Latest news with #FT819
Yahoo
6 days ago
- Business
- Yahoo
Fate Therapeutics, Inc. (FATE) Highlights Next-Gen iPSC Therapies for Autoimmune Diseases
Fate Therapeutics, Inc. (NASDAQ:FATE) announced today that it will present groundbreaking clinical data from its Phase 1 trial of FT819, an off-the-shelf, iPSC-derived CAR T-cell therapy, at the upcoming EULAR 2025 Congress in Barcelona. FT819 targets CD19 and is being evaluated in patients with moderate-to-severe systemic lupus erythematosus (SLE) without the use of fludarabine conditioning, a significant shift from traditional CAR T-cell approaches. The oral presentation, scheduled for June 11, will highlight FT819's safety and efficacy in lupus patients treated with either a fludarabine-free regimen or maintenance therapy without conditioning. This approach could eliminate the need for toxic chemotherapy, potentially enabling safer, more accessible outpatient treatment for autoimmune diseases. A biotechnologist in a lab overlooking a microscope, examining a sample of substances to test for therapeutic properties. Fate Therapeutics, Inc. (NASDAQ:FATE) will also showcase preclinical advances in its iPSC-derived CAR T and CAR-NK cell platforms, including Sword and Shield technology and multi-antigen targeting, aimed at broadening autoimmune therapy applications. The company's proprietary iPSC platform allows for scalable, off-the-shelf cell therapies, positioning Fate Therapeutics, Inc. (NASDAQ:FATE) as a leader in next-generation immunotherapies for autoimmune conditions. While we acknowledge the potential of AMZN to grow, our conviction lies in the belief that some AI stocks hold greater promise for delivering higher returns and have limited downside risk. If you are looking for an AI stock that is more promising than AMZN and that has 100x upside potential, check out our report about this READ NEXT: and Disclosure: None. Error 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
6 days ago
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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
14-05-2025
- Business
- Yahoo
Fate Therapeutics' Q1 Earnings & Revenues Beat, Pipeline in Focus
Fate Therapeutics FATE reported a loss of 32 cents per share for the first quarter of 2025, narrower than the Zacks Consensus Estimate of a loss of 39 cents. The company had reported a loss of 47 cents per share in the year-ago period. The company earned collaboration revenues of $1.6 million, which surpassed the Zacks Consensus Estimate of $1 million. Revenues declined 15.8% on a year-over-year basis. (Find the latest EPS estimates and surprises on Zacks Earnings Calendar.) Revenues in the first quarter were derived from preclinical development activities for a second collaboration candidate targeting an undisclosed solid tumor antigen under FATE's collaboration with Ono Pharmaceutical. Shares of Fate Therapeutics were up 5% in after-hours trading on May 13, owing to the better-than-expected earnings announcement. Year to date, the stock has plunged 39.4% compared with the industry's decline of 6.4%. Image Source: Zacks Investment Research Research and development (R&D) expenses decreased 9.3% to $29.1 million in the first quarter. General and administrative (G&A) expenses decreased around 34% to $13.8 million. Cash, cash equivalents and investments as of March 31, 2025, totaled $272.7 million. FATE expects the current cash balance to sustain the operating runway through the first half of 2027. FATE is focused on developing and manufacturing universal, off-the-shelf cell products using its proprietary induced pluripotent stem cell (iPSC) product platform. Its immuno-oncology pipeline includes iPSC-derived natural killer (NK) cells and T-cell product candidates. A phase I study of FT819, a T-cell product candidate for patients with systemic lupus erythematosus (SLE), is currently ongoing. The company has initiated dose expansion in up to 10 patients at 360 million cells, based on clinical data from the first three patients treated with FT819 in the ongoing multi-center, phase I study. The dose expansion stage will evaluate the safety and efficacy of a fludarabine (flu)-free conditioning regimen, consisting of either bendamustine or cyclophosphamide alone, followed by a single dose of FT819. Fate Therapeutics is also assessing the safety, pharmacokinetics and anti-B cell activity of FT819 at 900 million cells in dose escalation. The FDA granted the Regenerative Medicine Advanced Therapy (RMAT) designation to FT819 for the treatment of active moderate to severe SLE, including lupus nephritis, in April. Fate Therapeutics is co-developing FT825/ONO-8250, a multiplexed-engineered, iPSC-derived CAR T-cell product candidate, with ONO Pharmaceutical. It is conducting a phase I study to assess the safety, pharmacokinetics and activity of FT825/ONO-8250 in patients with advanced solid tumors. To date, treatment with FT825/ONO-8250 has shown a favorable safety profile with no dose-limiting toxicities. Fate Therapeutics, Inc. price-consensus-eps-surprise-chart | Fate Therapeutics, Inc. Quote Fate Therapeutics currently carries a Zacks Rank #2 (Buy). Some other top-ranked stocks in the biotech sector are Halozyme Therapeutics HALO and Allogene Therapeutics ALLO, each carrying a Zacks Rank #2 at present. You can see the complete list of today's Zacks #1 Rank (Strong Buy) stocks here. In the past 60 days, estimates for Halozyme's earnings per share have increased from $5.02 to $5.23 for 2025. During the same time, earnings per share estimates for 2026 have increased from $6.56 to $6.77. Year to date, shares of HALO have increased 5%. HALO's earnings beat estimates in each of the trailing four quarters, with the average surprise being 17.60%. In the past 60 days, estimates for Allogene Therapeutics' loss per share have narrowed from $1.26 to $1.15 for 2025. During the same time, loss per share estimates for 2026 have narrowed from $1.34 to $1.17. Year to date, shares of ALLO have plunged 46.9%. ALLO's earnings beat estimates in three of the trailing four quarters while meeting the same on the remaining occasion, the average surprise being 11.70%. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report Halozyme Therapeutics, Inc. (HALO) : Free Stock Analysis Report Fate Therapeutics, Inc. (FATE) : Free Stock Analysis Report Allogene Therapeutics, Inc. (ALLO) : Free Stock Analysis Report This article originally published on Zacks Investment Research ( Zacks Investment Research Error 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
