Tobevibart

▎药明康德内容团队编辑 Vir Biotechnology公司日前宣布，在研组合疗法tobevibart和elebsiran已获得美国FDA授予的突破性疗法认定，以及欧洲药品管理局（EMA）授予的PRIME认定，用于治疗慢性丁型肝炎（CHD）。这些认定基于来自2期临床试验SOLSTICE的积极安全性和疗效数据。该公司计划于2025年上半年启动评估tobevibart和elebsiran治疗CHD的注册性3期临床试验ECLIPSE。 CHD是一种由丁型肝炎病毒（HDV）引起的慢性进展性肝病，是最严重的慢性病毒性肝炎类型之一。只有乙肝病毒（HBV）感染者才会被HDV感染，同时HDV的复制依赖于乙型肝炎表面抗原（HBsAg）的存在。CHD会增加肝癌的风险，并加速发展为肝硬化和肝功能衰竭，通常在感染后5年内发生。 日前在美国肝病研究协会（AASLD）肝脏大会上公布的数据显示： 接受tobevibart和elebsiran联合治疗的所有参与者（100%）在接受治疗24周时达到HDV RNA水平下降幅度≥2 log10或低于检测下限，并在第36周保持了这一抑制率。 在联合治疗组中，第24周时41%（13/32）的参与者达到HDV RNA检测不到的标准，这一比例在第36周上升至64%。 接受联合治疗的参与者中，约90%在第24周时乙型肝炎表面抗原水平降低至<10 IU/mL，并在后续时间点保持了这一应答。 大多数参与者的丙氨酸转氨酶（ALT）在第1天至第24周之间显著下降。在联合治疗组中，47%（15/32）参与者的ALT在第24周时达到正常化。 ▲Tobevibart和elebsiran组合疗法显著降低患者HDV RNA水平（图片来源：Vir公司官网） Tobevibart是一种在研的广谱中和单克隆抗体，靶向HBsAg。其设计旨在抑制乙型肝炎病毒和丁型肝炎病毒进入肝细胞，并降低血液中的病毒和亚病毒颗粒水平。Tobevibart结合了Xencor公司的Xtend和其他Fc修饰技术，以延长其半衰期。 Elebsiran是一种在研小干扰RNA（siRNA），靶向乙型肝炎病毒，旨在降解乙型肝炎病毒RNA转录本并限制乙型肝炎表面抗原的生成。目前数据显示，它可能对乙型肝炎病毒和丁型肝炎病毒具有直接抗病毒活性。Elebsiran通过皮下注射给药，目前正在开展治疗慢性乙型肝炎和慢性丁型肝炎患者的临床开发工作。它是Vir Biotechnology与Alnylam Pharmaceuticals合作开发的首个进入临床研究的项目。 在治疗慢性丁型肝炎之外，tobevibart和elebsiran组合疗法也正在2期临床试验中用于治疗慢性乙型肝炎患者。在AASLD肝脏大会上发表的数据显示，在基线乙肝表面抗原水平较低（<1000 IU/mL）的参与者中，tobevibart和elebsiran联用（加或不加聚乙二醇化干扰素α）展示了较高的HBsAg清除率，其疗效和安全性结果支持进一步开发，以评估实现功能性治愈的潜力。 ▲欲了解更多前沿技术在生物医药产业中的应用，请长按扫描上方二维码，即可访问“药明直播间”，观看相关话题的直播讨论与精彩回放 参考资料： [1] Vir Biotechnology Receives FDA Breakthrough Therapy Designation and EMA PRIME Designation for Tobevibart and Elebsiran in Chronic Hepatitis Delta. Retrieved December 13, 2024, from https://www.businesswire.com/news/home/20241212919029/en [2] Vir Biotechnology Presents Positive Chronic Hepatitis Delta Clinical Trial Data and Announces Initiation of Phase 3 Registrational Program. Retrieved December 13, 2024, from https://investors.vir.bio/news/news-details/2024/Vir-Biotechnology-Presents-Positive-Chronic-Hepatitis-Delta-Clinical-Trial-Data-and-Announces-Initiation-of-Phase-3-Registrational-Program/default.aspx 免责声明：药明康德内容团队专注介绍全球生物医药健康研究进展。本文仅作信息交流之目的，文中观点不代表药明康德立场，亦不代表药明康德支持或反对文中观点。本文也不是治疗方案推荐。如需获得治疗方案指导，请前往正规医院就诊。 版权说明：本文来自药明康德内容团队，欢迎个人转发至朋友圈，谢绝媒体或机构未经授权以任何形式转载至其他平台。转载授权请在「药明康德」微信公众号回复“转载”，获取转载须知。 分享，点赞，在看，聚焦全球生物医药健康创新

SAN FRANCISCO--( BUSINESS WIRE )--Vir Biotechnology, Inc. (Nasdaq: VIR) today announced that tobevibart and elebsiran have received U.S. Food and Drug Administration (FDA) Breakthrough Therapy designation and European Medicines Agency (EMA) Priority Medicines (PRIME) designation for the treatment of chronic hepatitis delta (CHD). The designations are supported by compelling positive safety and efficacy data from the Phase 2 SOLSTICE trial, from which the Company recently presented new data at AASLD The Liver Meeting ® in San Diego, U.S. Vir Biotechnology’s Phase 3 ECLIPSE registrational program evaluating tobevibart and elebsiran in CHD will commence in the first half of 2025. CHD is a chronic, progressive liver disease caused by the hepatitis delta virus 1 and is the most severe form of chronic viral hepatitis 2 . CHD increases the risk of liver cancer and accelerates progression to cirrhosis and liver failure, which often occurs within 5 years of infection 3 . There is no approved treatment in the U.S., and options are limited in the European Union and globally. “ Chronic hepatitis delta has devastating effects on liver and overall health, yet people living with this condition are still waiting for highly effective therapeutic options,” said Mark Eisner, M.D., M.P.H., Executive Vice President and Chief Medical Officer, Vir