FDA Grants Breakthrough Therapy Status to Atara and MSK’s T Cell Therapy

Atara Biotherapeutics

Atara Biotherapeutics, Inc. and partner Memorial Sloan Kettering Cancer Center (MSK) announced that they have received Breakthrough Therapy designation for its promising T cell therapy.

The companies said that the US Food and Drug Administration (FDA) granted Breakthrough Therapy designation for Atara’s optioned cytotoxic T lymphocytes activated against Epstein-Barr Virus (EBV-CTL) 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), often called a bone marrow transplant.

According to the companies, EBV-CTL could serve as 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 the T-cells are collected, they are then exposed to certain antigens. The activated T-cells are then expanded, characterized and stored for future therapeutic use in appropriate partially human leukocyte antigen matched patient. For EBV-LPD, the EBV-CTL find the cancer cells expressing EBV and kill them.

“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,” said Richard O’Reilly, MD, Chair of the Department of Pediatrics and Chief of the Pediatric Bone Marrow Transplant Service at MSK.

The agency granted EBV-CTL breakthrough status based on data from two separate trials conducted by MSK. Data from the studies have been submitted for presentation at an upcoming medical conference. With the status, the drug receives expedited review, intensive FDA guidance and discussion, and eligibility for submission of a rolling biologic license application.

“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,” said Isaac Ciechanover, MD, President and Chief Executive Officer of Atara.

In September, Atara and MSK entered into an exclusive option agreement, giving them the right to acquire the exclusive, worldwide license rights to three clinical product candidates focusing on targets in cancers and serious infections.

Source: Atara Biotherapeutics, Inc.

Last updated: 3/2/15; 12:25pm EST

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