Perre Fabre Pharmaceuticals, Inc. Announces Transfer of Investigational New Drug Application for Tabelecleucel from Atara Biotherapeutics, Inc.
MWN-AI** Summary
Pierre Fabre Pharmaceuticals, Inc. has officially taken over the Investigational New Drug (IND) application for tabelecleucel from Atara Biotherapeutics, marking a pivotal moment in the development of this innovative therapy. The IND transfer consolidates global responsibility for all clinical trial activities regarding tabelecleucel, a cutting-edge allogeneic Epstein-Barr virus (EBV)-specific cytotoxic T cell therapy aimed at treating EBV-associated post-transplant lymphoproliferative disease (EBV+ PTLD), which can occur following organ or hematopoietic cell transplantation.
Active enrollment is ongoing for two significant studies: the Phase 3 ALLELE Study, investigating tabelecleucel in patients who have not responded to standard treatments, and a complementary Phase 2 study exploring its efficacy in other EBV-associated diseases. The shift in oversight from Atara to Pierre Fabre underscores the companies' collaborative effort, particularly as Atara recently resubmitted its Biologics License Application (BLA) to the U.S. FDA, having promptly addressed previous manufacturing concerns.
Tabelecleucel has already gained traction in Europe, receiving marketing authorization under the brand name EBVALLO® in December 2022 for patients who have undergone prior therapy. Moreover, a new global partnership was established between Atara and Pierre Fabre, expanding commercial rights for tabelecleucel across the U.S. and other markets.
Pierre Fabre’s commitment to pioneering therapies in oncology and rare diseases is evident through its extensive patient-centric approach, innovative research pipeline, and dedication to addressing significant unmet medical needs. This strategic transition enhances their capabilities to advance tabelecleucel’s development and ensure access to this vital therapy for affected patient populations.
MWN-AI** Analysis
The recent announcement regarding the transfer of the Investigational New Drug (IND) application for tabelecleucel from Atara Biotherapeutics to Pierre Fabre Pharmaceuticals presents a compelling opportunity for investors focused on biotech and pharmaceutical sectors. Tabelecleucel is an innovative allogeneic EBV-specific T-cell therapy, targeting an ultra-rare but significant market, particularly for patients with EBV+ post-transplant lymphoproliferative disease (EBV+ PTLD) who have failed standard treatment options.
As Pierre Fabre assumes complete control over the clinical development and manufacturing of tabelecleucel, this transition could streamline operations and enhance efficiency in clinical trials. Importantly, Pierre Fabre's ongoing enrollment in pivotal studies like the ALLELE study (NCT03394365) underscores their commitment to navigating the regulatory landscape actively, which may expedite potential market entry for tabelecleucel in the U.S. The recent resubmission of the Biologics License Application (BLA) by Atara, which indicates responsiveness to FDA concerns, also creates optimism regarding a favorable regulatory outcome.
The partnership between Pierre Fabre and Atara enhances both companies’ market positions, particularly given that tabelecleucel already has marketing authorization in Europe under the brand name EBVALLO®. With a substantial unmet need among patients with EBV+ PTLD, analysts foresee a robust demand for tabelecleucel if it obtains FDA approval.
Investors should keep a close eye on upcoming developments, particularly results from ongoing clinical trials and regulatory decisions, as successful outcomes could drive significant stock appreciation. Given Pierre Fabre’s innovative focus and strategic partnerships, this company appears well-positioned for growth, making it an appealing candidate for investment in the biotechnology sector.
**MWN-AI Summary and Analysis is based on asking OpenAI to summarize and analyze this news release.
PR Newswire
Pierre Fabre Laboratories is now responsible for all global clinical trial activities for the tabelecleucel clinical program
Enrollment is ongoing for pivotal, Phase 3 ALLELE Study (NCT03394365) investigating tabelecleucel in patients with EBV+PTLD in Solid Organ Transplant and Allogeneic Hematopoietic Cell Transplant after failure of standard therapy
NCT04554914 also open for enrollment to patients with EBV-associated diseases
Atara Biotherapeutics resubmitted the tabelecleucel Biologics License Application (BLA) to the U.S. Food and Drug Administration on July 11
SECAUCUS, N.J. , July 15, 2025 /PRNewswire/ -- Pierre Fabre Pharmaceuticals, Inc. today announced the transfer of the Investigational New Drug Application for tabelecleucel from its partner, Atara Biotherapeutics, Inc. (Nasdaq: ATRA). "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."
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.
About Pierre Fabre Pharmaceuticals (PFP) and Pierre Fabre Laboratories
The mission of PFP is to deliver breakthrough therapies in oncology and rare diseases to patient populations with high unmet needs and limited treatment options. Our belief is that every time we care for a single person, we make the whole world better.
PFP is the US pharmaceutical subsidiary of Pierre Fabre Laboratories, a foundation-owned company with seven decades of impact. Pierre Fabre Laboratories is a global healthcare company, established in 43 countries, with over 10,000 employees, and with products distributed in 120 territories across the globe.
The Pierre Fabre Laboratories foundation ownership enhances the ability of the company to create long-term value for patients. Partnerships and acquisitions drive its innovative precision treatment pipeline and are enabled by the unique corporate structure.
Building on the legacy of Pierre Fabre Laboratories, innovation is the life blood of PFP, and patient experience drives everything the company does. PFP aspires to design and develop therapeutic solutions inspired by patients and healthcare professionals; draw on science and nature as perpetual sources of inspiration; develop long-term partnerships with researchers and innovators worldwide; and place pharmaceutical ethics and climate transition at the heart of our action.
PFP has therapies in development for Epstein-Barr virus positive post-transplant lymphoproliferative disease (EBV+ PTLD), NRAS-mutant melanoma, non-small cell lung cancer with mutation or amplification of MET, and X-Linked Hypohidrotic Ectodermal Dysplasia (XLHED). PFP is headquartered in Secaucus, NJ .
For more information, visit www.pierrefabrepharmaceuticals.com , www.pierre-fabre.com , @Pierre Fabre Oncology .
SOURCE Pierre Fabre Pharmaceuticals
FAQ**
How does the transfer of the Investigational New Drug Application for tabelecleucel from Atara Biotherapeutics Inc. ATRA to Pierre Fabre Pharmaceuticals impact the strategic direction of both companies in the oncology sector?
What are the expected timelines for the pivotal Phase 3 ALLELE Study, and how might the ongoing enrollment affect the market perception of Atara Biotherapeutics Inc. ATRA and Pierre Fabre Pharmaceuticals?
What key factors contributed to Pierre Fabre Pharmaceuticals' assumption of global clinical trial and manufacturing responsibilities for tabelecleucel from Atara Biotherapeutics Inc. ATRA, and how do these enhance their competitive positioning?
With the recent partnership expansion between Pierre Fabre Pharmaceuticals and Atara Biotherapeutics Inc. ATRA, what regulatory hurdles remain for the tabelecleucel Biologics License Application, and how could this impact future clinical development?
**MWN-AI FAQ is based on asking OpenAI questions about Atara Biotherapeutics Inc. (NASDAQ: ATRA).
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