Fate Therapeutics Selected for Four Presentations Highlighting its Off-the-Shelf CAR T-Cell Portfolio in Autoimmune Disease at ACR Convergence 2026
SAN DIEGO, Sept. 16, 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 disease, today announced that four abstracts from its off-the-shelf CAR T-cell programs have been selected for presentation at the American College of Rheumatology (ACR) Convergence 2026, being held November 6-11 in Orlando, Florida.
Presentations span clinical, translational, and patient-centered research across the Company’s autoimmune focused, off-the-shelf, iPSC-derived CAR T-cell pipeline, including FT819 and FT839. Two FT819 presentations will feature updated clinical data, including administration of FT819 without the use of conditioning chemotherapy, the overview of a unique biomarker association with quality-of-life improvement, and continued progress on outpatient administration to expand community-based access, including in underserved regions. A third presentation details a patient perspective focus group study conducted in collaboration with the Lupus Foundation of America, which explores patient preferences for off-the-shelf, allogeneic CAR T-cell therapy in lupus. The final presentation will provide an update on preclinical studies and the design and progress of the COMPLETE Trial, a recently cleared Phase 1/2 clinical trial of FT839, the company’s off-the-shelf, dual-CAR T-cell product candidate co-targeting CD19 and CD38 for the comprehensive elimination of multicellular drivers of autoimmune diseases, including in rheumatoid arthritis (RA).
"The breadth of clinical progress we have made as a team and are sharing at the ACR Convergence reflects both the maturation of our off-the-shelf CAR T-cell portfolio in autoimmune disease and our commitment to making cell therapy accessible to all patients in need of such transformative therapy," said Bob Valamehr, President and Chief Executive Officer of Fate Therapeutics. "We continue to observe an encouraging and class-leading safety and tolerability profile for FT819, along with meaningful clinical outcomes that are driving enrollment and clinician engagement as well as enabling CAR T-cell administration in the outpatient and community setting with same-day discharge, a unique and meaningful step in extending access beyond specialized treatment centers. Through our continued partnership with the Lupus Foundation of America to keep the patient voice at the center of our work, a patient perspective presentation reinforces our conviction that cell therapy delivered with less intensive or no conditioning chemotherapy, in an off the shelf setting, is preferred and can simplify the CAR T-cell treatment paradigm to improve quality of life for people living with such challenging disease."
Details of the presentations are as follows:
Title: FT839: An Off-the-Shelf, Dual CAR T-Cell Therapy for the Comprehensive Elimination of Multicellular Drivers of Rheumatoid Arthritis
Presentation Type: Poster
Session: Poster Session A, Rheumatoid Arthritis - Treatment
Date and Time: Sunday, November 8, 2026, 10:30 a.m. – 12:30 p.m. ET
Abstract #: 0453
Title: Off-the-Shelf CD19 CAR T-cell Therapy Demonstrates Feasibility of Outpatient Administration, Expanding Access to Community-Based Care
Presentation Type: Poster
Session: Poster Session B, Systemic Lupus Erythematosus - Treatment
Date and Time: Monday, November 9, 2026, 10:30 a.m. – 12:30 p.m. ET
Abstract #: 1234
Title: Off-the-Shelf Anti-CD19 CAR T-cell Therapy Efficacy Reveals Biomarker Candidates for Fatigue in SLE
Presentation Type: Poster
Session: Poster Session B, Systemic Lupus Erythematosus – Etiology & Pathogenesis
Date and Time: Monday, November 9, 2026, 10:30 a.m. – 12:30 p.m. ET
Abstract #: 1024
Title: Patient Perspectives on Allogeneic CAR T Cell Therapy in Systemic Lupus Erythematosus: Findings from a Focus Group Study (Part 3)
Presentation Type: Poster
Session: Poster Session B, Patient Outcomes, Preferences, & Attitudes
Date and Time: Monday, November 9, 2026, 10:30 a.m. – 12:30 p.m. ET
Abstract #: 1539
The accepted abstracts can be accessed on the ACR Convergence 2026 website. Presentation materials will be available following the event on the Fate website, located here: Fate Publications & Presentations.
About FT819
FT819 is an off-the-shelf CD19-targeting chimeric antigen receptor (CAR) T-cell product candidate engineered to improve safety and efficacy. Analogous to master cell banks used to mass produce biopharmaceutical drug products such as monoclonal antibodies, a precisely engineered clonal master induced pluripotent stem cell (iPSC) bank serves as the starting cell source to manufacture FT819, overcoming numerous limitations associated with patient- and donor-sourced CAR T-cell therapies. FT819 is well-defined and uniform in composition, produced at a low cost of goods, and can be stored in inventory for off-the-shelf, on-demand availability to enable access for a broad patient population. This research was additionally made possible by funding from the California Institute for Regenerative Medicine (CIRM), a state agency in California that supports research in regenerative medicine, stem cell therapy, gene therapy, and clinical trials. (Grant number: CLIN2-16303)
About FT839
FT839 is the Company’s first multi-antigen, dual-CAR T-cell product candidate, designed to express two unique CARs—a first CAR targeting the B-cell lineage marker CD19 and a second CAR targeting CD38—to enable the comprehensive elimination of multiple cellular drivers of autoimmune disease. FT839 is armed with the Company’s novel Sword & Shield™ technology, which is designed to eliminate the need for conditioning chemotherapy. Following FDA clearance of its Investigational New Drug (IND) application, FT839 is advancing into a Phase 1/2 basket trial to evaluate FT839 across autoimmune indications, including rheumatoid arthritis, SLE, systemic sclerosis (SSc), ANCA-associated vasculitis (AAV), and idiopathic inflammatory myopathy (IIM).
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 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
