Failed facility inspection by partners places Atara’s Ebvallo pipeline candidate on clinical hold in the United States

Atara Biotherapeutics has now faced a second setback after getting a complete response from the FDA through its T-cell immunotherapies pipeline. Atara’s EBV+PTLD and ATA3219 therapy projects face study delays after the FDA required a clinical hold due to inspection findings at the European factory.
The suspension affects both drugs as new patient screening and enrollment activities stop across all development programs. Atara said they will continue treatment for specific patients in ongoing study protocols.
Atara blamed the clinical hold on the FDA’s poor inspection of a third-party manufacturer that showed in last week’s CRL for Ebvallo. ATA3219 drug material is not produced at the facility under warning but the raw materials for its manufacturing show the same quality deficiencies noted in the warning letter.

The Thousand Oaks location run by Fujifilm Diosynth Biotechnologies remains free from production delays due to the hold and CRL. Fujifilm continues to form an essential part of Atara’s product production plan.
CEO Cokey Nguyen stated that Atara is moving fast to meet FDA requirements for lifting the clinical hold.
Atara shareholders received two pieces of news today: first the CRL for Ebvallo then the clinical hold. The company noted the withdrawal stemmed from one facility inspection problem while assuring product effectiveness and safety had passed review.
The company plans to resubmit its application following the resolution of manufacturing compliance problems at the third-party facility and expects FDA approval within six months of this submission according to Nguyen’s press release.
Atara partners with Pierre Fabre Laboratories to gain approval for Ebvallo as a treatment for EBV+PTLD patients who have tried at least one previous treatment method.
Europe granted tabelecleucel its first licensing approval in December 2022 making it the inaugural allogeneic cellular therapy licensed anywhere.

The treatment method differs from standard autologous cell therapies where the patient’s cells get used by sourcing modified cells from healthy individuals. Manufacturers expect this new method to solve production and distribution problems that prevented earlier cell therapies from reaching patients successfully despite its popularity.
Pierre Fabre reached an agreement with Atara in 2021 to commercialize Ebvallo across Europe and select territories outside Europe. A 2023 agreement enabled Pierre Fabre to manage all U.S. manufacturing and testing operations for Ebvallo under a $640 million contract.