Fate Therapeutics cleared to begin clinical trial assessing NK cell therapy in blood cancer; shares up 9% – Seeking Alpha

Thinly traded micro cap Fate Therapeutics (FATE +9.4%) jumps out the blocks on more than a 6x surge in volume in response to its announcement that the FDA has approved its Investigational New Drug (IND) application for FATE-NK100, an adaptive memory natural killer (NK) cell product. The approval paves the way for a first-in-human clinical trial in patients with advanced acute myeloid leukemia (AML).

The early-stage study, to be conducted at the University of Minnesota, will determine the maximum tolerated dose of a single intravenous administration of FATE-NK100 in an accelerated dose escalation design in four patients.

FATE-NK100 is a next-generation immunotherapy based on a subset of NK cells that have shown robust anti-tumor activity in addition to promoting endogenous T cell response while resisting immune checkpoints.

NK cells identify and kill cancer cells by recognizing a range of stress signals expressed on tumor cells. Normal healthy cells are unaffected/unharmed. This is a different mechanism of action compared to T cells which require a specific tumor antigen to elicit an immune response and must be customized for each patient. The company says a significant advantage of NK-based immunotherapy is the avoidance of graft-versus-host disease, a common and potentially serious side-effect of T cell therapies.

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Fate Therapeutics cleared to begin clinical trial assessing NK cell therapy in blood cancer; shares up 9% - Seeking Alpha