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Fate Therapeutics Announces Expansion of FT516 Clinical Investigation and Publication of Preclinical Data in the Journal Blood
FT516 IND Application Cleared by FDA for Advanced Solid Tumors in Combination with PDL1-, EGFR- and HER2-targeting Therapeutic Antibodies Published
About this update from Fate Therapeutics, Inc.
[{"type":"text","content":"FT516 IND Application Cleared by FDA for Advanced Solid Tumors in Combination with PDL1-, EGFR- and HER2-targeting Therapeutic Antibodies\n Published Preclinical Data Demonstrate iPSC-derived NK Cells Engineered with High-affinity, Non-cleavable CD16 Enhance the Efficacy of Antibody Therapy SAN DIEGO, Jan. 13, 2020 (GLOBE NEWSWIRE) -- Fate Therapeutics, Inc. (NASDAQ: FATE), a clinical-stage biopharmaceutical company dedicated to the development of programmed cellular immunotherapies for cancer and immune disorders, announced today that the U.S. Food and Drug Administration (FDA) has allowed its second Investigational New Drug (IND) application for FT516, the Company’s off-the-shelf natural killer (NK) cell product candidate derived from a clonal master induced pluripotent stem cell (iPSC) line engineered to express a novel CD16 Fc receptor. This is the Company’s fourth IND from its proprietary iPSC product platform cleared by the FDA, and enables the clinical investigation of FT516 in combination with monoclonal antibody (mAb) therapy across a broad range of solid tumors. “While monoclonal antibodies are proven therapeutic agents that are often used early in the treatment of many cancers, the functional status of the patient’s NK cells has been shown to play an important role in mediating clinical activity and prolonging survival,” said Scott Wolchko, President and Chief Executive Officer of Fate Therapeutics. “In particular, stable expression of the NK cell activating receptor CD16, and its binding affinity to therapeutic antibodies, are critical to promoting antibody-dependent cellular cytotoxicity. Our first-of-kind, off-the-shelf approach with FT516 enables administration of multiple doses of CD16-engineered NK cells, and we are excited to investigate the potential of FT516 to augment the clinical efficacy of monoclonal antibody therapy in the setting of solid tumors.” FT516 expresses a novel high-affinity, non-cleavable variant of CD16 (hnCD16) that enhances its binding to therapeutic antibodies and prevents its down-regulation, which can significantly inhibit anti-tumor activity. A publication by scientists from the Company, the University of Minnesota, and the University of California, San Diego in the journal Blood (https://doi.org/10.1182/blood.2019000621), entitled “Pluripotent stem cell-derived NK cells with high-affi...