Atara Biotherapeutics Provides Update on Clinical Programs Related to EBVALLO™ (tabelecleucel) and ATA3219
Atara Biotherapeutics (ATRA) announced that the FDA has placed a clinical hold on its active Investigational New Drug (IND) applications for EBVALLO™ (tabelecleucel) and ATA3219 programs. The hold affects EBVALLO's treatment for EBV+ PTLD and ATA3219's therapy for non-Hodgkin's lymphoma and systemic lupus erythematosus.
The clinical hold stems from unresolved GMP compliance issues at a third-party manufacturing facility, which were previously identified in a Complete Response Letter (CRL) on January 16, 2025. While current participants showing potential clinical benefits may continue treatment, new enrollment has been paused.
The issues specifically affect one third-party facility and do not impact Atara's second manufacturer, FUJIFILM Diosynth Biotechnologies facility. Atara and FDA have agreed on necessary actions to release the holds, with FDA committing to work collaboratively for resolution.
Atara Biotherapeutics (ATRA) ha annunciato che la FDA ha imposto un fermo clinico sulle sue attive richieste di Nuovo Farmaco Investigativo (IND) per i programmi EBVALLO™ (tabelecleucel) e ATA3219. Il fermo colpisce il trattamento di EBVALLO per PTLD positivo per EBV e la terapia di ATA3219 per il linfoma non Hodgkin e il lupus eritematoso sistemico.
Il fermo clinico deriva da problemi di conformità GMP irrisolti presso un impianto di produzione di terzi, precedentemente identificati in una Lettera di Risposta Completa (CRL) del 16 gennaio 2025. Sebbene i partecipanti attuali che mostrano potenziali benefici clinici possano continuare il trattamento, le nuove registrazioni sono state sospese.
I problemi riguardano specificamente un impianto di terzi e non influenzano il secondo produttore di Atara, il FUJIFILM Diosynth Biotechnologies. Atara e la FDA hanno concordato le azioni necessarie per revocare i fermi, con la FDA che si impegna a lavorare collaborativamente per la risoluzione.
Atara Biotherapeutics (ATRA) anunció que la FDA ha impuesto una suspensión clínica en sus solicitudes activas de Nuevo Medicamento en Investigación (IND) para los programas EBVALLO™ (tabelecleucel) y ATA3219. La suspensión afecta el tratamiento de EBVALLO para PTLD positivo para EBV y la terapia de ATA3219 para linfoma no Hodgkin y lupus eritematoso sistémico.
La suspensión clínica se origina en problemas de cumplimiento de GMP no resueltos en una instalación de fabricación de terceros, que fueron identificados previamente en una Carta de Respuesta Completa (CRL) el 16 de enero de 2025. Mientras que los participantes actuales que muestran beneficios clínicos potenciales pueden continuar el tratamiento, la nueva inscripción ha sido pausada.
Los problemas afectan específicamente a una instalación de terceros y no impactan al segundo fabricante de Atara, la instalación de FUJIFILM Diosynth Biotechnologies. Atara y la FDA han acordado las acciones necesarias para liberar las suspensiones, comprometiéndose la FDA a trabajar de manera colaborativa para la resolución.
아타라 바이오테라퓨틱스 (ATRA)는 FDA가 EBVALLO™ (타벨클루셀) 및 ATA3219 프로그램에 대한 기존의 임상시험신청서 (IND)에 임시 중단을 발효했다고 발표했습니다. 이 부정적 결과는 EBV+ PTLD에 대한 EBVALLO의 치료와 비호지킨 림프종 및 전신 홍반성 루푸스에 대한 ATA3219의 치료에 영향을 미칩니다.
임상 중단은 제3자 제조 시설에서 해결되지 않은 GMP 준수 문제로 인해 발생했으며, 이는 2025년 1월 16일에 발송된 완전응답서 (CRL)에서 이전에 확인되었습니다. 현재 잠재적인 임상 혜택을 보여주는 참가자는 치료를 계속할 수 있지만, 새로운 등록은 일시 중지되었습니다.
문제는 특정 제3자 시설에만 영향을 미치며, 아타라의 두 번째 제조업체인 FUJIFILM Diosynth Biotechnologies 시설에는 영향을 미치지 않습니다. 아타라와 FDA는 조치를 취하여 중단을 해제하는 데 합의했으며, FDA는 해결을 위해 협력적으로 작업하겠다고 약속했습니다.
