Atara Biotherapeutics Announces Plans to Submit Tab-cel BLA in Q2 2024 Following FDA Agreement on Comparability

Atara Biotherapeutics, Inc. (Nasdaq: ATRA), a leader in T-cell immunotherapy, leveraging its novel allogeneic Epstein-Barr virus (EBV) T-cell platform to develop transformative therapies for patients with cancer and autoimmune diseases, today reported important progress related to the regulatory pathway for tabelecleucel (tab-cel) in the U.S.

Following productive discussions between Atara and the U.S. Food and Drug Administration (FDA), the FDA and Atara are now aligned on analytical comparability between manufacturing process versions. This alignment supports Atara's ability to pool the pivotal clinical trial data from different process versions in the Biologics License Application (BLA) submission.

Atara expects to submit the tab-cel BLA in Q2 2024, which will enable Atara to incorporate the latest tab-cel pivotal trial data from the ALLELE study into the BLA filing package.

“We are pleased with the FDA’s positive assessment and conclusion of comparability, and we look forward to progressing to the next stage of preparing our BLA submission for tab-cel,” said Pascal Touchon, President and Chief Executive Officer of Atara. “Following this clarity, we can also continue to advance our U.S. partnership discussions with several parties, selecting the best possible partner to bring this potentially life-saving treatment to patients.”

Tabelecleucel is an allogeneic, EBV-specific T-cell immunotherapy which targets and eliminates EBV-infected cells in an HLA-restricted manner. Epstein-Barr virus-positive post-transplant lymphoproliferative disease (EBV+ PTLD) is a rare, acute, and potentially deadly hematologic malignancy that occurs after transplantation when patient T-cell immune responses are compromised by immunosuppression. It can impact patients who have undergone solid organ transplant (SOT) or allogeneic hematopoietic cell transplant (HCT). Poor median survival of 0.7 months and 4.1 months for HCT and SOT, respectively, is reported in EBV+ PTLD patients for whom standard of care failed, underscoring the significant need for new therapeutic options.

Tabelecleucel is commercialized by Pierre Fabre in Europe as EBVALLO following European Commission marketing authorization in December 2022. In Europe, EBVALLO is indicated as a monotherapy for the treatment of adult and pediatric patients two years of age and older with relapsed or refractory EBV+ PTLD who have received at least one prior therapy. For solid organ transplant patients, prior therapy includes chemotherapy, unless chemotherapy is inappropriate.