Biotechnology. “ The Phase 2 SOLSTICE trial data suggests that tobevibart and elebsiran can rapidly and deeply suppress the hepatitis delta virus, driving it to undetectable levels. Receiving FDA Breakthrough Therapy and European PRIME designations recognizes this combination’s potential to transform the lives of people living with CHD. We look forward to advancing the Phase 3 ECLIPSE program as quickly as possible.” FDA Breakthrough Therapy designation aims to expedite the development and regulatory reviews of investigational therapies for serious conditions that demonstrate promising preliminary clinical evidence and potential improvement over existing therapies. EMA PRIME designation is granted to investigational medicines that target conditions with unmet medical needs for which no treatment option exists, or where they can offer a major therapeutic advantage over existing treatments. It fosters early exchange with the EMA to facilitate robust data collection, high-quality marketing authorization applications and expedited evaluations so that medicines can reach patients earlier. These designations follow FDA Fast Track designation and EMA Committee for Orphan Medicinal Products (COMP) positive opinion on orphan drug designation received earlier this year. About the Phase 2 SOLSTICE Trial SOLSTICE is a Phase 2 study to evaluate the safety, tolerability, and efficacy of tobevibart, alone or in combination with elebsiran, in patients with chronic hepatitis delta. This Phase 2 study is a multi-center, open-label, randomized study. Primary endpoints include proportion of participants with undetectable hepatitis delta virus (HDV) RNA (defined as HDV RNA equal or greater than 2 log 10 decrease from baseline or below limit of detection) up to week 24, alanine aminotransferase (ALT) normalization (defined as ALT below upper limit of normal) up to week 24, and treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) up to 118 weeks. Secondary endpoints include proportion of participants with undetectable HDV RNA and different timepoints and up to 192 weeks. More information about this trial can be found at clinicaltrials.gov (NCT05461170). About Tobevibart and Elebsiran Tobevibart is an investigational broadly neutralizing monoclonal antibody targeting the hepatitis B surface antigen. It is designed to inhibit the entry of hepatitis B and hepatitis delta viruses into hepatocytes, and to reduce the level of circulating viral and subviral particles in the blood. Tobevibart, which incorporates Xencor’s Xtend™ and other Fc technologies, has been engineered to have an extended half-life and was identified using Vir Biotechnology’s proprietary monoclonal antibody discovery platform. Tobevibart is administered subcutaneously, and it is currently in clinical development for the treatment of patients with chronic hepatitis B and patients with chronic hepatitis delta. Elebsiran is an investigational hepatitis B virus-targeting small interfering ribonucleic acid (siRNA) designed to degrade hepatitis B virus RNA transcripts and limit the production of hepatitis B surface antigen. Current data indicates that it has the potential to have direct antiviral activity against hepatitis B virus and hepatitis delta virus. Elebsiran is administered subcutaneously, and it is currently in clinical development for the treatment of patients with chronic hepatitis B and patients with chronic hepatitis delta. It is the first asset in Vir Biotechnology’s collaboration with Alnylam