Atara Biotherapeutics has opened its Atara T-Cell Operations and Manufacturing (ATOM) facility in Thousand Oaks, CA. ATOM features approximately 90,000 square feet dedicated to manufacturing the company’s off-the-shelf T-cell immunotherapies, as well as additional space for R&D labs and offices for Atara’s Southern California technical operations. The facility provides production capacity to support Atara’s pipeline, and its flexible design allows for potential manufacturing expansion of tab-cel (tabelecleucel), Atara’s most advanced off-the-shelf T-cell immunotherapy.

“The opening of ATOM in Thousand Oaks is a key milestone distinguishing Atara’s leading off-the-shelf T-cell immunotherapy technology platform,” said Isaac Ciechanover, chief executive officer and president, Atara Biotherapeutics. “As the cornerstone of our Southern California R&D and manufacturing hub, this dedicated facility will allow us to expand and accelerate our robust pipeline.”

Atara is co-located in South San Francisco and Southern California, with a newly established European headquarters in Zug, Switzerland. Atara also has an R&D site in Aurora, CO and an office in New York. The ATOM facility is projected to create around 100 new highly skilled jobs in the City of Thousand Oaks and Ventura County.

“ATOM encompasses all aspects of T-cell immunotherapy manufacturing and technical operations, and we designed the facility to provide flexibility to expand capacity as required,” said Joe Newell, executive vice president, chief technical operations officer and Steve Bertram, senior vice president of global human resources. “ATOM is further demonstration of Atara’s dedication to supporting the growth of the innovative life sciences community in Southern California.”

Atara is advancing Phase 3 development of tab-cel, the potential first commercially available off-the-shelf T-cell immunotherapy for the treatment of patients with Epstein-Barr virus associated post-transplant lymphoproliferative disorder (EBV+ PTLD). The company recently announced positive long-term outcomes for tab-cel in Phase 2 studies of patients with EBV+ PTLD at the 23rd Congress of European Hematology Association held in Stockholm, Sweden.

Atara plans to submit a conditional marketing authorization application in the EU for tab-cel, as well as report initial efficacy results from its Phase 3 program, in the first half of 2019.