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Autolus Therapeutics announced longer-term follow-up and additional data from the pivotal Phase 1b/2 FELIX study of obe-cel for relapsed/refractory (r/r) adult B-cell Acute Lymphoblastic Leukemia (ALL). Presented at ASCO 2024, the data revealed that 40% of patients remain in remission without further therapy, showing potential long-term survival benefits. Median overall survival (OS) was 23.8 months, and median event-free survival (EFS) was 11.9 months. The FDA BLA submission has a target action date of November 16, 2024. The results support obe-cel as a standalone therapy with CAR T persistence linked to improved outcomes.
Autolus Therapeutics (NASDAQ: AUTL) reported its Q1 2024 financial results, highlighting key developments and financial metrics. The company is progressing with its regulatory review processes for obe-cel in relapsed/refractory (r/r) B-cell Acute Lymphoblastic Leukemia (ALL) with the FDA and European Medicines Agency (EMA). Key milestones include longer follow-up data from the FELIX Phase 2 trial, initial data from the CARLYSLE Phase 1 trial for Systemic Lupus Erythematosus (SLE) expected by late 2024, and the strategic CAR T cell therapy collaboration with BioNTech. Financially, the company reported cash and cash equivalents totaling $758.5 million as of March 31, 2024. Operating expenses were $38.8 million, with a net loss of $52.7 million for the quarter.
Autolus Therapeutics (Nasdaq: AUTL) announced the publication of three abstracts for the upcoming 2024 European Hematology Association (EHA) Congress, set for June 13-16, 2024. The studies focus on obecabtagene autoleucel (obe-cel) for treating relapsed/refractory B-Cell acute lymphoblastic leukemia. Key presentations include:
- An oral presentation by Dr. Claire Roddie on survival rates and CAR-T cell persistence in the FELIX study.
- A poster by Dr. Jae H. Park discussing the effects of inotuzumab-containing bridging therapy.
- Another poster by Dr. Claire Roddie on the sensitivity of droplet digital PCR and flow cytometry in measuring CAR-T cell kinetics.
Autolus Therapeutics plc, a biopharmaceutical company, has delayed its first quarter 2024 earnings release and conference call. The company will file a Form 12b-25 for an extension to file its Quarterly Report on Form 10-Q. The earnings release and call scheduled for May 14, 2024, are canceled, with the Q1 2024 10-Q expected to be filed by May 20, 2024. The conference call is rescheduled to May 17, 2024, for discussing financial results.
