Poster #14-006 describes the first successful treatment of concomitant myasthenia gravis and Lambert-Eaton myasthenic syndrome with autologous CD19-targeted CAR-T cells

Kyverna to host a conference call on April 16 to review recent named-patient experience in patients suffering from multiple sclerosis and myasthenia gravis

EMERYVILLE, Calif., April 11, 2024 /PRNewswire/ -- Kyverna Therapeutics, Inc. (NASDAQ:KYTX), a patient-centered, clinical-stage biopharmaceutical company focused on developing cell therapies for patients suffering from autoimmune diseases, announced today its attendance at the 2024 annual meeting of the American Academy of Neurology to be held in Denver, Colorado, starting on April 13.

Of particular interest:

On April 15, Jeremias Motte, M.D., a senior physician and neurologist at the University Hospital in Bochum, Germany, will present a case study of a successful treatment of patients suffering from concomitant myasthenia gravis and Lambert-Eaton syndrome¹
On April 16, Kyverna will host a conference call discussing recent experience with KYV-101 in patients suffering from neurological autoimmune diseases. Call-in details will be published in advance on the company's website (ir.kyvernatx.com)
On April 16, Marinos Dalakas, M.D., FAAN, a professor at the Thomas Jefferson University Hospitals and a neurology specialist, will discuss advances in the therapeutic algorithm for autoimmune neuromuscular disorders

"We welcome the publication of these reports from named-patient case studies that contribute to building confidence in the desired safety and efficacy profile for innovating CAR T-cell therapies," said Jeffrey Dunn, M.D., the Lily Sarafan director of Neuroimmunology and clinical professor and chief of Neuroimmunology within the Department of Neurology and Neurological Sciences at Stanford University in Palo Alto, California.

"We look forward to attending AAN and engaging with the scientific community in seeking to develop paradigm-shifting treatment options for patients living with autoimmune diseases," said Peter Maag, Ph.D., chief executive officer of Kyverna.

Chimeric antigen receptor (CAR) T-cell therapy involves modifying a patient's T cells to recognize and remove B cells in the patient's body. CD19 CAR T-cell therapy specifically targets CD19, a protein expressed on the surface of B cells, which are involved in various types of autoimmune diseases.

About Multiple Sclerosis (MS)

Multiple sclerosis is a chronic neurodegenerative autoimmune disease affecting over 2.8 million individuals worldwide². It affects more frequently women, people of Northern European descent, and is also associated with certain environmental and genetic factors. Patients with MS can experience a range of symptoms including blurred vision, slurred speech, tremors, numbness, extreme fatigue, problems with memory and concentration, and, in severe cases, the inability to walk or stand.

Current disease-modifying treatments for MS aim to reduce the frequency of disease relapses and delay progression of disability, but the disease remains a chronic condition that will progressively worsen for most patients.

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.³

About 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 Medicine⁴.

KYV-101 is currently being evaluated in sponsored, open-label, Phase 1/2 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. Additionally, FDA's IND clearance has been obtained for Phase 2 trials of KYV-101 for multiple sclerosis and myasthenia gravis, and a Phase 1/2 trial for systemic sclerosis.

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.

About Kyverna Therapeutics

Kyverna Therapeutics, Inc. (NASDAQ:KYTX) is a patient-centered, clinical-stage biopharmaceutical company focused on developing cell therapies for patients suffering from autoimmune diseases.

Our lead CAR T-cell therapy candidate, KYV-101 is advancing through clinical development with sponsored clinical trials across two broad areas of autoimmune disease: rheumatology and neurology, including Phase 2 trials for multiple sclerosis and myasthenia gravis, a Phase 1/2 trial for systemic sclerosis, and two ongoing multi-center, open-label Phase 1/2 trials in the United States and Germany for patients with lupus nephritis.

Kyverna's pipeline includes next-generation 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.

Forward-Looking Statements

Statements in this press release about future expectations, plans and prospects, as well as any other statements regarding matters that are not historical facts, may constitute "forward-looking statements." The words, without limitation, "anticipate," "believe," "continue," "could," "estimate," "expect," "intend," "may," "plan," "potential," "predict," "project," "should," "target," "will," "would" and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these or similar identifying words. Forward-looking statements in this press release include, without limitation, those related to: the potential impact of named-patient case studies; Kyverna's goals to develop certain paradigm-shifting treatment options; Kyverna's beliefs about the differentiated properties of KYV-101; and Kyverna's clinical trials. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: uncertainties related to market conditions, and other factors discussed in the "Risk Factors" section of Kyverna's most recent Annual Report on Form 10-K and Quarterly Reports on Form 10-Q that Kyverna has filed or may subsequently file with the U.S. Securities and Exchange Commission. Any forward-looking statements contained in this press release are based on the current expectations of Kyverna's management team and speak only as of the date hereof, and Kyverna specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise.

For more information, please visit https://kyvernatx.com.

Kyverna Media Contact:

Consort Partners for Kyverna

kyvernatx@consortpartners.com

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1. Motte et al., 2024 AAN 2024 Annual Meeting. Poster #14-006. https://www.aan.com/msa/Public/Events/AbstractDetails/55878

2. Walton et al,. Mult Scler. 2020; 26:1816-1821.

3. Payus et al., Am J Case Rep. 2021; 22: e928419-1–e928419-4

4. Brudno et al., Nature Medicine 2020; 26:270-280.

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Kyverna Therapeutics to attend the 2024 American Academy of Neurology (AAN) Annual Meeting in Denver, CO, With Data on KYV-101 in the Treatment of Patients with Neurological Autoimmune Diseases