Pierre Fabre Pharmaceuticals Takes Charge of Tabelecleucel Clinical Program
Pierre Fabre Pharmaceuticals, Inc. has made a significant move in the world of oncology by announcing the transfer of the Investigational New Drug Application (IND) for tabelecleucel from Atara Biotherapeutics, Inc. This transition marks an important milestone as Pierre Fabre begins to manage all global clinical trial activities for the tabelecleucel program, which is primarily aimed at treating Epstein-Barr virus-associated post-transplant lymphoproliferative disease (EBV+PTLD).
Overview of Tabelecleucel
Tabelecleucel is an allogeneic, off-the-shelf immunotherapy designed to target and eliminate EBV-infected cells. Unlike traditional CAR-T therapies that are customized from a patient's own cells, tabelecleucel uses T-cells from healthy donors, which are expanded and activated against EBV antigens. This innovative approach provides a new avenue for treating patients whose standard therapies have failed.
Currently, enrollment is ongoing for the pivotal Phase 3 ALLELE study (NCT03394365), which focuses on individuals with EBV+PTLD after solid organ transplants and hematopoietic cell transplants. The urgency of this study stems from the dire need for effective treatment options for individuals afflicted by this rare hematologic malignancy, which can present after organ transplants when patients are typically immunosuppressed.
Why the Transition Matters
Adriana Herrera, the Chief Executive Officer of Pierre Fabre Pharmaceuticals, emphasized the company's commitment to advancing the clinical research of tabelecleucel. By assuming control of the clinical development, Pierre Fabre not only boosts its operational capabilities but also enhances its potential to deliver critical therapies to populations with significant unmet medical needs.
Earlier this year, Pierre Fabre also took over manufacturing responsibilities for tabelecleucel. This consolidation of operations underlines the company's comprehensive strategy to produce and manage the therapy from development through to global distribution.
On July 11, Atara Biotherapeutics completed a resubmission of the tabelecleucel Biologics License Application (BLA) to the U.S. Food and Drug Administration, responding to feedback received in a prior Complete Response Letter. Pierre Fabre's rapid and strategic actions in collaboration with Atara showcase a partnership focused on ensuring the therapeutic delivery of this life-saving treatment.
Open Trials for Tabelecleucel
Two significant studies are currently recruiting patients in the United States:
1.
NCT03394365 - This study focuses on solid organ transplant recipients or those who have had allogeneic hematopoietic cell transplants experiencing EBV-associated post-transplant lymphoproliferative disease (PTLD) after standard treatments have failed.
2.
NCT04554914 - A Phase 2 study that evaluates the efficacy and safety of tabelecleucel for patients with various EBV-associated diseases, in an open-label, multicenter format.
In addition to these studies, tabelecleucel received marketing authorization in December 2022 under the brand name EBVALLO® by the European Commission, reflecting its potential across different markets.
The Impact of EBV+PTLD
EBV+ PTLD is a rare but serious complication that can arise after transplant procedures, characterized by compromised immune responses. The reported median survival following the failure of standard treatments is alarmingly low, ranging only from weeks to months, which underscores the need for innovative therapeutic approaches like tabelecleucel.
Looking Ahead
Pierre Fabre Pharmaceuticals is committed to exploring pioneering therapies for patients battling challenging oncological conditions. With its deep-rooted heritage of more than seven decades in healthcare, the company aims to develop breakthrough solutions fueled by scientific advancements and patient-centric insights. As they continue their work with tabelecleucel, Pierre Fabre reinforces its mission to improve outcomes for patients and delivers hope to those battling rare diseases.
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