Pharma Focus America

Kyverna Therapeutics Receives FDA IND Approval for KYV-101, a Novel Fully Human CD19 CAR T-Cell Therapy Targeting Scleroderma

Thursday, October 12, 2023

Kyverna Therapeutics, a clinical-stage biotechnology company committed to advancing innovative therapies for severe autoimmune conditions, has obtained FDA clearance for its third Investigational New Drug (IND) application, KYV-101. This approval allows Kyverna to commence a Phase 1/2 open-label, multi-center clinical trial, named KYSA-5, with KYV-101, an autologous fully human Anti-CD19 Chimeric Antigen Receptor (CAR) T cell therapy. The primary objective is to treat diffuse cutaneous systemic sclerosis, a subtype of scleroderma.

This latest development complements the ongoing Phase 1 KYSA-1 trial in the United States and the Phase 1/2 KYSA-3 trial in Germany, where KYV-101 is being assessed in adults with active lupus nephritis.

Luke Evnin, Chairman of the Scleroderma Research Foundation, expressed optimism regarding the CAR-T approach in scleroderma treatment and its potential to achieve effective results with improved safety through B cell ablation using KYV-101.

Peter Maag, Ph.D., CEO of Kyverna Therapeutics, expressed immense pride in the opportunity to introduce KYV-101 as a treatment option for patients with scleroderma. He highlighted the potential for KYV-101 to reset the immune system and interrupt the vicious cycle of an overactive immune response.

KYV-101 is an autologous version of a fully human Anti-CD19 Chimeric Antigen Receptor (CAR) T cell construct designed for application in B cell-driven autoimmune diseases like lupus nephritis and scleroderma. Promising results, including the reduction of cytokines and associated side effects, were observed in a Phase 1/2 study in oncology. Kyverna Therapeutics exclusively licensed the use of this CD19 construct for both autologous and allogeneic CAR T-cell therapies from the National Institutes of Health (NIH).

Systemic sclerosis (scleroderma) is a rare, chronic autoimmune disorder with significant implications for the skin and internal organs. It can lead to severe pain, discomfort, and complications affecting various organs, including the lungs, heart, kidneys, and the gastrointestinal system, ultimately impacting life expectancy. Managing severe scleroderma is complex and typically requires a combination of medications, such as immunosuppressants and disease-modifying drugs, alongside specialized care.

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