The severely disabled and treatment-refractory patient was discharged without symptoms three weeks after KYV-101 infusion and was fully mobile 60 days after, with no observed adverse events related to CAR T-cell therapy
The late breaker abstract was presented on November 11, 2023 at the 96th Congress of the German Society of Neurology in Berlin, Germany
KYV-101 is a fully human CD19 CAR T-cell therapy designed for use in patients with B cell-driven autoimmune diseases
EMERYVILLE, Calif. Nov. 11, 2023 – Kyverna Therapeutics, Inc. (“Kyverna”), a patient-centered clinical-stage biopharmaceutical company focused on developing cell therapies for patients suffering from autoimmune diseases, today announced the presentation at the 96th Congress of the German Society of Neurology (DGN) in Berlin, Germany, of a late breaking abstract describing the case of a 33 year-old myasthenia gravis (MG) patient that underwent treatment with KYV-101 on a named patient basis outside of a clinical trial setting after having exhausted other treatment options. At the time of infusion the patient was requiring a wheelchair for ambulation and disease activity was poorly controlled despite treatment with high doses of cyclophosphamide and IVIG.
The abstract, co-authored by Drs. J. Motte, R. Schroers, , M. Sgodza, C. Schneider-Gold, R. Gold (University Clinic in Bochum), Drs. A. Haghikia , D. Mougiakakos, T. Hegelmeier, (University Clinic in Magdeburg), and Dr. D. Borie (Kyverna) describes the transformative events of a wheelchair-bound patient and the patient’s recovery after two months post-infusion with Kyverna’s autologous CD19 chimeric antigen receptor (CAR) T-cell therapy.
“We couldn’t be happier for the patient, their family, the caregivers, and the medical teams at Bochum and Magdeburg that spearheaded this paradigm-changing treatment in accordance with the German medical regulations.” said Peter Maag, PhD, chief executive officer at Kyverna. “Everyone at Kyverna is motivated by this success to continue in our quest to help investigators in the US and Europe generate more data in patients with serious autoimmune diseases.”
KYV-101 is an autologous, fully human CD19 CAR T-cell product candidate for use in B cell-driven autoimmune diseases such as MG.
CAR T-cell therapy involves modifying a patient’s T cells to recognize and remove B cells in the patient’s body. Kyverna’s CD19 CAR T-cell therapy, KYV-101, specifically targets CD19, a protein expressed on the surface of B cells, which is involved in various types of autoimmune diseases. Kyverna plans to continue to explore additional indications for KYV-101 and develop a robust pipeline of promising product candidate immunotherapies aimed at addressing unmet medical needs in autoimmune diseases.
About Myasthenia gravis (MG)
Myasthenia gravis is an autoimmune disorder associated with muscle weakness in tissues throughout the body, potentially manifesting in partial paralysis of eye movements, problems in chewing and swallowing, respiratory problems, speech difficulties and weakness in skeletal muscles. MG patients develop antibodies that lead to an immunological attack on critical signaling proteins at the junction between nerve and muscle cells, thereby inhibiting the ability of nerves to communicate properly with muscles. The symptoms of the disease can be transient and in the early stages of the disease can remit spontaneously. However, as the disease progresses, symptom-free periods become less frequent and disease exacerbations can last for months. Disease symptoms reach their maximum levels within two to three years in approximately 80% of patients. Up to 20% of MG patients experience respiratory crisis at least once in their lives.
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 Medicine1.
Kyverna is currently conducting two trials of KYV-101 in patients with lupus nephritis, an autoimmune disease in which more than half of patients do not achieve a complete response to current therapies and are at risk of developing kidney failure. Additional clinical trials of KYV-101 in systemic sclerosis, myasthenia gravis, and multiple sclerosis are in preparation. We believe that the differentiated properties of KYV-101 are critical for the potential success of CAR T cells as autoimmune disease therapies.
About Kyverna Therapeutics
Kyverna is a patient-centered, clinical-stage biopharmaceutical company focused on developing cell therapies for patients suffering from autoimmune diseases. As our lead product candidate, KYV-101 is advancing through clinical development across two broad areas of autoimmune disease: rheumatology and neurology, including two ongoing multi-center, open-label Phase 1 and Phase 1/2 trials of KYV-101 in the United States and Germany for patients with lupus nephritis.
Kyverna’s pipeline includes next-generation chimeric antigen receptor (CAR) T-cell therapies in both autologous and allogeneic formats with properties intended to be well suited for use in B cell-driven autoimmune diseases.
By advancing more than one mechanism for taming autoimmunity, Kyverna is positioned to act on its mission of transforming how autoimmune diseases are treated.
For more information, please visit https://kyvernatx.com.
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1Brudno et al., Nature Medicine 2020; 26:270-280.