The investigational therapy will be used in Kyverna's KYSA-5 Phase 1/2 open-label, multicenter study to evaluate KYV-101 in adult patients with diffuse cutaneous systemic sclerosis (scleroderma)

该研究性治疗将用于Kyverna的KYSA-5 1/2期开放标签多中心研究，以评估KYV-101在成人弥漫性皮肤系统性硬化症（硬皮病）患者中的应用

This is the third IND clearance for KYV-101, a novel, fully human CD19 CAR T-cell therapy designed for use in patients with B cell-driven autoimmune diseases

这是KYV-101的第三次IND清除，KYV-101是一种新型的全人CD19 CAR T细胞疗法，专为B细胞驱动的自身免疫性疾病患者设计

EMERYVILLE, Calif., Oct. 11, 2023 /PRNewswire/ -- Kyverna Therapeutics ('Kyverna'), a clinical-stage cell therapy company with the mission of engineering a new class of therapies for serious autoimmune diseases, today announced the clearance of the third Investigational New Drug (IND) application for KYV-101 by the U.S.

EMERYVILLE，CA，2023年10月11日/PRNewswire/-Kyverna Therapeutics（'Kyverna'），一家临床阶段细胞治疗公司，其任务是为严重的自身免疫性疾病设计一类新的治疗方法，今天宣布批准美国第三个KYV-101研究性新药（IND）申请。

Food and Drug Administration (FDA). This will allow Kyverna to initiate a Phase 1/2 open-label, multicenter study of KYV-101, an Autologous Fully Human Anti-CD19 Chimeric Antigen Receptor (CAR) T cell therapy for the treatment of diffuse cutaneous systemic sclerosis (scleroderma)..

食品药品监督管理局（FDA）。这将使Kyverna能够启动KYV-101的1/2期开放标签多中心研究，KYV-101是一种用于治疗弥漫性皮肤系统性硬化症（硬皮病）的自体全人抗CD19嵌合抗原受体（CAR）T细胞疗法。。

The trial, named KYSA-5, adds to the ongoing Phase 1 KYSA-1 trial in the U.S. and the Phase 1/2 KYSA-3 trial in Germany where KYV-101 is currently investigated in adults with active lupus nephritis.

该试验名为KYSA-5，增加了美国正在进行的1期KYSA-1试验和德国正在进行的1/2期KYSA-3试验，其中KYV-101目前在患有活动性狼疮性肾炎的成人中进行了调查。

'We welcome Kyverna's enthusiasm and interest to push forward with their CAR T approach in scleroderma patients with the KYSA-5 trial,' said Luke Evnin, chairman of the Scleroderma Research Foundation. 'We await the results with optimism that CAR-T driven B cell ablation may ultimately deliver efficacy with adequate safety for a broader range of our patients than immune-ablative chemotherapy alone.'.

“我们欢迎Kyverna的热情和兴趣，通过KYSA-5试验推动硬皮病患者的CAR T方法，”硬皮病研究基金会主席Luke Evnin说我们乐观地等待结果，CAR-T驱动的B细胞消融可能最终为更广泛的患者提供足够安全性的疗效，而不仅仅是免疫消融化疗。

'We are immensely proud of being able to bring KYV-101 to patients suffering from scleroderma,' said Peter Maag, Ph.D., chief executive officer of Kyverna Therapeutics. 'We are keen to initiate our KYSA-5 trial in this new patient population and generate data to support our KYV-101 design goals. With the deep B cell depletion from KYV-101 treatment, patients with scleroderma may have a full reset of their immune system to stop the vicious cycle of their overactive immune system.' .

Kyverna Therapeutics首席执行官Peter Maag博士说：“我们为能够将KYV-101带到患有硬皮病的患者感到非常自豪。”我们热衷于在这个新的患者群体中启动我们的KYSA-5试验并生成数据以支持我们的KYV-101设计目标。随着KYV-101治疗的深度B细胞耗竭，硬皮病患者可能会完全重置其免疫系统，以阻止其过度活跃的免疫系统的恶性循环 .

About KYV-101KYV-101 is an autologous version of a novel, fully human clinical-stage anti-CD19 chimeric antigen receptor (CAR) T cell construct with properties well suited for use in B cell-driven autoimmune diseases such as lupus nephritis, scleroderma, and other B cell-driven autoimmune diseases. In a 20-patient Phase 1/2 study in oncology, expected anti-lymphoma activity was associated with a significant reduction of cytokines released that translated into a strong reduction of cytokine-driven side effects such as the rate of immune effector cell-associated neurotoxicity syndrome (ICANS).1 The fully human anti-CD19 CAR also translated into reduced immunogenicity that favorably impacted cell persistence at one month.

