Research & Development
Kyverna Therapeutics' fifth KYV-101 Investigational New Drug application receives US FDA approval
14 November 2023 -

Kyverna Therapeutics Inc, a California-based, clinical-stage biopharmaceutical company involved in developing cell therapies for patients suffering from autoimmune diseases, announced on Monday that it has received approval for its fifth Investigational New Drug (IND) application for KYV-101 from the US Food and Drug Administration (FDA).

This will allow Kyverna to initiate a Phase 2 open-label, multi-centre 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 US.