The U.S. Food and Drug Administration (FDA) has cleared an investigational new drug (IND) application for GDX012 to be examined as a therapy for patients with hematologic malignancies. GDX012 is an allogeneic variable delta 1 gamma delta T-cell therapy based on Vδ1 γδ T cells, a subset of T cells that recognize and are activated by molecular patterns of dysregulation on cancer cells.
GDX012 also received FDA orphan drug designation for the treatment of acute myeloid leukemia (AML).
GammaDelta Therapeutics, GDX012’s manufacturer, will initiate a phase I study in late 2021 that will evaluate the treatment’s safety and activity in patients with measurable residual disease–positive AML. The T-cell platform is being developed in partnership with Takeda Pharmaceutical Co.