Atara Biotherapeutics Provides Update on EBVALLO™ (tabelecleucel)
Atara Biotherapeutics, Inc. (Nasdaq: ATRA), a leader in T-cell immunotherapy, recently received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding its Biologics License Application (BLA) for EBVALLO™ (tabelecleucel). EBVALLO is an innovative allogeneic Epstein-Barr virus (EBV)-specific T-cell immunotherapy designed to treat adult and pediatric patients aged two and older with EBV-positive post-transplant lymphoproliferative disease (EBV+ PTLD). This condition arises in patients who have received at least one prior therapy, including an anti-CD20 containing regimen.
The CRL was issued as part of a standard pre-license inspection at a third-party manufacturing facility, and it was solely related to compliance issues. Importantly, the CRL did not cite any concerns regarding the manufacturing process, the clinical efficacy, or the safety data associated with EBVALLO. The FDA did not request additional clinical trials to support approval.
“We are working closely with our partner Pierre Fabre Laboratories, the FDA, and the third-party manufacturer to address the feedback to support marketing approval for EBVALLO,” said Cokey Nguyen, Ph.D., President and CEO of Atara. “We expect to resubmit the application after the third-party manufacturer has addressed GMP compliance issues, which we hope will result in approval within six months.” Atara remains confident in EBVALLO’s potential and its ability to meet the significant unmet needs of patients with EBV+ PTLD.
Pierre Fabre Laboratories, a key partner, expressed their disappointment at the delay but reiterated their commitment to supporting Atara in advancing EBVALLO for U.S. patients, especially given the lack of approved therapies for this rare and deadly condition.
EBVALLO, which received marketing authorization from the European Commission in December 2022, targets EBV-infected cells and has shown a promising clinical profile. The pivotal ALLELE study, which served as the basis for the BLA submission, demonstrated a 50% Objective Response Rate (ORR) and a favorable safety profile for EBVALLO, reinforcing the therapeutic potential of this treatment in EBV+ PTLD.
To support the global manufacturing of EBVALLO, a second third-party manufacturing facility, FUJIFILM Diosynth Biotechnologies (FDB) in Thousand Oaks, CA, has been approved by the European Medicines Agency (EMA). This facility will be a critical part of Atara’s long-term global manufacturing strategy for EBVALLO.
Corporate Updates: Strategic Alternatives and Financial Moves
As part of its ongoing commitment to maximizing value for shareholders, Atara’s board of directors regularly reviews the company’s strategic plans and business opportunities. In light of recent developments, Atara engaged a renowned financial advisor to explore a wide range of strategic alternatives. These include potential mergers, acquisitions, sales of assets, or other business combinations. Atara is actively in discussions with several parties, though no assurances can be made regarding the outcome of these efforts.
Atara has also been proactive in securing future value from its EBVALLO program. The company remains eligible for a $60 million milestone payment from Pierre Fabre upon FDA approval of the EBVALLO BLA. In addition, Atara will be entitled to significant double-digit tiered royalties on net sales of EBVALLO, alongside further commercial milestones.
In the absence of a strategic resolution to secure funding for its CAR-T development programs by the first quarter of 2025, Atara plans to suspend CAR-T activities and significantly reduce its operations, focusing exclusively on advancing EBVALLO. This includes transferring all operational activities related to EBVALLO to Pierre Fabre to streamline processes and reduce costs.
In addition, Atara entered into a non-binding term sheet with Redmile Group for a potential equity line of credit of up to $15 million. This funding is intended to support the company’s ongoing efforts to achieve BLA approval for EBVALLO. The company is also exploring other financing options, including non-dilutive sources of capital, to further secure its financial position.
“We are pleased to have the strong confidence of Redmile Group, which demonstrates belief in the future success of EBVALLO,” stated Dr. Nguyen. “This funding will help facilitate the transfer of EBVALLO activities to Pierre Fabre, positioning the company for success with the anticipated U.S. approval and eventual launch.”
Financial Overview
As of December 31, 2024, Atara reported approximately $43 million in cash, cash equivalents, and short-term investments. The company is in discussions with several parties to assess additional strategic alternatives and financing options. Atara has also entered into a non-binding agreement with Redmile Group, which would provide up to $15 million in funding through an equity line of credit.
About Atara Biotherapeutics, Inc.
Atara is harnessing the immune system’s natural power to develop off-the-shelf cell therapies for hard-to-treat cancers and autoimmune diseases. Atara’s unique T-cell platform offers transformative solutions, and the company is the first to receive regulatory approval for an allogeneic T-cell immunotherapy. Atara’s portfolio includes therapies targeting EBV, as well as next-generation CAR-Ts designed for hematological malignancies and autoimmune diseases. The company is headquartered in Southern California.
