On November 1, 2018 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 three oral and four poster presentations detailing clinical and preclinical data will be featured at the 60thAmerican Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition. The meeting will be held December 1-4, 2018 in San Diego, California (Press release, Fate Therapeutics, NOV 1, 2018, View Source [SID1234530540]).
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iPSC Product Platform
The Company’s iPSC product platform will be highlighted in two oral presentations and three poster presentations. An oral presentation will highlight new preclinical data of FT500, the Company’s universal, off-the-shelf natural killer (NK) cell product candidate derived from a clonal master induced pluripotent stem cell (iPSC) line. Using an in vitro three-dimensional tumor spheroid model, the Company demonstrated that FT500, in combination with activated T cells and an anti-PD1 antibody, led to near complete elimination of target cells (>99% reduction) as compared to FT500 or activated T cells alone. A second oral presentation will highlight in vitro proof-of-concept data demonstrating the anti-tumor activity of iPSC-derived, receptor-engineered NK cells in combination with tumor-specific engager molecules, such as a NKG2C/IL15/CD33 tri-specific killer engager. Additional off-the-shelf cell product candidates, including the Company’s first iPSC-derived chimeric antigen receptor (CAR) T-cell (FT819) and CAR NK cell (FT519) product candidates, will be featured in poster presentations.
FATE-NK100
An oral presentation will describe a next-generation, GMP-compliant protocol established by Dr. Karl-Johan Malmberg for production of adaptive memory NK cells having homogeneous expression of a single inhibitory killer cell immunoglobulin-like receptor (KIR). Notably, the NK cells also lack expression of the HLA-E binding inhibitory receptor NKG2A, which is a dominant NK cell immune checkpoint receptor. The approach, which was developed under the Company’s research collaboration with Oslo University Hospital, enables highly-specific, adaptive memory NK cells to be robustly expanded ex vivo for administration to KIR-mismatched patients to maximize anti-tumor potency.
ProTmune
The Company will present new clinical data from the Phase 1 PROTECT study of ProTmune, the Company’s next-generation hematopoietic cell graft for patients with hematologic malignancies undergoing allogeneic hematopoietic cell transplantation (HCT). Key clinical outcomes, including disease-free survival and freedom from chronic graft-versus-host disease (GvHD), cancer relapse, and death at one-year following HCT, from the seven subjects receiving ProTmune in the Phase 1 clinical trial will be featured in a poster presentation.
2018 ASH (Free ASH Whitepaper) Oral Presentations
FT500 iPSC-Derived NK Cell Cancer Immunotherapy
Title: iPSC-Derived NK Cells and Anti-PD1 Antibody Synergize to Enhance T-Cell Cytokine and Cytolytic Responses Against Multiple Tumors
Last Author: Jeffrey S. Miller, MD, Deputy Director of the Masonic Cancer Center, University of Minnesota
Publication Number: 730
Session: 203. Lymphocytes, Lymphocyte Activation, and Immunodeficiency, including HIV and Other Infections: Pre-clinical T and NK Cell Immunotherapies
Date and Time: Monday, December 3, 2018, 3:30 PM
Location: San Diego Convention Center, Room 8
iPSC Product Platform
Title: iPSC-Derived NK Cells Genetically Modified to Express NKG2C/DAP12 Mediate Potent Function When Targeted through an NKG2C/IL15/CD33 Tri-Specific Killer Engager (TriKE)
Last Author: Jeffrey S. Miller, MD, Deputy Director of the Masonic Cancer Center, University of Minnesota
Publication Number: 729
Session: 203. Lymphocytes, Lymphocyte Activation, and Immunodeficiency, including HIV and Other Infections: Pre-clinical T and NK Cell Immunotherapies
Date and Time: Monday, December 3, 2018, 3:15 PM
Location: San Diego Convention Center, Room 8
Adaptive Memory NK Cells
Title: Efficient Scale-up and Preclinical Evaluation of NKG2C+ Adaptive NK Cell Expansion for Therapy Against High-risk AML/MDS
