FT596 Selected by ASH for Feature at “CAR-T and Beyond” Press Conference on December 7

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

Company to Host Investor Event at ASH on December 6

SAN DIEGO, Nov. 06, 2019 (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 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 61^st American Society of Hematology (ASH) Annual Meeting and Exposition. The meeting will be held December 7-10, 2019 in Orlando, Florida.

In addition, this year’s ASH 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 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 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.”

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 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 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.

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

Source: Fate Therapeutics, Inc.