Pharmaceuticals, Inc. to enter clinical studies. About Vir Biotechnology, Inc. Vir Biotechnology, Inc. is a clinical-stage biopharmaceutical company focused on powering the immune system to transform lives by discovering and developing medicines for serious infectious diseases and cancer. Its clinical-stage portfolio includes infectious disease programs for chronic hepatitis delta and chronic hepatitis B infections and multiple double-masked T-cell engagers across validated targets in solid tumor indications. Vir Biotechnology also has a preclinical portfolio of programs across a range of infectious diseases and oncologic malignancies. Vir Biotechnology routinely posts information that may be important to investors on its website. References: 1 NIH National Institute of Diabetes and Digestive and Kidney Diseases Hepatitis D - NIDDK (nih.gov) , accessed September 2024. 2 WHO Hepatitis Delta Factsheet - Hepatitis D (who.int) , accessed September 2024. 3 CDC What is Hepatitis D - FAQ | CDC . Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as “may,” “will,” “plan,” “potential,” “aim,” “expect,” “anticipate,” “promising” and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. These forward-looking statements are based on Vir Biotechnology’s expectations and assumptions as of the date of this press release. Forward-looking statements contained in this press release include, but are not limited to, statements regarding Vir Biotechnology’s strategy and plans, the potential clinical effects of tobevibart and elebsiran, the potential benefits, safety and efficacy of tobevibart and elebsiran, the timing, nature and significance of data from Vir Biotechnology’s multiple ongoing trials evaluating tobevibart and elebsiran, Vir Biotechnology’s plans and expectations for its CHD and CHB programs, and risks and uncertainties associated with drug development and commercialization. Many factors may cause differences between current expectations and actual results, including unexpected safety or efficacy data or results observed during clinical trials or in data readouts; the occurrence of adverse safety events; risks of unexpected costs, delays or other unexpected hurdles; difficulties in collaborating with other companies; successful development and/or commercialization of alternative product candidates by Vir Biotechnology’s competitors; changes in expected or existing competition; delays in or disruptions to Vir Biotechnology’s business or clinical trials due to geopolitical changes or other external factors; and unexpected litigation or other disputes. Drug development and commercialization involve a high degree of risk, and only a small number of research and development programs result in commercialization of a product. Results in early-stage clinical trials may not be indicative of full results or results from later stage or larger scale clinical trials and do not ensure regulatory approval. You should not place undue reliance on these statements, or the scientific data presented. Other factors that may cause actual results to differ from those expressed or implied in the forward-looking statements in this press release are discussed in Vir Biotechnology’s filings with the U.S. Securities and Exchange Commission, including the section titled “Risk Factors” contained therein. Except as required by law, Vir Biotechnology assumes no obligation to update any forward-looking statements contained herein to reflect any change in expectations, even as new information becomes available.