Pascal Touchon, Atara Biotherapeutics CEO

EC ap­proves first al­lo­gene­ic T cell ther­a­py for rare post-trans­plant com­pli­ca­tion

The Eu­ro­pean Com­mis­sion signed off on the con­ti­nent’s first al­lo­gene­ic T cell ther­a­py Mon­day. And for its mak­er Atara Bio­ther­a­peu­tics, the ap­proval marks the biotech’s first ap­proved ther­a­py.

Ebval­lo, made by Atara Bio­ther­a­peu­tics, is now ap­proved by the EMA for mar­ket­ing au­tho­riza­tion for a spe­cif­ic sub­group of pa­tients with post-trans­plant lym­pho­pro­lif­er­a­tive dis­ease who are pos­i­tive for Ep­stein-Barr virus. The dis­ease, al­so known as EBV+ PTLD for short, is a rare com­pli­ca­tion that can oc­cur af­ter a sol­id or­gan or hematopoi­et­ic stem cell trans­plant.

The biotech had in-li­censed the can­di­date from Memo­r­i­al Sloan Ket­ter­ing, where it was dis­cov­ered, back in 2015.

Pa­tients aged 2 years and old­er who have had at least one pri­or ther­a­py are el­i­gi­ble for the treat­ment. Atara and mar­ket­ing part­ner Pierre Fab­re added in a state­ment that in pa­tients suf­fer­ing from com­pli­ca­tions of sol­id or­gan trans­plants, pri­or ther­a­py in­cludes chemother­a­py un­less chemother­a­py is deemed in­ap­pro­pri­ate.

CHMP gave a pos­i­tive opin­ion for Ebval­lo back in Oc­to­ber, set­ting the stage for the ap­proval and mark­ing a pos­i­tive turn for the biotech af­ter it an­nounced plans to lay off 77 em­ploy­ees ear­li­er in the year as part of a slim­ming plan to re­duce cash burn.

The price for the ther­a­py is still con­fi­den­tial. Atara CEO Pas­cal Tou­chon tells End­points News that since Pierre Fab­re is tak­ing the lead on com­mer­cial­iza­tion in Eu­rope, Pierre Fab­re will dis­close the price some­time in Q1 2023. Q1 next year is al­so the time­line for when Tou­chon ex­pects mar­ket­ing in Eu­rope to start.

That mar­ket­ing deal, reached last year, gives Pierre Fab­re prac­ti­cal­ly all com­mer­cial­iza­tion rights in the EU and sev­er­al oth­er se­lect mar­ketsAnd per an amend­ment to the mar­ket­ing deal ear­li­er this year, Atara will re­ceive $30 mil­lion once a trans­fer of the mar­ket­ing au­tho­riza­tion oc­curs — which Tou­chon said takes about a month.

Tou­chon said that what Atara now has is a trio of firsts. Not on­ly is it Atara’s first ap­proved prod­uct, but it’s al­so the first ap­proved prod­uct for PTLD and the first al­lo­gene­ic T cell im­munother­a­py to be ap­proved. Al­lo­gene­ic T cell ther­a­pies are T cell prod­ucts that use T cells de­rived from donors. Oth­er ap­proved prod­ucts in the T cell ther­a­py space use the pa­tient’s own T cells.

Pierre Fab­re, on top of ne­go­ti­at­ing prices and get­ting Ebval­lo launched in Ger­many and Aus­tria, is next work­ing on get­ting the ther­a­py ap­proved in the UK and Switzer­land, ac­cord­ing to Tou­chon. For Atara, the biotech is in dis­cus­sions with the FDA to align on fil­ing re­quire­ments for a BLA on Ebval­lo. The chief ex­ec­u­tive added that like its part­ner­ship in Eu­rope, Atara will be uti­liz­ing a com­mer­cial­iza­tion part­ner if and when Atara’s prod­uct gets the reg­u­la­to­ry green light. How­ev­er, those dis­cus­sions are still on­go­ing.

Atara is not stop­ping with just the sec­ond-line in­di­ca­tion. Tou­chon added that oth­er clin­i­cal tri­als with Ebval­lo are on­go­ing, in­clud­ing in first-line PTLD where pa­tients are not rec­om­mend­ed for oth­er ther­a­pies.

Image courtesy of The Janssen Pharmaceutical Companies of Johnson & Johnson.

Pro­tect­ing the glob­al phar­ma­ceu­ti­cal in­no­va­tion ecosys­tem – what’s at stake?

We are living in a new era of healthcare that is rapidly advancing progress impacting patient outcomes and experiences. We’ve seen a remarkable pace of transformational innovation, applied research, and advanced clinical development over the last decade.

Despite this tremendous progress, there is much more work to be done, and patients are counting on us – now more than ever – to continue that momentum. At the heart of our industry is a focus on developing and delivering medicines for some of the world’s most challenging diseases, including those that have few or no effective treatments today.

Roger Perl­mut­ter lines up deals, fresh fund­ing at Eikon; Sec­ond RSV vac­cine ap­proved; Sev­er­al biotechs flash­ing red; 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.

