About obe-cel (AUTO1)Obe-cel is an investigational CD19 CAR T-cell treatment designed to overcome limitations in clinical activity and protection compared to existing CD19 CAR T-cell therapies. Obe-cel is designed with a fast target binding rate to minimize over-activation of programmed T cells. Clinical trials of obe-cel have shown that this “rapid discontinuation rate” profile reduces T-cell toxicity and depletion, resulting in increased patience and leading to maximum degrees of sustained remissions. The results of the FELIX trial, a pivotal trial for adult ALL, were submitted and accepted through the FDA with a PDUFA action date set for November 16, 2024 and a regulatory submission to the EMA is being prepared. . In collaboration with Autolus’ educational partner, UCL, obe-cel is currently being evaluated in Phase 1 clinical trials for NHL-B.
About the obe-celFELIX Clinical TrialAutolus Phase Ib/II Clinical Trial with Adult Patients Enrolled in Obe-CEL With Relapsed/Refractory B-Precursor ALL. The trial had a phase Ib component before moving to the single-arm phase II clinical trial. The number one endpoint is overall reaction rate and secondary endpoints include reaction duration, negative CR rate for MRD, and safety. The trial enrolled more than 100 patients at 30 of the leading educational and non-educational centers in the United States. the United Kingdom and Europe. [NCT04404660]
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Contact:
Julia Wilson (0) 7818 430877j. wilson@autolus. com
Susan A. NoonanS. A. Noonan Communications 1-917-513-5303susan@sanoonan. com