Kyverna Therapeutics has received fast track designation from the US Food and Drug Administration (FDA) for KYV-101, its autologous, fully human CD19 chimeric antigen receptor (CAR) T-cell product candidate for refractory myasthenia gravis (MG) treatment.
Kyverna is a clinical-stage biopharmaceutical firm focused on the development of cell therapies for individuals suffering from autoimmune disorders.
KYV-101 is an autologous, fully human CD19 CAR T-cell product asset to treat B cell-driven autoimmune diseases.
The latest designation comes after Investigational New Drug (IND) clearance for KYV-101 for use in Kyverna’s KYSA-6 Phase 2 open-label, multi-centre trial.
Kyverna CEO Peter Maag said: “We are very happy to receive this important designation for KYV-101 in the KYSA-6 trial and remain committed to improving the lives of patients living with severe and debilitating neurological autoimmune diseases.
“This is the second time KYV-101 has received such designation, after obtaining the first one for lupus nephritis earlier this year.”
In CAR T-cell therapy, a patient’s T cells are altered to identify and eliminate B cells from their body.
KYV-101 focuses on the protein CD19, which is expressed on the surface of B cells and linked to several autoimmune disorders.
The biopharmaceutical company intends to build a strong pipeline of viable product candidates and pursue further exploration of indications for KYV-101 to meet unmet medical needs in autoimmune illnesses.
The CAR in KYV-101 was created by the National Institutes of Health (NIH) to enhance tolerability and tested in a 20-patient Phase 1 oncology study.
Kyverna is presently conducting two trials of KYV-101 in patients with lupus nephritis in the US and Germany.
Additional plans include more clinical trials for multiple sclerosis, myasthenia gravis, and systemic sclerosis.
In September this year, the biopharmaceutical company signed a multi-year licence and supply agreement with Oxford Biomedica to use its LentiVector platform.
