Kyverna Therapeutics has received clearance from the US Food and Drug Administration (FDA) for its Investigational New Drug (IND) application for KYV-101, an autologous, fully human CD19 chimeric antigen receptor (CAR) T-cell product candidate.
This therapy is designed for the treatment of multiple sclerosis (MS), a chronic neurodegenerative autoimmune disease.
CAR T-cell therapy involves modifying a patient’s T cells to target and eliminate B cells.
KYV-101 specifically targets CD19, a protein found on the surface of B cells, which plays a role in various autoimmune conditions.
Kyverna is committed to further exploring KYV-101’s potential for additional indications and developing a pipeline of immunotherapies to address unmet medical needs in autoimmune diseases.
Worldwide, over 2.8 million individuals suffer from MS, which causes symptoms ranging from blurred vision and slurred speech to severe mobility issues.
Kyverna’s KYV-101 is also undergoing trials for lupus nephritis, an autoimmune disease in which over half of the patients do not fully respond to existing treatments and face the risk of kidney failure.
In addition to lupus nephritis, Kyverna is preparing for additional clinical trials of KYV-101 in systemic sclerosis and myasthenia gravis, aiming to expand the therapy’s applications and benefit a broader patient population.
Kyverna CEO Peter Maag said: “As a patient-centred organisation, we are thrilled to see KYV-101 being cleared for a large patient demographic as part of our KYSA-7 trial.
“This is a clear paradigm shift for autoimmune diseases, and a testament to our commitment to expand potentially life-changing therapeutic benefits to multiple indications.”