Fate Therapeutics Announces FDA Clearance of IND Application for FT538, First CRISPR-edited, iPSC-derived Cell Therapy

Fate Therapeutics, Inc , a clinical-stage biopharmaceutical company dedicated to the development of programmed cellular immunotherapies for cancer and immune disorders, announced on May 20th that the U.S. Food and Drug Administration (FDA) has cleared the Company’s Investigational New Drug (IND) application for FT538, the first CRISPR-edited, iPSC-derived cell therapy. FT538 is an off-the-shelf natural killer (NK) cell cancer immunotherapy that is derived from a clonal master induced pluripotent stem cell (iPSC) line engineered with three functional components to enhance innate immunity: a novel high-affinity, non-cleavable CD16 (hnCD16) Fc receptor; an IL-15/IL-15 receptor fusion (IL-15RF); and the elimination of CD38 expression. The Company plans to initiate clinical investigation of three once-weekly doses of FT538 as a monotherapy in acute myeloid leukemia (AML) and in combination with daratumumab, a CD38-directed monoclonal antibody therapy, for the treatment of multiple myeloma.

For further information, see Fate Therapeutics (https://ir.fatetherapeutics.com/news-releases/news-release-details/fate-therapeutics-announces-fda-clearance-ind-application-ft538?elqTrackId=bfddd44744e2462888d58cb2f392fe8e&elq=6403caf8c0ea4facb00e9eb6737a488a&elqaid=28246&elqat=1&elqCampaignId=10609)

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