publication date: Dec. 15, 2017
Drugs and Targets Fate Therapeutics completes technology transfer and starts IND-enabling manufacture of FT500
Fate Therapeutics Inc. said that IND-enabling production of FT500 has commenced at University of Minnesota, Molecular and Cellular Therapeutics.
Jeffrey Miller, professor of medicine, deputy director of the Masonic Cancer Center, University of Minnesota presented an overview of the clinical translation of FT500 at the 59th American Society of Hematology annual meeting and exposition.
FT500 is a first-of-kind natural killer cell cancer immunotherapy generated from a self-renewing clonal master pluripotent cell line. The clonal MPCL was created from a single induced pluripotent stem cell using the company’s proprietary iPSC product platform.
The company expects to file an Investigation New Drug application in the first quarter of 2018 for the clinical testing of multiple dosing cycles of FT500 in combination with FDA-approved checkpoint inhibitor therapies for advanced solid tumors in the outpatient setting.
In November, Fate Therapeutics received a Type B Pre-IND meeting written response from FDA for FT500. The written response and subsequent FDA correspondence aligned the company’s approach to safety testing, product manufacture, quality assessment and clinical trial design in support of IND submission.
The company estimates that a single manufacturing campaign conducted in one cGMP suite can yield hundreds of doses of up to … Continue reading Fate Therapeutics completes technology transfer and starts IND-enabling manufacture of FT500
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