Kyverna, Charité partner to study effects of B-cell-targeting therapies

Deal also covers studies on CAR T-cell therapies, including Kyverna's KYV-101

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by Margarida Maia |

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Kyverna Therapeutics has signed a research funding deal with Charité – Universitätsmedizin Berlin, in Germany, to study how therapies targeting immune B-cells may improve clinical outcomes of people with whole-body, or systemic, autoimmune diseases such as lupus.

The deal also covers studies on CAR T-cell therapies, including Kyverna’s experimental candidate KYV-101, which is under Phase 1 clinical testing in people with lupus nephritis, a common and serious complication of lupus characterized by kidney damage and inflammation.

Valid for an undisclosed number of years, the deal “will help advance knowledge on B-cell driven diseases, which will increase our understanding of how patients suffering from autoimmune diseases can further benefit from our potentially life-saving therapies,” Peter Maag, PhD, Kyverna’s CEO, said in a company press release.

Findings resulting from this research agreement will be owned by both entities.

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Researchers focus on how treatment affects immune profile of patients

Scientists at Charité’s department of rheumatology and clinical immunology will focus on the effects approved and experimental therapies have on the immune profile of people with systemic autoimmune diseases treated at their center.

This will involve counting B-cells and plasma cells — the most activated form of B-cells that produce high amounts of antibodies — in blood and other tissues before and after treatment.

“We see this opportunity as a further demonstration of how physician scientists at Charité can effectively collaborate with leading biotech companies in studying and understanding changes in the molecular and cellular immune signature of patients with systemic autoimmune diseases that receive different B-cell and plasma cell-targeting therapies as part of their routine treatment,” said Gerhard Krönke, MD, who directs the department of rheumatology and clinical immunology, and serves as Charité’s project manager.

Autoimmune attacks in lupus are driven by self-reactive antibodies that B-cells mistakenly produce against the body’s own tissues. About 40% of adults with lupus eventually develop lupus nephritis, and more than half of these patients are refractory, or fail to respond, to approved therapies.

KYV-101 involves collecting a patient’s own immune T-cells and modifying them in the lab with a chimeric antigen receptor, or CAR, designed to recognize and promote the death of B-cells once infused back to the patient. The CAR T-cell therapy specifically targets CD19, a protein found on the surface of B-cells.

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KYV-101 granted fast track designation in US

KYV-101 received fast track designation from the U.S. Food and Drug Administration for the treatment of refractory lupus nephritis. This status is meant to accelerate the therapy’s clinical development and regulatory review.

An ongoing  Phase 1 clinical trial (NCT05938725) is evaluating the safety of escalating doses of the cell therapy in up to 12 adults with refractory lupus nephritis recruited at U.S. sites. Enrollment may still be ongoing. Interim data from the first dosed participant showed no signs of neurotoxicity for the first 28 days after treatment with KYV-101.

Kyverna is also planning to launch a similar Phase 1/2 trial in Germany.