The CAR is designed to have a “fast-off” kinetic which mimics physiological T cell receptor interactions. Clinical trials of obe-cel have demonstrated that this enhanced kinetic profile results in increased T cell persistence leading to high levels of durable remissions and remarkably low levels of cytokine release syndrome and other immunotoxicities.
Obe-cel is currently being evaluated in the pivotal Phase 2 FELIX study in adult ALL and in Phase 1 studies for other B-NHL indications as well as pre-clinical work in autoimmune disease, with a Phase 1 study in systemic lupus erythematosus (SLE) expected to start in early 2024.
Obe-cel Phase 2 pivotal FELIX clinical trial met its primary endpoint at an interim analysis in 2022 and additional data at ASCO and EHA in 2023 confirmed the attractive product profile with potential best-in-class tolerability and very low levels of high-grade CRS and ICANS. Longer term follow up data and subgroup analysis data is expected to be presented at ASH in late 2023, as well as at medical conferences in H1 2024. A BLA submission for obe-cel is on-track to be submitted to the FDA at the end of 2023.
Autolus are applying extensive cell programming capability to develop product candidates across hematological malignancies, solid tumors and autoimmune disease.