Atara Biotherapeutics Faces Clinical Hold on EBVALLO and Pipeline Candidate Due to Manufacturing Site Inspection Issues

Clinical Hold:
The FDA has placed a clinical hold on Atara Biotherapeutics' EBVALLO (tabelecleucel) and ATA3219 studies due to unresolved GMP compliance issues at a third-party manufacturing facility13.

Manufacturing Issues:
The Complete Response Letter (CRL) issued by the FDA was solely related to inspection findings at the third-party manufacturer and did not identify any issues with clinical efficacy, safety data, or the manufacturing process itself14.

Financial Impact:
Atara Biotherapeutics may need to secure additional funding to support ongoing activities, with a current cash position of $43 million and potential access to $15 million through an equity line of credit1.

Strategic Alternatives:
Atara is exploring strategic alternatives, including potential acquisitions, mergers, or sale of assets, to advance and realize value from its CAR-T assets15.

European Approval:
EBVALLO has already received marketing authorization in Europe for the treatment of Epstein-Barr virus positive post-transplant lymphoproliferative disease (EBV+ PTLD)14.

Potential Milestone Payment:
Atara is eligible for a $60 million milestone payment upon FDA approval and double-digit tiered royalties from Pierre Fabre1.

Clinical Efficacy:
EBVALLO demonstrated a 50% Objective Response Rate in the pivotal ALLELE study, with no clinical efficacy or safety concerns identified in the FDA review14.

Regulatory Path Forward:
Atara is working with the FDA, Pierre Fabre Laboratories, and the third-party manufacturer to address the feedback and expects potential approval within six months of resubmission13.

Sources:

1. https://www.stocktitan.net/news/ATRA/atara-biotherapeutics-provides-regulatory-and-business-update-on-q4998gv3mghj.html

3. https://investors.atarabio.com/news-events/press-releases/detail/368/atara-biotherapeutics-provides-update-on-clinical-programs

4. https://www.biospace.com/fda/manufacturing-issues-result-in-fda-rejection-of-ataras-cell-therapy

5. https://www.bioworld.com/articles/716349-atara-sinks-on-ebvallo-crl-seeks-strategic-alternatives?v=preview