Kyverna Therapeutics announces Phase 2 trial approval for KYV-101, a full human CD19 CAR T-Cell therapy for Myasthenia Gravis, by the FDA

Kyverna Therapeutics, Inc., a clinical-stage biopharmaceutical company with a patient-oriented approach to developing cell therapies for those afflicted with autoimmune disorders, has stated that its fifth IND submission for KYV-101 has obtained approval from FDA.

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Kyverna is now authorized to commence a Phase 2 open-label, multicenter trial of KYV-101, a human CD19 chimeric antigen receptor T cell product candidate fully autologous, intended to treat myasthenia gravis patients. The clinical study, termed KYSA-6, broadens Kyverna's ongoing initiatives, such as the U.S. based Phase 1 KYSA-1 study and the Phase 1/2 KYSA-3 study happening in Germany, wherein the efficacy of KYV-101 is being examined in adults afflicted with active lupus nephritis. 

Also ongoing is the Phase 1/2 KYSA-5 study for adults with diffuse cutaneous systemic sclerosis within the U.S. Kyverna has additionally secured clearance for an extra pair of INDs for KYV-101 investigator-driven trials within the U.S. Prof. Aiden Haghikia, Head of Neurology Department at Otto-von-Guericke University, Magdeburg, Germany stated, "We have witnessed firsthand how KYV-101 can transform the lives of MG patients in our clinic. 

I welcome this decision by the FDA and anticipate more clinical data to broaden our understanding of CAR T-cell therapy within patients with severe neurological autoimmune disorders." Peter Maag, Ph.D., CEO of Kyverna, expressed, "We are appreciative of the FDA's approval of our IND for Phase 2 KYSA-6 trial. This will facilitate Kyverna to provide this investigational treatment, which could alter the paradigm, to patients likely to see benefits from deep B cell depletion and possible durable immune system reset."

Kyverna's CAR T-cell therapy involves adapting a patient's T cells to identify and eliminate B cells in the body. KD19 CAR T-cell therapy, KYV-101, particularly targets CD19, a protein shown on the surface of B cells, playing a part in multiple autoimmune diseases. Kyverna intends to expand the applications for KYV-101 and develop a strong pipeline of potential immunotherapies that address the unmet medical demands in autoimmune diseases.

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According to the data provided by the Synapse Database, As of November 21, 2023, there are 455 investigational drugs for the CD19 target, including 161 indications, 378 R&D institutions involved, with related clinical trials reaching 1116, and as many as 30027 patents.

KYV-101 is an autologous, fully human CD19 CAR T-cell product candidate for use in B cell-driven autoimmune diseases. The CAR in KYV-101 was designed by NIH to improve tolerability and tested in a 20-patient Phase 1 trial in oncology. Results were published by the NIH in Nature Medicine.