Kyverna Therapeutics, Inc. (Kyverna), a patient-centered clinical-stage biopharmaceutical company focused on developing cell therapies for patients suffering from autoimmune diseases, today announced the clearance of its fifth Investigational New Drug (IND) application for KYV-101 by the U.S. Food and Drug Administration (FDA).
The investigational therapy will be used in Kyverna’s KYSA-6 Phase 2 open-label, multicenter study to evaluate KYV-101 in adult patients with myasthenia gravis This is the fifth IND clearance for KYV-101, a fully human CD19 CAR T-cell therapy designed for use in patients with B cell-driven autoimmune diseases. EMERYVILLE, Calif., November 13, 2023 /PRNewswire/ -- Kyverna Therapeutics, Inc. (Kyverna), a patient-centered clinical-stage biopharmaceutical company focused on developing cell therapies for patients suffering from autoimmune diseases, today announced the clearance of its fifth Investigational New Drug (IND) application for KYV-101 by the U.S. Food and Drug Administration (FDA). This will allow Kyverna to initiate a Phase 2 open-label, multicenter study of KYV-101, an autologous, fully human CD19 chimeric antigen receptor (CAR) T cell product candidate for the treatment of myasthenia gravis (MG). The trial, named KYSA-6, expands Kyverna’s current pipeline, which includes the ongoing Phase 1 KYSA-1 trial in the U.S. and the ongoing Phase 1/2 KYSA-3 trial in Germany, where KYV-101 is currently investigated in adults with active lupus nephritis, and the ongoing Phase 1/2 KYSA-5 trial in adults with diffuse cutaneous systemic sclerosis in the U.S. Kyverna also obtained clearance of two additional INDs for investigator-initiated trials of KYV-101 in the U.S. “We have seen firsthand the transformative effects of KYV-101 in MG patients treated with the investigational therapy in our clinic,” said Prof. Aiden Haghikia, Director, Department of Neurology, Medical Faculty, Otto-von-Guericke University, Magdeburg, Germany. “I welcome the FDA’s decision and look forward to more clinical data to further our knowledge about CAR T-cell therapy in patients with severe neurological autoimmune diseases.” “We are grateful that the FDA’s decision to clear the IND for our Phase 2 KYSA-6 trial will allow Kyverna to offer this potentially paradigm-shifting investigational treatment to patients that may benefit from a deep B cell depletion and possibly durable reset of their immune system,” said Peter Maag, Ph.D., chief executive officer of Kyverna. CAR T-cell therapy involves modifying a patient’s T cells to recognize and remove B cells in the patient’s body. Kyverna’s CD19 CAR T-cell therapy, KYV-101, specifically targets CD19, a protein expressed on the surface of B cells, which is involved in various types of autoimmune diseases. Kyverna plans to continue to explore additional indications for KYV-101 and develop a robust pipeline of promising product candidate immunotherapies aimed at addressing unmet medical needs in autoimmune diseases. About Myasthenia gravis (MG) About KYV-101 Kyverna is currently conducting two trials of KYV-101 in patients with lupus nephritis, an autoimmune disease in which more than half of patients do not achieve a complete response to current therapies and are at risk of developing kidney failure. Additional clinical trials of KYV-101 in systemic sclerosis, myasthenia gravis, and multiple sclerosis are in preparation. We believe that the differentiated properties of KYV-101 are critical for the potential success of CAR T cells as autoimmune disease therapies. About Kyverna Therapeutics Kyverna Media Contact: 1. Brudno et al., Nature Medicine 2020; 26:270-280. View original content to download multimedia:https://www.prnewswire.com/news-releases/kyverna-therapeutics-announces-fda-clearance-of-phase-2-ind-for-kyv-101-a-fully-human-cd19-car-t-cell-therapy-to-treat-myasthenia-gravis-301986135.html SOURCE Kyverna Therapeutics |