Atara Bio Doses First Patient in Multi-Center Expanded Access Protocol for Study of Allogeneic Epstein-Barr Virus Specific Cytotoxic T-lymphocytes (EBV-CTLs) in EBV-Associated Lymphomas and Lymphoproliferative Disorders
SOUTH SAN FRANCISCO, Calif., July 12, 2016 (GLOBE NEWSWIRE) -- Atara Biotherapeutics, Inc. (Nasdaq:ATRA), a biopharmaceutical company focused on developing meaningful therapies for patients with severe and life-threatening diseases, today announced the dosing of its first patient in the multi-center Expanded Access Protocol (EAP) for Study of Allogeneic EBV-CTLs in EBV-Associated Lymphomas and Lymphoproliferative Disorders. This EAP trial is designed to provide continued availability of off-the-shelf allogeneic EBV-CTLs to patients ahead of planned pivotal trials, which are on track to commence later this year. Further information regarding the EAP trial can be found at https://clinicaltrials.gov/ct2/show/NCT02822495.
“We are pleased to broaden access to our investigational allogeneic EBV-CTLs at transplant centers in the U.S., providing a treatment option to immunocompromised patients with a serious and often life-threatening condition,” commented Chris Haqq, M.D., Ph.D., and Chief Medical Officer of Atara Bio. “We look forward to commencing our two upcoming pivotal trials in patients with rituximab-refractory EBV Post-Transplant Lymphoproliferative Disorder (EBV-PTLD) after solid organ transplant (SOT) and hematopoietic cell transplant (HCT) later this year.”
T-cells are a critical component of the body's immune system and can be harnessed to counteract viral infections and some cancers. By focusing T-cells on specific proteins involved in cancers and infections, the power of the immune system can be employed to combat these diseases. Atara’s EBV-CTL utilizes a technology in which T-cells are collected from the blood of third-party donors and then exposed to EBV antigens. The resulting activated T-cells are then expanded, characterized, and stored for future therapeutic use in an appropriate partially human leukocyte antigen, or HLA, matched patient, providing an "off-the-shelf", allogeneic, cellular therapeutic option for patients. In the context of EBV-PTLD, Atara’s EBV-CTL finds the cancer cells expressing EBV and kills them. EBV-CTL is currently being studied in ongoing Phase 2 clinical trials in patients with EBV-associated cancers, including PTLD and nasopharyngeal carcinoma.
About Atara Biotherapeutics, Inc.
Atara Biotherapeutics, Inc. is a biopharmaceutical company focused on developing meaningful therapies for patients with severe and life-threatening diseases that have been underserved by scientific innovation, with an initial focus on immunotherapy and oncology. Atara Bio's programs include T-cell product candidates and molecularly targeted product candidates. The T-cell product candidates include EBV-CTL, CMV-CTL, and WT1-CTL and harness the power of the immune system to recognize and attack cancer cells and cells infected with certain viruses. The molecularly targeted product candidates include STM 434. These product candidates target activin and myostatin, members of the TGF-beta family of proteins, and have demonstrated the potential to have therapeutic benefit in a number of clinical indications.
This press release contains or may imply “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. For example, forward-looking statements include statements regarding the potential for the commencement of our pivotal trials in EBV Post-Transplant Lymphoproliferative Disorder (EBV-PTLD) after hematopoietic cell transplant (HCT) and solid organ transplant (SOT) later this year. Because such statements deal with future events and are based on Atara Bio's current expectations, they are subject to various risks and uncertainties and actual results, performance or achievements of Atara Bio could differ materially from those described in or implied by the statements in this press release. These forward-looking statements are subject to risks and uncertainties, including those discussed under the heading "Risk Factors" in Atara Bio's Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission (SEC) on May 6, 2016, including the documents incorporated by reference therein, and subsequent filings with the SEC. Except as otherwise required by law, Atara Bio disclaims any intention or obligation to update or revise any forward-looking statements, which speak only as of the date hereof, whether as a result of new information, future events or circumstances or otherwise.
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Released July 12, 2016