Fu­ji­film ex­pands in US af­ter $100M deal for Atara's man­u­fac­tur­ing site and em­ploy­ees

Atara Bio­ther­a­peu­tics has worked on ad­vanc­ing its al­lo­gene­ic T-cell ther­a­py plat­form for pa­tients with can­cer and au­toim­mune dis­ease for years, with much of the fo­cus on the ever-tricky task of man­u­fac­tur­ing such a ther­a­py. On Wednes­day, the com­pa­ny an­nounced a deal to hand its Cal­i­for­nia man­u­fac­tur­ing site over to Fu­ji­film Diosynth in ex­change for $100 mil­lion up­front and a long-term li­cens­ing deal.

Fu­ji­film will give Atara ac­cess to flex­i­ble ca­pac­i­ty and spe­cif­ic ca­pa­bil­i­ties need­ed to man­u­fac­ture clin­i­cal and com­mer­cial-stage al­lo­gene­ic cell ther­a­pies. That in­cludes tab-cel, an off-the-shelf, al­lo­gene­ic in­ves­ti­ga­tion­al ther­a­py for the treat­ment of Ep­stein-Barr virus-dri­ven post-trans­plant lym­pho­pro­lif­er­a­tive dis­ease. Cur­rent­ly, there are no ap­proved treat­ments avail­able for the dis­ease, which is a virus that can af­fect pa­tients af­ter sol­id or­gan or al­lo­gene­ic hematopoi­et­ic cell trans­plan­ta­tion.

Pas­cal Tou­chon

In ex­change, the CD­MO be­he­moth gets 140 skilled staff mem­bers at the Thou­sand Oaks site. It’s a deal that made sense, in large part, be­cause al­lo­gene­ic ther­a­pies don’t re­quire the need for full ca­pac­i­ty all the time or the abil­i­ty to quick­ly scale up at a mo­ment’s no­tice, Atara CEO Pas­cal Tou­chon said in an in­ter­view with End­points News. When the com­pa­ny first built the fa­cil­i­ty, con­trol over the en­tire fa­cil­i­ty was a key goal. But what they’ve dis­cov­ered af­ter hav­ing a ton of suc­cess in scal­ing the num­ber of dos­es per batch is that the com­pa­ny doesn’t need full ca­pac­i­ty all the time, es­pe­cial­ly in-house. And since Atara de­vel­oped the process, it can eas­i­ly tech trans­fer the process to any­one.

“It’s com­plete­ly off the shelf, which means we have an in­ven­to­ry of prod­uct, like a mon­o­clon­al an­ti­body,” he said. “When we re­ceive a par­tic­u­lar re­quest from a pa­tient … we just need to find the right prod­uct for the right pa­tient with­in our in­ven­to­ry, and we do that in three days.”

Ep­stein-Barr is the virus that caus­es mononu­cle­o­sis. Atara has sub­mit­ted Phase III tri­al da­ta to the EU for reg­u­la­to­ry re­view, and plans to sub­mit da­ta to the FDA for a BLA by Q2 of this year. Its pipeline al­so in­cludes ATA188 for mul­ti­ple scle­ro­sis and CAR T-cell ther­a­pies ATA3271 and ATA3219.

Eleven of the 19 re­spon­ders in the Phase III AL­LELE tri­al saw a du­ra­tion of re­sponse longer than six months, Atara said. Of the eight re­main­ing re­spon­ders, four pa­tients ex­pe­ri­enced ei­ther dis­ease pro­gres­sion or death, and four weren’t evalu­able for a six-month re­sponse at the da­ta cut. There were no treat­ment-re­lat­ed deaths, ac­cord­ing to CMO AJ Joshi. Over­all re­sponse rate, which was the pri­ma­ry end­point of the study, was 50% in 38 pa­tients with EBV PTLD with re­lapsed or re­frac­to­ry re­spons­es to rit­ux­imab and chemother­a­py were treat­ed.

Mar­tin Mee­son

The site has 90,000 square feet set to sup­port both clin­i­cal and com­mer­cial op­er­a­tions, and it can ex­pand to sup­port oth­er prod­ucts as well. The ac­qui­si­tion al­so helps Fu­ji­film ex­pand its foot­print in the US, CEO Mar­tin Mee­son said in a state­ment. Just in the fall, the com­pa­ny broke ground on a new head­quar­ters in North Car­oli­na, a project that is es­ti­mat­ed to cost $2 bil­lion.

“This agree­ment we be­lieve it’s prob­a­bly the way for­ward,” Tou­chon said. “I strong­ly be­lieve that the fu­ture of al­lo­gene­ic cell ther­a­py is go­ing to be like it was for mon­o­clon­al an­ti­bod­ies 20-30 years ago. When you con­trol the man­u­fac­tur­ing process, the more you can lever­age oth­er com­pa­nies, the more you in­crease your man­u­fac­tur­ing pro­duc­tiv­i­ty.”

Has the mo­ment fi­nal­ly ar­rived for val­ue-based health­care?

