Business
Atara Biotherapeutics Announces Second Quarter 2023 Financial Results and Operational Progress
Discussions With FDA Progressing on Potential BLA Submission for Tab-cel® With Meeting Scheduled To Resolve Remaining Topic of Comparability ATA188 Phase 2
About this update from Atara Biotherapeutics, Inc.
[{"type":"text","content":"\nDiscussions With FDA Progressing on Potential BLA Submission for Tab-cel® With Meeting Scheduled To Resolve Remaining Topic of Comparability\n\n\nATA188 Phase 2 EMBOLD Study Primary Analysis and Communication Will Now Occur in Early November To Include the Last Patient Visits From More Than 90 Patients\n\n\nIND Cleared for Atara's First Allogeneic CAR T, ATA3219, in Relapsed/Refractory B-Cell NHL\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 second quarter 2023, recent business highlights and key upcoming catalysts.\n\n\n“We are pleased to announce IND clearance for ATA3219, our first allogeneic CAR-T cell product candidate expected to enter the clinic in the coming months as a potential best-in-class treatment for patients with certain B-cell malignancies,” said Pascal Touchon, President and Chief Executive Officer of Atara. “Building on this momentum, our discussions with FDA and potential commercial partners for tab-cel in the U.S. are progressing well and we are excited to soon conduct the primary analysis of the EMBOLD Phase 2 study in progressive MS, with clinical and biomarker data from more than 90 patients.”\n\n\nTabelecleucel (tab-cel® or EBVALLO™) for Post-Transplant Lymphoproliferative Disease (PTLD)\n\n\n\nContinued productive discussions between Atara and FDA have addressed outstanding chemistry, manufacturing, and controls (CMC) questions. A meeting is scheduled to resolve the remaining topic of comparability between clinical and intended commercial process versions which should provide clarity on timing for a potential BLA submission\n\n\n\nFollowing significant levels of engagement, discussions with potential U.S. commercialization partners are advancing\n\n\n\nPatients in Europe are now receiving treatment with EBVALLO in the commercial setting, as Pierre Fabre is progressively launching on a country-by-country basis\n\n\n\nAtara is investigating label expansion opportunities with its ongoing Phase 2 multi-cohort study with initial data expected in Q4 2023\n\n\n\nATA188 for Progressive Multiple Sclerosis (MS)\n\n\n\nAtara plans to com...