Atara Biotherapeutics (ATRA) a annoncé que la FDA a imposé un arrêt clinique sur ses demandes d'Autorisation de Mise sur le Marché (IND) actives pour les programmes EBVALLO™ (tabelecleucel) et ATA3219. Cet arrêt affecte le traitement d'EBVALLO pour PTLD positif à l'EBV et la thérapie d'ATA3219 pour le lymphome non Hodgkinien et le lupus érythémateux systémique.
L'arrêt clinique provient de problèmes de conformité GMP non résolus dans une installation de fabrication tierce, précédemment identifiés dans une lettre de réponse complète (CRL) le 16 janvier 2025. Bien que les participants actuels montrant des bénéfices cliniques potentiels puissent continuer leur traitement, les nouvelles inscriptions ont été suspendues.
Les problèmes concernent spécifiquement une installation tierce et n'affectent pas le deuxième fabricant d'Atara, FUJIFILM Diosynth Biotechnologies. Atara et la FDA ont convenu des actions nécessaires pour lever les arrêts, la FDA s'engageant à travailler en collaboration pour la résolution.
Atara Biotherapeutics (ATRA) gab bekannt, dass die FDA eine klinische Suspendierung für ihre aktiven Anträge auf Arzneimittelzulassung (IND) für die Programme EBVALLO™ (tabelecleucel) und ATA3219 verhängt hat. Die Suspendierung betrifft die Behandlung von EBVALLO bei EBV+ PTLD sowie die Therapie von ATA3219 bei Non-Hodgkin-Lymphom und systemischem Lupus erythematodes.
Der klinische Halt ergibt sich aus ungelösten GMP-Konformitätsproblemen in einer externen Produktionsstätte, die zuvor in einem vollständigen Antwortschreiben (CRL) vom 16. Januar 2025 identifiziert wurden. Während derzeitige Teilnehmer, die potenzielle klinische Vorteile zeigen, die Behandlung fortsetzen können, wurde die Neueintragung ausgesetzt.
Die Probleme betreffen spezifisch eine externe Anlage und beeinflussen nicht Ataras zweiten Hersteller, die FUJIFILM Diosynth Biotechnologies. Atara und die FDA haben die notwendigen Maßnahmen vereinbart, um die Aussetzungen aufzuheben, wobei die FDA sich verpflichtet hat, zusammenzuarbeiten, um eine Lösung zu finden.
- Current patients showing benefits can continue treatment
- Second manufacturing facility (FUJIFILM) remains unaffected and compliant
- FDA has committed to work collaboratively for quick resolution
- Clinical hold placed on both EBVALLO and ATA3219 programs
- New patient enrollment and screening suspended
- Manufacturing compliance issues at third-party facility affecting both products
- Development timeline delays expected due to clinical holds
Insights
The FDA's clinical hold on EBVALLO and ATA3219 represents a severe regulatory setback for Atara Biotherapeutics, directly stemming from GMP compliance issues at a third-party manufacturing facility. This development compounds the negative impact of the recent Complete Response Letter (CRL) for EBVALLO.
The implications are particularly concerning because the hold affects two key pipeline assets: EBVALLO for EBV+ PTLD treatment and ATA3219 for non-Hodgkin's lymphoma and lupus. While existing patients may continue treatment, the pause in new enrollment will delay clinical development timelines and potentially impact future commercialization prospects.
The silver lining is that these issues are specific to one third-party facility and don't affect their FUJIFILM Diosynth Biotechnologies partnership. However, resolving GMP compliance issues typically requires extensive remediation efforts and regulatory reinspection, which could take 6-12 months. For a company with Atara's market cap, this delay could strain financial resources and potentially necessitate additional capital raising.
The GMP compliance issues triggering this clinical hold highlight critical vulnerabilities in Atara's manufacturing strategy. The impact extends beyond EBVALLO to ATA3219 due to shared starting materials, demonstrating how upstream quality issues can cascade through multiple product lines.
What's particularly concerning is that these issues were significant enough to prompt both a CRL and clinical hold, suggesting systematic quality control deficiencies at the third-party facility. The fact that ATA3219's final manufacturing occurs at a compliant facility doesn't mitigate the fundamental problems with starting materials.
