On August 14, 2019 Fate Therapeutics, Inc. (NASDAQ: FATE), a clinical-stage biopharmaceutical company dedicated to the development of programmed cellular immunotherapies for cancer and immune disorders, reported that the U.S. Patent and Trademark Office has issued U.S. Patent No. 10,370,452 covering compositions and uses of effector T cells expressing a chimeric antigen receptor (CAR), where such T cells are derived from a pluripotent stem cell including an induced pluripotent stem cell (iPSC) (Press release, Fate Therapeutics, AUG 14, 2019, View Source [SID1234538739]). The foundational patent, which expires in 2034, is owned by Memorial Sloan Kettering Cancer Center (MSK) and is licensed exclusively to Fate Therapeutics for all human therapeutic uses.
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"The breadth of this newly-issued patent, which is not restricted by the signaling domain of the CAR construct nor by the antigen to which the CAR targets and binds, covers off-the-shelf, iPSC-derived CAR T cell therapy for the treatment of cancer, infectious disease and immune disorders," said Scott Wolchko, President and Chief Executive Officer of Fate Therapeutics. "This patent is a testament to the prescient work of MSK’s Dr. Michel Sadelain in combining CAR and iPSC technologies in an effort to overcome the significant challenges that limit the widespread adoption of patient- and donor-sourced engineered T-cell immunotherapy."
Fate Therapeutics and MSK are conducting research and development of T-cell product candidates derived from iPSCs. These activities include the conduct of IND-enabling studies for FT819, an off-the-shelf CAR T-cell product candidate derived from a clonal master engineered iPSC line with complete elimination of T-cell receptor (TCR) expression and a novel 1XX CAR targeting CD19 inserted into the T-cell receptor alpha constant (TRAC) locus. Fate Therapeutics recently expanded its laboratory operations to New York City to support its research and development of off-the-shelf, iPSC-derived T cells.
Fate Therapeutics has built a dominant intellectual property position broadly covering iPSC technology and iPSC-derived cell products. Its proprietary portfolio includes compositions and methods for generating iPSCs, including engineering their biological properties using CRISPR and other nucleases, and for producing genetically edited cells of the hematopoietic lineage, including NK cells and T cells, from iPSCs. Fate Therapeutics’ iPSC product platform is supported by over 250 issued patents and 150 pending patent applications.
About FT819
FT819 is an off-the-shelf, T-cell receptor (TCR)-less CD19 chimeric antigen receptor (CAR) T-cell product candidate manufactured from a clonal master iPSC line that is undergoing IND-enabling activities in collaboration with Memorial Sloan Kettering Cancer Center (MSK). FT819 is manufactured from a clonal master engineered iPSC line with complete elimination of TCR expression and a novel 1XX CD19-specific CAR inserted into the T-cell receptor alpha constant (TRAC) locus. These synthetic features are intended to mitigate the risk of graft-versus-host disease, a severe life-threatening condition that occurs when donor T cells attack a patient’s healthy tissue, and to regulate CAR expression to enhance the therapeutic potency and durability of CAR T cells. Scientists from the Company and MSK have presented preclinical data demonstrating that FT819 lacks TCR expression, is highly cytotoxic and specific to CD19 antigen and controls tumor progression comparable to peripheral blood CAR19 T cells in a mouse model of acute lymphoblastic leukemia.
About Fate Therapeutics’ iPSC Product Platform
The Company’s proprietary induced pluripotent stem cell (iPSC) product platform enables mass production of off-the-shelf, engineered, homogeneous cell products that can be administered in repeat doses to mediate more effective pharmacologic activity, including in combination with cycles of other cancer treatments. Human iPSCs possess the unique dual properties of unlimited self-renewal and differentiation potential into all cell types of the body. The Company’s first-of-kind approach involves engineering human iPSCs in a one-time genetic modification event and selecting a single iPSC for maintenance as a clonal master iPSC line. Analogous to master cell lines used to manufacture biopharmaceutical drug products such as monoclonal antibodies, clonal master iPSC lines are a renewable source for manufacturing cell therapy products which are well-defined and uniform in composition, can be mass produced at significant scale in a cost-effective manner, and can be delivered off-the-shelf for patient treatment. As a result, the Company’s platform is uniquely capable of overcoming numerous limitations associated with the production of cell therapies using patient- or donor-sourced cells, which is logistically complex and expensive and is fraught with batch-to-batch and cell-to-cell variability that can affect safety and efficacy.