关于KYV-101KYV-101是新型全人类临床阶段抗CD19嵌合抗原受体（CAR）T细胞构建体的自体形式，其性质非常适合用于B细胞驱动的自身免疫疾病，例如狼疮性肾炎，硬皮病和其他B细胞驱动的自身免疫性疾病。在20名患者的肿瘤学1/2期研究中，预期的抗淋巴瘤活性与释放的细胞因子的显着减少相关，所述细胞因子转化为细胞因子驱动的副作用的强烈减少，例如免疫效应细胞相关神经毒性综合征（ICANS）的速率.1完全人抗CD19 CAR也转化为降低的免疫原性，其在一个月时有利地影响细胞持久性。

Kyverna recognized that these properties singled out KYV-101 as a product ideally poised for use in patients with autoimmune diseases, and the company obtained exclusive, worldwide licenses from the National Institutes of Health (NIH) to use this CD19 construct in both autologous and allogeneic CAR T-cell therapies. .

Kyverna认识到，这些特性将KYV-101作为理想的自身免疫性疾病患者使用的产品，并且该公司获得了美国国立卫生研究院（NIH）的独家全球许可，可以在自体和自体中使用该CD19构建体。同种异体CAR T细胞疗法。 .

About Systemic SclerosisSystemic sclerosis (scleroderma) is a rare, chronic autoimmune disorder that affects the skin and internal organs and can have life-threatening complications.2,3 Severe scleroderma is associated with widespread pain, discomfort, and stiffness due to skin and joint involvement. Organ involvement may include interstitial lung disease, pulmonary hypertension, heart complications, kidney dysfunction, and gastrointestinal issues and may significantly reduce life expectancy.

关于系统性硬化症系统性硬化症（硬皮病）是一种罕见的慢性自身免疫性疾病，会影响皮肤和内脏，并可能危及生命.2,3严重硬皮病与皮肤和关节受累引起的广泛疼痛，不适和僵硬有关。器官受累可能包括间质性肺病，肺动脉高压，心脏并发症，肾功能不全和胃肠道问题，并可能显着降低预期寿命。

Managing severe scleroderma is complex and often requires a combination of medications, including immunosuppressants and disease-modifying drugs, as well as specialized care..

管理严重的硬皮病很复杂，通常需要药物的组合，包括免疫抑制剂和疾病缓解药物，以及专业护理。。

About Kyverna Therapeutics Kyverna Therapeutics is a clinical-stage cell therapy company with the mission of engineering a new class of therapies for autoimmune and inflammatory diseases. The Kyverna therapeutic platform combines advanced T-cell engineering and synthetic biology technologies to suppress and eliminate the autoreactive immune cells at the origin of autoimmune and inflammatory diseases.

关于Kyverna Therapeutics Kyverna Therapeutics是一家临床阶段细胞治疗公司，致力于为自身免疫性和炎症性疾病设计一类新的治疗方法。Kyverna治疗平台结合了先进的T细胞工程和合成生物学技术，以抑制和消除自身免疫和炎症疾病起源的自身反应性免疫细胞。

Kyverna's pipeline includes next-generation chimeric antigen receptor (CAR) T-cell therapies in both autologous and allogeneic formats with properties well suited for use in B cell-driven autoimmune diseases. By offering more than one mechanism for taming autoimmunity, Kyverna is positioned to act on its mission of transforming how autoimmune diseases are treated.

Kyverna的管道包括自体和同种异体形式的下一代嵌合抗原受体（CAR）T细胞疗法，其性质非常适合用于B细胞驱动的自身免疫疾病。通过提供多种控制自身免疫的机制，Kyverna的定位是根据其改变自身免疫性疾病治疗方式的使命。

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

欲了解更多信息，请访问 https://kyvernatx.com. .

Kyverna Media Contact:Christian Pflaumer+1 (917) 841-4525[email protected]

Kyverna媒体联系人：Christian Pflaumer+1（917）841-4525[电子邮件保护]

References: 1. Brudno et al., Nature Medicine 2020; 26:270-280. 2. Bergamasco et al., Clin Epidemiol 2019; 11:257-2733. Adigun et al. Systemic Sclerosis. [Updated 2022 May 8]. https://www.ncbi.nlm.nih.gov/books/NBK430875/

参考文献：1。Brudno等，Nature Medicine 2020；26:270-280. 2. Bergamasco等，Clin Epidemiol 2019；11： 257-2733.Adigun等。系统性硬化症。[于5月8日2022年更新]。 https://www.ncbi.nlm.nih.gov/books/NBK430875/

SOURCE Kyverna Therapeutics

来源Kyverna Therapeutics