Chronicle Journal: Finance

Fate Therapeutics Announces Twelve Presentations at the 2020 ASH Annual Meeting

Four Oral Presentations Covering iPSC-derived Cell-based Cancer Immunotherapy Pipeline Accepted for Presentation

Company to Host Investor Event on Friday, December 4

SAN DIEGO, Nov. 05, 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, today announced 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) Annual Meeting and Exposition being held virtually from December 5-8, 2020.

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 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.

About Fate Therapeutics, Inc.
Fate Therapeutics is a clinical-stage biopharmaceutical company dedicated to the development of first-in-class cellular immunotherapies for cancer and immune disorders. The Company has established a leadership position in the clinical development and manufacture of universal, off-the-shelf cell products using its proprietary induced pluripotent stem cell (iPSC) product platform. The Company’s immuno-oncology product candidates include natural killer (NK) cell and T-cell cancer immunotherapies, which are designed to synergize with well-established cancer therapies, including immune checkpoint inhibitors and monoclonal antibodies, and to target tumor-associated antigens with chimeric antigen receptors (CARs). The Company’s immuno-regulatory product candidates include ProTmune™, a pharmacologically modulated, donor cell graft that is currently being evaluated in a Phase 2 clinical trial for the prevention of graft-versus-host disease, and a myeloid-derived suppressor cell immunotherapy for promoting immune tolerance in patients with immune disorders. Fate Therapeutics is headquartered in San Diego, CA. For more information, please visit www.fatetherapeutics.com.

Forward-Looking Statements
This release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995 including statements regarding the Company’s clinical studies and preclinical research and development programs. These and any other forward-looking statements in this release are based on management's current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to, the risk that results observed in prior studies of its product candidates, including preclinical studies and clinical trials of any of its product candidates, will not be observed in ongoing or future studies involving these product candidates, and the risk that the Company may cease or delay preclinical or clinical development of any of its product candidates for a variety of reasons (including requirements that may be imposed by regulatory authorities on the initiation or conduct of clinical trials or to support regulatory approval, difficulties or delays in subject enrollment in current and planned clinical trials, difficulties in manufacturing or supplying the Company’s product candidates for clinical testing, and any adverse events or other negative results that may be observed during preclinical or clinical development). For a discussion of other risks and uncertainties, and other important factors, any of which could cause the Company’s actual results to differ from those contained in the forward-looking statements, see the risks and uncertainties detailed in the Company’s periodic filings with the Securities and Exchange Commission, including but not limited to the Company’s most recently filed periodic report, and from time to time in the Company’s press releases and other investor communications. Fate Therapeutics is providing the information in this release as of this date and does not undertake any obligation to update any forward-looking statements contained in this release as a result of new information, future events or otherwise.

Contact:
Christina Tartaglia
Stern Investor Relations, Inc.
212.362.1200
christina@sternir.com

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