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.”

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.

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.