Latest news with #EULAR2025
Yahoo
6 days ago
- Business
- Yahoo
Fate Therapeutics Announces Phase 1 Data Presentation of FT819 Off-the-Shelf CAR T-cell Product Candidate for SLE at EULAR 2025 Congress
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 BeyondPresentation 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 VIIIPresentation Date / Time: Saturday, June 14, 2025 / 10:15-11:45am CEST About Fate Therapeutics' iPSC Product PlatformHuman 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, 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 Forward-Looking StatementsThis 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 TartagliaPrecision
Yahoo
6 days ago
- Business
- Yahoo
Fate Therapeutics Announces Phase 1 Data Presentation of FT819 Off-the-Shelf CAR T-cell Product Candidate for SLE at EULAR 2025 Congress
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 BeyondPresentation 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 VIIIPresentation Date / Time: Saturday, June 14, 2025 / 10:15-11:45am CEST About Fate Therapeutics' iPSC Product PlatformHuman 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, 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 Forward-Looking StatementsThis 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 TartagliaPrecision in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Yahoo
7 days ago
- Business
- Yahoo
Sobi to share new clinical data and research at EULAR 2025
STOCKHOLM, May 28, 2025 /PRNewswire/ -- Sobi® (STO: SOBI) will present new clinical data and research outcomes at the annual European Congress of Rheumatology (EULAR 2025) in Barcelona from the 11-14 June 2025. Research will include clinical trial outcomes on the efficacy and safety of Gamifant in the treatment of macrophage activating syndrome, updates on trial details of Vonjo investigating the potential treatment of VEXAS, and an analysis on the management of uncontrolled gout. Sobi will host a symposium on the dermatologic, rheumatologic, and hematologic features of VEXAS syndrome during the congress. The symposium will be chaired by Dr Sophie Georgin-Lavialle MD, PhD from the French National Reference Centre for auto-inflammatory diseases and inflammatory amyloidosis. The symposium will be followed by a panel discussion and Q&A. "We are delighted that our continued advancements in treating rare disease, including those suffering with the most debilitating rheumatology conditions will be presented at this year's EULAR conference. Sobi's presentations will provide insights and treatment options for those working with patients with rheumatological conditions, providing them with the most up-to-date clinical data and approaches," said Lydia Abad-Franch, MD, MBA, Head of Research, Development, and Medical Affairs (RDMA), and Chief Medical Officer at Sobi. "With several poster and oral presentations and a longer form symposium, we are proud to be able to show how research and collaboration can advance clinical practice – and we look forward to meeting and connecting with colleagues in Barcelona," Lydia Abad-Franch concluded. Key data to be presented at EULAR 2025 Gamifant (emapalumab) Efficacy and Safety of emapalumab in Patients with Macrophage Activation Syndrome in Still's disease: Results from a Pooled Analysis of Two Prospective Trials Speaker: Professor Fabrizio De Benedetti (principal investigator of the study) Oral presentation Session title: Clinical Abstract Session: Proceedings in Juvenile Idiopathic Arthritis Session date: Thursday 12 June Session time: 10:30 - 12:00 CEST Presentation time: 10:48 - 10:57 CEST Location: Room 6.1 Exposure-safety analysis from two clinical trials of emapalumab in patients with macrophage activation syndrome in Still's disease Speaker: Professor Fabrizio De Benedetti (principal investigator of the study) Poster presentation Session title: Poster View VI Session date: Friday 13 June Session time: 12:00 – 13:30 CEST Location: Poster Hall NASP (formerly SEL-212) Variations in uncontrolled gout between Rheumatologists and Nephrologists Poster presentation Session title: Poster View VIII Session date: Friday 13 June Session time: 10:15 - 11:45 CEST Location: Poster Hall Vonjo (pacritinib) Development of a Consensus Definition of VEXAS Flare for Use in Clinical Research Poster presentation Session title: Poster View VII Session date: Friday 13 June Session time: 14 :45 - 15 :45 CEST Location: Poster Hall PAXIS: A Randomized, Double-Blind, Placebo-Controlled, Dose Finding Phase 2 Study (Part 1) Followed by an Open-Label Period (Part 2) to Assess the Efficacy and Safety of Pacritinib in Patients with VEXAS Syndrome Poster tour Session Title: Poster Tour II/ Clinical and Basic Poster Tours: Autoinflammatory Diseases including VEXAS Session date: Saturday 14 June Session time: 10:15 -11:45 CEST Presentation time: 10:29 - 10:36 CEST (4 mins + 2 mins Q&A) Location: Poster Tour II Development of a Disease Activity Index for the Assessment of VEXAS Syndrome (VEXAS-DAI) Poster tour Session title: Poster Tour II/ Clinical and Basic Poster Tours: Autoinflammatory Diseases including VEXAS Session date: Saturday 14 June Session time: 10:15 - 11:45 CEST Presentation time: 10:43 - 10:50 CEST (4 mins + 2 mins Q&A) Location: Poster Tour II Medical Symposium An in-depth presentation on VEXAS syndrome: the dermatologic, rheumatologic, and hematologic features of the condition. Followed by a panel discussion and Q&A Symposium title: Putting on your VEXAS goggles: Seeing what's