On July 14, 2025 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, reported that it has resubmitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for tabelecleucel (EBVALLO or tab-cel) indicated as monotherapy for treatment of adult and pediatric patients two years of age and older with Epstein-Barr virus positive post-transplant lymphoproliferative disease (EBV+ PTLD) who have received at least one prior therapy (Press release, Atara Biotherapeutics, JUL 14, 2025, View Source [SID1234654366]). There are no FDA approved therapies in this treatment setting.
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"The BLA resubmission for tab-cel represents the collaborative efforts with our partner, Pierre Fabre Laboratories, to address the third-party manufacturing facility observations outlined in the January 2025 Complete Response Letter," said Cokey Nguyen, President and Chief Executive Officer of Atara. "We look forward to continued engagement with the FDA throughout its review and with Pierre Fabre Laboratories as they actively prepare for the potential launch of this innovative therapy in the U.S."
Tab-cel is an allogeneic, EBV-specific T-cell immunotherapy designed to target and eliminate EBV-infected cells. The BLA is supported by pivotal and supportive data covering more than 430 patients treated with tab-cel across multiple life-threatening diseases, including the latest pivotal ALLELE study data that demonstrated a statistically significant 48.8% Objective Response Rate (ORR) (p<0.0001) and favorable safety profile consistent with previous analyses.
Tab-cel has been granted Breakthrough Therapy Designation for the treatment of rituximab-refractory EBV-associated lymphoproliferative disease by the U.S. FDA and has orphan drug designation for the treatment of Epstein-Barr virus-positive post-transplant lymphoproliferative disorders.
Corporate Updates
Tab-cel Transition Activities: The company is finalizing the transfer of the following clinical studies associated with tab-cel:
NCT03394365: Tabelecleucel for Solid Organ or Allogeneic Hematopoietic Cell Transplant Participants with Epstein-Barr Virus-Associated Post-Transplant Lymphoproliferative Disease (EBV+ PTLD) After Failure of Rituximab or Rituximab and Chemotherapy (ALLELE)
NCT04554914: A Study to Evaluate Tabelecleucel in Participants with Epstein-Barr Virus-associated Diseases. This study is a multicenter, multicohort, open-label, single-arm, Phase 2 study investigating the efficacy and safety of tabelecleucel for the treatment of EBV-associated diseases.
Upon completion substantially all operational activities and associated costs related to tab-cel will transfer to Pierre Fabre Laboratories.
The sponsorship of the BLA continues to be maintained by Atara.
Cash Runway and Future Tabelecleucel (Tab-cel) Milestone and Royalty Income: Atara projects that its cash, cash equivalents and short-term investments of approximately $22M as of June 30, 2025, combined with the cost reduction initiatives implemented in the first half of 2025, will enable funding of all currently planned operations, including one-time restructuring costs, into the first quarter of 2026, that Atara believes will be sufficient to fund the ongoing activities required to achieve potential BLA approval.
Additionally, under its commercialization agreement with Pierre Fabre Laboratories, Atara is eligible to receive a $40 million milestone payment upon FDA approval of the tab-cel BLA, as well as significant double-digit tiered royalties as a percentage of net sales, and milestones related to commercial sales of EBVALLO.
The estimate of our cash, cash equivalents and short-term investments as of June 30, 2025, is preliminary, has not been audited and it is subject to change upon completion of our financial statement closure procedures. Our independent registered public accounting firm has not audited or completed any procedures with respect to this estimate. Such estimates are based on assumptions and plans that are subject to change and such changes could materially impact our expected cash runway. These assumptions include the completion of specific development and regulatory activities by us and actions taken by third parties, and are, therefore, uncertain at this time. Any delay in these activities will create additional expenses and cash needs for us.
We have not yet completed our quarter-end financial close process for the quarter ended June 30, 2025. This estimate of our cash, cash equivalents and short-term investments as of June 30, 2025, is preliminary and is subject to change upon completion of our financial statement closing procedures. Additional information and disclosure would be required for a more complete understanding of our financial position and results of operations as of and for the quarter ended June 30, 2025.