Kyverna Therapeutics

Kyverna Therapeutics is a clinical-stage biopharmaceutical company focused on developing cell therapies for patients suffering from autoimmune diseases. Their lead product candidate, KYV-101, is an autologous, fully human CD19 chimeric antigen receptor (CAR) T-cell therapy designed for use in B cell-driven autoimmune diseases. KYV-101 targets CD19, a protein expressed on the surface of B cells involved in various autoimmune conditions.

In January 2024, KYV-101 received US FDA clearance for a Phase two trial (KYSA-7) to treat patients with refractory, progressive multiple sclerosis. KYV-101 is being evaluated in sponsored clinical trials across rheumatology and neurology indications, including lupus nephritis, systemic sclerosis, myasthenia gravis, and multiple sclerosis. As of December 2023, 14 autoimmune patients had been treated with KYV-101 cumulatively.

In March 2024, results from a named patient program using KYV-101 in two multiple sclerosis patients in Germany were published, showing an acceptable safety profile. Kyverna obtained additional FDA clearances for KYV-101 trials in myasthenia gravis (November 2023) and multiple sclerosis (January 2024). The company plans to explore more indications and develop a robust autoimmune disease therapy pipeline.

Key customers and partnerships

In February 2024, Kyverna completed an upsized USD 366.9 million initial public offering, strengthening its financial position to fund operations into 2026. The company partnered with ElevateBio's BaseCamp to advance its Ingenui-T manufacturing process, aiming to improve patient experience and manufacturing efficiencies.