US regulators have cleared Fate Therapeutics’ Investigational New Drug (IND) application for FT516, the first-ever cell therapy derived from an engineered pluripotent stem cell.
FT516 is the company’s second off-the-shelf natural killer (NK) cell product candidate cleared by the FDA within the past two months.
Fate Therapeutics said that it now intends to initiate clinical testing of FT516 in patients with certain relapsed/refractory hematologic malignancies, including acute myelogenous leukaemia (AML) as a monotherapy, non-Hodgkin’s lymphoma (NHL) in combination with rituximab, and multiple myeloma (MM) in combination with elotuzumab.
“This allowance by the FDA of our FT516 IND application is a watershed event in the clinical development of engineered cell therapies,” said Scott Wolchko, President and CEO of Fate Therapeutics.
He added: “FT516 is a first-of-kind cell product in that it originates from a single genetically engineered pluripotent stem cell, which serves as a clonal master cell line that can be repeatedly used to mass-produce large quantities of homogeneous cell product in a cost-effective manner.
“This innovative approach uniquely supports a new treatment paradigm with engineered cell therapies, where multiple doses of cell product are readily available for administration with the goal of driving deeper and more durable responses.”