The US Food and Drug Administration (FDA) has granted fast track designation for Kyverna Therapeutics’ autologous, fully human CD19 chimeric antigen receptor (CAR) T-cell therapy KYV-101 to treat myasthenia gravis.

The latest development comes after the regulator granted clearance for the investigational new drug application to commence an open-label, multicentre Phase II KYSA-6 clinical trial of the therapy.

The product candidate acts on the CD19 protein, which is seen on the surface of B cells associated with a range of autoimmune ailments. 

The US National Institutes of Health created KYV-101 to boost tolerability and for assessment in a Phase I oncology trial in 20 subjects. 

KYV-101 is also being analysed in two open-label, multicentre Phase I trials for treating lupus nephritis, an autoimmune ailment in which more than 50% of patients do not attain a complete response to standard treatments and are at risk of developing kidney failure.

These trials are progressing in the US and Germany. 

The company intends to analyse the cell therapy for further indications and create a pipeline of immunotherapy product candidates for autoimmune ailments.

KYV-101 will also be analysed for use in conditions such as systemic sclerosis and multiple sclerosis.

Kyverna Therapeutics CEO Peter Maag stated: “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 August 2023, the company secured $60m in a Series B extension funding round.

Kyverna used the capital to advance the clinical development of its fully human anti-CD19 CAR T-cell therapies for autoimmune ailments.