Treating hematological malignancies and solid tumors
The company’s lead therapeutic candidate, obe-cel, met its primary endpoint at an interim analysis of the pivotal phase 2 FELIX study for adult ALL. Additional data were presented at ASCO and EHA in June 2023, with longer term follow up data and subgroup analysis data presented at ASH in December 2023, with more 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.
The opportunity for obe-cel extends beyond adult ALL. Obe-cel is currently being investigated in ongoing clinical studies for B-NHL indications and pediatric ALL. Alongside obe-cel, Autolus is progressing a number of pipeline assets both in preclinical and clinical development across hematological malignancies and solid tumors.