Fate Therapeutics Announces Phase 1 Data Presentation of FT819 Off-the-Shelf CAR T-cell Product Candidate for SLE at EULAR 2025 Congress
Fate Therapeutics (NASDAQ: FATE) has announced that it will present clinical data from its Phase 1 trial of FT819, an off-the-shelf CD19-targeted CAR T-cell therapy, for systemic lupus erythematosus (SLE) at the EULAR 2025 Congress in Barcelona. The study evaluates FT819's safety and activity using either a fludarabine-free conditioning regimen or maintenance therapy without conditioning.
The company will deliver an oral presentation on treating refractory SLE with their iPSC-derived therapy, along with two poster presentations focusing on next-generation CAR T-cells and CAR-NK cell therapy. These presentations highlight Fate's innovative approaches, including Sword and Shield technology and multi-antigen targeting, aimed at eliminating the need for conditioning chemotherapy and enabling outpatient treatment.
Fate Therapeutics (NASDAQ: FATE) ha annunciato che presenterà i dati clinici del suo trial di Fase 1 su FT819, una terapia CAR T-cellulare off-the-shelf mirata al CD19, per il lupus eritematoso sistemico (LES) al Congresso EULAR 2025 a Barcellona. Lo studio valuta la sicurezza e l'efficacia di FT819 utilizzando un regime di condizionamento senza fludarabina o una terapia di mantenimento senza condizionamento.
L'azienda terrà una presentazione orale sul trattamento del LES refrattario con la loro terapia derivata da iPSC, insieme a due presentazioni poster focalizzate sulle CAR T-cell di nuova generazione e sulla terapia CAR-NK. Queste presentazioni mettono in evidenza gli approcci innovativi di Fate, tra cui la tecnologia Sword and Shield e il targeting multi-antigene, volte a eliminare la necessità della chemioterapia di condizionamento e a permettere un trattamento ambulatoriale.
Fate Therapeutics (NASDAQ: FATE) ha anunciado que presentará datos clínicos de su ensayo de Fase 1 de FT819, una terapia CAR T celular dirigida al CD19 y lista para usar, para lupus eritematoso sistémico (LES) en el Congreso EULAR 2025 en Barcelona. El estudio evalúa la seguridad y actividad de FT819 usando un régimen de acondicionamiento sin fludarabina o terapia de mantenimiento sin acondicionamiento.
La compañía realizará una presentación oral sobre el tratamiento del LES refractario con su terapia derivada de iPSC, junto con dos presentaciones en formato póster centradas en células CAR T de próxima generación y terapia CAR-NK. Estas presentaciones destacan los enfoques innovadores de Fate, incluyendo la tecnología Sword and Shield y el direccionamiento multiantígeno, orientados a eliminar la necesidad de quimioterapia de acondicionamiento y permitir el tratamiento ambulatorio.
Fate Therapeutics (NASDAQ: FATE)는 바르셀로나에서 열리는 EULAR 2025 학회에서 전신성 홍반성 루푸스(SLE)를 위한 CD19 표적 오프더쉘프 CAR T 세포 치료제인 FT819의 1상 임상 데이터를 발표할 예정입니다. 본 연구는 플루다라빈이 없는 조절 요법 또는 조절 없이 유지 요법을 사용한 FT819의 안전성과 효능을 평가합니다.
회사는 iPSC 유래 치료제를 이용한 난치성 SLE 치료에 대해 구두 발표를 진행하며, 차세대 CAR T 세포 및 CAR-NK 세포 치료를 주제로 한 두 개의 포스터 발표도 함께 진행합니다. 이 발표들은 조절 화학요법의 필요성을 없애고 외래 환자 치료를 가능하게 하는 Sword and Shield 기술 및 다중 항원 표적화 등 Fate의 혁신적인 접근법을 강조합니다.
Fate Therapeutics (NASDAQ : FATE) a annoncé qu'elle présentera des données cliniques issues de son essai de Phase 1 sur FT819, une thérapie CAR T-cellulaire ciblant CD19 prête à l'emploi, pour le lupus érythémateux systémique (LES) lors du Congrès EULAR 2025 à Barcelone. L'étude évalue la sécurité et l'activité de FT819 en utilisant soit un régime de conditionnement sans fludarabine, soit une thérapie d'entretien sans conditionnement.
L'entreprise donnera une présentation orale sur le traitement du LES réfractaire avec leur thérapie dérivée de cellules iPSC, ainsi que deux présentations par affiches axées sur les CAR T-cells de nouvelle génération et la thérapie CAR-NK. Ces présentations mettent en lumière les approches innovantes de Fate, notamment la technologie Sword and Shield et le ciblage multi-antigénique, visant à éliminer le besoin de chimiothérapie de conditionnement et à permettre un traitement en ambulatoire.
Fate Therapeutics (NASDAQ: FATE) hat bekannt gegeben, dass es klinische Daten aus seiner Phase-1-Studie zu FT819, einer sofort einsatzbereiten CD19-gerichteten CAR-T-Zelltherapie für systemischen Lupus erythematodes (SLE), auf dem EULAR 2025 Kongress in Barcelona präsentieren wird. Die Studie bewertet die Sicherheit und Wirksamkeit von FT819 unter Verwendung eines fludarabinfreien Konditionierungsregimes oder einer Erhaltungstherapie ohne Konditionierung.
