Pharma Focus Europe

Kyverna Therapeutics Receives Regulatory Approval for Phase 1/2 Clinical Trial of KYV-101 in Germany

Friday, July 07, 2023

Kyverna Therapeutics, a cell therapy company focused on addressing serious autoimmune diseases, has received approval from the Paul-Ehrlich-Institut (PEI) in Germany for its first Clinical Trial Application (CTA). The approved therapy, known as KYV101, is a novel approach to treating lupus nephritis (LN), a complication of systemic lupus erythematosus (SLE).

KYV101 is a fully human anti-CD19 chimeric antigen receptor (CAR) T-cell therapy that targets B cell-driven autoimmune diseases like LN. By modifying a patient's immune T cells to recognize and eliminate B cells, this therapy offers new hope for patients who have exhausted conventional treatment options. The approval of the CTA by the PEI recognizes the potential impact of novel CD19 CAR T-cell therapies in treating aggressive autoimmune diseases and opens doors for generating additional insights through rigorous clinical data.

Peter Maag, CEO of Kyverna Therapeutics, believes in changing the treatment paradigm by developing therapies supported by strong clinical evidence. The company aims to explore additional indications for KYV101 and develop a robust pipeline of immunotherapies to address unmet medical needs.

LN affects approximately 40 percent of adults diagnosed with lupus, and a significant portion of LN patients do not respond to standard treatments. The long-term use of corticosteroids and immunosuppressants can have detrimental consequences for young adults with LN. In some cases, LN can progress to kidney failure, requiring dialysis or a kidney transplant for survival.

KYV101, an autologous therapy, has shown promising results in a Phase 1/2 study involving 20 lymphoma patients. The therapy demonstrated a significant reduction in cytokines associated with side effects and improved cell persistence. These positive outcomes led Kyverna to obtain exclusive licenses from the National Institutes of Health (NIH) to utilize the CD19 construct in both autologous and allogeneic CAR T-cell therapies, making KYV101 ideally suited for autoimmune disease patients.

Kyverna's approval of the CTA for KYV101 represents a significant milestone in the development of innovative therapies for autoimmune diseases. The company's commitment to generating robust clinical data and exploring new treatment avenues provides hope for patients with LN and other B cell-driven autoimmune diseases.

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