On November 5, 2020 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 four oral and eight poster presentations for the Company’s induced pluripotent stem cell (iPSC) product platform were accepted for presentation at the 62nd American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition being held virtually from December 5-8, 2020 (Press release, Fate Therapeutics, NOV 5, 2020, View Source [SID1234570002]).

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Accepted abstracts include a clinical case study of a patient treated with FT596 at the first dose level (30 million cells) as a monotherapy in the Company’s Phase 1 clinical trial for the treatment of relapsed / refractory B-cell lymphoma (NCT04245722). FT596 is the Company’s universal, off-the-shelf, chimeric antigen receptor (CAR) natural killer (NK) cell product candidate derived from a clonal master induced pluripotent stem cell (iPSC) line engineered with three anti-tumor functional modalities: a proprietary CAR optimized for NK cell biology that targets CD19 (CAR19); a novel high-affinity, non-cleavable CD16 (hnCD16) Fc receptor that enhances antibody-dependent cellular cytotoxicity (ADCC); and an IL-15 receptor fusion (IL-15RF) that augments NK cell activity. The accepted abstracts are available online through the ASH (Free ASH Whitepaper) conference website (www.hematology.org/Annual-Meeting/Abstracts/).

In addition, the Company plans to host a virtual investor event entitled "The Power of hnCD16" to highlight the unique therapeutic features and functionality of its novel hnCD16 Fc receptor, a core component incorporated in its iPSC-derived NK cell product candidates. The Company’s hnCD16 Fc receptor is designed to maximize ADCC, a potent anti-tumor mechanism by which NK cells recognize, bind and kill antibody-coated cancer cells, through enhanced binding to tumor-targeting antibodies and prevention of down-regulation commonly observed in cancer patients. Scientists from the Company have shown in a peer-reviewed publication (Blood. 2020;135(6):399-410) that hnCD16 iPSC-derived NK cells, compared to peripheral blood NK cells, elicit a more durable anti-tumor response and extend survival in combination with anti-CD20 monoclonal antibodies in an in vivo xenograft mouse model of human lymphoma.

Oral Presentations

CAR19 iPSC-Derived NK Cells Utilize the Innate Functional Potential Mediated through NKG2A-Driven Education and Override the HLA-E Check Point to Effectively Target B Cell Lymphoma
93; Session Name: 203. Lymphocytes, Lymphocyte Activation, and Immunodeficiency, including HIV and Other Infections: Pathogenesis and Immunotherapy; December 5, 2020
Development of a Novel MICA/B-Specific CAR as a Pan-Tumor Targeting Strategy for Off-the-Shelf, Cell-Based Cancer Immunotherapy
613; Session Name: 703. Adoptive Immunotherapy: Mechanisms and New Approaches: Adoptive Cell Therapy beyond CAR T cells; December 7, 2020
Generation of Multiplexed Engineered, Off-the-Shelf CAR T Cells Uniformly Carrying Multiple Anti-Tumor Modalities to Prevent Tumor Relapse
566; Session Name: 802. Chemical Biology and Experimental Therapeutics: Innovations in Therapy and Drug Screening; December 7, 2020
Engineered iPSC-Derived NK Cells Expressing Recombinant CD64 for Enhanced ADCC
67; Session Name: 704. Immunotherapies: Beyond T to NK; December 5, 2020
Poster Presentations

Initial Clinical Activity of FT596, a First-in-Class, Multi-Antigen Targeted, Off-the-Shelf, iPSCDerived CD19 CAR NK Cell Therapy in Relapsed / Refractory B-Cell Lymphoma
2356; Session Name: 704. Immunotherapies: Poster II; December 6, 2020
A Phase I Study of FT819, a First-of-Kind, Off-the-Shelf, iPSCDerived TCRLess CD19 CAR T Cell Therapy for the Treatment of Relapsed / Refractory B-Cell Malignancies
3267; Session Name: 704. Immunotherapies: Poster III; December 7, 2020
A Phase I Study of FT538, a First-of-Kind, Off-the-Shelf, Multiplexed Engineered, iPSC-Derived NK Cell Therapy As Monotherapy in Relapsed / Refractory Acute Myelogenous Leukemia and in Combination with Daratumumab or Elotuzumab in Relapsed / Refractory Multiple Myeloma
1449; Session Name: 704. Immunotherapies: Poster I; December 5, 2020
Triple Gene-Modified iPSC-Derived NK Cells Combined with Daratumumab for Targeted Immunotherapy Against AML
1947; Session Name: 615. Acute Myeloid Leukemia: Commercially Available Therapy, excluding Transplantation: Poster II; December 6, 2020
cGMP Mass Production of FT538, a First-of-Kind, Off-the-Shelf, Multiplexed Engineered Natural Killer Cell Cancer Immunotherapy Derived from a Clonal Master Induced Pluripotent Stem Cell Line
3279; Session Name: 711. Cell Collection and Processing: Poster III; December 7, 2020
FT576: Multi-Specific Off-the-Shelf CAR-NK Cell Therapy Engineered for Enhanced Persistence, Avoidance of Self-Fratricide and Optimized Mab Combination Therapy to Prevent Antigenic Escape and Elicit a Deep and Durable Response in Multiple Myeloma
1402; Session Name: 653. Myeloma/Amyloidosis: Therapy, excluding Transplantation: Poster I; December 5, 2020
Multiplexed Engineered, Off-the-Shelf T Cells Carrying Three Tumor-Associated Antigen-Targeting Modalities: CAR + Pan-Tumor Targeting TCR + CD16 Fc Receptor
1434; Session Name: 703. Adoptive Immunotherapy: Poster I; December 5, 2020
Novel Method for Clonal Selection of Multiplexed Engineered CAR-T Cells Which Uniquely Demonstrate Anti-Tumor Functionality in the Tumor Microenvironment
3263; Session Name: 703. Adoptive Immunotherapy: Mechanisms and New Approaches: Poster III; December 7, 2020
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 with multiple doses to deliver more effective pharmacologic activity, including in combination with 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 engineered 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 subject to batch-to-batch and cell-to-cell variability that can affect clinical safety and efficacy. Fate Therapeutics’ iPSC product platform is supported by an intellectual property portfolio of over 300 issued patents and 150 pending patent applications.