Perre Fabre Pharmaceuticals, Inc. Announces Transfer of Investigational New Drug Application for Tabelecleucel from Atara Biotherapeutics, Inc.
Pierre Fabre Pharmaceuticals has taken over the Investigational New Drug (IND) Application for tabelecleucel from Atara Biotherapeutics (NASDAQ: ATRA). This transfer follows Atara's July 11 resubmission of the Biologics License Application (BLA) to the FDA, addressing manufacturing facility observations from January 2025's Complete Response Letter.
Pierre Fabre now manages all global clinical trial activities for tabelecleucel, including the pivotal Phase 3 ALLELE study and another trial for EBV-associated diseases. The company assumed global manufacturing responsibilities on March 31, including commercial supply for European markets where the therapy is already approved as EBVALLO庐.
Tabelecleucel is an allogeneic, off-the-shelf, EBV-specific T-cell immunotherapy designed to target EBV-infected cells, approved in Europe since December 2022 for treating EBV+ PTLD in patients who have received prior therapy.
Pierre Fabre Pharmaceuticals ha assunto la responsabilit脿 della Domanda di Nuovo Farmaco Sperimentale (IND) per tabelecleucel da Atara Biotherapeutics (NASDAQ: ATRA). Questo trasferimento segue la nuova presentazione, avvenuta l'11 luglio, della Domanda di Autorizzazione Biologica (BLA) alla FDA da parte di Atara, che ha risposto alle osservazioni riguardanti lo stabilimento produttivo contenute nella Lettera di Risposta Completa di gennaio 2025.
Pierre Fabre gestisce ora tutte le attivit脿 cliniche globali relative a tabelecleucel, inclusi lo studio cruciale di Fase 3 ALLELE e un altro trial per malattie associate al virus EBV. L'azienda ha assunto anche la responsabilit脿 globale della produzione dal 31 marzo, compresa la fornitura commerciale per i mercati europei dove la terapia 猫 gi脿 approvata con il nome EBVALLO庐.
Tabelecleucel 猫 un'immunoterapia allogenica, pronta all'uso, specifica per le cellule T contro EBV, progettata per colpire le cellule infettate dal virus EBV, approvata in Europa da dicembre 2022 per il trattamento della PTLD EBV+ in pazienti che hanno gi脿 ricevuto terapie precedenti.
Pierre Fabre Pharmaceuticals ha asumido la solicitud de Nuevo F谩rmaco en Investigaci贸n (IND) para tabelecleucel de Atara Biotherapeutics (NASDAQ: ATRA). Esta transferencia sigue a la re-presentaci贸n del 11 de julio de la Solicitud de Licencia Biol贸gica (BLA) a la FDA por parte de Atara, abordando las observaciones sobre la planta de fabricaci贸n indicadas en la Carta de Respuesta Completa de enero de 2025.
Pierre Fabre ahora gestiona todas las actividades de ensayos cl铆nicos globales para tabelecleucel, incluyendo el estudio pivotal de Fase 3 ALLELE y otro ensayo para enfermedades asociadas al EBV. La compa帽铆a asumi贸 las responsabilidades globales de fabricaci贸n el 31 de marzo, incluyendo el suministro comercial para los mercados europeos donde la terapia ya est谩 aprobada bajo el nombre EBVALLO庐.
Tabelecleucel es una inmunoterapia al贸gena, lista para usar, espec铆fica para c茅lulas T contra EBV, dise帽ada para atacar las c茅lulas infectadas por EBV, aprobada en Europa desde diciembre de 2022 para tratar la PTLD EBV+ en pacientes que han recibido tratamiento previo.
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Tabelecleucel鞚� EBV 臧愳椉 靹疙彫毳� 響滌爜鞙茧 頃橂姅 霃欖, 歃夓嫓 靷毄 臧赌電ロ暅 EBV 韸轨澊 T靹疙彫 氅挫棴旃橂鞝�搿�, 2022雲� 12鞗旊秬韯� 鞙犽熃鞐愳劀 鞚挫爠 旃橂毳� 氚涭潃 EBV 鞏戩劚 PTLD 頇橃瀽 旃橂鞖╈溂搿� 鞀轨澑霅橃棃鞀惦媹雼�.
Pierre Fabre Pharmaceuticals a repris la demande d鈥橧nvestigational New Drug (IND) pour tabelecleucel aupr猫s de Atara Biotherapeutics (NASDAQ : ATRA). Ce transfert fait suite 脿 la nouvelle soumission par Atara, le 11 juillet, de la Biologics License Application (BLA) 脿 la FDA, r茅pondant aux observations concernant les installations de fabrication mentionn茅es dans la lettre de r茅ponse compl猫te de janvier 2025.
