Fate Therapeutics Inc. (NASDAQ:FATE) has announced that the FDA has cleared its Investigational New Drug FT538 application, which is the first iPSC-derived, CRISPR-edited cell therapy.
Fate delighted to expand its iPSC-derived FT538 therapy
The company’s FT538 drug is an off-shelf natural killer cell cancer immunotherapy derived from an induced pluripotent stem cell line. It has been contrived with three components that help in enhanced innate immunity, which are an IL-15/IL-15 receptor fusion, non-cleavable CD16 Fc Receptor as well as CD38 expression elimination.
Fate Therapeutics is planning to begin a clinical study of there once per week doses of the drug as a monotherapy in the treatment of acute myeloid leukemia as well as in combination with daratumumab in multiple myeloma treatment.
Scott Wolchko, the CEO and president of the company, indicated that they were delighted to expand the iPSC product platform application to multiple myeloma in cases where there are high rates of relapse. According to clinical data, natural killer cell-mediated immunity deficiencies are evident at the onset of myeloma that continue to increase as the disease progresses. Scott added that they hope the administration of the drug to patients can help in restoring innate immunity. Also, they expect it to have the anti-cancer effect in a particular standard of care treatment like monoclonal antibodies can be enhanced through the combination with the FT538 drug.
Functional components of FT538 enhances innate immunity
The functional components of the therapy are meant to enhance innate immunity in cancer patients. At the same time, it reduced endogenous NK cells in terms of number and function due to previous treatment therapies and tumor-suppressing mechanisms. Preclinical studies of FT538 have indicated that the drug has a superior NK cell effect function relative to endogenous cells. It has the potential of conferring substantial anti-tumor active in myeloma patients through various mechanisms.
Phase 1 of the study of FT538 will be the first-in-human trial meant to establish the maximum tolerated dose of three once per week doses in around 105 subjects in four dose groups.