FDA Agrees to Early Trial of KYV-101, Cell Therapy for Lupus Nephritis

Kyverna Therapeutics planning to initiate Phase 1 testing in early 2023

Marisa Wexler, MS avatar

by Marisa Wexler, MS |

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The U.S. Food and Drug Administration (FDA) has agreed to allow Kyverna Therapeutics to begin clinical testing of KYV-101, the company’s investigational cell therapy for lupus nephritis, a form of lupus that causes kidney damage.

Kyverna submitted a request, in the form of an investigational new drug (IND) application, to the regulatory agency last month asking to open a Phase 1 trial.

“We are pleased with the FDA’s clearance of our IND application for our lead candidate KY-101 in lupus nephritis. This is a huge achievement for Kyverna and a significant moment in the field of cell therapies targeting autoimmune disease,” Peter Maag, PhD, Kyverna’s CEO, said in a company press release.

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KYV-101 aims to treat lupus nephritis by preventing immune attacks

“We look forward to working with investigators to initiate our Phase 1 clinical trial in early 2023,” Maag said.

In lupus, the body’s immune system launches an inflammatory attack that damages healthy tissues. This attack is driven mainly by B-cells, a type of immune cell that is responsible for making antibodies. KYV-101 is designed to reduce the severity of the autoimmune attack by targeting these cells.

KYV-101 treatment entails harvesting another type of immune cell, called T-cells, from a patient. Researchers then engineer these T-cells in a laboratory to equip them with a chimeric antigen receptor, or CAR, which can bind to a protein called CD19 found on the surface of B-cells. The modified T-cells are then infused back to the patient. When the CAR binds to CD19 on a patient’s B-cells, it causes T-cells to attack and destroy the B-cells.

According to Kyverna, about 40% of adults with lupus will develop lupus nephritis. Most of these individuals will not fully respond to current treatments, with up to 10% of lupus nephritis patients ultimately progressing to kidney failure.

“There is a clear need for additional therapies for lupus nephritis, as current interventions are limited in their rates of response. Given recent publications showing the potential of cell-based therapy for patients with lupus nephritis, it is exciting to see that a clinical trial is commencing in this indication,” said Peter Merkel, MD, chief of rheumatology and professor of medicine and epidemiology at the University of Pennsylvania.

“This work also holds promise for other B-cell-driven autoimmune diseases,” Merkel added.