Last Author: Karl-Johan Malmberg, MD, PhD, Group Leader, Department of Cancer Immunology, Oslo University Hospital
Publication Number: 195
Session: 711. Cell Collection and Processing II
Date and Time: Saturday, December 1, 2018, 2:30 PM
Location: Manchester Grand Hyatt San Diego, Grand Hall A
2018 ASH (Free ASH Whitepaper) Poster Presentations
FT819 iPSC-derived CAR T-Cell Cancer Immunotherapy
Title: Pluripotent Cell-Derived Off-the-Shelf TCR-Less CAR-Targeted Cytotoxic T Cell Therapeutic for the Allogeneic Treatment of B Cell Malignancies
Last Author: Bob Valamehr, PhD, Chief Development Officer, Fate Therapeutics
Publication Number: 4546
Session: 703. Adoptive Immunotherapy: Poster III
Date and Time: Monday, December 3, 2018, 6:00 PM – 8:00 PM
Location: San Diego Convention Center, Hall GH
FT519 iPSC-derived CAR NK Cell Cancer Immunotherapy
Title: Off-the-Shelf Natural Killer Cells with Multi-Functional Engineering Using a Novel Anti-CD19 Chimeric Antigen Receptor Combined with Stabilized CD16 and IL15 Expression to Enhance Directed Anti-Tumor Activity
Last Author: Dan S. Kaufman, MD, PhD, Director of Cell Therapy, UCSD
Publication Number: 4541
Session: 703. Adoptive Immunotherapy: Poster III
Date and Time: Monday, December 3, 2018, 6:00 PM – 8:00 PM
Location: San Diego Convention Center, Hall GH
FT538 iPSC-derived hnCD16, CD38-null NK Cell Cancer Immunotherapy
Title: CD38 Deficient, CD16 Engineered NK Cells Exhibit Enhanced Antibody Dependent Cellular Cytotoxicity without NK Cell Fratricide to Augment Anti-Myeloma Immunity in Combination with Daratumumab
Last Author: Jeffrey S. Miller, MD, Deputy Director of the Masonic Cancer Center, University of Minnesota
Publication Number: 3224
Session: 652. Myeloma: Pathophysiology and Pre-Clinical Studies, excluding Therapy: Poster II
Date and Time: Sunday, December 2, 2018, 6:00 PM – 8:00 PM
Location: San Diego Convention Center, Hall GH
ProTmune
Title: ProTmune, a Next-Generation Graft for GvHD Prophylaxis in Allogeneic Hematopoietic Cell Transplantation: 1-Year Safety and Efficacy Phase 1 Data
First Author: Richard Maziarz, MD, Principal Investigator, Oregon Health Sciences University
Session: 732. Clinical Allogeneic Transplantation: Results
Publication Number: 2167
Date and Time: Saturday, December 1, 2018, 6:15 PM – 8:15 PM
Location: San Diego Convention Center, Hall GH
About ProTmune
ProTmune is an investigational next-generation hematopoietic cell graft for the prevention of acute graft-versus-host disease (GvHD) in patients undergoing allogeneic hematopoietic cell transplantation (HCT). ProTmune is manufactured by pharmacologically modulating a donor-sourced, mobilized peripheral blood graft ex vivo with two small molecules (FT1050 and FT4145) to decrease the incidence and severity of acute GvHD while maintaining the anti-leukemia activity of the graft. ProTmune has been granted Orphan Drug and Fast Track Designations by the U.S. Food and Drug Administration, and Orphan Medicinal Product Designation by the European Commission. ProTmune is currently being investigated in a randomized, controlled and double-blinded Phase 2 clinical trial in adult subjects with hematologic malignancies undergoing matched unrelated donor HCT.
About FATE-NK100
FATE-NK100 is an investigational, first-in-class, allogeneic donor-derived natural killer (NK) cell cancer immunotherapy comprised of adaptive memory NK cells, a highly specialized and functionally distinct subset of activated NK cells expressing the maturation marker CD57. Higher frequencies of CD57+ NK cells in the peripheral blood or tumor microenvironment in cancer patients have been linked to better clinical outcomes. In August 2017, non-clinical data describing the unique properties and anti-tumor activity of FATE-NK100 were published by Cancer Research (doi:10.1158/0008-5472.CAN-17-0799), a peer-reviewed journal of the American Association of Cancer Research. Three clinical trials of FATE-NK100 are currently being conducted: VOYAGE for the treatment of refractory or relapsed acute myelogenous leukemia; APOLLO for the treatment of recurrent ovarian cancer; and DIMENSION for the treatment of advanced solid tumors, including in combination with monoclonal antibody therapy.