DURHAM, N.C. & SEATTLE--(

北卡罗来纳州达勒姆和西雅图--(

BUSINESS WIRE

商业热线

)--Leading epigenetic therapy company Tune Therapeutics announced today that it will begin a clinical trial in Hong Kong after receiving a Certificate for Clinical Trial from the Hong Kong Department of Health. This marks the second global approval to commence a Phase 1b clinical trial for Tune-401, an investigational epigenetic silencing therapy designed to treat chronic hepatitis B (CHB)..

)--领先的表观遗传治疗公司Tune Therapeutics今天宣布，在获得香港卫生署的临床试验证书后，将在香港开始临床试验。这标志着第二次全球批准开始Tune-401的1b期临床试验，Tune-401是一种旨在治疗慢性乙型肝炎（CHB）的研究性表观遗传沉默疗法。。

“We’re taking a fresh angle on the battle against chronic hepatitis B,” said Derek Jantz, Chief Scientific Officer at Tune Therapeutics. “Current standard-of-care treatments are rarely curative due to the virus mechanism of infection. But by employing epigenetic silencing to target both integrated viral DNA and cccDNA, we are replicating the natural processes observed in spontaneous functional cure and aiming to make that outcome the norm in HBV treatment.”.

Tune Therapeutics首席科学官德里克·扬茨（DerekJantz）说：“我们正在从一个新的角度来对抗慢性乙型肝炎。”。“由于感染的病毒机制，目前的标准治疗方法很少能治愈。但通过采用表观遗传沉默来靶向整合的病毒DNA和cccDNA，我们正在复制自发功能治愈中观察到的自然过程，旨在使这一结果成为HBV治疗的规范。”。

The Hong Kong trial will be led by Professor Man-Fung Yuen – world-renowned hepatologist and Chair Professor of The University of Hong Kong and the Chief of the Division of Gastroenterology and Hepatology at Queen Mary Hospital, Hong Kong. With a career spanning 30 years and over 600 published papers, Dr Yuen’s pioneering research has significantly advanced our understanding of chronic hepatitis B and liver cancer treatment in Asia and worldwide..

香港试验将由世界著名肝病学家、香港大学主席教授、香港玛丽医院消化内科和肝病科主任ManFung Yuen教授领导。袁博士的职业生涯长达30年，发表了600多篇论文，他的开创性研究极大地提高了我们对亚洲和全球慢性乙型肝炎和肝癌治疗的理解。。

“Over 257 million people are still living with chronic hepatitis B, and worldwide the disease disproportionately impacts Asian and Pacific Islander populations,” explains Dr. Yuen. “While early screening and detection is still paramount, this novel epigenetic silencing approach offers new hope for clinicians, and could make a major impact in these patient groups in particular.”.

袁博士解释说：“超过2.57亿人仍然患有慢性乙型肝炎，全世界这种疾病对亚洲和太平洋岛民的影响不成比例。”。“虽然早期筛查和检测仍然至关重要，但这种新型表观遗传沉默方法为临床医生提供了新的希望，尤其可能对这些患者群体产生重大影响。”。

According to the

根据

World Health Organization

世界卫生组织

, the burden of Hepatitis infection is highest in the Western Pacific Region – including China, Japan, Cambodia, New Zealand, and Australia. With a parallel clinical trial occurring in Auckland, New Zealand, Tune is focusing on countries that would see the most immediate impact and benefit from a new HBV treatment paradigm..

，西太平洋地区的肝炎感染负担最高，包括中国、日本、柬埔寨、新西兰和澳大利亚。随着在新西兰奥克兰进行的一项平行临床试验，Tune正在关注那些将从新的HBV治疗模式中产生最直接影响和受益的国家。。

Tune

调谐

shared

共享

encouraging preclinical data in November 2024 demonstrating Tune-401’s ability to repress both cccDNA and integrated DNA in target cells and animal models.

2024年11月令人鼓舞的临床前数据证明了Tune-401在靶细胞和动物模型中抑制cccDNA和整合DNA的能力。

About Tune Therapeutics

关于Tune Therapeutics

Armed with its powerful and innovative genetic tuning platform (TEMPO), Tune Therapeutics aims to bring gene, cell, and regenerative therapies into a new era of human medicine – expanding their range of application to common, chronic, and age-related diseases that are straining healthcare systems and limiting human healthspan on a global scale..

凭借其强大而创新的基因调节平台（TEMPO），Tune Therapeutics旨在将基因，细胞和再生疗法带入人类医学的新时代-将其应用范围扩展到常见，慢性和与年龄相关的疾病，这些疾病正在使医疗保健系统紧张，并在全球范围内限制人类健康。。

About Tune-401

关于Tune-401

Tune-401 is a first-in-class investigational product candidate for treating Hepatitis B (HBV) infection. Tune-401 utilizes the company’s versatile, modular TEMPO platform to epigenetically silence viral HBV intDNA and cccDNA necessary for sustained HBV infection. Lipid nanoparticle technology for Tune-401 has been provided by Acuitas Therapeutics Inc..

Tune-401是治疗乙型肝炎（HBV）感染的一流候选研究产品。Tune-401利用该公司的多功能模块化TEMPO平台表观遗传沉默持续HBV感染所需的病毒HBV intDNA和cccDNA。用于Tune-401的脂质纳米颗粒技术由Acuitas Therapeutics Inc.提供。。