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Fate Therapeutics Announces Presentation of FT819 Proof-of-Concept Data for B cell-mediated Autoimmune Diseases at ASGCT Annual Meeting

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Fate Therapeutics announces presentation of FT819 proof-of-concept data for B cell-mediated autoimmune diseases at ASGCT Annual Meeting. The data highlights key therapeutic mechanisms of clinical activity, including B cell depletion, tissue infiltration, and immune reconstitution, from Phase 1 study of FT819 in relapsed/refractory B-cell malignancies. The company also initiated patient enrollment in a Phase 1 study of FT819 off-the-shelf, CD19-targeted, iPSC-derived CAR T-cell therapy for systemic lupus erythematosus.
Fate Therapeutics annuncia la presentazione dei dati prova-di-concetto di FT819 per le malattie autoimmuni mediate da cellule B durante il meeting annuale dell'ASGCT. I dati evidenziano i principali meccanismi terapeutici dell'attività clinica, inclusa la deplezione delle cellule B, l'infiltrazione tissutale e la ricostituzione immunitaria, da uno studio di Fase 1 su FT819 in malattie maligne delle cellule B recidivate/refrattarie. L'azienda ha inoltre avviato l'arruolamento di pazienti in uno studio di Fase 1 sulla terapia CAR T-cell derivata da iPSC, mirata al CD19 e pronta all'uso, per il lupus eritematoso sistemico.
Fate Therapeutics anuncia la presentación de datos de prueba de concepto de FT819 para enfermedades autoinmunes mediadas por células B en la Reunión Anual de ASGCT. Los datos destacan los principales mecanismos terapéuticos de la actividad clínica, incluyendo la depleción de células B, la infiltración tisular y la reconstitución inmune, a partir de un estudio de Fase 1 de FT819 en malignidades de células B recurrentes/refractarias. La compañía también inició el reclutamiento de pacientes en un estudio de Fase 1 de terapia CAR T-cell derivada de iPSC orientada a CD19 y lista para usar, para el lupus eritematoso sistémico.
Fate Therapeutics가 ASGCT 연례 회의에서 B 세포 매개 자가면역 질환에 대한 FT819 개념 증명 데이터를 발표합니다. 이 데이터는 재발/내성 B 세포 악성 종양에 대한 FT819 1상 연구에서 B 세포 고갈, 조직 침입 및 면역 재구성을 포함한 주요 치료 메커니즘을 강조합니다. 또한 회사는 전신성 홍반성 루푸스를 위한 iPSC 유래 CD19 표적 CAR T-세포 치료제의 임상 1상 연구에 환자 등록을 시작했습니다.
Fate Therapeutics annonce la présentation des données de preuve de concept de FT819 pour les maladies auto-immunes médiées par les cellules B lors de la réunion annuelle de l'ASGCT. Les données mettent en évidence les principaux mécanismes thérapeutiques de l'activité clinique, y compris la déplétion des cellules B, l'infiltration tissulaire et la reconstitution immunitaire, à partir d'une étude de phase 1 sur FT819 dans les malignités des cellules B récidivantes/réfractaires. La société a également initié l'enrôlement de patients dans une étude de phase 1 de la thérapie CAR T-cell dérivée d'iPSC ciblée CD19 pour le lupus érythémateux systémique.
Fate Therapeutics kündigt die Präsentation von Proof-of-Concept-Daten für FT819 bei B-Zell-vermittelten Autoimmunerkrankungen auf der jährlichen ASGCT-Tagung an. Die Daten unterstreichen die wesentlichen therapeutischen Mechanismen der klinischen Aktivität, einschließlich B-Zell-Depletion, Gewebeinfiltration und Immunrekonstitution, aus einer Phase-1-Studie von FT819 bei rezidivierenden/refraktären B-Zell-Malignomen. Das Unternehmen hat auch die Patientenrekrutierung in einer Phase-1-Studie von FT819 als CD19-zielgerichtete, iPSC-abgeleitete CAR-T-Zell-Therapie für systemischen Lupus erythematodes begonnen.
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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.

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.

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, including the initiation and continuation of enrollment in the Company’s clinical trials, the timing and availability of data from the Company’s clinical trials, the therapeutic and market potential of the Company’s research and development programs and product candidates, and the potential capabilities and benefits of the Company’s iPSC product platform. 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), 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
Stern Investor Relations, Inc.
212.362.1200
christina.tartaglia@sternir.com


FAQ

What is the focus of Fate Therapeutics' presentation at the ASGCT Annual Meeting?

The focus of Fate Therapeutics' presentation is on FT819 proof-of-concept data for B cell-mediated autoimmune diseases.

What are the key therapeutic mechanisms highlighted in the presentation?

The presentation highlights key therapeutic mechanisms of clinical activity, including B cell depletion, tissue infiltration, and immune reconstitution.

What is FT819 and its primary target?

FT819 is an off-the-shelf, CD19-targeted, iPSC-derived CAR T-cell therapy program targeting B cell-mediated autoimmune diseases.

What study did Fate Therapeutics initiate patient enrollment for FT819 in?

Fate Therapeutics initiated patient enrollment in a Phase 1 study for FT819 in systemic lupus erythematosus.

When and where will the ASGCT Annual Meeting be held?

The ASGCT Annual Meeting will be held in Baltimore, Maryland on May 7-11, 2024.

Fate Therapeutics, Inc.

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About FATE

fate therapeutics is applying leading expertise in stem cell biology and conventional drug discovery to develop small molecule and biologic drugs that: 1) activate stem cells in the body to stimulate healing and repair or block cancer growth; and 2) create and differentiate "pharmaceutical grade"​ ips cells to enable their use in drug discovery and development, disease modeling, and eventually personalized cell therapies. the company’s approach has broad therapeutic potential in areas such as regenerative medicine, hematological diseases, metastatic cancer, traumatic injury and degenerative diseases.