Cell therapy KYV-101 put on FDA fast track as MG treatment

Kyverna cleared last month to begin Phase 2 clinical trial of therapy

Marisa Wexler, MS avatar

by Marisa Wexler, MS |

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KYV-101, an experimental cell therapy for myasthenia gravis (MG) in development by Kyverna Therapeutics, has been granted fast track status by the U.S. Food and Drug Administration (FDA).

The FDA gives this designation to therapies that have the potential to improve care for serious illnesses. The designation is meant to help speed their development of and entitles their makers to more frequent communication with the FDA during the development process.

The announcement comes just a month after the FDA cleared Kyverna to begin an open-label, multicenter Phase 2 clinical trial called KYSA-6 that will test KYV-101 in people with MG.

“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,” Peter Maag, PhD, CEO of Kyverna, said in a company press release.

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What is KYV-101?

Maag said MG is the second indication KYV-101 has been put on the fast track for. It also earned the designation for lupus nephritis, a serious complication of lupus marked by kidney inflammation, earlier this year.

MG is usually caused by antibodies that target healthy proteins on muscle cells, interfering with the molecular signaling between nerves and muscles in a way that leads to symptoms like muscle weakness. KYV-101 is designed to treat the disorder by depleting B-cells, the immune cells chiefly responsible for producing MG-driving antibodies.

KYV-101 belongs to a class of treatments called CAR T-cell therapies. They work by collecting T-cells, another type of immune cell, from a patient that are then engineered with a chimeric antigen receptor (CAR) — a man-made receptor that directs the cells to attack a particular target.

In KYV-101, T-cells are equipped with a CAR that targets CD19, a protein expressed by B-cells. The engineered cells are then infused back into the patient, where they attack and destroy B-cells expressing CD19.

Kyverna is developing the cell therapy as a potential treatment for patients with refractory MG and other disorders driven by B-cells. A case report recently published showed KYV-101 safely and effectively eased disease symptoms for a woman with hard to treat generalized MG.