First-in-Disease Use of Kyverna Therapeutics' KYV-101 in Patients With Progressive Multiple Sclerosis Published in Med
First-in-Disease Use of Kyverna Therapeutics' KYV-101 in Patients With Progressive Multiple Sclerosis Published in Med
Two patients were treated with KYV-101, a fully human anti-CD19 CAR T-cell product candidate, in Germany as part of a named patient program after failure to respond to conventional therapies
由於對傳統療法沒有反應，兩名患者在德國接受了全人源抗CD19 CAR T細胞候選產品 KYV-101 的治療，這是一項指定患者計劃的一部分
The treatment resulted in an acceptable safety profile, with no observed clinical signs of early neurotoxicity, warranting larger clinical studies in subjects with multiple sclerosis
該治療產生了可接受的安全性，沒有觀察到早期神經毒性的臨床症狀，因此有必要對多發性硬化症受試者進行更大規模的臨床研究
EMERYVILLE, Calif., March 29, 2024 /PRNewswire/ -- Kyverna Therapeutics, Inc. (Kyverna), a patient-centered, clinical-stage biopharmaceutical company focused on developing cell therapies for patients suffering from autoimmune diseases, announces today the publication in Med1, of a report describing the first use of KYV-101, a fully human anti-CD19 chimeric antigen receptor (CAR) T-cell product candidate, in two patients suffering from progressive multiple sclerosis (MS) as part of a named patient program for critically ill patients after both patients failed to respond to conventional therapies.
加利福尼亞州埃默裏維爾，2024年3月29日 /PRNewswire/ — Kyverna Therapeutics, Inc.（Kyverna）是一家以患者爲中心、處於臨床階段的生物製藥公司，專注於爲自身免疫性疾病患者開發細胞療法，今天宣佈在 地中海1， 一份報告描述了在兩名進行性多發性硬化症（MS）患者中首次使用完全人源化的抗CD19嵌合抗原受體（CAR）T細胞候選產品 KYV-101，這是兩名患者對常規療法均未產生反應的危重患者指定患者計劃的一部分。
"We are very pleased about offering this potentially paradigm-shifting treatment opportunity to patients that have exhausted other medical recourses," said Christoph Heesen, M.D., professor for clinical and rehabilitative MS research at the University Medical Center Hamburg-Eppendorf in Hamburg, Germany, and senior co-author. "Emerging findings indicating that this approach may affect disease biology in the central nervous system are promising, as preventing disease progression remains one of the most difficult challenges in MS therapy."
德國漢堡埃彭多夫大學醫學中心臨床和康復多發性硬化症研究教授、資深合著者克里斯托夫·海森醫學博士說：“我們很高興爲已經用盡其他醫療資源的患者提供這種可能改變模式的治療機會。”“新發現表明這種方法可能會影響中樞神經系統的疾病生物學，這令人鼓舞，因爲預防疾病進展仍然是多發性硬化症治療中最困難的挑戰之一。”
"Exploring the safety profile of CAR T administration in this population and hopefully establishing that it compares favorably to hematopoietic stem cell transplant may bring the cell therapy approach to a larger number of patients in need," said Nicolaus Kröger, M.D., professor of Medicine and medical director, Department of Stem Cell Transplantation at the University Medical Center Hamburg-Eppendorf in Hamburg, Germany, and senior co-author. "If safe administration can be replicated in other patients and efficacy be formally established in clinical trials, this may bring a relevant therapeutic option to patients with MS."
德國漢堡埃彭多夫大學醫學中心醫學教授兼幹細胞移植系醫學主任、資深合著者尼古拉斯·克羅格醫學博士說：“探索該人群中CAR-T給藥的安全狀況，並希望確定它與造血幹細胞移植相比具有優勢，可以爲更多有需要的患者提供細胞療法。”“如果能夠在其他患者身上覆制安全給藥，並在臨床試驗中正式確定療效，這可能會爲多發性硬化症患者帶來相關的治療選擇。”
"We are committed to transforming the standard of treatment for patients living with multiple sclerosis," said Peter Maag, Ph.D., chief executive officer of Kyverna. "The pioneering work done with KYV-101 by medical teams in Hamburg and in our trials in the U.S. helps build the data backbone needed to further advance our knowledge and hopefully accelerate development of CAR T-cell therapies in autoimmune diseases."
Kyverna首席執行官彼得·馬格博士說：“我們致力於改變多發性硬化症患者的治療標準。”“漢堡醫療團隊以及我們在美國的試驗中在 KYV-101 方面所做的開創性工作有助於建立所需的數據基礎，以進一步提高我們的知識，並有望加速 CAR T 細胞療法在自身免疫性疾病中的開發。”
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.
