Atara Bio Receives Advanced Therapy Medicinal Product Classification for Allogeneic Epstein-Barr Virus Specific Cytotoxic T-lymphocytes (EBV-CTLs) from European Medicines Agency (EMA)
SOUTH SAN FRANCISCO, Calif., June 23, 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 that the EMA has classified the Company’s EBV-CTL product candidate as an Advanced Therapy Medicinal Product (ATMP) that falls within the definition of a somatic cell therapy medicinal product. Atara’s EBV-CTLs are under development for the treatment of patients with EBV Post-Transplant Lymphoproliferative Disorder (EBV-PTLD).
Therapies classified as ATMP have the potential to reshape the treatment of a wide range of conditions, particularly in disease areas where conventional approaches are inadequate. ATMP classification was established to regulate cell and gene therapy and tissue engineered medicinal products, support development of these products and provide a benchmark for the level of quality compliance for pharmaceutical practices. ATMP classification can provide developers with scientific regulatory guidance, help clarify the applicable regulatory framework and development path, provide access to all relevant services and incentives offered by the EMA and can also be advantageous when submitting clinical trial dossiers to national EU regulatory authorities.
“We are pleased to receive EMA’s classification of our EBV-CTL product candidate as an ATMP in the European Union. ATMP classification, together with the recent orphan drug designation granted by both the US FDA and EMA, underscores the compelling need for new treatments for PTLD following hematopoietic cell transplant (HCT) and solid organ transplant (SOT),” said Isaac Ciechanover, M.D., President and Chief Executive Officer of Atara Bio. "We are committed to expanding our T-cell platform globally, and we are looking forward to commencing our pivotal trials in EBV-PTLD following HCT and SOT 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 ATMP classification to provide developers with scientific regulatory guidance and help clarify the applicable regulatory framework and development path for the product and 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.
INVESTOR & MEDIA CONTACT: Investors: Steve Klass 212-213-0006 x331 firstname.lastname@example.org Media: Justin Jackson 212-213-0006 x327 email@example.com
Released June 23, 2016