To simplify: Think of it like a recipe - even if you're cooking in a clean kitchen (compliant facility), using contaminated ingredients (starting materials) compromises the entire dish. The FDA's stance reflects their zero-tolerance approach to GMP violations in cell therapy manufacturing, where quality directly impacts patient safety.
The clinical hold for EBVALLO is directly linked to inadequately addressed GMP compliance issues identified during the pre-license inspection of the third-party manufacturing facility referenced in the Complete Response Letter (CRL) for EBVALLO that was announced on January 16, 2025. While ATA3219 drug product is manufactured at a separate, fully compliant GMP-certified facility, the starting materials used in its production are affected by the compliance issues at the same third-party facility referenced in the CRL. These issues, which underlie both the CRL and the clinical hold, are specific to the referenced third-party manufacturing facility and do not affect Atara’s second third-party manufacturer, FUJIFILM Diosynth Biotechnologies (FDB) facility in
Atara and FDA have discussed and agreed upon the actions necessary to release the clinical holds. The FDA has confirmed its commitment to working collaboratively and expeditiously with Atara to resolve the clinical holds.
“We intend to work closely with the FDA to address these issues as expeditiously as possible,” said Cokey Nguyen, Ph.D., President and Chief Executive Officer of Atara. “We are encouraged with ongoing correspondence with the Agency and a potential path to submitting the necessary data to release the clinical hold. Patient safety remains our priority and maintaining the highest standards for our programs.”
About Atara Biotherapeutics, Inc.
Atara is harnessing the natural power of the immune system to develop off-the-shelf cell therapies for difficult-to-treat cancers and autoimmune conditions that can be rapidly delivered to patients from inventory. With cutting-edge science and differentiated approach, Atara is the first company in the world to receive regulatory approval of an allogeneic T-cell immunotherapy. Our advanced and versatile T-cell platform does not require T-cell receptor or HLA gene editing and forms the basis of a diverse portfolio of investigational therapies that target EBV, the root cause of certain diseases, in addition to next-generation AlloCAR-Ts designed for best-in-class opportunities across a broad range of hematological malignancies and B-cell driven autoimmune diseases. Atara is headquartered in
Forward-Looking Statements
This press release contains or may imply "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. For example, forward-looking statements include statements regarding: (1) the development, timing and progress of tab-cel, including the BLA and potential indications, the timing for FDA review of any resubmission of the BLA, the potential characteristics and benefits of tab-cel, the tab-cel clinical trials; (2) the development, timing and progress of Atara’s AlloCAR-T programs (including ATA3219 and ATA3431), including the clinical trials; and (3) Atara’s ability to address the FDA’s concerns and to complete the activities necessary to release the clinical hold. Because such statements deal with future events and are based on Atara’s current expectations, they are subject to various risks and uncertainties and actual results, performance or achievements of Atara could differ materially from those described in or implied by the statements in this press release. These forward-looking statements are subject to risks and uncertainties, including, without limitation, risks and uncertainties associated with the costly and time-consuming pharmaceutical product development process and the uncertainty of clinical success; risks related to FDA feedback and the ability of Atara and its third-party manufacturer to address the issues identified in the CRL and the clinical hold; our ability to access capital; the sufficiency of Atara’s cash resources and need for and ability to obtain additional capital on favorable terms or at all; risks and uncertainties related to Atara’s financial close and audit procedures; the timing of the strategic review process; whether Atara will pursue any strategic alternatives; in the event Atara pursues a strategic alternative, that the strategic alternative may not be attractive or ultimately consummated; whether any strategic alternative will result in additional value for Atara and its shareholders; whether the process will have an adverse impact on Atara; and other risks and uncertainties affecting Atara’s and its development programs, including those discussed in Atara’s filings with the Securities and Exchange Commission , including in the “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” sections of the Company’s most recently filed periodic reports on Form 10-K and Form 10-Q and subsequent filings and in the documents incorporated by reference therein. Except as otherwise required by law, Atara disclaims any intention or obligation to update or revise any forward-looking statements, which speak only as of the date hereof, whether as a result of new information, future events or circumstances or otherwise.
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Investor and Media Relations
Jason Awe, Ph.D.
Head of Corporate Communications & Investor Relations
(805) 217-2287
jawe@atarabio.com
Source: Atara Biotherapeutics, Inc.
FAQ
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