Three Oral and Four Poster Presentations Covering Product Pipeline Accepted for Presentation

Company to Host Investor Event at ASH on November 30

SAN DIEGO, Nov. 01, 2018 (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, announced today that three oral and four poster presentations detailing clinical and preclinical data will be featured at the 60^thAmerican Society of Hematology (ASH) Annual Meeting and Exposition. The meeting will be held December 1-4, 2018 in San Diego, California.

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 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 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.

About Fate Therapeutics’ iPSC Product Platform
The Company’s proprietary 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. Fate Therapeutics’ iPSC product platform is supported by an intellectual property portfolio of over 100 issued patents and 100 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 is pioneering the development of off-the-shelf cell products using its proprietary induced pluripotent stem cell (iPSC) product platform. The Company’s immuno-oncology pipeline is comprised of FATE-NK100, a donor-derived natural killer (NK) cell cancer immunotherapy that is currently being evaluated in three Phase 1 clinical trials, as well as iPSC-derived NK cell and T-cell immunotherapies, with a focus on developing augmented cell products intended to synergize with checkpoint inhibitor and monoclonal antibody therapies and to target tumor-specific antigens. The Company’s immuno-regulatory pipeline includes ProTmune™, a next-generation 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

Source: Fate Therapeutics, Inc.