Atara en­lists Juno co-founder Michel Sade­lain in CAR-T ef­fort; Valeant no more, Bausch is the new mar­quee name

Michel Sade­lain

→ The day af­ter Atara an­nounced that it is bring­ing Genen­tech vet Di­et­mar Berg­er on board as R&D chief, the biotech is back with a signed deal aimed at ex­pand­ing its work with Memo­r­i­al Sloan Ket­ter­ing on off-the-shelf CAR-Ts. As part of that arrange­ment, Atara is get­ting an ex­clu­sive re­la­tion­ship with Michel Sade­lain, the top CAR-T in­ves­ti­ga­tor who helped cre­ate the sci­en­tif­ic foun­da­tion for Juno. Said Sade­lain: “We are ea­ger to work with Atara to con­tin­ue ad­vanc­ing promis­ing al­lo­gene­ic T-cell im­munother­a­py tech­nolo­gies that orig­i­nat­ed at MSK. The new CAR T tech­nolo­gies seek to over­come per­sis­tent ther­a­peu­tic chal­lenges, such as safe­ty and tol­er­a­bil­i­ty, dura­bil­i­ty of treat­ment re­sponse, and ac­tiv­i­ty in ar­eas of sig­nif­i­cant un­met med­ical need that are un­der­served by the cur­rent gen­er­a­tion of CAR T im­munother­a­pies.”

→ Af­ter be­ing pum­meled with bad pub­lic­i­ty for its dis­as­trous cor­po­rate strate­gies, Valeant is throw­ing out its old name in fa­vor of some­thing with con­sid­er­ably less bag­gage. You can now call the com­pa­ny Bausch Health Com­pa­nies, says CEO Joe Pa­pa. Adds Pa­pa: “We be­lieve Bausch Health Com­pa­nies more ac­cu­rate­ly rep­re­sents the full scope of the Com­pa­ny to­day – a leader in the de­vel­op­ment and man­u­fac­ture of a wide range of phar­ma­ceu­ti­cal, med­ical de­vice and over-the-counter prod­ucts, pri­mar­i­ly in the ther­a­peu­tic ar­eas of eye health, gas­troen­terol­o­gy and der­ma­tol­ogy.” The re­brand­ed com­pa­ny will trade un­der the stock tick­er $BHC in­stead of $VRX.

As­traZeneca is sell­ing off more drug rights for some quick cash. In this in­stance, the phar­ma gi­ant is sell­ing rights to Sero­quel in a num­ber of mar­ket, in­clud­ing the UK and Chi­na. And it’s get­ting $260 mil­lion now from Luye Phar­ma as part of a $538 mil­lion deal.

Spark Ther­a­peu­tics’ Q1 re­port in­clud­ed news that its pi­o­neer­ing gene ther­a­py Lux­tur­na has been used on three pa­tients in the roll­out. CEO Jef­frey Mar­raz­zo $ONCE says he is en­cour­aged by the ini­tial de­mand.

→ The mR­NA biotech Cure­Vac is see­ing a change­up at the top. CEO In­g­mar Ho­err plans to tran­si­tion up to the chair­man’s job while Daniel Menichel­la moves in­to the CEO suite.

Mi­no­ryx and Sper­o­genix ink an ex­clu­sive li­cense agree­ment to de­vel­op and com­mer­cial­ize lerigli­ta­zone in Chi­na

September 23, 2020 – Hong Kong, Beijing, Shanghai (China) and Mataró, Barcelona (Spain)  

Minoryx will receive an upfront and milestone payments of up to $78 million, as well as double digit royalties on annual net sales 

Sperogenix will receive exclusive rights to develop and commercialize leriglitazone for the treatment of X-linked adrenoleukodystrophy (X-ALD), a rare life-threatening neurological condition

David Berry (Flagship)

Flag­ship's next big tech­no­log­i­cal bet? The cloud

Earlier this month, Flagship announced their big bet on the software half the industry is talking about, launching the AI and machine learning startup. Now, they and a couple other investors are gambling $100 million on a software that much of the public generally thinks of as a cool, IT afterthought: cloud computing.

The idea, says founder and Flagship partner David Berry, is one of scale: The sheer magnitude of biological data that you can store on cloud technology is unprecedented. And that size, when leveraged properly, can allow you to ask questions and form insights that are similarly unprecedented.

Vas Narasimhan (AP Images)

UP­DAT­ED: Still held down by clin­i­cal hold, No­var­tis' Zol­gens­ma falls fur­ther be­hind Bio­gen and Roche as FDA asks for a new piv­otal study

Last October, the FDA slowed down Novartis’ quest to extend its gene therapy to older spinal muscular atrophy patients by slapping a partial hold on intrathecal administration. Almost a year later, the hold is still there, and regulators are adding another hurdle required for regulatory submission: a new pivotal confirmatory study.