As you come back to our website this weekend for ASCO news, don’t forget to check out our updated event lineup at BIO, which will cover everything from the current state of VC investing in biotech to top pharma R&D chiefs discussing how to make pipeline decisions.

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Bris­tol My­er­s' Op­di­vo keeps can­cer at bay in more lym­phoma pa­tients than Seagen's Ad­cetris in PhI­II: #AS­CO23

CHICAGO — In a study pitting Seagen’s Adcetris against Bristol Myers Squibb’s Opdivo in newly diagnosed patients with advanced classic Hodgkin lymphoma, a greater proportion of those who received Opdivo saw no cancer growth at one year compared to those who got Adcetris.

In addition, patients in the Opdivo arm of the Phase III trial reported reduced toxicities, according to lead investigator Alex Herrera, a hematologist-oncologist at City of Hope’s cancer cancer in Duarte, CA. Notably, the trial included more than 200 children across both arms. Generally, more than half of children with advanced Hodgkin lymphoma receive radiation therapy, but in this trial, dubbed SWOG S1826, only a handful of patients in the two arms received radiotherapy, sparing many children from long-term side effects of radiation.

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Full TIG­IT da­ta from Gilead, Ar­cus show low­er PFS rates than De­cem­ber read­out: #AS­CO23

CHICAGO — Gilead and Arcus unveiled a fuller snapshot of a Phase II study testing their experimental cancer immunotherapy combo that showed lower progression-free survival rates than its previous update, results that are likely to spark further debate over the closely-watched clinical trial.

Last December, the anti-TIGIT/anti-PD-L1 combo, positioned as a first-line treatment for non-small cell lung cancer, recorded data that drew mixed reactions. The latest analysis, presented Saturday afternoon at ASCO, included only a handful more patients than the previous update, but PFS rates fell — in one cohort by nearly three months.

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Servi­er’s vo­rasi­denib stalls pro­gres­sion of brain can­cer by 61% in piv­otal PhI­II IN­DI­GO study: #AS­CO23

An experimental pill from Servier Pharmaceuticals showed potentially practice-changing results in a narrow group of brain cancer patients, cutting the risk of their cancers progressing by 61%, according to a late-stage clinical trial.

The drug, vorasidenib, is a precision medicine that only works in certain people whose cancer carries mutations in one of two genes called IDH1/2. Doctors hope that the therapy will delay the need for chemotherapy or radiation, which are often used to combat relapses in patients who’ve previously undergone surgery to remove brain tumors.

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GSK pro­motes rou­tine im­mu­niza­tions for adults amid post-pan­dem­ic vac­cine back­slide

GSK launched a new initiative on Thursday and committed up to $1 million in grant funding to improve adult routine vaccination rates.

While the pandemic spotlight was trained on the race for novel Covid-19 vaccines, other routine vaccination rates plummeted, raising concerns that missed doses may put children and even some adults at risk of preventable diseases such as measles or shingles. The World Health Organization last year reported the largest drop in childhood vaccinations in roughly three decades.

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Tammie Denyse speaks up about Black women and breast cancer inequity in Gilead's first TikTok campaign. (Gilead Sciences)

Gilead joins Tik­Tok with on­col­o­gy aware­ness cam­paign fea­tur­ing di­verse group of can­cer ad­vo­cates

Gilead Sciences is taking over the opening page on TikTok for the next two weeks. A Gilead-sponsored video, featuring cancer advocates talking about equity and other issues, will show up as the landing page, called the “For You” page, for millions of TikTok watchers.

The cancer awareness campaign will begin on Monday and run for two weeks, a Gilead spokesperson told Endpoints News. The TikTok ad debut is timed around the ASCO medical conference, but the work is aimed more broadly at healthcare professionals, as well as people touched by cancer and people interested in advancing Black and general health equity.

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Stephen MacMillan, Hologic CEO (Photo by Riccardo Savi/Getty Images for Concordia Summit)

Il­lu­mi­na names Ho­log­ic CEO as new board mem­ber and chair

Illumina’s board appointed two new members, including Hologic CEO Stephen MacMillan as the non-executive chair, a move that followed a proxy fight that saw shareholders oust the company’s board chair.

The DNA sequencing company also appointed Scott Ullem, the CFO of Edwards Lifesciences, to the board, according to a company statement.

Illumina’s plans to add two new board members came as Carl Icahn waged a board proxy campaign culminating with shareholders electing his candidate, Andrew Teno, over board chair John Thompson. Illumina CEO Francis deSouza survived a threat to his board seat by securing more than twice the shareholder votes than his challenger. Another Illumina candidate, Robert Epstein, was also elected and remained on the board.

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Take­da ax­es gene ther­a­py deal with Po­sei­da Ther­a­peu­tics amid broad­er re­think

Less than two years after Takeda inked a collaboration with Poseida Therapeutics to develop six liver-directed and hematopoietic stem cell-directed in vivo gene therapies, Takeda will end the partnership on July 30, the company confirmed to Endpoints News.

The breakup is not unexpected, coming on the heels of Takeda’s April announcement that it planned to stop discovery and preclinical work in AAV gene therapy, as well as research and preclinical work on rare hematology. A representative for Takeda confirmed that the partnership ended because of the company’s decision to stop that work.

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