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US FDA Grants RMAT Designation for Kyverna's KYV-101

18 Jul 2024
Admin
News Article

US FDA Grants RMAT Designation for Kyverna's KYV-101

US FDA grants RMAT designation for Kyverna's KYV-101 to treat patients with refractory stiff-person syndrome

Overview

Kyverna Therapeutics, Inc. (Kyverna), a patient-centred, clinical-stage biopharmaceutical company focused on developing cell therapies for patients suffering from autoimmune diseases, announced the designation as Regenerative Medicine Advanced Therapy (RMAT) by the US Food and Drug Administration (FDA) for its autologous, fully human CD19 chimeric antigen receptor (CAR) T-cell product candidate, KYV-101, to be used for the treatment of patients suffering from refractory stiff-person syndrome.

Statement from an Expert

"Stiff-person syndrome has devastating and life-altering effects on patients suffering from this rare autoimmune disease," said Amanda Piquet, M.D., director of the Autoimmune Neurology Programme at CU Anschutz Medical Campus, Aurora, CO.
"I look forward to the data that will emerge from the KYSA-8 trial as this trial could drastically change the treatment landscape for SPS."
Words from CEO: Kyverna
"We are eager to begin generating data from our sponsored trial to advance the knowledge on a potential immunological reset of the patient's immune system," said Peter Maag, Ph.D., chief executive officer at Kyverna.
"We are humbled by the resilience of the SPS patients and their hope for a potential paradigm-shifting treatment option that could provide durable, immunosuppressant-free remission."

Stiff Person Syndrome

Stiff Person Syndrome (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 patients' posture 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 disorder.

KYV-101

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 Medicine.
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 US, 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.

Kyverna Therapeutics

Kyverna Therapeutics, Inc. is a patient-centred, clinical-stage biopharmaceutical company focused on developing cell therapies for patients suffering from autoimmune diseases.