Kyverna and NIH Co-Author Review on Cell Therapy for Autoimmunity in Nature Reviews Immunology

Kyverna Therapeutics, a clinical-stage biopharmaceutical company dedicated to developing cell therapies for autoimmune diseases, has announced promising early clinical results using anti-CD19 CAR T cells for patients with autoimmune disorders. The company is actively recruiting for several KYSA trials involving their product candidate, KYV-101, targeting conditions such as myasthenia gravis, multiple sclerosis, and lupus nephritis.

The announcement coincided with the publication of a manuscript in Nature Reviews Immunology, co-authored by Kyverna and the National Institutes of Health (NIH). This manuscript, titled "Chimeric antigen receptor T cell therapy for autoimmune disease," highlights the significant considerations in the development of CAR T-cell therapy for autoimmune conditions. These include identifying optimal target cell populations, designing effective CAR constructs, managing acceptable levels of toxicity, and the potential for enduring immune system reset.

James Kochenderfer, M.D., a senior investigator at the National Cancer Institute, expressed enthusiasm about the application of CAR T-cell therapy, initially developed for cancer treatment, to autoimmune diseases. He anticipates further advancements in this field, which could lead to groundbreaking treatments for patients.

Peter Maag, Ph.D., CEO of Kyverna, emphasized the importance of their collaboration with leading experts in CAR T-cell therapy. He noted that their rapid progress in evidence-based science aims to provide long-lasting, treatment-free therapeutic options for patients in need.

KYV-101 is an autologous, fully human CD19 CAR T-cell product designed for B cell-driven autoimmune diseases. This CAR construct, created by the NIH to enhance tolerability, has been tested in a Phase 1 oncology trial involving 20 patients, with results published in Nature Medicine.

Currently, KYV-101 is being evaluated in several Phase 1/2 and Phase 2 clinical trials in the United States and Germany, focusing on autoimmune diseases in rheumatology and neurology. To date, over 50 patients have been treated with KYV-101 across various locations in Europe and the U.S. The unique properties of KYV-101 are considered essential for the potential success of CAR T-cell therapies in treating autoimmune diseases.

Kyverna is also exploring KYV-101 in investigator-initiated trials for multiple indications across various geographic regions. The company's pipeline includes next-generation CAR T-cell therapies in both autologous and allogeneic formats, tailored for use in B cell-driven autoimmune diseases.

Kyverna Therapeutics' ongoing mission is to advance CAR T-cell therapy to provide innovative treatment options for patients with autoimmune diseases. With numerous clinical trials underway, the company's lead candidate, KYV-101, continues to progress through clinical development. This includes Phase 2 trials for multiple sclerosis and myasthenia gravis, a Phase 1/2 trial for systemic sclerosis, and two multi-center, open-label Phase 1/2 trials in the U.S. and Germany for lupus nephritis.

The company envisions a future where CAR T-cell therapies offer long-lasting, treatment-free solutions for patients with autoimmune diseases, representing a significant advancement in medical treatment and patient care.