Key Therapeutic Mechanisms of Clinical Activity for Autoimmune Diseases, including B cell Depletion, Tissue Infiltration and Immune Reconstitution Data, from Phase 1 Study of FT819 in Relapsed / Refractory B-cell Malignancies to be Highlighted

Patient Enrollment Initiated in Phase 1 Study of FT819 Off-the-shelf, CD19-targeted, iPSC-derived CAR T-cell Therapy for Systemic Lupus Erythematosus

SAN DIEGO, April 22, 2024 (GLOBE NEWSWIRE) -- Fate Therapeutics, Inc. (NASDAQ: FATE), a clinical-stage biopharmaceutical company dedicated to bringing a first-in-class pipeline of induced pluripotent stem cell (iPSC)-derived cellular immunotherapies to patients with cancer and autoimmune diseases, today announced that two presentations will be featured at the American Society of Gene and Cell Therapy (ASGCT) 27^th Annual Meeting, being held in Baltimore, Maryland on May 7-11, 2024.

The Company will present data of key therapeutic mechanisms of activity for autoimmune diseases, including B cell depletion, tissue infiltration and immune reconstitution, from its Phase 1 study of FT819 in relapsed / refractory B-cell malignancies. FT819 is the Company’s off-the-shelf, CD19-targeted, iPSC-derived CAR T-cell program, which is also being investigated in a Phase 1 study for patients with moderate-to-severe systemic lupus erythematosus (SLE) including lupus nephritis and extrarenal lupus (NCT06308978). In addition, the Company will highlight preclinical data from its off-the-shelf, iPSC-derived, CAR T-cell product platform for solid tumors, with an oral presentation of a novel MICA/B-targeted CAR T-cell product candidate that is designed to target a broad array of tumor types and to overcome immune cell evasion by shedding of stress ligands.

Accepted abstracts are available on the ASGCT Annual Meeting website. Presentations details are as follows:

Presentations

FT819-102: Clinical translation of off-the-shelf, TCR-less, CD8αβ+ anti-CD19 CAR-T cells for the treatment of B cell-mediated autoimmune disorders
Abstract Number: 1415
Session: Cell Therapy and Cell-Based Gene Therapy Trials
Location: Exhibit Hall
Presentation Date / Time: Thursday, May 9, 2024 12:00 PM

Novel α3-MICA/B-specific CAR T-cell immunotherapy demonstrates ubiquitous targeting of cancer cells and resistance to immune-surveillance evasion
Abstract Number: 45
Session: Genetically Modified Immune Cells for Malignant and Non-Malignant Diseases
Location: Room 307-308
Presentation Date / Time: Tuesday May 7, 2024 3:00 PM

About Fate Therapeutics’ iPSC Product Platform
Human induced pluripotent stem cells (iPSCs) possess the unique dual properties of unlimited self-renewal and differentiation potential into all cell types of the body. The Company’s proprietary iPSC product platform combines multiplexed-engineering of human iPSCs with single-cell selection to create clonal master iPSC lines. Analogous to master cell lines used to mass produce biopharmaceutical drug products such as monoclonal antibodies, the Company utilizes its clonal master iPSC lines as a starting cell source to manufacture engineered cell products which are well-defined and uniform in composition, can be stored in inventory for off-the-shelf availability, can be combined and administered with other therapies, and can potentially reach a broad patient population. As a result, the Company’s platform is uniquely designed to overcome numerous limitations associated with the manufacture of cell therapies using patient- or donor-sourced cells. Fate Therapeutics’ iPSC product platform is supported by an intellectual property portfolio of over 500 issued patents and 500 pending patent applications.

About Fate Therapeutics, Inc.
Fate Therapeutics is a clinical-stage biopharmaceutical company dedicated to bringing a first-in-class pipeline of induced pluripotent stem cell (iPSC)-derived cellular immunotherapies to patients with cancer and autoimmune diseases. Using its proprietary iPSC product platform, the Company has established a leadership position in creating multiplexed-engineered master iPSC lines and in the manufacture and clinical development of off-the-shelf, iPSC-derived cell products. The Company’s pipeline includes iPSC-derived natural killer (NK) cell and T-cell product candidates, which are selectively designed, incorporate novel synthetic controls of cell function, and are intended to deliver multiple therapeutic mechanisms to patients. 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 advancement of and plans related to the Company's product candidates, clinical studies and preclinical research and development programs, the Company’s progress, plans and timelines for the clinical investigation of its product candidates, including the initiation and continuation of enrollment in the Company’s clinical trials, the timing and availability of data from the Company’s clinical trials, the therapeutic and market potential of the Company’s research and development programs and product candidates, and the potential capabilities and benefits of the Company’s iPSC product platform. 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 the Company’s research and development programs and product candidates, including those product candidates in clinical investigation, may not demonstrate the requisite safety, efficacy, or other attributes to warrant further development or to achieve regulatory approval, the risk that results observed in prior studies of the Company’s product candidates, including preclinical studies and clinical trials, will not be observed in ongoing or future studies involving these product candidates, the risk of a delay or difficulties in the manufacturing of the Company’s product candidates or in the initiation and conduct of, or enrollment of patients in, any clinical trials, 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, changes in the therapeutic, regulatory, or competitive landscape for which the Company’s product candidates are being developed, the amount and type of data to be generated or otherwise to support regulatory approval, difficulties or delays in patient enrollment and continuation in the Company’s ongoing and planned clinical trials, difficulties in manufacturing or supplying the Company’s product candidates for clinical testing, failure to demonstrate that a product candidate has the requisite safety, efficacy, or other attributes to warrant further development, and any adverse events or other negative results that may be observed during preclinical or clinical development), and the risk that its product candidates may not produce therapeutic benefits or may cause other unanticipated adverse effects. 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.tartaglia@sternir.com