Autolus Therapeutics Highlights Advancing Autoimmune Pipeline at R&D Investor Event

Core Insights - Autolus Therapeutics plc is advancing its development pipeline, particularly focusing on the expansion of its programmed T cell therapy, obe-cel, into autoimmune diseases such as lupus nephritis (LN) and multiple sclerosis (MS) [1][2][5] Development Plans - The company aims to establish a potential registrational path for obe-cel in LN, supported by insights from key opinion leaders in the field [2][3] - Preliminary data from the Phase 1 CARLYSLE trial in systemic lupus erythematosus (SLE) indicate a strong rationale for progressing to a pivotal Phase 2 study, with the first patient expected to be dosed by year-end 2025 [5][6] Clinical Data - In the CARLYSLE trial, three out of six patients achieved complete renal response by month three, and all patients showed normalization of complement levels by month one [6] - The trial reported no dose-limiting toxicities or severe neurotoxicity, with only mild cytokine release syndrome observed in some patients [6] Regulatory and Market Updates - Autolus is aligned with the U.S. FDA on the Phase 2 trial design and anticipates dosing the first patient in this trial before the end of 2025 [6] - The company expects notifications regarding regulatory approvals for obe-cel in the UK and EU in Q2 and H2 2025, respectively [11] Anticipated News Flow - Key upcoming milestones include notifications from the UK MHRA and EU EMA regarding approval for obe-cel in relapsed/refractory adult acute lymphoblastic leukemia (ALL) in Q2 and H2 2025, respectively [7] - Initial data from the pediatric ALL trial and the presentation of the Phase 1 CARLYSLE trial at a medical conference are also expected in H2 2025 [7] Financial and Commercial Strategy - The launch of AUCATZYL, an FDA-approved product for adult patients with relapsed or refractory B-ALL, is progressing with 38 centers activated as of April 2025 [11] - The company is leveraging its proprietary manufacturing and commercial infrastructure to maximize the value of its assets, particularly obe-cel [3][11]