CD58

SAN DIEGO, April 29, 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 cellular immunotherapies to patients, today announced that five presentations of clinical and preclinical data from the Company’s induced pluripotent stem cell (iPSC) product platform will be featured at the American Society of Gene and Cell Therapy (ASGCT) 28th Annual Meeting, being held in New Orleans, Louisiana on May 13-17, 2025. The Company has been selected to deliver an oral presentation on the translational data from its Phase 1 clinical trial of FT522, an off-the-shelf, CD19-targeted CAR NK cell product candidate, in patients with relapsed / refractory B-cell lymphoma (BCL) (NCT05950334). FT522 is the first product candidate to incorporate Alloimmune Defense Receptor (ADR) technology, which is designed to reduce or eliminate the need for administration of conditioning chemotherapy to patients receiving cell therapies. In addition, the Company will highlight preclinical data from its off-the-shelf, iPSC-derived, CAR T-cell product platform across autoimmune disease, hematological malignancy and solid tumor indications. Accepted abstracts are available on the ASGCT Annual Meeting website. Presentation details are as follows: Oral Presentation Phase 1 Translational Assessment of an Off-The-Shelf CAR NK Cell Armed with Alloimmune Defense Technology for Conditioning-free Therapy Session: Innovation in Alternative Cell Therapy Sources Location: Room 391-392 Presentation Date / Time: Saturday, May 17, 2025, 11:00 AM CT Poster Presentations Alloimmune Defense Receptor Combined with Genetic Ablation of Adhesion Ligand CD58 is a Comprehensive Approach to Promote Functional Persistence of Allogeneic Cell Therapies without Conditioning Chemotherapy Poster Number: 758 Presentation Date / Time: Tuesday, May 13, 2025, 6:00 PM CT Targeting UPAR With Multiplexed-Engineered iPSC-Derived CAR T Cells to Reverse Age- and Insult-Related Fibrotic Disease Poster Number: 789 Presentation Date / Time: Tuesday, May 13, 2025, 6:00 PM CT Next-Generation Off-the-Shelf CAR T-Cell Therapies for Conditioning-Free Treatment of a Broad Spectrum of Autoimmune Diseases and Hematologic Malignancies Poster Number: 1259 Presentation Date / Time: Wednesday, May 14, 2025, 5:30 PM CT FT836, a Novel MICA/B-targeting CAR T-cell Therapy Engineered to Eliminate the Need for Conditioning Chemotherapy with Broad Activity Across Solid Tumor Indications Poster Number: 1229 Presentation Date / Time: Wednesday, May 14, 2025, 5:30 PM CT 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 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 Precision AQ 212.362.1200 christina.tartaglia@precisionaq.com Source: Fate Therapeutics, Inc.

Multiplexed-engineered, iPSC-derived CAR T Cell Targets Proteins Expressed on Cancer Cells in Response to Cellular Stress and Malignant Transformation Off-the-shelf Product Candidate Incorporates Novel Sword & Shield Technology Designed to Promote Functional Persistence without Conditioning Chemotherapy FT836 Preclinical Data Shows Robust Antigen-mediated Expansion, Functional Persistence, and Durable Anti-tumor Activity in the Presence of Alloreactive T Cells SAN DIEGO, CA, USA I November 08, 2024 I 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 disorders, today presented initial preclinical data for FT836, a multiplexed-engineered, chimeric antigen receptor (CAR) T-cell product candidate targeting major histocompatibility complex (MHC) proteins A (MICA) and B (MICB) at the 2024 Society of Immunotherapy of Cancer (SITC) 39 th Annual Meeting being held in Houston, TX on November 6-10, 2024. The expression of MICA/B cell-surface proteins is induced by cellular stress or malignant transformation, and is detectable across many types of cancer cells with limited expression on healthy tissue. FT836 incorporates multiple next-generation synthetic controls of CAR T-cell function including the Company’s novel Sword & Shield technology, which is comprised of a constellation of genetic edits that both target and evade host alloreactive immune cells and is designed to promote functional persistence of off-the-shelf CAR T-cell therapies without conditioning chemotherapy. “The novel suite of synthetic controls incorporated into FT836 is intended to address critical challenges that have limited CAR T-cell safety and efficacy in treating solid tumors including on-target, off-tumor toxicity, effector cell suppression in the tumor microenvironment, tumor heterogeneity, and limited functional persistence,” said Bob Valamehr, Ph.D., President of Research & Development of Fate Therapeutics. “Our FT836 preclinical data presented today at SITC support the pan-cancer activity of MICA/B targeting, and indicate that our next-generation, iPSC-derived CAR T-cell platform has the potential to drive potent and durable anti-tumor activity without the need for administration of conditioning chemotherapy to deplete host immune cells.” Preclinical Data MICA/B targeting is emerging as a novel cancer-specific strategy to attack a wide range of solid tumors, however, proteolytic cleavage and shedding of MICA/B at the membrane-proximal α3 domain is a common mechanism of cancer resistance and escape from canonical NKG2D-mediated recognition. FT836 is designed to uniquely target and bind the α3 domain, which has been shown to stabilize MICA/B expression and induce robust cytolytic killing of tumor cells. At an oral presentation today at SITC entitled “Development of an Off-the-Shelf, MICA/B Targeting CAR T Cell to Overcome Pan-tumor Escape Mechanism for Solid Tumors” , scientists from the Company highlighted that FT836 exerted potent and durable anti-tumor activity in vivo across a broad array of solid tumors. In addition, treatment of tumor cells with chemotherapy or radiation therapy in vitro elicited an increase in MICA/B expression and further enhanced the cytolytic activity of FT836, indicating the potential for combination with standard-of-care regimens used for the treatment of solid tumors. Novel Sword & Shield Technology FT836 is also the Company’s first product candidate to incorporate its novel Sword & Shield technology, which utilizes a 4-1BB-targeted CAR (ADR) alongside the complete knock-out of CD58 (CD58KO), to both target and evade host alloreactive immune cells. In preclinical studies presented at SITC, iPSC-derived Sword & Shield CAR T cells demonstrated functional persistence and durable anti-tumor activity in vivo that was uniquely maintained upon supraphysiological challenge with alloreactive T cells, indicating the potential of Sword & Shield CAR T cells to thrive without administration of conditioning chemotherapy to deplete host immune cells. The Company’s novel Sword & Shield technology was also featured in a poster presentation at SITC entitled “Alloimmune Defense Receptor Combined with Genetic Ablation of Adhesion Ligand CD58 is a Comprehensive Approach to Promote Functional Persistence of Allogeneic Cell Therapies without Conditioning Chemotherapy” . 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 . SOURCE: Fate Therapeutics

