The US Food and Drug Administration (FDA) has granted fast track designation to Kyverna Therapeutics’ autologous, fully human CD19 chimeric antigen receptor (CAR) T-cell therapy, KYV-101, for the treatment of multiple sclerosis (MS).
The development comes after the company received investigational new drug application (IND) clearance for the KYSA-7 Phase II multicentre, open-label clinical trial of KYV-101.
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The designation aims to expedite the development and review of new products that address unmet medical needs.
A lead product candidate of the company, KYV-101 is designed to act on the CD19 protein found on the B cell surface, which is implicated in a range of autoimmune ailments.
The therapy modifies patients’ T cells to detect and kill B cells.
Originating from a partnership with the US National Institutes of Health, the CAR in KYV-101 was engineered to enhance tolerability and has been assessed in a 20-subject Phase I oncology trial.
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By GlobalDataKyverna is carrying out two trials of KYV-101 in lupus nephritis patients.
The company also plans to launch further trials of KYV-101 for systemic sclerosis, myasthenia gravis and multiple sclerosis.
Last month, the FDA granted fast track designation for KYV-101 to treat myasthenia gravis.
Kyverna CEO Peter Maag stated: “We appreciate the FDA’s support to accelerate the development of potentially life-changing CAR T-cell therapies that could greatly benefit patients living with severe and debilitating neurological autoimmune diseases.
“This marks another important milestone in our endeavour to change the treatment paradigm with KYV-101.”
As a clinical-stage biopharmaceutical company, Kyverna focuses on the development of cell therapies for autoimmune ailments.
Its pipeline also features next-generation CAR T-cell therapies in both autologous and allogeneic formats designed to fit for treating B cell-driven autoimmune diseases. The company anticipates that the properties of its KYV-101 are vital for the success of CAR T cells in treating autoimmune diseases.