CAR T 細胞療法包括修改患者的 T 細胞，以識別和移除患者體內的 B 細胞。CD19 CAR T細胞療法專門靶向CD19，這是一種在B細胞表面表達的蛋白質，參與各種類型的自身免疫性疾病。
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.
關於多發性硬化 (MS)
多發性硬化症是一種慢性神經退行性自身免疫性疾病，影響全球超過280萬人2。它更頻繁地影響婦女、北歐後裔人群，還與某些環境和遺傳因素有關。多發性硬化症患者可能會出現一系列症狀，包括視力模糊、言語不清、震顫、麻木、極度疲勞、記憶力和注意力問題，以及在嚴重的情況下無法行走或站立。
目前的多發性硬化症治療旨在減少疾病復發的頻率和延緩殘疾的進展，但這種疾病仍然是一種慢性疾病，對大多數患者來說將逐漸惡化。
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 Medicine3.
關於 KYV-101
KYV-101 是一種自體、全人類 CD19 CAR T 細胞候選產品，可用於 B 細胞驅動的自身免疫性疾病。KYV-101 中的 CAR 由美國國立衛生研究院 (NIH) 設計，旨在提高耐受性，並在 20 名患者的 1 期腫瘤學試驗中進行了測試。研究結果由美國國立衛生研究院於 自然醫學3。
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.
目前正在贊助的針對狼瘡腎炎患者的 KYV-101 的 1/2 期試驗中對 KYV-101 進行評估。狼瘡腎炎是一種自身免疫性疾病，其中一半以上的患者對當前療法沒有完全反應，有發生腎衰竭的風險。此外，針對多發性硬化症和重症肌無力的 KYV-101 二期試驗和系統性硬化症的 1/2 期試驗已獲得 FDA 的 IND 許可。
We believe that the differentiated properties of KYV-101 are critical for the potential success of CAR T cells as autoimmune disease therapies.
我們認爲，KYV-101 的差異化特性對於 CAR T 細胞作爲自身免疫性疾病療法的潛在成功至關重要。
KYV-101 is also being evaluated in investigator-initiated trials for multiple indications in multiple geographies.
研究者發起的針對多個地區多種適應症的試驗也正在對 KYV-101 進行評估。
About Kyverna Therapeutics
Kyverna Therapeutics (NASDAQ: KYTX) is a patient-centered, clinical-stage biopharmaceutical company focused on developing cell therapies for patients suffering from autoimmune diseases.
關於凱維納療法
Kyverna Therapeutics（納斯達克股票代碼：KYTX）是一家以患者爲中心的臨床階段生物製藥公司，專注於爲自身免疫性疾病患者開發細胞療法。
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.
我們的主要 CAR T 細胞療法候選藥物 KYV-101 正在通過臨床開發取得進展，贊助了自身免疫性疾病兩個廣泛領域的臨床試驗：風溼病學和神經病學，包括多發性硬化和重症肌無力的 2 期試驗、系統性硬化症的 1/2 期試驗，以及在美國和德國針對狼瘡腎炎患者的兩項正在進行的多中心、開放標籤的 1/2 期試驗。
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.
Kyverna的產品線包括自體和異體形式的下一代嵌合抗原受體（CAR）T細胞療法，其特性旨在非常適合用於B細胞驅動的自身免疫性疾病。
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. 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 the final prospectus. 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.
前瞻性陳述
本新聞稿中有關未來預期、計劃和前景的陳述，以及有關非歷史事實事項的任何其他陳述，可能構成 “前瞻性陳述”。但不限於 “預期”、“相信”、“繼續”、“可能”、“預期”、“打算”、“可能”、“計劃”、“潛在”、“預測”、“項目”、“應該”、“目標”、“將” 和類似的表述旨在識別前瞻性陳述，儘管並非所有前瞻性陳述都包含這些或類似的識別詞。由於各種重要因素，包括：與市場狀況相關的不確定性以及最終招股說明書 “風險因素” 部分中討論的其他因素，實際業績可能與此類前瞻性陳述所示的結果存在重大差異。本新聞稿中包含的任何前瞻性陳述均基於Kyverna管理團隊當前的預期，僅代表截至本新聞稿發佈之日，Kyverna明確表示沒有義務更新任何前瞻性陳述，無論是由於新信息、未來事件還是其他原因。
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Kyverna 媒體聯繫人：
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[電子郵件保護]
1. Fischbach et al., Med (2024),
2. Walton C, et al., Mult Scler. 2020; 26:1816-1821.
3. Brudno et al., Nature Medicine 2020; 26:270-280.
1。菲施巴赫等人，《醫學》（2024），
2。Walton C 等人，《Mult Scler》，2020；26:1816-1821。
3.Brudno 等人，《自然醫學 2020》；26:270-280。
SOURCE Kyverna Therapeutics
來源 Kyverna Therautics
譯文內容由第三人軟體翻譯。