Kyverna, Verily team up to identify KYV-101 response biomarkers

Therapy is being evaluated in 12 patients in open-label trial

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by Steve Bryson PhD |

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Kyverna Therapeutics will use Verily Life Sciences’ high-resolution Immune Profiler to identify biomarkers to measure responses to KYV-101, Kyverna’s experimental cell therapy for lupus-related kidney disease.

KYV-101 is being evaluated in an open-label trial, which is recruiting nine to 12 patients at clinical sites across the U.S. Kyverna has been given the go-ahead to test the cell therapy in a Phase 1/2 trial in Germany.

The multiyear collaboration will focus on optimizing data collection methods to design more efficient clinical trials, providing solutions for people with autoimmune diseases treated with cell therapy.

“This collaboration links Verily’s deep molecular capabilities with its extensive suite of tools for real-world evidence generation, providing a comprehensive and detailed understanding of the biology and participant experience with this new therapeutic modality in autoimmune disease,” Amy Abernethy, president of product development and chief medical officer at Verily, said in a press release.

In lupus, the immune system wrongly targets various healthy tissues. Lupus nephritis is a serious complication of the autoimmune disease that can result in kidney failure, but 60% of patients fail to respond to treatment.

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Immune response to KYV-101

KYV-101 is a CAR T-cell therapy to target the CD19 protein on B-cells, the antibody-producing immune cells that drive the autoimmune attack in lupus.

The treatment involves harvesting immune T-cells from a patient and then modifying them in the lab to equip them with a chimeric antigen receptor (CAR) that recognizes CD19. Modified T-cells are then expanded and infused back into the patient, where they’re expected to attack and destroy disease-driving B-cells.

In preclinical studies presented at a conference, KYV-101, created from patients with systemic lupus erythematosus (SLE) or lupus nephritis, successfully targeted B-cells for destruction. A now-completed Phase 1/2 study (NCT02659943) showed it had anti-cancer and anti-inflammatory effects in patients with B-cell cancers.

“B cell depletion using CAR T-cells represents a new frontier with curative potential for autoimmune patients, and together we will be uncovering the biological basis of the immune reset that confers durable therapeutic response in these patients,” said Charlie Kim, head of molecular science at Verily.

Kyverna will apply Verily’s Immune Profiler to track immune responses to KYV-101, including changes in genes, gene activity, cell types, and protein production. Along with finding biomarkers that can differentiate patient outcomes, the Immune Profiler can uncover disease mechanisms, predict and validate new therapy targets using human data, and identify alternative uses to current therapies.

“We are excited to explore our emerging patient dataset, which will enable us to generate a first look into the biology underlying immune reset after administration of CAR T-cell therapy,” said James Chung, chief medical officer at Kyverna.

As part of their collaboration, the companies will use digital tools to optimize data generation strategies, using data from real-world settings and study sites. The goal is to provide solutions that are tailored to suit the needs of autoimmune disease patients treated with CAR T-cell therapy.

“We are pleased to partner with Verily based on our shared vision to create the future landscape of clinical research, and to enable broader data collection from real-world settings that may contribute to regulatory decision-making,” said Peter Maag, Kyverna’s CEO.

KYV-101 was granted fast-track designation in the U.S. for treating hard-to-treat lupus nephritis.