KYV-101 CAR-T cell therapy for lupus nephritis on FDA fast track

Phase 1 trial of KYV-101 recruiting adults with lupus nephritis in US

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by Lindsey Shapiro |

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KYV-101, an investigational cell therapy from Kyverna Therapeutics, has been granted a fast track designation by the U.S. Food and Drug Administration (FDA) for the treatment of refractory lupus nephritis — a serious lupus complication characterized by kidney damage.

Fast track status is granted to experimental therapies for life-threatening diseases with unmet medical need. Such a designation is intended to help accelerate a therapy’s development by offering manufacturers more frequent interactions with the FDA, as well as opportunities to apply for accelerated approval and priority review.

In November, the FDA cleared an open-label Phase 1 clinical trial of KYV-101. The trial is now actively recruiting lupus nephritis patients at multiple sites in the U.S., according to Kyverna. The company has also filed an application to conduct a parallel Phase 1/2 trial in lupus nephritis patients in Germany.

“The FDA granting us Fast Track designation for KYV-101 means we can move more quickly toward bringing this potentially transformative and life-saving medicine to patients with lupus,” Peter Maag, PhD, CEO of Kyverna, said in a company press release.

“We believe KYV-101 has the potential to drive greater and more rapid reduction of disease activity in patients with [lupus nephritis], and we look forward to sharing clinical data on patients in the second half of 2023,” Maag said.

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

Lupus nephritis can lead to kidney failure

Lupus is an autoimmune disease that occurs when a person’s immune system mistakenly launches an attack against the body’s own tissues, driving symptoms that can affect virtually every part of the body.

Lupus nephritis is a serious complication of lupus that can lead to kidney failure. It occurs when the structures in the kidneys that are responsible for filtering waste are affected by the disease.

Nearly half of adults with lupus will develop lupus nephritis at some point, according to Kyverna. Moreover, about 60% of people who develop the condition will fail to respond, or be refractory, to currently available treatments.

CAR T-cell therapies are gaining ground as potential treatments for lupus and other autoimmune conditions. This type of therapy works to reduce the severity of disease attacks by destroying B-cells, the immune cells responsible for producing the antibodies that drive autoimmunity.

To do this, a person’s own T-cells — a type of immune cell that can attack and destroy threats — is equipped with the means to specifically target B-cells. Essentially, T-cells are harvested from a patient and then modified in the lab to express a lab-made receptor — a chimeric antigen receptor (CAR) — that specifically recognizes proteins found exclusively on B-cells.

The modified cells are then infused back into the patient, where they seek to recognize and destroy B-cells.

We look forward to sharing clinical data on patients in the second half of 2023.

KYV-101 being developed for certain autoimmune conditions, cancers

KYV-101 is a CAR T-cell therapy that specifically targets the CD19 protein found on B-cells. Kyverna is developing it for B-cell associated autoimmune conditions like lupus nephritis, as well as for certain types of B-cell associated cancers.

Preclinical data presented at a recent scientific conference indicated that KYV-101 generated from people with systemic lupus erythematosus (SLE) or lupus nephritis could successfully kill off B-cells in lab studies.

Moreover, a previous Phase 1/2 study (NCT02659943) found that the therapy had anti-cancer and anti-inflammatory activity among 20 people with B-cell cancers.

The Phase 1 study is now seeking to understand the effects of KYV-101 in adults with lupus nephritis.

KYV-101’s fast track status comes about a month after the FDA issued a similar designation for CABA-201, another investigational CD19-targeted CAR T-cell therapy being developed by Cabaletta Bio for the treatment of lupus nephritis and SLE.