from the FDA for Spravato today. But this latest advance will likely bring fresh scrutiny to a drug that’s spurred some serious questions about the data, as well as the price.

First, the approval.

Regulators stamped their OK on the use of Spravato — developed as esketamine, a nasal spray version of the party drug Special K or ketamine — for patients suffering from major depressive disorder with acute suicidal ideation or behavior.

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Ben Dake (Source: Aerovate)

RA Cap­i­tal-backed Aerovate launch­es with $72.6M to treat PAH with a re­pur­posed can­cer med

The landmark cancer drug imatinib has been on the market since 2001, first sold by Novartis as Gleevec and in recent years as a generic. Now, a new Boston biotech is aiming to repurpose the drug as a treatment for pulmonary arterial hypertension.

Aerovate emerged from stealth Thursday and announced a $72.6 million Series A, which will be used to develop and run trials for its candidate AV-101 — a dry powder version of imatinib meant to be used with an inhaler. The company emerged from RA Capital’s incubator and funding was led by Sofinnova.