Fate Therapeutics’ CRISPR-edited, iPSC-derived Cell Therapy Cleared for Clinical Investigation

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

Fate Therapeutics, Inc. (NASDAQ: FATE), a clinical-stage biopharmaceutical company focused on the development of programmed cellular immunotherapies for cancer and immune disorders, announced the U.S. FDA has cleared its Investigational New Drug (IND) application for FT538.

FT538 is the first CRISPR-edited, iPSC-derived cell therapy under development worldwide.

From a technical perspective, FT538 is an off-the-shelf natural killer (NK) cell cancer immunotherapy derived from a clonal master induced pluripotent stem cell (iPSC) line engineered with three functional components to enhance innate immunity.

These functional components include:

1. A novel high-affinity, non-cleavable CD16 (hnCD16) Fc receptor;
2. An IL-15/IL-15 receptor fusion (IL-15RF)
3. The elimination of CD38 expression

Fate plans to begin clinical investigation of three 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 (MM).

FT538 is the fourth off-the-shelf, iPSC-derived NK cell product candidate from Fate Therapeutic’s proprietary iPSC product platform to be cleared for clinical investigation by the FDA.

Overcoming COVID-19 related complications, the company has initiated the clinical manufacture of FT538 at its GMP facility in San Diego, California. To learn more, view the full announcement here.

Source: Fate Therapeutics

To learn more, view the “Global Induced Pluripotent Stem Cell (iPS Cell) Industry Report 2020.”