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 were presented at ASH in December 2023, with additional data expected at medical conferences in H1 2024. A BLA submission was accepted by the US FDA in January 2024 with a PDUFA goal date of November 16, 2024.
Autolus are applying extensive cell programming capability to develop product candidates across hematological malignancies, solid tumors and autoimmune disease.