On September 11, 2017 Atara Biotherapeutics, Inc. (Nasdaq:ATRA), a leading "off-the-shelf" T-cell immunotherapy company developing novel treatments for patients with cancer and autoimmune diseases, reported receipt of positive regulatory feedback from Health Canada for ATA129, the Company’s most advanced T-cell immunotherapy in development for the treatment of cancer patients with rituximab-refractory Epstein-Barr virus (EBV) associated post-transplant lymphoproliferative disorder (EBV-PTLD) following a hematopoietic cell transplant (HCT) or solid organ transplant (SOT).
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Based on feedback from a meeting with Health Canada’s Biologics and Genetic Therapies Directorate (BGTD), Atara plans to request advance consideration under the Notice of Compliance with Conditions (NOC/c) policy for ATA129 in the treatment of patients with rituximab-refractory EBV-PTLD after HCT. A Notice of Compliance issued under the NOC/c policy is an authorization to market a drug in Canada with the condition that the sponsor undertake additional studies to verify the clinical benefit, and is analogous to a conditional marketing authorization in the EU.
Consistent with Atara’s previously communicated regulatory plan in Europe, the Canadian filing is expected to be based on results from the Phase 1 and 2 clinical studies conducted at Memorial Sloan Kettering Cancer Center (MSK) and supported by available data from the Company’s planned MATCH and ALLELE Phase 3 studies, which are anticipated to be ongoing at the time of the NDS filing.
"Health Canada represents the second major regulatory body to provide feedback supporting the submission of ATA129 for an expedited approval pathway based on the compelling results of the prior Phase 1 and 2 studies," said Isaac Ciechanover, M.D., Chief Executive Officer and President of Atara Biotherapeutics. "We look forward to working closely with Health Canada and other global health authorities to make ATA129 available to patients as expeditiously as possible."
Following completion of the Phase 3 studies, Atara also expects to file a ATA129 supplemental NDS for the treatment of cancer patients with rituximab-refractory EBV-PTLD after SOT, as well as request to remove the conditions of the NOC/c for the HCT indication.
About EBV-PTLD
Since its discovery as the first human oncovirus, Epstein-Barr virus (EBV) has been implicated in the development of a wide range of lymphoproliferative disorders, including lymphomas and other cancers. EBV is widespread in all human populations and persists as a lifelong, asymptomatic infection. In immunocompromised patients, such as those undergoing hematopoietic cell transplants (HCT) or solid organ transplants (SOT), EBV-associated post-transplant lymphoproliferative disorder (EBV-PTLD), represents a life-threatening condition. Median overall survival in EBV-PTLD patients after HCT who have failed rituximab-based first line therapy is 16-56 days. In EBV-PTLD following SOT, patients failing rituximab experience increased chemotherapy-induced treatment-related mortality compared to other lymphoma patients. One and two-year survival in high-risk EBV-PTLD patients after SOT is 36% and 0%, respectively.
About ATA129
Atara’s most advanced T-cell immunotherapy in development, ATA129, is a potential treatment for cancer patients with rituximab-refractory EBV-PTLD as well as other EBV positive hematologic and solid tumors including nasopharyngeal carcinoma (NPC). In February 2015, FDA granted ATA129 Breakthrough Therapy Designation for EBV-PTLD following allogeneic hematopoietic cell transplant (HCT) and in October 2016, ATA129 was accepted into the EMA Priority Medicines (PRIME) regulatory pathway for the same indication, providing enhanced regulatory support. In addition, ATA129 also has orphan status in the U.S. and EU. Phase 3 studies of ATA129 in EBV-PTLD after HCT (MATCH study) or solid organ transplant (ALLELE study) are expected to start in 2017, and a Phase 1/2 study in NPC is planned for 2018. ATA129 is also available to eligible patients with EBV-positive tumors through an ongoing multicenter expanded access protocol (EAP) clinical study. Atara expects to submit ATA129 for conditional marketing authorization in EBV-PTLD following HCT in the EU in 2018.
About Atara Biotherapeutics, Inc.