Kyverna to conduct Phase 2 trial of cell therapy KYV-101 in MG
The FDA clears the company's latest investigational new drug application
The U.S. Food and Drug Administration (FDA) has cleared an investigational new drug (IND) application from Kyverna Therapeutics, giving the company the go-ahead to launch a Phase 2 clinical trial that will test its cell therapy, KYV-101, in people with myasthenia gravis (MG).
This is the fifth IND application for KYV-101 to be cleared by the FDA. According to Kyverna, the upcoming Phase 2 trial will be an open-label, multicenter study called KYSA-6. The company did not provide additional details on the design or timeline of the trial.
“We are grateful that the FDA’s decision to clear the IND for our Phase 2 KYSA-6 trial will allow Kyverna to offer this potentially paradigm-shifting investigational treatment to patients,” Peter Maag, PhD, Kyverna’s CEO, said in a press release.
“We have seen firsthand the transformative effects of KYV-101 in MG patients treated with the investigational therapy in our clinic,” said Aiden Haghikia, MD, director of the department of neurology at the Medical Faculty of Otto-von-Guericke University in Germany. “I welcome the FDA’s decision and look forward to more clinical data to further our knowledge about CAR T-cell therapy in patients with severe neurological autoimmune diseases.”
Antibodies are immune proteins made by B-cells, a specialized type of immune cell. B-cells and the antibodies they produce are normally a key part of the body’s immune defense against infectious invaders. But in autoimmune disorders like MG, they target the body’s healthy tissues to drive disease.
KYV-101 is designed to destroy B-cells. According to Maag, the therapy is expected to provide MG patients with “a deep B cell depletion and possibly durable reset of their immune system,” which is expected to reduce MG-driving autoimmune activity.
KYV-101 is a CAR T-cell therapy. With this type of treatment, clinicians first collect a patient’s T-cells, which are a type of immune cell that’s able to kill other cells. T-cells then are engineered in a laboratory to be equipped with a chimeric antigen receptor or CAR, which is a man-made protein that directs them to attack a specific molecular target.
Targeting the CD19 protein in B-cells
With KYV-101, T-cells are equipped with a CAR that targets CD19, a protein that’s found on the surface of B-cells. The engineered T-cells are then infused back into the patient where they are expected to attack and destroy B-cells containing CD19.
Kyverna is developing KYV-101 as a potential treatment for multiple B-cell driven autoimmune disorders. The company is conducting two clinical trials — a Phase 1/2 trial in Germany called KYSA-3 and a Phase 1 trial called KYSA-1 (NCT05938725) in the U.S. — testing the therapy in people with lupus nephritis, a serious complication of lupus characterized by kidney damage and inflammation.