On Tuesday, the U.S. Food and Drug Administration (FDA) placed a clinical hold on Atara Biotherapeutics, Inc.’s (NASDAQ:ATRA) active Investigational New Drug (IND) applications.
These INDs include the EBVALLO (tabelecleucel) program for patients two years of age and older with Epstein-Barr virus-positive post-transplant lymphoproliferative disease (EBV+ PTLD), as well as ATA3219, a CAR-T therapy for non-Hodgkin’s lymphoma and systemic lupus erythematosus.
Specifically, identified subjects currently enrolled in the clinical studies who have the potential to derive clinical benefit may continue to receive treatment.
Screening and enrollment of new participants in both programs have been paused.
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 last week.
While the ATA3219 drug product is manufactured at a separate, fully compliant GMP-certified facility, the compliance issues at the same third-party facility referenced in the CRL affect the starting materials used in its production.
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 Thousand Oaks, California.
The FDB facility remains a critical component of Atara’s long-term manufacturing strategy for both assets.
Last week, Atara engaged a financial advisor to support the assessment of opportunities to advance and realize value from Atara’s CAR-T assets.
Atara says it remains eligible to receive a $60 million milestone payment from Pierre Fabre upon FDA approval of the EBVALLO BLA, as well as significant double-digit tiered royalties as a percentage of net sales and milestones related to EBVALLO’s commercial sales.
The company added that if a strategic resolution is not reached to provide funding for its CAR-T development programs in the first quarter of 2025, Atara plans to suspend all CAR-T activities and significantly reduce company expenses and activities to only those that support the approval of EBVALLO, including through a near-term progressive transfer of all operational activities related to EBVALLO to Pierre Fabre.
Atara has entered into a non-binding term sheet with Redmile Group to provide up to $15 million in funding through an equity line of credit.
Price Action: ATRA stock is down 4.09% at $6.302 at last check Tuesday.
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