Fate Therapeutics: Subject in dose 2 cohort achieves mLFS at day 14 in study
Fate Therapeutics announced initial clinical data from the ongoing VOYAGE Phase 1 study of FATE-NK100 as a monotherapy for the treatment of refractory or relapsed acute myelogenous leukemia. The data were presented today in a poster session at the Society for Immunotherapy of Cancer 2017 Annual Meeting in National Harbor, Maryland. Anti-leukemia activity was observed with FATE-NK100, the company's first-in-class adaptive memory natural killer cell cancer immunotherapy, in each of the treated dose cohorts of the VOYAGE study. The subject in the second dose cohort achieved a morphologic leukemia-free state following a single intravenous infusion of FATE-NK100 as a monotherapy. Prior to treatment, the subject presented in relapse, was refractory to conventional NK cell therapy and had 50% leukemic blasts in the bone marrow. At Day 14 following treatment, a bone marrow biopsy showed clearance of leukemic blasts in the marrow, and approximately 3x104 FATE-NK100 cells per mL were measured in the peripheral blood. The subject in the first dose cohort of VOYAGE presented in primary induction failure with 87% leukemic blasts in the bone marrow. Two weeks following a single infusion of FATE-NK100, a bone marrow biopsy revealed a nearly 50% reduction in leukemic blasts. In addition, approximately 76% of NK cells in the peripheral blood were of FATE-NK100 origin. The accelerated dose-escalation design of VOYAGE is designed to evaluate the safety and determine the maximum dose of a single intravenous infusion of FATE-NK100 as a monotherapy. The three dose levels are 1x10, 2x10 and up to 1x10 adjusted to kg of body weight. FATE-NK100 has now advanced through the first two dose cohorts with no reports of dose limiting toxicities The third dose cohort is currently enrolling. A ten-subject expansion cohort is expected to be enrolled at the maximum dose level.