RBC Capital Markets’ Healthcare Technology Analyst, Sean Dodge, spotlights a new breed of tech-enabled providers who are rapidly transforming the way clinicians deliver healthcare, and explores the key question: can this accelerating revolution overturn the US healthcare system?

Key points

Tech-enabled healthcare providers are poised to help the US transition to value, not volume, as the basis for reward.
The move to value-based care has policy momentum, but is risky and complex for clinicians.
Outsourced tech specialists are emerging to provide the required expertise, while healthcare and tech are also converging through M&A.
Value-based care remains in its early stages, but the transition is accelerating and represents a huge addressable market.

Lat­est on ul­tra-rare dis­ease ap­proval; Pos­i­tive, if mixed, signs for Bio­gen's ALS drug; Clay Sie­gall finds a new job; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

Over the last four years, we’ve honored 80 women whose extraordinary accomplishments have changed the game in biopharma R&D. You can now nominate someone to be highlighted in this year’s special report. Details are here.

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FDA spells out how can­cer drug de­vel­op­ers can use one tri­al for both ac­cel­er­at­ed and full ap­provals

The FDA’s Oncology Center of Excellence has been a bright spot within the agency in terms of speeding new treatments to patients. That flexibility was on full display this morning as FDA released new draft guidance spelling out exactly how oncology drug developers can fulfill both the accelerated and full approval’s requirements with just a single randomized controlled trial.

While Congress recently passed legislation that will allow FDA to require confirmatory trials to be recruiting and ongoing prior to granting an accelerated approval, the agency is now making clear that the initial trial used to win the AA, if designed appropriately, can also serve as the trial for converting the accelerated approval into a full approval.

FDA ad­vi­sors unan­i­mous­ly rec­om­mend ac­cel­er­at­ed ap­proval for Bio­gen's ALS drug

A panel of outside advisors to the FDA unanimously recommended that the agency grant accelerated approval to Biogen’s ALS drug tofersen despite the drug failing the primary goal of its Phase III study, an endorsement that could pave a path forward for the treatment.

By a 9-0 vote, members of the Peripheral and Central Nervous System Drugs Advisory Committee said there was sufficient evidence that tofersen’s effect on a certain protein associated with ALS is reasonably likely to predict a benefit for patients. But panelists stopped short of advocating for a full approval, voting 3-5 against (with one abstention) and largely citing the failed pivotal study.

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No­vo Nordisk oral semaglu­tide tri­al shows re­duc­tion in blood sug­ar, plus weight loss

Novo Nordisk is testing higher levels of its oral version of its GLP-1, semaglutide, and its type 2 diabetes trial results released today show reductions in blood sugar as well as weight loss.

In the Phase IIIb trial, Novo compared its oral semaglutide in 25 mg and 50 mg doses with the 14 mg version that’s currently the maximum approved dose. The trial looked at how the doses compared when added to a stable dose of one to three oral antidiabetic medicines in people with type 2 diabetes who were in need of an intensified treatment.

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Ly­me vac­cine test com­ple­tion is pushed back by a year as Pfiz­er, Val­ne­va say they'll ad­just tri­al

Valneva and Pfizer have adjusted the end date for the Phase III study of their investigational Lyme disease vaccine, pushing it back by a year after issues at a contract researcher led to thousands of US patients being dropped from the test.

In a March 20 update to clinicaltrials.gov, Valneva and Pfizer moved the primary completion date on the trial, called VALOR, from the end of 2024 to the end of 2025.

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Clay Siegall, Morphimmune CEO

Up­dat­ed: Ex-Seagen chief Clay Sie­gall emerges as CEO of pri­vate biotech

Clay Siegall will be back in the CEO seat, taking the helm of a private startup working on targeted cancer therapies.

It’s been almost a year since Siegall resigned from Seagen, the biotech he co-founded and led for more than 20 years, in the wake of domestic violence allegations by his then-wife. His eventual successor, David Epstein, sold the company to Pfizer in a $43 billion deal unveiled last week.

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Eu­ro­pean doc­tors di­al up dig­i­tal com­mu­ni­ca­tion with phar­mas, but still lean to­ward in-per­son med meet­ings, study finds

As in-person sales rep access declines in the big five European countries, a corresponding uptick in virtual rep access is happening. It’s not surprising, but it does run counter to pharma companies’ assessment – along with long-held sales rep sway in Europe – that in-person access hadn’t changed.

CMI Media Group and Medscape’s recent study reports that 75% of physicians in the EU5 countries of Spain, Germany, Italy, France and the UK already limit engagements with pharma sales reps, and 25% of those surveyed plan to decrease time with reps.

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Judge al­lows ex­pert tes­ti­mo­ny in GSK tri­al al­leg­ing Zan­tac link to can­cer

A California judge will allow a plaintiff in a state court case to introduce expert testimony connecting a potential carcinogen in former blockbuster medicine Zantac to cancer.

The order was handed down on Thursday from state judge Evelio Grillo, who is now allowing both parties to introduce expert testimony in an upcoming trial after what’s known as a Sargon hearing, where a judge determines the admissibility of expert witnesses and expert opinions.