Recently,the Center for Drug Evaluation of the National Medical Products Administration announced the acceptance of the investigational new drug (IND) application for Novartis's PIT565 injection. PIT565 is a tri-specific antibody targeting CD3, CD2, and CD19, with a potentially first-in-class mechanism of action. It is currently being developed for several indications, including B-cell acute lymphoblastic leukemia, B-cell lymphoma, systemic lupus erythematosus, and non-Hodgkin lymphoma. About PIT565 PIT565 can simultaneously bind to CD19+ on tumor cells, and CD3 (TCR signaling component) and CD2 (co-stimulatory receptor) on T cells, thereby redirecting T-cell cytotoxicity towards CD19-positive malignant B cells. CD2 signaling is associated with a non-exhausted T-cell phenotype. The interaction between CD2 and its ligand CD58 is crucial for CD19 CAR-T cells to kill tumor cells, while a loss of CD58 expression on lymphoma cells is linked to resistance and relapse in patients treated with CD19 CAR-T therapy. Compared to CD3 bispecific antibodies, CD2 co-stimulation via PIT565 may overcome T-cell exhaustion and enhance the depth and duration of patient responses. Studies have shown that: ·In redirected T-cell cytotoxicity (RTCC) assays in vitro, which co-culture CD19+ tumor cells and primary T cells, PIT565 mediates more sustained T-cell activity in tumor cell killing and proliferation than control bispecific products.  ·In a human peripheral blood mononuclear cell adoptive transfer model, PIT565 exhibited stronger anti-tumor responses in an established diffuse large B-cell lymphoma tumor model compared to control bispecific products.  ·In safety and pharmacological studies, PIT565 demonstrated IgG-like pharmacokinetics and expected pharmacological and tolerability characteristics similar to CD3 bispecific products in cynomolgus monkeys. Advancements in Tri-specific Antibody Research In recent years, tumor-targeting immunotherapies have been a hot topic in research. Tri-specific antibodies, engineered to recognize three targets simultaneously, represent a promising class of anti-tumor drugs capable of more precisely and effectively eradicating tumor cells.  Unlike bispecific antibodies, which can only bridge immune cells, activate them, or block two signaling pathways, tri-specific antibodies have a broader range of applications. They can simultaneously bridge and activate immune cells or link immune cells and block dual signaling pathways. This mechanism is closely related to the human immune system and offers strong cytotoxicity against target cells.  T-cell activation relies on two signals: the first signal and the second signal. A tri-specific antibody binds a tumor target antigen through one binding site, allowing the second binding site on another arm to specifically engage with TCR on T cells, thus activating the first signaling pathway to recruit/position immune cells near target cells. The third binding site can activate the second signaling pathway, further promoting immune cell activation.  Until now, no tri-specific antibody has been approved for market release. It is predicted that the global market for tri-specific antibodies will exceed $2 billion by 2028.  Novartis' Strategy in B-Cell LymphomaAccording to incomplete statistics, there are currently over a hundred tri-specific antibody drugs under development. Besides Novartis, multinational companies like Merck, Sanofi, Pfizer, BMS, AbbVie, and Johnson & Johnson are also building portfolios through in-house development and collaboration. In China, companies such as CStone Pharmaceuticals, Biotheus , Chimagen, BioRay and Innovent Biologics have also made strides in this field. According to statistics, Novartis has strategically positioned itself with nearly forty products for B-cell lymphoma. Their portfolio includes small molecule inhibitors, monoclonal antibodies, bispecific antibodies, and multispecific antibodies targeting multiple targets, as well as cell therapies. How to obtain the latest research advancements in the field of biopharmaceuticals? In the Synapse database, you can keep abreast of the latest research and development advances in drugs, targets, indications, organizations, etc., anywhere and anytime, on a daily or weekly basis. Click on the image below to embark on a brand new journey of drug discovery!