in plain sight Session date: Friday 13 June Session time: 17:30 - 18:30 CEST Location: Fira de Barcelona, Room B4 About Gamifant® (emapalumab) Gamifant® (emapalumab) is indicated for the treatment of adult and paediatric (newborn and older) patients with primary hemophagocytic lymphohistiocytosis (HLH) with refractory, recurrent or progressive disease or intolerance with conventional HLH therapy. About Macrophage activation syndrome (MAS) Macrophage activation syndrome (MAS) is a potentially life-threatening complication of Still's disease characterised by interferon-gamma (IFNγ)–driven systemic hyperinflammation. More than one-third of patients inadequately respond to high-dose glucocorticoids. Emapalumab, an anti-IFNγ antibody, demonstrated efficacy and safety in a phase 2 pilot study in patients with MAS in Still's disease and an inadequate response to high-dose glucocorticoids. About NASP, formerly SEL-212 NASP is a novel investigational medicine designed to reduce serum urate (SU) levels in people with uncontrolled gout, potentially reducing harmful tissue urate deposits which when left untreated can lead to debilitating gout flares and joint deformity. NASP is administered every 4-weeks as a sequential, two-component, infusion therapy consisting of tolerogenic nanoencapsulated sirolimus (NAS) which mitigates the formation of anti-drug antibodies (ADAs) and a uricase, pegadricase (P), which reduces serum uric acid. ADAs develop due to unwanted immune responses to biologic medicines, reducing their efficacy and tolerability, which remains an issue across multiple therapeutic modalities and disease states including uncontrolled gout. About VONJO® (pacritinib) VONJO is a kinase inhibitor that is indicated in the US for the treatment of adults with intermediate or high-risk primary or secondary (post-polycythemia vera or post-essential thrombocythemia) myelofibrosis with a platelet count below 50 × 109/L. This indication is approved under accelerated approval based on spleen volume reduction. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). About VEXAS VEXAS syndrome is a disease that causes inflammatory and hematologic (blood) manifestations. The syndrome is caused by mutations in the UBA1 gene of blood cells and acquired later in life. The condition is not genetically inherited. About Sobi Sobi is a global biopharma company unlocking the potential of breakthrough innovations, transforming everyday life for people living with rare diseases. Sobi has approximately 1,900 employees across Europe, North America, the Middle East, Asia and Australia. In 2024, revenue amounted to SEK 26 billion. Sobi's share (STO: SOBI) is listed on Nasdaq Stockholm. More about Sobi at and LinkedIn. Contacts For details on how to contact the Sobi Investor Relations Team, please click here. For Sobi Media contacts, click here. This information was brought to you by Cision The following files are available for download: Sobi share New clinical Data and Research at EULAR 2025 View original content:
Yahoo
27-05-2025
- Business
- Yahoo
Avalyn Announces Upcoming Presentation on its Lead Program AP01, Inhaled Pirfenidone, for the Treatment of Pulmonary Fibrosis at the European Congress of Rheumatology 2025
CAMBRIDGE, Mass., May 27, 2025 (GLOBE NEWSWIRE) -- Avalyn Pharma Inc., a clinical-stage biopharmaceutical company developing inhaled therapies for the treatment of life-threatening pulmonary diseases, today announced an upcoming presentation at the European Congress of Rheumatology (EULAR) 2025, being held June 11-14, 2025, in Barcelona, Spain. Avalyn's poster presentation at EULAR 2025 will include the Phase 2b study design of AP01 (inhaled pirfenidone) in various forms of progressive pulmonary fibrosis (PPF), including autoimmune ILDs. EULAR 2025 Poster Presentation: Title: Inhaled Pirfenidone as an innovative therapeutic approach to treat autoimmune ILD and other forms of Progressive Pulmonary Fibrosis: Phase 2b Study DesignAuthors: Colin Reisner, Sebastien Tilleux, Allison Trucillo, Deepthi Nair, Felix Woodhead, Howard M. Lazarus, Craig Conoscenti, Martin Kolb About Avalyn PharmaAvalyn is reimagining the future of pulmonary fibrosis treatment with a pipeline of new inhaled formulations of approved medicines. Pulmonary fibrosis is characterized by scarring of lung tissue, decline in lung function, reduced exercise capacity, and quality of life, and is associated with increased mortality. Currently approved therapeutic options slow pulmonary fibrosis progression but are associated with significant toxicities that restrict their use and dosing. Avalyn's inhaled approach tackles the underlying pathophysiology of pulmonary fibrosis at its source by safely delivering treatments directly into the lungs, thereby improving tolerability by decreasing systemic exposure and improving efficacy by increasing lung exposure. Avalyn's AP01 is an optimized inhaled formulation of pirfenidone, currently being studied in the ongoing MIST Phase 2b study in progressive pulmonary fibrosis (PPF). AP01 has been assessed in over 150 individuals with different forms of pulmonary fibrosis and demonstrated clinical proof-of-concept with improved efficacy and safety compared to historical data with existing therapies. The company completed two Phase 1 studies for AP02, inhaled nintedanib, for the treatment of idiopathic pulmonary fibrosis (IPF). For more information, please visit and follow us on LinkedIn. Investor Contact:Alex Straus, THRUST alex@ Media Contact:media@
