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news.The US Food and Drug Administration (FDA) has granted Regenerative Medicine Advanced Therapy (RMAT) designation for Kyverna Therapeutics’ chimeric antigen receptor (CAR) T-cell product candidate, KYV-101 for treating refractory stiff-person syndrome (SPS).
Till date, approximately 50 patients have been treated with KYV-101's CAR technology. Credit: Steve Buissinne from Pixabay.
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SPS is a rare, debilitating neurological autoimmune disorder characterised by muscle stiffness and spasms.
Kyverna’s KYV-101 is an autologous, fully human CD19 CAR T-cell therapy designed to address B cell-driven autoimmune diseases.
The CAR technology was designed by the National Institutes of Health (NIH) and has shown promise in a Phase I oncology trial with results published in Nature Medicine.
Currently, KYV-101 is undergoing clinical evaluation in the US and Germany through sponsored Phase I/II and Phase II trials.
Kyverna CEO Peter Maag said: “We are eager to begin generating data from our sponsored trial to advance the knowledge on a potential immunological reset of the patient’s immune system.
“We are humbled by the resilience of the SPS patients and their hope for a potential paradigm-shifting treatment option that could provide durable, immunosuppressant-free remission.”
Till date, approximately 50 patients have been treated with KYV-101’s CAR technology across over 15 locations in Europe and the US for both oncological and autoimmune conditions.
The therapy is also being assessed in various investigator-initiated trials for multiple indications across different regions.
KYV-101 is advancing through clinical development with trials in two main areas of autoimmune disease: rheumatology and neurology.
These include Phase II trials for SPS, multiple sclerosis, and myasthenia gravis, a Phase I/II trial for systemic sclerosis, and ongoing multi-centre, open-label Phase I/II studies for lupus nephritis in the US and Germany.
