On January 13, 2025 Autolus Therapeutics plc (Nasdaq: AUTL), a commercial stage biopharmaceutical company developing, manufacturing and delivering next-generation T cell therapies to patients, reported business updates and an overview of 2025 milestones (Press release, Autolus, JAN 13, 2025, View Source [SID1234649718]).
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"We enter 2025 with good momentum following the recent U.S. Food and Drug Administration (FDA) approval of AUCATZYL (obecabtagene autoleucel, or "obe-cel") and publication of the FELIX trial data in the New England Journal of Medicine. In addition, the inclusion of AUCATZYL in the NCCN Guidelines, noting the lack of REMS program associated with our therapy, provides further validation of the demonstrated clinical benefit, favorable safety profile and the potential impact of the therapy for patients in need," said Dr. Christian Itin, Chief Executive Officer of Autolus. "We are executing to plan with the commercial launch and are encouraged to enter the year with 24 authorized treatment centers out of the 30 we anticipated by end of Q1."
"With the AUCATZYL launch on track, we look forward to updating the market on additional clinical pipeline programs that we believe will drive future growth," Dr. Itin continued. "In the second half of 2024, we undertook an R&D portfolio review to evaluate the highest priority areas for strategic investment. In our upcoming R&D investor event we will provide an outlook and plan to share initial data from the ongoing CARLYSLE Phase 1 trial in systemic lupus erythematosus (SLE)."
AUCATZYL was approved by the FDA on November 8, 2024. Autolus expects to complete authorization of the first 30 treatment centers, covering approximately 60% of the identified target patient population, by the end of January 2025. The Company expects to complete authorization of 60 treatment centers, covering approximately 90% of the target patient population, by the end of 2025.
In December 2024, the National Comprehensive Cancer Network (NCCN) added AUCATZYL (obecabtagene autoleucel) to its Clinical Practice Guidelines in Oncology (NCCN Guidelines) for the treatment of adult patients with relapsed/refractory B-cell precursor acute lymphoblastic leukemia (r/r B-ALL). The NCCN is a not-for-profit alliance of 30 leading cancer centers devoted to patient care, research, and education. The NCCN Guidelines are a comprehensive set of guidelines detailing the sequential management decisions and interventions that currently apply to 97% of cancers affecting patients in the U.S and are intended to ensure that all patients receive preventive, diagnostic, treatment, and supportive services that reflect the latest evidence in oncological patient care.
Obe-cel is also under regulatory review in both the European Union and the United Kingdom, with marketing authorization submissions accepted by the European Medicines Agency (EMA) in April 2024, and the UK Medicines and Healthcare products Regulatory Agency (MHRA) in August 2024. Assuming precedent regulatory timelines, Autolus expects potential marketing approvals from the MHRA and EMA in the second half of 2025.
2025 Events & Milestones
Obe-cel in autoimmune disease: initial data from SLE Phase 1 study Q1 2025
R&D Investor Event, New York City April 23, 2025
Initial data from PY01 trial of obe-cel in pediatric ALL H2 2025
MHRA & EMA approvals for obe-cel in ALL H2 2025
SLE Phase 1 trial presentation at medical conference H2 2025
Additional details regarding the R&D investor event, including registration link, will be communicated in the near future.