SAN DIEGO, April 30, 2026 (GLOBE NEWSWIRE) -- Fate Therapeutics, Inc. (NASDAQ: FATE), a clinical-stage biopharmaceutical company dedicated to bringing a transformative pipeline of induced pluripotent stem cell (iPSC)-derived cellular immunotherapies to patients with cancer and autoimmune diseases, today announced that clinical data from the Company’s off-the-shelf CAR T-cell product candidate, FT819, will be featured at the Congress of Clinical Rheumatology – East meeting, being held in Destin, FL on April 30 - May 3, 2026.
The Company is participating in a Poster Rounding Session and will present an encore of its clinical data from the systemic lupus erythematosus (SLE) study arm of its ongoing Phase 1 trial evaluating FT819 in various autoimmune diseases. The presentation includes clinical safety, efficacy and translational data from 13 SLE patients with a data cutoff of December 23, 2025.
Highlights of the presentation include data from the first 10 SLE patients treated in Regimen A illustrating clinically meaningful improvements in disease activity and patient-reported outcome measures following a single dose treatment of FT819 combined with less-intensive fludarabine-free conditioning chemotherapy, among patients with at least 1 month of follow-up. These response were observed early and were maintained over time, as demonstrated by, i) SLEDAI-2K: Scores decreased by 13 points from baseline at Month 6 (mean ± SEM), ii) PGA: Scores decreased by 1.75 points from baseline at Month 6 (mean ± SEM); iii) UPCr: Levels decreased by 0.90 and 1.14 mg/mg from baseline at Months 3 and 6, respectively (mean ± SEM), and iv) FACIT-Fatigue: Scores improved by 23.4 ± 5.98 and 24.3 ± 3.07 points from baseline at Months 3 and 6, respectively (mean ± SEM).
Poster Presentation
Title: Safety and Efficacy of an Off-the-Shelf Anti-CD19 CAR T-Cell Therapy with Reduced Conditioning in SLE: A Phase 1 Study
Session: CCR-East Faculty Poster Rounding Session
Presentation Date / Time: Friday, May 1, 2026 / 2:55 p.m. to 6:00 p.m. EDT
About Fate Therapeutics, Inc.
Fate Therapeutics is a clinical-stage biopharmaceutical company dedicated to bringing a pipeline of induced pluripotent stem cell (iPSC)-derived cellular immunotherapies to patients. Using its proprietary iPSC product platform, the Company has established a leadership position in creating multiplexed-engineered iPSC lines and in the manufacture and clinical development of off-the-shelf, iPSC-derived cell products. The Company’s pipeline includes iPSC-derived T-cell and natural killer (NK) 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 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 Company’s plans to submit IND applications for its product candidates, the initiation and continuation of enrollment in the Company’s clinical trials, the initiation of additional clinical trials, including in new indications, and additional dose cohorts in ongoing clinical trials of the Company’s product candidates, the availability of data from the Company’s clinical trials and the Company’s plans to provide updates on its clinical trials, the therapeutic and market potential of the Company’s research and development programs and product candidates, the Company’s clinical and product development strategy, and the Company’s progress and plans relating to, and the anticipated timing and outcome of, interactions with the FDA and other regulatory authorities, including its expectations relating to alignment with regulatory authorities on potential registrational pathways for FT819. 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), the risk that its product candidates may not produce therapeutic benefits or may cause other unanticipated adverse effects, and risks relating to regulatory interactions and the outcome of such interactions. 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:
Ryan Douglas
Fate Therapeutics, Inc.
IR@fatetherapeutics.com
