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FDA grants breakthrough therapy designation to Epstein-Barr Virus (EBV) targeted t-cells for treatment of EBV- associated lymphoproliferative disease

, has announced that its collaborative partner, (MSK) has received breakthrough therapy designation from the U.S. Food and Drug Administration (FDA) for Atara’s optioned cytotoxic T lymphocytes activated against Epstein-Barr Virus () in the treatment of patients with rituximab-refractory, EBV-associated lymphoproliferative disease (EBV-LPD), a type of malignancy occurring after allogeneic hematopoietic cell transplantation (HCT). Allogeneic HCT is also commonly called a bone marrow transplant.

EBV-CTL may provide an “off-the-shelf”, allogeneic, cellular therapeutic option for patients with EBV-LPD. EBV-CTL are made from T-cells collected from the blood of third-party donors. Once collected, the T-cells are exposed to certain antigens. The resulting activated T-cells are expanded, characterized and stored for future therapeutic use in an appropriate partially human leukocyte antigen matched patient. In the context of EBV-LPD, the EBV-CTL find the cancer cells expressing EBV and kill them.

Richard O’Reilly, M.D., Chair of the Department of Pediatrics and Chief of the Pediatric Bone Marrow Transplant Service at MSK noted “The receipt of breakthrough therapy designation brings us one step closer to our ultimate goal of making EBV-CTL available to all patients with EBV-LPD, a serious and life threatening condition with limited treatment options. We are excited to have the resources and expertise of the Atara team on board to help us achieve our goals.”

Isaac Ciechanover, M.D., President and Chief Executive Officer of Atara said, “We are very pleased that our collaboration partner, MSK, has received breakthrough therapy designation, and we look forward to continuing our collective work to further develop this promising approach. The designation underscores an urgent need to bring novel treatments to patients with EBV-LPD after HCT. We believe that this off-the-shelf, adoptive T-cell therapy has the potential to be an important option for patients for whom there are no approved treatments.”

Breakthrough therapy designation for EBV-CTL was based on data from two separate clinical trials of EBV-CTL conducted by MSK. Data from these studies have been submitted for presentation at an upcoming medical conference in 2015.

The FDA’s breakthrough therapy designation is designed to expedite the development and review of new drugs for the treatment of serious or life-threatening conditions. To qualify for this designation, a drug must show credible evidence of a substantial improvement on a clinically significant endpoint over available therapies, or over placebo if there is no available therapy, or in a study that compares the new treatment plus standard of care to the standard of care alone. The designation confers several benefits, including intensive FDA guidance and discussion and eligibility for submission of a rolling biologic license application.

Source

Source: Atara Biotherapeutics, Inc.