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Atara Biotherapeutics Announces First Quarter 2021 Financial Results and Operational Progress
Conference Call and Webcast Today at 4:30 p.m. EDT SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)-- Atara Biotherapeutics, Inc. (Nasdaq: ATRA), a pioneer in
About this update from Atara Biotherapeutics, Inc.
[{"type":"text","content":"\nConference Call and Webcast Today at 4:30 p.m. EDT\n\n SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--\nAtara Biotherapeutics, Inc. (Nasdaq: ATRA), a pioneer in T-cell immunotherapy, leveraging its novel allogeneic EBV T-cell platform to develop transformative therapies for patients with serious diseases including solid tumors, hematologic cancers and autoimmune diseases, today reported financial results for the first quarter 2021, recent business highlights and key catalysts over the next 18 months.\n\n“Atara is off to a strong start in 2021, advancing all three strategic priorities to deliver on key value drivers,” said Pascal Touchon, President and Chief Executive Officer of Atara. “We look forward to several milestones in 2021, including the expected tab-cel® BLA and MAA filings, progress on the ATA188 program – especially the presentation of clinical and translational data from the Phase 1 OLE study, and the first clinical data on our mesothelin CAR T franchise.”\n\nTabelecleucel (tab-cel®) for Post-Transplant Lymphoproliferative Disease (PTLD)\n\n\nAtara is in active discussions with the FDA and progressing toward alignment on the content of CMC Module 3, including methodologies to assess comparability between the product used in the pivotal ALLELE study and the intended commercial product\n\n\nA recent analysis shows that duration of response (DoR) in its ALLELE study is maturing as anticipated with a larger number of responders followed for at least six months and a safety profile consistent with previously published data with no new safety signals\n\n\nAtara is working toward completing a BLA submission in Q3 2021 pending alignment with the FDA\n\n\nThe Company has submitted a letter of intent to the European Medicines Agency (EMA), starting the process for a submission of an EU Marketing Authorization Application (MAA) for tab-cel® in patients with EBV+ PTLD expected in Q4 2021\n\n\nAtara has data at two medical congresses from a combined long-term overall survival (OS) analysis from three clinical studies of tab-cel® demonstrating that patients with EBV+ PTLD, following both HCT (hematopoietic cell transplantation) and SOT (solid organ transplant), that is relapsed or refractory (R/R) to initial treatment, derived similar OS benefit greater than 80 percent at two years whether they achieved complete or partial respon...