On April 24, 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 Fate scientists and collaborators will present data highlighting the Company’s induced pluripotent stem cell (iPSC) product platform and its iPSC-derived cell product candidates at the American Society of Gene & Cell Therapy (ASGCT) (Free ASGCT Whitepaper) 22nd Annual Meeting being held from April 28 – May 2, 2019 in Washington, D.C (Press release, Fate Therapeutics, APR 24, 2019, View Source [SID1234535357]).
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"Our strong scientific presence at ASGCT (Free ASGCT Whitepaper) demonstrates the unique value of our proprietary iPSC product platform for gene editing and the development of universal, off-the-shelf, engineered cell therapies," said Bob Valamehr, Ph.D., Chief Development Officer of Fate Therapeutics. "We look forward to showcasing the critical importance of characterizing and selecting a single clone from a heterogeneous population of engineered cells, our unmatched expertise in creating large numbers of clinical-grade NK cells and T cells from clonal master engineered iPSC lines, and the breadth of our highly-differentiated off-the-shelf cancer immunotherapy pipeline."
Three oral and two poster presentations will highlight several product candidates from the Company’s universal, off-the-shelf, iPSC-derived cancer immunotherapy pipeline, including NK cell product candidates FT500 for the treatment of advanced solid tumors and FT516 for the treatment of advanced hematologic malignancies. FT500 is the first-ever iPSC-derived cell therapy to be administered to patients in the U.S., and FT516 is the first-ever engineered iPSC-derived cell therapy allowed for clinical investigation in the world. The Company’s iPSC-derived, dual-targeted CD16-CAR19 NK cell product candidate FT596 and its iPSC-derived, TCR-less, TRAC-targeted, 1XX CAR19 T-cell product candidate FT819, which is being developed under a collaboration with Memorial Sloan Kettering Cancer Center led by Michel Sadelain, M.D., Ph.D., will also be featured.
2019 ASGCT (Free ASGCT Whitepaper) Oral Presentations
Workshop – CAR T and Related Immune Effector Cell Therapies
Title: iPSC-Derived Immune Effector Cells
Presenter: Michel Sadelain, M.D., Ph.D., Director, Center for Cell Engineering, Memorial Sloan Kettering Cancer Center
Date and Time: Sunday, April 28, 2019, 3:30 PM – 6:00 PM
Location: Jefferson East
Session 132 – Induced Pluripotent Stem Cells
Title: Pluripotent Cell-Derived T and NK Cells as a Cornerstone Approach for Off-the-Shelf Cancer Immunotherapy
Presenter: Bob Valamehr, Ph.D., Chief Development Officer, Fate Therapeutics
Date and Time: Monday, April 29, 2019, 1:30 PM – 3:00 PM
Location: Monroe Room
Session 134 – NK Cells versus NKT Cells
Title: Clinical Development of NK Cell Cancer Therapy
Presenter: Sarah Cooley, M.D., Senior V.P., Clinical Translation, Fate Therapeutics
Date and Time: Monday, April 29, 2019, 1:30 PM – 3:00 PM
Location: Georgetown Room
2019 ASGCT (Free ASGCT Whitepaper) Poster Presentations
Poster 877 – iPSC Product Platform
Title: A Versatile Platform for Generation of Single-Cell Derived, Genetically Engineered, Fully Characterized Pluripotent Master Cell Lines as a Renewable Source for Off-the-Shelf Cell Therapy
First Author: Mochtar Pribadi, Ph.D., Scientist, Molecular Biology, Fate Therapeutics
Date and Time: Wednesday, May 1, 2019, 5:00 PM – 6:00 PM
Location: Columbia Hall
Poster 882 – CRISPR-based iPSC Generation
Title: A Novel Platform Combining Chemical and CRISPRa Approaches for the Generation of Human iPSCs
First Author: Jason Dinella, Ph.D., Scientist, Reprogramming Biology, Fate Therapeutics
Date and Time: Wednesday, May 1, 2019, 5:00 PM – 6:00 PM
Location: Columbia Hall
About FT500
FT500 is an investigational, universal, off-the-shelf natural killer (NK) cell cancer immunotherapy derived from a clonal master induced pluripotent stem cell (iPSC) line. FT500 is being investigated in an open-label, repeat-dose Phase 1 clinical trial for the treatment of advanced solid tumors in up to 64 patients, both as a monotherapy and in combination with FDA-approved checkpoint inhibitor therapy. Despite the favorable response rates observed with checkpoint inhibitor therapy, the majority of patients do not respond and many responders relapse. One common mechanism of resistance to checkpoint inhibitor therapy is associated with loss-of-function mutations in genes critical for antigen presentation. A potential strategy to overcome resistance is through the administration of allogeneic NK cells, which have the inherent capability to recognize and directly kill tumor cells with these mutations.
About FT516
FT516 is an investigational, universal, off-the-shelf natural killer (NK) cell cancer immunotherapy derived from a clonal master induced pluripotent stem cell (iPSC) line engineered to express a novel high-affinity (158V), non-cleavable CD16 (hnCD16) Fc receptor. CD16 mediates antibody-dependent cellular cytotoxicity (ADCC), a potent anti-tumor mechanism by which NK cells recognize, bind and kill antibody-coated cancer cells. CD16 occurs in two variants, either with high (158V) or low (158F) affinity for the Fc domain of IgG1 antibodies. Numerous clinical studies with FDA-approved tumor-targeting antibodies, including rituximab, trastuzumab and cetuximab, have demonstrated that patients homozygous for the CD16 high-affinity variant (approximately 15% of patients) have improved clinical outcomes. In addition, the expression of CD16 can undergo considerable down-regulation in cancer patients, which significantly inhibits the immune system’s anti-tumor response. FT516 incorporates a novel CD16 Fc receptor, which has been modified to prevent its down-regulation and augment its binding to tumor-targeting antibodies for enhanced ADCC. The Company announced in February 2019 that the FDA allowed its FT516 IND application for the treatment of relapsed / refractory hematologic malignancies including in combination with certain FDA-approved monoclonal antibody therapies.
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 to treat many patients. 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. Fate Therapeutics’ iPSC product platform is supported by an intellectual property portfolio of over 100 issued patents and 100 pending patent applications.