Kyverna Therapeutics, Inc. Announces First-In-Disease Use of it's KYV-101 in Patient with Severe Stiff-Person Syndrome Published in Results

Kyverna Therapeutics, Inc. announced the publication in Proceedings of the National Academy of Sciences (PNAS)1 of a report describing the first use of KYV-101, a fully human anti-CD19 chimeric antigen receptor (CAR) T-cell product candidate, in a 69-year-old patient suffering from treatment-refractory stiff-person syndrome (SPS) as part of a named-patient use in Germany for critically ill individuals who fail conventional therapies. SPS is a rare, progressive neurological autoimmune disorder causing debilitating muscle stiffness in the torso, arms, and legs, impacting the ability to walk or move. Patients typically present with muscle spasms and stiffness, resulting in difficulty turning and bending.

When stiffness is severe, the patient's walking resembles a statue. Muscle spasms and stiffness can be precipitated by unexpected stimuli, including sounds, like a phone ring or a siren, sudden touches or conditions triggering anxiety and emotional upset which, when severe, are misdiagnosed as a primary anxiety disorder2. There is no cure for SPS, but only treatments focused on the symptoms. KYV-101 is an autologous, fully human CD19 CAR T-cell product candidate for use in B cell-driven autoimmune diseases.

The CAR in KYV-101 was designed by the National Institutes of Health (NIH) to improve tolerability and tested in a 20-patient Phase 1 trial in oncology. Results were published by the NIH in Nature Medicine3. KYV-101 is currently being evaluated in sponsored, open-label, Phase 1/2 and Phase 2 trials of KYV-101 in the United States and Germany across two broad areas of autoimmune disease: rheumatology and neurology.

With 50 patients treated so far with the CAR in KYV-101 in both oncological and autoimmune conditions at more than 15 locations in Europe and the U.S., we believe that the differentiated properties of KYV-101 are critical for the potential success of CAR T cells as autoimmune disease therapies. KYV-101 is also being evaluated in investigator-initiated trials for multiple indications in multiple geographies.