Release Details

Data to include insights from 12 indications from more than 15 CAR T centers in US and Europe 

KYV-101 experience in Rheumatological disease spans 9 patients, with 7 lupus nephritis and 2 systemic sclerosis patients

Kyverna to host a press conference on June 14 at 5pm CEST

EMERYVILLE, Calif., June 7, 2024 /PRNewswire/ -- Kyverna Therapeutics, Inc. (Kyverna), a patient-centered, clinical-stage biopharmaceutical company focused on developing cell therapies for patients suffering from autoimmune diseases, announced today that it will host a sponsored symposium to present the largest and most diverse set of data to date from a cohort of 50 patients treated with the CAR in KYV-101, an autologous, fully human anti-CD19 CAR T-cell immunotherapy. The data support the differentiated safety profile of the CAR in various indications, including a 30-patient data set that spans >28 day follow-up in various autoimmune disease patients with early efficacy data. A 12-month follow-up of the first patient treated with KYV-101 for myasthenia gravis will also be presented.

The symposium titled "Anti-CD19 CAR T-Cell Therapy in Rheumatologic Autoimmune Diseases and Beyond" will take place on June 14, 2024, from 8:15 a.m. to 9:30 a.m. CEST. The symposium will offer insights on the ongoing clinical trials and named-patient initiatives from leading experts in rheumatology and neurology, including:

• Dr. Gerhard Krönke, University of Erlangen-Nuremberg, Germany
• Dr. Peter A. Merkel, University of Pennsylvania, USA
• Dr. Richard Furie, Northwell Health, USA
• Dr. Roberto Caricchio, University of Massachusetts, USA
• Dr. James Chung, Kyverna Therapeutics, USA
• Peter Maag, Ph.D., Kyverna Therapeutics, USA

A press conference will be hosted later in the day featuring Georg Schett, M.D., vice president of research at the Friedrich-Alexander-University in Erlangen, Germany, and Peter A. Merkel, M.D., M.P.H. Both are members of Kyverna's Scientific Advisory Board.

Additionally, Kyverna will showcase two posters on Wednesday, June 12 focusing on the preclinical development of KYV-201 - the Company's allogeneic product candidate - and proteomic markers associated with CAR T therapeutic response in autoimmune diseases, respectively.

"CAR T-cell therapies are rapidly establishing themselves as the new North star in the autoimmune disease treatment universe," said Peter Maag, Ph.D., chief executive officer of Kyverna. "We are seeing rising interests in unlocking the full potential of cell therapies in rheumatological and neurological B cell-driven autoimmune diseases."

Kyverna will also set up an exhibit at EULAR (booth E22-23) to serve as a meeting point for interested healthcare practitioners and patient advocates.

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 Medicine¹.

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.

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 of cell therapies in rheumatological and neurological B cell-driven autoimmune diseases and rising interests related thereto; Kyverna's goals to develop certain paradigm-shifting treatment options; Kyverna's beliefs about the differentiated safety profile and other 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.

^{1. Brudno et al., Nature Medicine 2020; 26:270-280.}

Kyverna Media Contact:
Consort Partners for Kyverna
kyvernatx@consortpartners.com

SOURCE Kyverna Therapeutics