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Kyverna's KYV-101 Receives U.S. FDA IND Clearance for Treatment of Patients With Treatment-Refractory Stiff-Person Syndrome in the KYSA-8 Phase 2 Trial
This IND clearance expands the use of KYV-101 CAR T-cell therapy in a Phase 2, open-label KYSA-8 clinical trial targeting a devastating neuroimmunological
About this update from Kyverna Therapeutics, Inc.
[{"type":"text","content":"This IND clearance expands the use of KYV-101 CAR T-cell therapy in a Phase 2, open-label KYSA-8 clinical trial targeting a devastating neuroimmunological autoimmune disease\nKYV-101 is a fully human anti-CD19 CAR T-cell therapy designed for use in patients with B cell-driven autoimmune diseases\nEMERYVILLE, Calif., June 20, 2024 /PRNewswire/ -- Kyverna Therapeutics, Inc. (Kyverna), a patient-centered, clinical-stage biopharmaceutical company focused on developing cell therapies for patients suffering from autoimmune diseases, announced today the clearance of its Investigational New Drug (IND) application by the U.S. Food and Drug Administration (FDA) for its autologous, fully human anti-CD19 chimeric antigen receptor (CAR) T-cell product candidate, KYV-101, to be used for the treatment of stiff-person syndrome (SPS) in Kyverna's trial, named KYSA-8. \n\n \n \n \n \n \n \n\n \n\"CAR T-cell therapy has already shown preliminary but promising results in patients with SPS treated outside of the US,\" said Marinos Dalakas, M.D., FAAN, Professor of Neurology, Director of the Neuromuscular Division at Thomas Jefferson University School of Medicine in Philadelphia, PA, and a leading physician and researcher on SPS. \"I find the KYSA-8 trial of extraordinary importance as a promising novel therapy for patients with stiff person syndrome who do not respond to current therapies, with implications in providing potentially long-lasting benefits.\"\n\"The IND clearance gives us confidence in our dedication to bringing a potential paradigm shift in the treatment of patients suffering from SPS and reaffirms a target dose of 100 million cells for KYV-101,\" said Sham Dholakia, M.D., business unit head rare diseases at Kyverna. \"We are also very grateful to the FDA for the collaborative approach and timely vetting of our clinical trial design.\"\nAbout Stiff Person Syndrome (SPS) SPS is a rare, progressive neurological autoimmune disorder causing debilitating muscle stiffness in the torso, arms, and legs, impacting the ability to walk or move. Patients typically present with muscle spasms and stiffness, resulting in difficulty turning and bending. When stiffness is severe, the patient's walking resembles a statue. Muscle spasms and stiffness can be precipitated by unexpected stimuli, including sounds, like a phone ring or a siren, sudden touche...