On July 15, 2025 Pierre Fabre Pharmaceuticals, Inc. reported the transfer of the Investigational New Drug Application for tabelecleucel from its partner, Atara Biotherapeutics, Inc. (Nasdaq: ATRA) (Press release, Pierre Fabre, JUL 15, 2025, View Source [SID1234654391]). "This announcement marks an important milestone as Pierre Fabre Laboratories assumes global responsibility for clinical development of tabelecleucel following transfer of manufacturing responsibilities earlier in the year," said Adriana Herrera, Chief Executive Officer of Pierre Fabre Pharmaceuticals., the Pierre Fabre Laboratories pharmaceutical subsidiary in the United States. "Ongoing recruitment into the ALLELE study demonstrates our commitment to clinical research and development as we await regulatory action on the BLA resubmitted by our partner Atara."
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Atara Biotherapeutics resubmitted the tabelecleucel BLA on July 11, having rapidly addressed the third-party manufacturing facility observations outlined in the January 2025 Complete Response Letter in collaboration with Pierre Fabre Pharmaceuticals (PFP). On March 31, PFP assumed global responsibility for tabelecleucel manufacturing, including commercial product supply for European markets where the innovative cell therapy is already approved, as well as for global clinical trial supply. On July 14, 2025, Atara Biotherapeutics transferred the tabelecleucel IND to Pierre Fabre Medicament, a subsidiary of Pierre Fabre Laboratories.
The two studies currently open for tabelecleucel access in the US are:
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)
The ALLELE study is investigating the effects of tabelecleucel, an off-the-shelf allogeneic Epstein-Barr virus (EBV)-specific cytotoxic T cell therapy, to treat relapsed/refractory EBV-associated post-transplant lymphoproliferative disease arising after SOT or HCT.
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.
Tabelecleucel is an allogeneic, off-the-shelf, EBV-specific T-cell immunotherapy designed to selectively target and eliminate EBV-infected cells. Unlike autologous CAR-T therapies, allogeneic T-cells are derived from third party donors and are not genetically modified. Immune cells are collected from the blood of healthy donors and exposed to Epstein-Barr virus antigens to help enrich for T cells that recognize EBV. These EBV T cells are expanded, characterized, kept alive and stored for future use to treat patients.
Tabelecleucel was granted marketing authorization under the brand name EBVALLO in December 2022 by the European Commission (EC) as a monotherapy for the treatment of adult and pediatric patients two years of age and older with r/r EBV+ PTLD who have received at least one prior therapy.
In December 2023, Atara announced an expanded global partnership with Pierre Fabre Laboratories for the U.S. and remaining global commercial markets for tabelecleucel, building on an initial partnership covering Europe, Middle East, Africa, and other select emerging markets.
About EBV+PTLD
EBV+ PTLD is an ultra-rare, acute, and potentially deadly hematologic malignancy that occurs after transplantation when patent T-cell immune responses are compromised by immunosuppression. It can impact patients who have undergone solid organ transplant (SOT) or allogeneic HCT. Poor median survival of 3 weeks and 4.1 months for HCT and SOT, respectively, is reported in EBV+ PTLD patents for whom standard of care failed, underscoring the significant need for new therapeutic options.