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Fate Therapeutics, Inc. FATE presented encouraging initial clinical and translational data from the first patient treated in its early-stage study on experimental pipeline candidate FT819.
Data showed that the first patient suffering from active lupus nephritis (LN) and treated with FT819 had favorable clinical experience, achieved drug-free clinical remission and continued on-study free of all immunosuppressive therapy.
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FATE’s Six-Month Follow-up Data on FT819
FT819 is FATE’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.
The ongoing multi-center phase I study for patients with moderate-to-severe systemic lupus erythematosus (SLE) is designed to evaluate the safety, pharmacokinetics and anti-B cell activity of FT819 (NCT06308978).
The first three patients, all of whom presented with active LN despite having been treated with multiple standard-of-care therapies, received fludarabine-free conditioning consisting of either cyclophosphamide alone or bendamustine alone, followed by a single dose of FT819 at 360 million cells.
Among these, a 27-year-old African American-Asian woman diagnosed with LN over ten years ago achieved DORIS (definition of remission in SLE) clinical remission and LLDAS (low lupus disease activity state) at follow-up after six months. The patient also experienced a resolution of fatigue, something that rheumatologists struggle to improve with other treatments.
This woman continues to be on study, in clinical remission, and free of all immunosuppressive therapies as of a data cutoff date of Nov. 11, 2024.
As of the same date, the patient did not experience any serious event or events of any grade of cytokine release syndrome, immune effector-cell associated neurotoxicity syndrome, or graft-versus-host disease.
The initial results are promising, and FATE believes this differentiated therapeutic approach has the potential to transform outcomes for patients with autoimmune diseases without requiring patient apheresis, discontinuation of maintenance therapy, intense conditioning chemotherapy and extended hospitalization.
FATE is also enrolling a second treatment arm under the FT819 phase I autoimmunity study to assess the safety, pharmacokinetics, and anti-B cell activity of a single dose of FT819 as an add-on to maintenance therapy without conditioning chemotherapy in patients with SLE. This new arm is being conducted with the study’s conditioning arm.