On April 26, 2023 Autolus Therapeutics plc (Nasdaq: AUTL), a clinical-stage biopharmaceutical company developing next-generation programmed T cell therapies, reported a data update from the AUTO1/22 study (CARPALL) in Pediatric B-cell Acute Lymphoblastic Leukemia in an oral presentation at the 49th Annual Meeting of the European Society for Blood and Marrow Transplantation (EBMT), which is being held in Paris from April 23 to 26, 2023 (Press release, Autolus, APR 26, 2023, View Source [SID1234630550]).

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CD19 negative relapse is a major cause of treatment failure after CD19 CAR T cell therapy for pediatric B-ALL. To address this, AUTO1/22 is designed to target both CD19 and CD22 using the fast-off rate CD19 CAR from obe-cel combined with a novel CD22 CAR capable of effective signaling in response to low antigen density1.

Twelve patients with advanced pediatric B-ALL were treated in a study. AUTO1/22 maintained the safety profile of obe-cel alone, with no cases of severe cytokine release syndrome. AUTO1/22 induced MRD (minimal residual disease) negative CR in 83% (10 of 12) patients. This includes 2 (of 3) patients who had CD19 negative disease, demonstrating the efficacy of the CD22 CAR.

Notably, remissions were induced despite the high-risk nature of this cohort (including 4 patients who had failed prior CD19 CAR therapy, 3 patients with a CD19-negative disease component, 3 patients with non-CNS extramedullary disease and 6 patients who had received prior blinatumomab). The 12-month OS and EFS in this study were comparable to the ELIANA study2. Crucially, amongst the 10 responding patients, with a median follow up of 8.7 months, there have been no cases of leukemic relapse or emergence of MRD related to antigen escape.

"We are pleased to see the updated data for AUTO1/22 in pediatric B-ALL," said Dr. Christian Itin, Chief Executive Officer of Autolus. "AUTO1/22 demonstrated a favorable safety profile and good efficacy in a heavily pre-treated cohort of patients and, importantly, we have not observed antigen negative relapse indicating that the combining of our optimized CD22 CAR design with the CD19 CAR used in obe-cel may be effective in preventing antigen-loss driven relapse in pediatric B-ALL."

Title: Dual Antigen Targeting with Co-Transduced CD19/22 CAR T cells may Prevent Antigen-Negative Relapse after CAR T Cell Therapy for Relapsed/Refractory ALL

Link to Abstract
Session date and time: Wednesday, April 26, 2023, 11:57 to 12.06 BST
Presenting Author: Dr Giovanna Lucchini, Consultant BMT, Great Ormond Street Hospital, London