Included in the Company’s product candidate pipeline is FT819, the Company’s off-the-shelf, CD19-targeted, 1XX CAR T-cell product candidate comprised of CD8αß+ T cells. FT819 is currently in an ongoing multi-center, Phase 1 clinical trial for patients with moderate-to-severe systemic lupus erythematosus (SLE) where the trial is designed to evaluate the safety, pharmacokinetics, and anti-B cell activity of FT819 (NCT06308978). The first three patients, all of whom presented with active lupus nephritis, received fludarabine-free conditioning followed by a single dose of FT819. All three patients remain on-study, and there have been no dose-limiting toxicities. (Goulding et al., American College of Rheumatology Annual Conference 2024).
“The initial data from our use of FT819, where we have observed a favorable safety profile, first in the treatment of aggressive B cell lymphoma, and now in the initial stages of our SLE clinical trial, provide support for the potential of the company’s iPSC platform across different diseases”, said Dr. Valamehr, “The first lupus nephritis patient treated with a single dose of FT819 and fludarabine-free conditioning has achieved drug-free clinical remission and continues free of all immunosuppressive therapy. We will continue the trial of FT819 in SLE as we gather insights to implement an approval strategy for this novel off-the-shelf cellular immunotherapy. We also continue to push forward our other clinical programs, including FT825 / ONO-8250 CAR T-cell product candidate for treatment of advanced solid tumors pursued in collaboration with our partner Ono Pharmaceutical.”
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.
