March 13, 2017 12:57pm
FATE jumps $0.33 or +6.87% to $5.13 and holding; hoping a natural killer cell immunotherapy is a safe and efficacious approach to target and durably destroy leukemia cells in these patients - HOLD
FATE-NK100 is a next-generation immunotherapy that is uniquely tailored to fully realize the anti-cancer activity of natural killer cells, and we are excited to pioneer the clinical investigation of this novel NK cell therapy.
FATE expects a first-in-human clinical trial of FATE-NK100 for advanced acute myeloid leukemia (AML) to open enrollment at the Masonic Cancer Center, University of Minnesota following approval of the Center's institutional review board.
The Bottom Line: The first-in-human study will evaluate the safety and determine the maximum dose of a single intravenous infusion of FATE-NK100 in subjects with refractory or relapsed AML. Secondary and investigational endpoints will assess anti-tumor activity including rates of complete response, clearance of minimal residual disease, disease-free survival and overall survival. The clinical trial will utilize an accelerated dose escalation design, which is intended to test up to four dose levels of FATE-NK100 with one subject enrolled per dose level until a dose-limiting toxicity (:DLT) is observed. The study will convert to a 3+3 design in the event a DLT is observed, and will enroll a ten subject expansion cohort at the maximum dose level.
BIG move with 3.257 M shares trade <3 month average = 253.5 K shares>