FT839 / Fate Therapeutics - LARVOL DELTA

The development of FT839: An off-the-shelf CD19xCD38 dual-CAR T cell for the treatment of multiple myeloma (ASH 2025) - "In vitro cytotoxicity assays against MM cell lines RPMI-8226, OPM2, MM1.s and H929 demonstrated durable and potent cell cytotoxicity at low effector:target ratios, as a monotherapy with further deepening of response when combined with mAbs such as daratumumab or sarclisa, or T cell engagers such as teclistamab or talquetamab (exceeding 90% cytotoxicity in each case). Collectively, FT839 is engineered to eliminate cancer cells with broad and heterogenous antigen expression by a unique dual-CAR system and in combination with standard of care therapeutics, including mAbs and TCEs via hnCD16 and CD3-CFR transgenes, to overcome multiple challenges that have limited autologous CAR T-cell therapies in treating MM. Moreover, as an off-the-shelf CAR T-cell therapy, FT839 is intended for broad and on-demand access without the need for complicated and variable manufacturing processes or intense conditioning chemotherapy."

CAR T-Cell Therapy • IO biomarker • Hematological Malignancies • Multiple Myeloma

The development of an off-the-shelf CAR T-cell therapy co-targeting CD19 and CD38 for broad application in autoimmune disease (ASH 2025) - "These results demonstrate the unique ability of FT839 tofunctionally persist in an allogeneic and mismatched setting without the need for intensive conditioningchemotherapy.In summary, FT839 enables the simultaneous and selective elimination of multiple disease-drivingimmune cells without the need for supportive conditioning chemotherapy. Its scalable, cost-effectivemanufacturing and off-the-shelf delivery supports broad clinical accessibility across a range ofautoimmune disease settings."

CAR T-Cell Therapy • IO biomarker • CNS Disorders • Graft versus Host Disease • Immunology • Infectious Disease • Inflammatory Arthritis • Multiple Sclerosis • Rheumatoid Arthritis • Rheumatology • CD4 • CD58 • CD8

Development of next generation multi-antigen targeting off-the-shelf CAR T cells for conditioning-free treatment of B-cell lymphoma (ASH 2025) - "Indeed, in combination with the CD20-specific mAb rituximab or theCD38-specific mAb daratumumb, FT839 potently eliminated the mantle cell lymphoma cell line Jeko-1(97.8% CD20+, 54,888 rMFI) and Burkitt's lymphoma cell line RAJI (91.6% CD38+, 101,129 rMFI),respectively, highlighting the flexible and broad multi-antigen targeting of FT839 via CAR and hnCD16activation. Finally, FT839 maintained durable anti-tumor activity againstrepeat challenges with NALM6 tumor cells 1.17x p=ns) even in the presence of primed allogeneic PBMCsthat elicit potent reaction against mismatched cells.Compared to traditional CAR T-cells, FT839 demonstrates versatility in targeting cancer cells via multipleantigen-receptor activation pathways, enabling potent and flexible multi-antigen targeting for thesuccessful treatment of relapsed/refractory B cell lymphomas that is otherwise challenging to treatbecause of its heterogenous cellular composition. Furthermore, unlike autologous and allogeneic..."

CAR T-Cell Therapy • IO biomarker • Acute Lymphocytic Leukemia • B Acute Lymphoblastic Leukemia • B Cell Lymphoma • Burkitt Lymphoma • Graft versus Host Disease • Hematological Malignancies • Immunology • Leukemia • Lymphoma • Mantle Cell Lymphoma • Non-Hodgkin’s Lymphoma • CD20 • CD58

The Company has now generated a master iPSC bank for conducting IND-enabling studies and is currently evaluating opportunities for clinical investigation of FT839 in hematological malignancies and autoimmune disease in 2026. (Fate Therapeutics Press Release)

New trial • Hematological Malignancies • Immunology

Fate Therapeutics Reports Second Quarter 2025 Financial Results and Business Updates (GlobeNewswire) - "At the American Society of Gene & Cell Therapy (ASGCT) Annual Meeting in May, the Company presented preclinical data demonstrating robust eradication of aberrant CD19+ B cells, CD38+ plasma cells, and CD38+ activated T cells by FT839....The Company...is currently evaluating opportunities for clinical investigation of FT839 in hematological malignancies and autoimmunity, beginning in 2026."

New trial • Preclinical • Hematological Malignancies • Immunology

Fate Therapeutics Reports First Quarter 2025 Financial Results and Business Updates (GlobeNewswire) - "Next-generation iPSC-derived CAR T-cell Programs:...FT839 Dual CAR T-cell Program: FT839 is the Company’s dual CAR T-cell product candidate that incorporates its novel Sword & Shield technology and is designed to express two unique CARs: a first CAR targeting CD19+ B cells, and a second CAR targeting additional disease-causing cells. At the ASGCT Annual Meeting in May, the Company plans to present preclinical data demonstrating iPSC-derived CAR T cells targeting CD19 and the cell-surface glycoprotein CD38 specifically eliminated a variety of malignant cell types, including CD19+ lymphoma and CD38+ multiple myeloma cell lines."

Preclinical • Multiple Myeloma