On November 6, 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 two oral and four poster presentations covering the Company’s off-the-shelf, induced pluripotent stem cell (iPSC)-derived natural killer (NK) cell and chimeric antigen receptor (CAR) T-cell product candidates will be featured at the 61stAmerican Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition (Press release, Fate Therapeutics, NOV 6, 2019, View Source [SID1234550461]). The meeting will be held December 7-10, 2019 in Orlando, Florida.
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In addition, this year’s ASH (Free ASH Whitepaper) press program will feature the Company’s FT596 product candidate. The "CAR-T and Beyond" press briefing will take place at 7:30 a.m. EST, Saturday, December 7, in the ASH (Free ASH Whitepaper) Press Briefing Room (W221DE) of the Orange County Convention Center. It is open to all media registered to attend the meeting.
"We are honored that FT596 has been selected by the ASH (Free ASH Whitepaper) Program Committee for feature in this year’s prestigious Annual Meeting Press Program," said Scott Wolchko, President and Chief Executive Officer of Fate Therapeutics. "The multi-antigen targeting functionality and off-the-shelf availability of FT596, combined with the intrinsic anti-tumor activity of NK cells, is a promising approach to overcome antigen escape and time-to-patient treatment, and has the potential to convey deeper and more durable responses to more patients. We look forward to highlighting the breadth of our novel off-the-shelf, iPSC-derived cell-based cancer immunotherapy pipeline this year at ASH (Free ASH Whitepaper)."
FT596 is among the first cell-based cancer immunotherapies to be manufactured from a master iPSC line, and is the first-ever cellular immunotherapy allowed for clinical investigation that is genetically engineered to contain three active anti-tumor modalities: a proprietary chimeric antigen receptor (CAR) targeting B-cell antigen CD19; a novel high-affinity, non-cleavable CD16 Fc receptor for enhanced binding to tumor-targeting antibodies; and an interleukin-15 receptor fusion (IL-15RF) for improved potency.
2019 ASH (Free ASH Whitepaper) Oral Presentations
FT538: Preclinical Development of an Off-the-Shelf Adoptive NK Cell Immunotherapy with Targeted Disruption of CD38 to Prevent Anti-CD38 Antibody-Mediated Fratricide and Enhance ADCC in Multiple Myeloma When Combined with Daratumumab
Publication Number: 133
Session Name: 652. Myeloma: Pathophysiology and Pre-Clinical Studies, excluding Therapy: Modeling Cellular Immunity and Tumor Microenvironment in Multiple Myeloma
Date and Time: Saturday, December 7, 2019, 9:30 AM
Location: Orange County Convention Center, Valencia A (W415A)
FT596: Translation of First-of-Kind Multi-Antigen Targeted Off-the-Shelf CAR-NK Cell with Engineered Persistence for the Treatment of B Cell Malignancies
Publication Number: 301
Session: 625. Lymphoma: Pre-Clinical – Chemotherapy and Biologic Agents: Targeting Apoptosis Pathways in Lymphoma Infections: Pre-clinical T and NK Cell Immunotherapies
Date and Time: Saturday, December 7, 2019, 4:00 PM
Location: Orange County Convention Center, Valencia A (W415A)
2019 ASH (Free ASH Whitepaper) Poster Presentations
FT500 iPSC-Derived NK Cells Synergize with T Cells and Anti-PD-1 Antibody to Mediate Durable Anti-Tumor Responses In Vivo
Publication Number: 1933
Session: 703. Adoptive Immunotherapy: Mechanisms and New Approaches: Poster I
Date and Time: Saturday, December 7, 2019, 5:30 PM – 7:30 PM
Location: Orange County Convention Center, Hall B
FT576: A Novel Multiplexed Engineered Off-the-Shelf Natural Killer Cell Immunotherapy for the Dual-Targeting of CD38 and BCMA for the Treatment of Multiple Myeloma
Publication Number: 3214
Session: 703. Adoptive Immunotherapy: Mechanisms and New Approaches: Poster II
Date and Time: Sunday, December 8, 2019, 6:00 PM – 8:00 PM
Location: Orange County Convention Center, Hall B
NK Cells Lacking CD38 Are Resistant to Oxidative Stress-Induced Death
Publication Number: 3215
Session: 703. Adoptive Immunotherapy: Mechanisms and New Approaches: Poster II
Date and Time: Sunday, December 8, 2019, 6:00 PM – 8:00 PM
Location: Orange County Convention Center, Hall B
FT819: Translation of Off-the-Shelf TCR-Less Trac-1XX CAR-T Cells in Support of First-of-Kind Phase I Clinical Trial
Session: 703. Adoptive Immunotherapy: Mechanisms and New Approaches: Poster III
Publication Number: 4434
Date and Time: Monday, December 9, 2019, 6:00 PM – 8:00 PM
Location: Orange County Convention Center, Hall B
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 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 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 250 issued patents and 150 pending patent applications.
About FT596
FT596 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 with three anti-tumor functional modalities: a proprietary chimeric antigen receptor (CAR) optimized for NK cell biology, which contains a NKG2D transmembrane domain, a 2B4 co-stimulatory domain and a CD3-zeta signaling domain, that targets B-cell antigen CD19; a novel high-affinity 158V, non-cleavable CD16 Fc receptor that has been modified to augment antibody-dependent cellular cytotoxicity by preventing CD16 down-regulation and enhancing CD16 binding to tumor-targeting antibodies; and an IL-15 receptor fusion (IL-15RF) that promotes enhanced NK cell activity. The FDA has allowed investigation of FT596 in an open-label Phase 1 clinical trial as a monotherapy and in combination with rituximab for the treatment of advanced B-cell malignancies and in combination with obinutuzumab for the treatment of chronic lymphocytic leukemia. In preclinical studies of FT596, the Company has demonstrated that dual activation of the CAR19 and CD16 receptors, in combination with IL-15RF signaling, convey synergistic anti-tumor activity. Increased degranulation and cytokine release were observed upon dual receptor activation in lymphoma cancer cells as compared to activation of each receptor alone, indicating that multi-antigen engagement may elicit a deeper and more durable response. Additionally, in a mixed cellular composition cytotoxicity assay comprised of CD19+ and CD19- tumor cells, FT596 combined with CD20-directed monoclonal antibody therapy effectively eliminated the heterogeneous population of tumor cells, a result that was not observed with single-antigen targeted CAR19 T cells.