Business
Atara Biotherapeutics Announces Fourth Quarter and Full Year 2023 Financial Results and Operational Progress
Tab-cel® U.S. BLA on Track for Submission in Q2 2024 Following Positive Pre-BLA Meeting Allogeneic CAR T Pipeline Expands Into Autoimmune Disease With Plans
About this update from Atara Biotherapeutics, Inc.
[{"type":"text","content":"\nTab-cel® U.S. BLA on Track for Submission in Q2 2024 Following Positive Pre-BLA Meeting\n\n\nAllogeneic CAR T Pipeline Expands Into Autoimmune Disease With Plans to Initiate an ATA3219 Lupus Nephritis Study in H2 2024, and Initial Clinical Data Expected H1 2025\n\n\nATA3219 NHL Study Enrolling With Initial Clinical Data Expected in Q4 2024\n\n\nCash Runway Into 2027 Enables Key Pipeline Readouts\n\n\n THOUSAND OAKS, Calif.--(BUSINESS WIRE)--\nAtara Biotherapeutics, Inc. (Nasdaq: ATRA), a leader in T-cell immunotherapy, leveraging its novel allogeneic Epstein-Barr virus (EBV) T-cell platform to develop transformative therapies for patients with cancer and autoimmune diseases, today reported financial results for the fourth quarter and full year 2023, recent business highlights, and key upcoming milestones for 2024.\n\n\n“We are expanding Atara’s proven EBV T-cell platform into allogeneic CAR T therapy for both oncology and autoimmune disease,” said Pascal Touchon, President and Chief Executive Officer of Atara. “This includes strong momentum for our lead CAR T program, ATA3219, which is positioned to deliver near-term clinical data for both non-Hodgkin’s lymphoma and lupus nephritis. We also are focused on submitting our BLA for tab-cel in the second quarter, the progress of which triggers financial milestones and sales royalty opportunities in our partnership with Pierre Fabre.”\n\n\nTabelecleucel (tab-cel® or Ebvallo™) for Post-Transplant Lymphoproliferative Disease (PTLD)\n\n\n\nAtara recently held a positive pre-BLA meeting with the U.S. Food and Drug Administration (FDA) that supports its plan to submit the tab-cel relapsed or refractory Epstein-Barr virus positive post-transplant lymphoproliferative disease (EBV+ PTLD) Biologics License Application (BLA) in Q2 2024\n\n\n\nData from the pivotal Phase 3 ALLELE study of tab-cel were published in The Lancet Oncology and showed a significant 51.2% objective response rate (ORR) and 23.0-month median duration of response in relapsed or refractory EBV+ PTLD subjects. Tab-cel was well tolerated with no events of graft-versus-host disease related to tab-cel\n\n\n\nPositive new data presented at the 2023 ESMO-IO meeting from the actively enrolling, multicohort Phase 2 EBVision trial with a pooled analysis demonstrated a 77.8% ORR in 18 central nervous system (CNS) EBV+ PTLD subjects...