Fate Therapeutics, Inc., a clinical-stage biopharma company focused on the development of programmed cellular immunotherapies for cancer and immune disorders, began IND-enabling production of FT500 at the University of Minnesota, Molecular and Cellular Therapeutics, an FDA-registered GMP facility.

FT500 is a first of its kind, natural killer (NK) cell cancer immunotherapy generated from a self-renewing clonal master pluripotent cell line (MPCL). It was created using the company’s iPSC product platform. The company expects to file an Investigation New Drug (IND) application in 1Q18 for the clinical testing of multiple dosing cycles of FT500 in combination with FDA-approved checkpoint inhibitor therapies for advanced solid tumors.

“Preclinical studies demonstrate that FT500 has direct anti-tumor activity and the capacity to secrete inflammatory cytokines and chemokines upon activation. This enables the cell product to potentially exploit both innate and adaptive immunity and elicit a broad, multi-targeted immune response against tumor cells by engaging a diverse set of stress ligands, recruiting a polyclonal T-cell population to the tumor site and augmenting T-cell activation in the tumor microenvironment,” said Scott Wolchko, president and chief executive officer of Fate Therapeutics.

In preclinical studies, FT500 displays multiple potential mechanisms by which it may synergize with T cells to activate the immune system in patients with tumors that are non-responsive to checkpoint inhibitors alone.