The new requirement — which departs significantly from Novartis’ prior expectations — will likely stretch the path to registration beyond 2021, when analysts were expecting a BLA submission. That could mean more time for Biogen to reap Spinraza revenues and Roche to ramp up sales of Evrysdi in the absence of a rival.

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FDA commissioner Stephen Hahn at the White House (AP Images)

Un­der fire, FDA to is­sue stricter guid­ance for Covid-19 vac­cine EUA this week — re­port

The FDA has been insisting for months that a Covid-19 vaccine had to be at least 50% effective – a measure of transparency meant to shore public trust in the agency and in a vaccine that had been brought forward at record speed and record political pressure. But now, with concerns of a Trump-driven authorization arriving before the election, the agency may be raising the bar.

The FDA is set to release new guidance that would raise safety and efficacy requirements for a vaccine EUA above earlier guidance and above the criteria used for convalescent plasma or hydroxychloroquine, The Washington Post reported. Experts say this significantly lowers the odds of an approval before the election on November 3, which Trump has promised despite vocal concerns from public health officials, and could help shore up public trust in the agency and any eventual vaccine.

News brief­ing: PureTech plans Nas­daq de­but with sec­ondary list­ing; GoodRx prices $725M IPO

London Stock Exchange-listed PureTech Health announced Wednesday that it’s looking to extend to Nasdaq. But due to its “strong cash position,” the biotech says it isn’t issuing any new shares in the potential secondary listing.

The company’s shares closed at £256.50 Tuesday on the London Stock Exchange. Its candidate LYT-100 is currently in Phase I development for various indications, including lymphatic flow disorders and fibrotic and inflammatory disorders. PureTech is expecting a Phase Ib readout in lymphatic flow disorders later this year, and is also planning to launch a Phase II study for the drug to treat respiratory conditions experienced after Covid-19.

PhII Alzheimer's fail­ure deals new blow to Roche, AC Im­mune — but the tau hy­poth­e­sis is far from dead

The leading anti-tau antibody has failed its first Phase II testing, casting a shadow on a popular target (just trailing amyloid beta) for Alzheimer’s disease.

Roche and AC Immune are quick to acknowledge disappointment in the topline readout, which suggested that semorinemab did not reduce cognitive decline among patients with early Alzheimer’s disease, who are either just starting to have symptoms or have mild manifestations.

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Covid-19 roundup: J&J be­gins piv­otal Phase III tri­al for vac­cine; Con­tro­ver­sial hu­man chal­lenge tri­als to be­gin in Lon­don — re­port

Johnson & Johnson announced it’s beginning a pivotal Phase III trial for its Covid-19 candidate, JNJ-78436735 — the first single-dose vaccine in this stage.

The Phase III trial, dubbed ENSEMBLE, will enroll 60,000 patients worldwide, making it the largest Phase III study of a Covid-19 vaccine to date. J&J said the candidate achieved positive interim results in a Phase I/IIa study, which will be published “imminently.” There’s a possibility that the first batches will be ready for potential emergency use in early 2021, according to the company.

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Patrick Enright, Longitude co-founder (Longitude)

As its biotechs hit the pan­dem­ic ex­it, Lon­gi­tude rais­es $585M for new neu­ro, can­cer, ag­ing and or­phan-fo­cused fund

The years have been kind to Longitude Capital. This year, too.

A 2006 spinout of Pequot Capital, its founders started their new firm just four years before the parent company would go under amid insider trading allegations. Their first life sciences fund raised $325 million amid the financial crisis, they added a second for $385 million and then in, 2016, a third for $525 million. In the last few months, the pandemic biotech IPO boom netted several high-value exits from those funds, as Checkmate, Vaxcyte, Inozyme and Poseida all went public.

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Scoop: ARCH’s Bob Nelsen is back­ing an mR­NA up­start that promis­es to up­end the en­tire man­u­fac­tur­ing side of the glob­al busi­ness

For the past 2 years, serial entrepreneur Igor Khandros relied on a small network of friends and close insiders to supply the first millions he needed to fund a secretive project to master a new approach to manufacturing mRNA therapies.

Right now, he says, he has a working “GMP-in-a-box” prototype for a new company he’s building — after launching 3 public companies — which plans to spread this contained, precise manufacturing tech around the world with a set of partners. He’s raised $60 million, recruited some prominent experts. And not coincidentally, he’s going semi-public with this just as a small group of pioneers appears to be on the threshold of ushering in the world’s first mRNA vaccines to fight a worldwide pandemic.

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