Atara Biotherapeutics is halving its head count as it navigates the fallout from the FDA’s move to halt trials of the allogeneic T-cell immunotherapy Ebvallo and a CAR-T candidate.
Atara revealed in January that the FDA has placed a clinical hold on the company’s investigational new drug applications for the Europe-approved Ebvallo in Epstein-Barr virus-positive post-transplant lymphoproliferative disease (EBV+PTLD) and the allogeneic CD19-targeted CAR-T candidate ATA3219 for non-Hodgkin lymphoma and systemic lupus erythematosus.
Atara linked the clinical hold to a lackluster FDA inspection of a third-party manufacturing facility, citing the complete response letter it had recently received for Ebvallo.
While drug product for ATA3219 is manufactured at a separate facility than the one implicated in the inspection, the starting materials used in the med’s production are “affected by compliance issues at the same third-party facility referenced in the CRL,” Atara explained at the time.
Yesterday, the biopharma announced it is halting all work on the ATA3219 program and another CAR-T called ATA3431. As a result, Atara has decided to lay off about 50% of its employees.
These layoffs are expected to be completed by June and cost Atara around $3 million, the company explained in a Securities and Exchange Commission filing.
Layoffs are almost an annual occurrence at Atara. The biopharma waved goodbye to 20% of its staff in 2022 and then shrunk its head count by a further 25% last year as it moved its focus from a failed multiple sclerosis cell therapy toward its CAR-T prospects.
Yesterday’s announcement made no mention of whether further progress has been made to lift the FDA hold. Atara had been working with Pierre Fabre Laboratories in a bid to secure approval for Ebvallo in EBV+PTLD for U.S. patients who’ve received at least one prior therapy for their disease.
The drug, which also goes by the name tabelecleucel, was approved in Europe back in December 2022, becoming the first allogeneic—or off-the-shelf—T-cell therapy to score a green light anywhere.