Autolus announces FELIX trial of obe-cel meets its primary endpoint

Autolus announces FELIX trial of obe-cel meets its primary endpoint

09 December 2022

Syncona Ltd, a leading healthcare company focused on creating, building and scaling global leaders in life science, notes that its portfolio company, Autolus Therapeutics Plc (Nasdaq: AUTL) (“Autolus”), has announced that the pivotal Phase II FELIX clinical trial in relapsed/refractory (r/r) adult Acute Lymphoblastic Leukemia (ALL) patients has met its primary endpoint at interim analysis. A copy of the announcement is set out below, with key highlights:

• Obe-cel demonstrated an overall remission rate (ORR), the primary endpoint for the trial, of 70% in an interim analysis of 50 patients

• Encouraging safety data observed from a wider group of 92 patients, with 3% of patients experiencing Grade 3 or higher cytokine release syndrome (CRS) and 8% experiencing Grade 3 or higher immune effector cell-associated neurotoxicity syndrome (ICANS)

• Enrolment is now complete for the initial target (so-called “morphological”) cohort, meeting the pre-specified goal of 90 patients enrolled, with this cohort to form the basis of a Biological License Application (BLA) submission by the end of CY2023 to the US Food and Drug Administration (FDA)

• Autolus plans to present updated results from the FELIX trial at a medical conference in midCY2023, with longer term follow up data to be reported at the end of CY2023

The achievement of the primary endpoint milestone has triggered a $35 million payment from Blackstone Life Sciences (“Blackstone”), with Autolus also announcing an additional $35 million payment from Blackstone as a result of the completion of planned activities supporting the obe-cel manufacturing process.

Martin Murphy, Chief Executive Officer and Chair of Syncona Investment Management Limited, said: “Today’s announcement from Autolus marks an important moment for the company as it progresses its lead programme of obe-cel in adult ALL. The data is consistent with what was previously presented in the ALLCAR19 academic study, underlining the potential of obe-cel as a drug which can provide meaningful impact for patients suffering from ALL whilst also showing a very positive safety profile in a last line setting. We are also encouraged by the expansion and persistence of obe-cel and look forward to future updates on whether this translates into potential best-in-class clinical durability.

We are excited about the data announced today and look forward to seeing further follow up data from the company in 2023 as it prepares to file a BLA submission and moves closer towards delivering a approved medicine for patients, thereby achieving one of Syncona’s foundational long-term goals.”