Pierre Fabre g猫re d茅sormais toutes les activit茅s cliniques mondiales li茅es 脿 tabelecleucel, y compris l鈥櫭﹖ude pivot de phase 3 ALLELE ainsi qu鈥檜n autre essai pour des maladies associ茅es au virus EBV. La soci茅t茅 a pris en charge la fabrication mondiale depuis le 31 mars, incluant l鈥檃pprovisionnement commercial pour les march茅s europ茅ens o霉 la th茅rapie est d茅j脿 approuv茅e sous le nom EBVALLO庐.
Tabelecleucel est une immunoth茅rapie allog茅nique, pr锚te 脿 l鈥檈mploi, sp茅cifique des lymphocytes T contre EBV, con莽ue pour cibler les cellules infect茅es par EBV, approuv茅e en Europe depuis d茅cembre 2022 pour le traitement de la PTLD EBV+ chez des patients ayant d茅j脿 re莽u un traitement pr茅alable.
Pierre Fabre Pharmaceuticals hat die Investigational New Drug (IND)-Anmeldung f眉r tabelecleucel von Atara Biotherapeutics (NASDAQ: ATRA) 眉bernommen. Diese 脺bertragung erfolgte nach Ataras erneuter Einreichung des Biologics License Application (BLA) bei der FDA am 11. Juli, mit der die Anmerkungen zur Produktionsst盲tte aus dem Complete Response Letter vom Januar 2025 adressiert wurden.
Pierre Fabre verantwortet nun alle globalen klinischen Studienaktivit盲ten f眉r tabelecleucel, einschlie脽lich der entscheidenden Phase-3-ALLELE-Studie und einer weiteren Studie zu EBV-assoziierten Erkrankungen. Das Unternehmen 眉bernahm am 31. M盲rz auch die globale Produktionsverantwortung, einschlie脽lich der kommerziellen Versorgung f眉r europ盲ische M盲rkte, wo die Therapie bereits unter dem Namen EBVALLO庐 zugelassen ist.
Tabelecleucel ist eine allogene, sofort verf眉gbare, EBV-spezifische T-Zell-Immuntherapie, die darauf abzielt, EBV-infizierte Zellen zu bek盲mpfen, und seit Dezember 2022 in Europa zur Behandlung von EBV+ PTLD bei Patienten mit vorheriger Therapie zugelassen ist.
- Transfer consolidates global development and manufacturing under Pierre Fabre, potentially streamlining operations
- Tabelecleucel already has European approval as EBVALLO庐
- BLA resubmission completed, addressing previous manufacturing concerns
- Expanded global partnership between Atara and Pierre Fabre covers major commercial markets
- Previous Complete Response Letter from FDA indicates regulatory challenges
- Manufacturing facility observations required addressing before BLA resubmission
Insights
Atara's transfer of tabelecleucel IND to Pierre Fabre represents strategic outsourcing while maintaining BLA resubmission momentum.
This announcement reveals a significant operational milestone in the Atara-Pierre Fabre partnership for tabelecleucel, an allogeneic EBV-specific T-cell therapy. After Pierre Fabre assumed manufacturing responsibilities in March, they've now taken over the IND application and global clinical trial management, completing a comprehensive transfer of development activities. Critically, Atara has simultaneously resubmitted its BLA to the FDA (July 11), having addressed third-party manufacturing facility observations from the January Complete Response Letter.
The timing here is strategically significant. Atara maintains momentum on the regulatory front by resubmitting the BLA before transferring the IND, suggesting a coordinated approach to ensure no disruption in the approval pathway. This structured handoff allows Atara to focus on regulatory interactions while Pierre Fabre handles resource-intensive manufacturing and clinical operations.
For ATRA investors, this represents a positive operational efficiency strategy. The company has effectively outsourced capital-intensive aspects of bringing tabelecleucel to market while presumably maintaining economic interest through their partnership agreement. With tabelecleucel already approved in Europe as EBVALLO庐, this arrangement enables Atara to potentially realize value from their asset without bearing the full financial burden of commercialization.
The continued enrollment in both the pivotal ALLELE study and the Phase 2 EBV-associated diseases trial indicates Pierre Fabre's commitment to expanding tabelecleucel's potential market opportunities beyond its current European approval for r/r EBV+ PTLD. This handoff appears to represent a well-coordinated strategic realignment rather than a distress sale, reinforcing the value proposition of tabelecleucel while streamlining operational responsibilities.
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
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:
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.
:听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庐 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
About EBV+PTLD听
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
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FAQ
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