Kyverna Asks FDA to Begin Clinical Test on Lupus Nephritis Treatment

KYV-101's aim is to kill B-cells, reducing inflammatory attack that drives lupus

Marisa Wexler, MS avatar

by Marisa Wexler, MS |

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Kyverna Therapeutics has submitted an investigational new drug (IND) application asking regulators for permission to begin clinical testing on KYV-101, an experimental cell therapy for lupus nephritis — a severe manifestation of lupus that causes kidney damage.

The company is actively working with sites in the U.S. and Europe to support the initiation of the Phase 1/2 study, pending a response from the U.S. Food and Drug Administration (FDA).

“We are extremely proud to be leading a possible revolution in how we treat severe immune-related and inflammatory diseases. The filing of this IND for KYV-101 in lupus nephritis is an important milestone for Kyverna and we are excited by the prospect of KYV-101 opening a new era in the care of patients with [lupus nephritis],” Peter Maag, PhD, Kyverna’s CEO, said in a press release. “We strongly believe that KYV-101 may drastically change the course of this devastating disease. We look forward to working with the FDA to initiate the KYV-101 clinical study.”

Lupus is an autoimmune disease driven by the activity of immune cells called B-cells. The overarching aim of KYV-101 is to kill B-cells, thereby reducing the autoimmune inflammatory attack that drives lupus.

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KYV-101 is an autologous CAR T-cell therapy. This means it uses T-cells — another type of immune cell — that are taken from the person being treated, engineered in a laboratory, and then transfused back into the patient.

T-cells are equipped with a molecular receptor that lets them identify potential threats: when a T-cell’s receptor binds to its target, it triggers the cell to attack. In CAR T-cell therapy, T-cells are equipped with a human-made receptor called chimeric antigen receptor, or CAR for short.

In KYV-101, T-cells from the person being treated are specifically equipped with a CAR that will bind to CD-19, a protein found on the surface of the B-cells that drive lupus. Kyverna obtained exclusive, worldwide licenses from the National Institutes of Health to use this CD19-targeting CAR construct on its cell therapies.

The National Cancer Institute  sponsored a Phase 1/2 study (NCT02659943) that tested KYV-101 in 20 people with B-cell cancers (lymphomas). The therapy showed expected anti-cancer activity and reduced the levels of inflammatory signaling molecules, with substantially less toxicity compared with other CAR T-cell therapies.

“Patients with lupus nephritis too often experience serious complications from the medications used to control the disease process or from the disease itself. We applaud the team at Kyverna for developing novel treatment approaches for these patients that today have very limited treatment options,” said Richard Furie, MD, a professor at Northwell Health in New York.