NEW YORK – Hemogenyx Pharmaceuticals said Monday that it will use its new FLT3 protein expression assay to identify patients with FLT3-expressing acute myeloid leukemia who are likely to respond to its investigational CAR T-cell therapy in a Phase I clinical trial.
The trial for the autologous HEMO-CAR-T is expected to launch first at MD Anderson Cancer Center, then expand to the University of Pennsylvania Medical Center. Hemogenyx inked a research partnership with UPenn Medical Center in 2020 to advance this CAR T-cell therapy in AML.
London-based Hemogenyx's development program for HEMO-CAR-T ran into some difficulty last year when the US Food and Drug Administration placed a clinical hold on the firm's investigational new drug application (IND) due to a splicing issue that occurred during lentivirus manufacturing of the therapy. Hemogenyx devised a plan to address the FDA's concerns, which the agency accepted.
Now, with IND clearance, Hemogenyx is initiating a clinical trial of HEMO-CAR-T using a FLT3 assay to identify eligible patients. "This assay will ensure we can accurately identify and recruit the right patients for the trials, bringing us one step closer to providing potentially life-saving treatment for those battling AML," Hemogenyx CEO and Cofounder Vladislav Sandler said in a statement.