Das Unternehmen wird eine mündliche Präsentation zur Behandlung von refraktärem SLE mit ihrer iPSC-abgeleiteten Therapie halten sowie zwei Posterpräsentationen zu CAR-T-Zellen der nächsten Generation und CAR-NK-Zelltherapie vorstellen. Diese Präsentationen heben Fates innovative Ansätze hervor, darunter die Sword and Shield-Technologie und Multi-Antigen-Targeting, die darauf abzielen, die Notwendigkeit einer Konditionierungschemotherapie zu beseitigen und eine ambulante Behandlung zu ermöglichen.
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Insights
Fate Therapeutics will present early clinical data for its off-the-shelf CAR-T therapy for lupus, potentially offering a conditioning-free treatment option.
Fate Therapeutics has secured an oral presentation slot at the upcoming EULAR 2025 congress to showcase Phase 1 clinical data for FT819, their off-the-shelf CD19-targeted CAR T-cell therapy for systemic lupus erythematosus (SLE). This represents a significant development in the autoimmune disease space, where CAR-T approaches remain experimental but highly promising.
The most notable aspect of this study is its evaluation of fludarabine-free conditioning regimens. Traditional CAR-T therapies require intense lymphodepletion with chemotherapy agents like fludarabine, which can cause significant toxicity. Fate's approach could potentially eliminate this requirement, representing a major advance in patient safety and accessibility if the data proves positive.
Their iPSC-derived platform offers key advantages over traditional autologous CAR-T therapies. By creating cells from induced pluripotent stem cells rather than the patient's own T-cells, Fate can produce standardized, immediately available "off-the-shelf" products that don't require the weeks of manufacturing time needed for conventional CAR-T approaches.
The company will also present preclinical data on their "Sword and Shield" technology designed to enhance CAR-cell performance without conditioning chemotherapy. This suggests a comprehensive platform approach rather than a single product strategy.
While SLE affects approximately 1.5 million Americans and currently lacks curative treatments, it's important to note that this is still early-phase data. The oral presentation format suggests promising results, but without actual efficacy numbers in the press release, we should maintain measured expectations pending the actual data presentation in June.
Oral presentation of clinical data from FT819 Phase 1 study highlights safety and efficacy of fludarabine-free treatment paradigm in moderate-to-severe systemic lupus erythematosus (SLE)
SAN DIEGO, May 28, 2025 (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 off-the-shelf cellular immunotherapies to patients, today announced that clinical and preclinical data from the Company’s off-the-shelf cell therapy product platform will be featured at the European Alliance of Associations for Rheumatology European Congress of Rheumatology (EULAR 2025), being held in Barcelona, Spain on June 11-14, 2025.
The Company has been selected to provide an oral presentation featuring clinical data from its ongoing Phase 1 clinical trial of FT819, its off-the-shelf, CD19-targeted, 1XX CAR T-cell product candidate, in patients with moderate-to-severe systemic lupus erythematosus (SLE) (NCT06308978). The Phase 1 study is designed to evaluate the safety and activity of FT819 in patients receiving either a fludarabine (flu)-free conditioning regimen or maintenance therapy without conditioning. In addition, the Company will highlight preclinical and translational data from its off-the-shelf, iPSC-derived, CAR T-cell and CAR-NK cell product platform across multiple autoimmune indications, including the use of Sword and Shield technology and multi-antigen targeting to circumvent the need for conditioning chemotherapy, enhance therapeutic outcomes, and maximize patient access by enabling outpatient treatment.
Accepted abstracts are available on the EULAR 2025 website. Presentation details are as follows:
Oral Presentation
Treatment of Refractory Systemic Lupus Erythematosus with Off-the-Shelf iPSC-derived Anti-CD19 CAR T-cell Therapy
Session: Cell Therapies – CAR-T and Beyond
Presentation Date / Time: Wednesday, June 11, 2025 / 3:20 PM CEST
Poster Presentations
Next-Generation Off-the-Shelf CAR T Cells: A Novel Platform to Enable Comprehensive Elimination of Aberrant Effector Cells for the Treatment of Autoimmune Diseases in the Absence of Conditioning Chemotherapy
Session: Basic and Clinical Poster Tours: CAR T-cells and other emerging Therapies
Presentation Date / Time: Thursday, June 12, 2025 / 9:54am CEST
Next Generation CAR-NK cell Therapy Leverages Alloimmune Defense Technology to Persist Without Conditioning Chemotherapy for the Treatment of Autoimmune Disease
Session: Poster View VIII
Presentation Date / Time: Saturday, June 14, 2025 / 10:15-11:45am CEST
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 administered in combination 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 patient- and donor-sourced cell therapies. 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 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 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 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 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, 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, and the Company’s clinical and product development strategy. 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 and continued participation 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
Precision AQ
212.362.1200
christina.tartaglia@precisionaq.com
FAQ
What will Fate Therapeutics present at EULAR 2025 regarding FT819?
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