27-year-old African American-Asian Woman with Active Lupus Nephritis Achieved DORIS Clinical Remission; Patient Remains On-study, in Clinical Remission, and Free of All Immunosuppressive Therapies

Patient Treated with Fludarabine-free Conditioning and Single-dose FT819; Favorable Safety Profile with No Grade ≥3 Adverse Events and No Events of CRS, ICANS, or GvHD

Reconstituted B Cell Compartment Predominantly Consists of Naïve, Non-class Switched B Cells with Deep Depletion of Aberrant B Cells and Plasmablasts, Indicative of Immune Reset

Second Treatment Arm Adding FT819 to Maintenance Therapy without Conditioning Chemotherapy Opened for Enrollment

SAN DIEGO, Nov. 18, 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 disorders, today presented initial clinical and translational data from the first patient treated in its FT819 Phase 1 Autoimmunity study for moderate-to-severe systemic lupus erythematosus (SLE) at the American College of Rheumatology (ACR) Convergence being held in Washington, D.C. The patient, a 27-year-old African American-Asian woman diagnosed with lupus nephritis (LN) over ten years ago, received fludarabine-free conditioning followed by a single dose of FT819. The patient achieved DORIS (definition of remission in SLE) clinical remission and LLDAS (low lupus disease activity state) as of Month 6 follow-up. The patient continues on-study, in clinical remission, and free of all immunosuppressive therapies as of a data cutoff date of November 11, 2024. FT819 is the Company's off-the-shelf, CD19-targeted, 1XX CAR T-cell product candidate comprised of CD8αβ+ T cells with a memory phenotype and high CXCR4 expression to promote tissue trafficking.