The T-cell product candidate is intended for the treatment of myasthenia gravis. Credit: Toa55 / Shutterstock.com.

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.

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These trials are progressing in the US and Germany. 

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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.