Germany approves Phase 1/2 trial of KYV-101 for lupus nephritis

Similar trial recently launched in US with several sites enrolling patients

Patricia Inacio, PhD avatar

by Patricia Inacio, PhD |

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Kyverna Therapeutics is planning to launch a Phase 1/2 trial in Germany to test KYV-101, its investigational cell therapy for lupus nephritis, a lupus complication characterized by kidney damage.

The study was approved by the Paul Ehrlich Institute (PEI), which is responsible for examining clinical trials of investigational vaccines and biomedicines in Germany, and follows the recent launch of a similar trial in the U.S.

The U.S. trial recently enrolled its first patient. Several sites are currently recruiting participants, who will receive escalating doses of KYV-101 to test the treatment’s safety.

“We believe in changing the treatment paradigm by generating rigorous clinical data, and the PEI’s approval paves the way to generate additional insights,” Peter Maag, PhD, CEO of Kyverna Therapeutics, said in a company press release.

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Most adults with lupus nephritis fail to respond to available treatments

In lupus, the immune system generates antibodies that attack the body’s own tissues. This mistargeted inflammatory attack is driven mainly by B-cells, a type of immune cell that is responsible for making antibodies.

About half of adult patients will develop lupus nephritis at some point, and around 60% of them fail to respond to available therapies. Kyverna believes KYV-101 may be an alternative for these difficult-to-treat patients.

The therapy is designed to reduce the severity of the autoimmune attack that drives lupus by specifically targeting B-cells using another type of immune cell, called T-cells.

The process starts with the collection of T-cells from a patient, which are then engineered in the lab to recognize a specific protein. In the case of lupus, T-cells are engineered to recognize a protein located on the surface of B-cells, called CD19.

Once infused back into the patient, the modified T-cells are expected to attack and destroy B-cells.

“This approval recognizes the potential impact novel CD19 CAR T-cell therapies may bring to patients living with aggressive autoimmune diseases and reflects the global potential for KYV–101,” Maag said.

Preclinical studies with T-cells harvested from patients with systemic lupus erythematosus or lupus nephritis showed that KYV-101 successfully targeted B-cells for destruction.

A Phase 1/2 study (NCT02659943) tested KYV-101 in 20 people with B-cell cancers. Results confirmed the treatment’s anti-cancer and anti-inflammatory activity.

These findings prompted Kyverna to extend clinical testing of KYV-101 to other B-cell-driven autoimmune disorders, with trials launched in the U.S. and Europe.

KYV-101 has been given fast track designation in the U.S. for the treatment of refractory lupus nephritis.