Syncona Limited (LON:SYNC), a leading healthcare company focused on creating, building and scaling a portfolio of global leaders in life science, noted that its portfolio company, Autolus Therapeutics Plc (Nasdaq: AUTL), has presented clinical data updates, including from its pivotal Phase II FELIX study of obe-cel in adult r/r B-cell acute lymphoblastic leukaemia (B-ALL), at the 2023 American Society of Hematology (ASH) Annual Meeting.
Highlights from the presentations include:
· Pooled analysis from the pivotal FELIX study of obe-cel in adult ALL shows the therapy has a differentiated safety profile with very low rates of severe toxicity, as well as continued high response rates and prolonged event free survival.
· The observed response rate[1] of 78% in evaluable patients amongst the 127 patients dosed in the study at a median follow up of 16.6 months continues to be consistent with previously presented data.
· Longer-term follow-up data from a pooled analysis from the pivotal FELIX and academic ALLCAR19 studies show durable remissions amongst a subset of patients after a median follow-up of > three years.
· Data from the Phase I ALLCAR19 extension study in B-cell non-Hodgkin lymphoma (B-NHL) and chronic lymphocytic leukemia (B-CLL) also show the strong durability and safety profile of obe-cel in other B-cell malignancies.
· Initial data from the MCARTY Phase I study of AUTO8, Autolus’ next generation product candidate targeting multiple myeloma, show the therapy was well tolerated with responses observed in all patients.
Autolus recently announced that it has submitted its Biologics License Application (BLA) to the US Food and Drug Administration (FDA) for obe-cel in r/r adult ALL and plans to file a Marketing Authorisation Application with the European Medicines Agency (EMA) in the first half of CY2024.
Martin Murphy, Director on the Board of Autolus Therapeutics, said: “The updated data from the FELIX study of obe-cel further underline the strong safety profile of the drug and importantly show a durable response for patients. The FELIX study is one of the largest CAR-T cell studies in adults with r/r B-ALL and I am pleased to see the continued data supporting our belief that obe-cel has the potential to transform the lives of patients with ALL.”
[1] Complete response / CR with incomplete haematological recovery
Syncona is a large British closed-ended investment trust dedicated to life science investments.
