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) 27th 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.