Autolus(AUTL) GlobeNewswire·2025-01-13 12:00Core Insights - Autolus Therapeutics is progressing with the commercial launch of AUCATZYL, having 24 treatment centers authorized as of January 10, 2025, with plans to reach 30 by the end of Q1 2025 [1][2] - AUCATZYL has been included in the National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines for treating adult patients with relapsed/refractory B-cell precursor acute lymphoblastic leukemia (r/r B-ALL) [3] - The company will provide updates on its clinical development program, including expansion into autoimmune diseases, at an R&D investor event scheduled for April 23, 2025 [1][4] Company Updates - The FDA approved AUCATZYL on November 8, 2024, and the company anticipates completing authorization for 60 treatment centers by the end of 2025, covering approximately 90% of the target patient population [2][4] - Autolus is also under regulatory review for AUCATZYL in the European Union and the United Kingdom, with expected marketing approvals in the second half of 2025 [4] Clinical Development - Initial data from the ongoing CARLYSLE Phase 1 trial in systemic lupus erythematosus (SLE) will be shared at the upcoming R&D investor event [2][4] - The company plans to present initial data from the PY01 trial of AUCATZYL in pediatric ALL in the second half of 2025 [4] Product Information - AUCATZYL is a CD19-directed CAR T cell therapy designed to improve clinical activity and safety compared to existing therapies, specifically for adult patients with relapsed or refractory B-ALL [7][8] - The therapy has a fast target binding off-rate to minimize excessive activation of T cells [7] Safety and Efficacy - The safety profile of AUCATZYL was evaluated in the FELIX study, which included 100 patients, with a median dose of 410 × 10^6 CD19 CAR-positive viable T cells [27] - Common serious adverse reactions included infections, febrile neutropenia, and cytokine release syndrome (CRS) [28]