FDA puts clinical hold on Atara’s active IND applications due to manufacturing issues
Atara Biotherapeutics announced that the FDA has put a clinical hold on the company’s active Investigational New Drug (IND) applications, just days after being hit with a Complete Response Letter from the regulator due to third-party manufacturing issues.
The INDs impacted by the clinical hold include the Ebvallo (tabelecleucel) program, a monotherapy treatment for adult and pediatric patients two years of age and older with Epstein-Barr virus positive post-transplant lymphoproliferative disease (EBV+ PTLD), as well as ATA3219, an allogeneic CD19-targeted CAR-T therapy for the treatment of non-Hodgkin’s lymphoma and systemic lupus erythematosus.
The screening and enrollment of new participants in the Ebvallo and ATA3219 programs have been paused, according to Atara’s announcement.
Atara said the clinical hold for Ebvallo is “directly linked” to inadequately addressed GMP compliance issues identified during a pre-license inspection of a third-party manufacturing facility, which was referenced in a Complete Response Letter (CRL) announced last week.
“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,” Atara said.
The company noted that the GMP compliance issues cited in 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 Thousand Oaks, California,” which Atara said “remains a critical component” of its “long-term manufacturing strategy for both assets.”
According to Atara, it has discussed the issues with the FDA and has agreed with the agency on the actions necessary to release the clinical holds on Ebvallo and ATA3219.
“We intend to work closely with the FDA to address these issues as expeditiously as possible,” Atara CEO Cokey Nguyen said in a statement. “We are encouraged with ongoing correspondence with the agency and a potential path to submitting the necessary data to release the clinical hold.”
In a Jan. 21 note to investors, a Seeking Alpha analyst said that while the CRL “was undeniably a major setback” for Atara, the company has handled the situation “well” and the GMP compliance issues appear to be “minor and easily addressable.”
The analyst expects a “relatively quick resolution” of the issues and FDA approval of Ebvallo “by the end of the 2025 (maybe early 2026).” Ebvallo has already been approved in Europe, where it is marketed for EBV+ PTLD patients with limited treatment options.