Autolus Therapeutics to Present Three Clinical Data Updates on obecabtagene autoleucel (obe-cel) in relapsed/refractory (r/r) B-Cell acute lymphoblastic leukemia (ALL) patients at the 2024 European Hematology Association (EHA) Congress

Autolus Therapeutics plc (Nasdaq: AUTL), a clinical-stage biopharmaceutical company developing next-generation programmed T cell therapies, today announces the online publication of three abstracts submitted to the European Hematology Association (EHA) Congress, to be held June 13-16, 2024.

Oral presentation:

1. Title: obecabtagene autoleucel in adult relapsed/refractory B Cell acute lymphoblastic leukemia: Survival and potential impact of CAR-T cell persistence and stem cell transplantation in the FELIX studySession Title: s419 Acute lymphoblastic leukemia - Clinical 1: Immunotherapy: antibodies and CAR-T cellsSession date and time: Friday, June 14 from 14:45 - 16:00 CESTSession room: N104Final Abstract Code: S114Presenting Author: Dr. Claire Roddie

Poster presentations:

1. Title: obecabtagene autoleucel (obe-cel, AUTO1) for relapsed/refractory adult B-Cell acute lymphoblastic leukemia (R/R B-ALL): The impact of inotuzumab-containing bridging therapy on treatment outcomesSession Title: Poster sessionSession date and time: Friday, June 14 from 18:00 - 19:00 CESTFinal Abstract Code: P418Presenting Author: Dr. Jae H. Park
2. Title: Droplet digital PCR and flow cytometry sensitivity for measuring CAR-T cell kinetics in adult patients with relapsed/refractory B Cell acute lymphoblastic leukemia treated with obecabtagene autoleucelSession Title: Poster sessionSession date and time: Friday, June 14 from 18:00 - 19:00 CESTFinal Abstract Code: P1469Presenting Author: Dr. Claire Roddie

About Autolus Therapeutics plcAutolus is a clinical-stage biopharmaceutical company developing next-generation, programmed T cell therapies for the treatment of cancer and autoimmune disease. Using a broad suite of proprietary and modular T cell programming technologies, Autolus is engineering precisely targeted, controlled and highly active T cell therapies that are designed to better recognize target cells, break down their defense mechanisms and eliminate these cells. Autolus has a pipeline of product candidates in development for the treatment of hematological malignancies, solid tumors and autoimmune diseases. For more information, please visit www.autolus.com

About obe-cel (AUTO1)Obe-cel is a CD19 CAR T cell investigational therapy designed to overcome the limitations in clinical activity and safety compared to current CD19 CAR T cell therapies. Obe-cel is designed with a fast target binding off-rate to minimize excessive activation of the programmed T cells. In clinical trials of obe-cel, this “fast off-rate” profile reduced toxicity and T cell exhaustion, resulting in improved persistence and leading to high levels of durable remissions in r/r Adult ALL patients. The results of the FELIX trial, a pivotal trial for adult ALL, have been submitted and accepted by the FDA with a PDUFA target action date of November 16, 2024. A regulatory submission to the EMA was made in the first half of 2024. In collaboration with Autolus’ academic partner, UCL, obe-cel is currently being evaluated in a Phase 1 clinical trials for B-NHL.

About obe-cel FELIX clinical trialAutolus’ Phase 1b/2 clinical trial of obe-cel enrolled adult patients with relapsed / refractory B-precursor ALL. The trial had a Phase 1b component prior to proceeding to the single arm, Phase 2 clinical trial. The primary endpoint was overall response rate, and the secondary endpoints included duration of response, MRD negative CR rate and safety. The trial enrolled over 100 patients across 30 of the leading academic and non-academic centers in the United States, United Kingdom and Europe. [NCT04404660]

Contact:

Olivia Manser+44 (0) 7780 471 [e-mail]

Julia Wilson+44 (0) 7818 [e-mail]

Susan A. NoonanS.A. Noonan [e-mail]