L-HBsAg

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.

正在进行的2期ENSURE研究提供的48周治疗结束数据清楚地表明，elebsiran联合PEG-IFNα可实现更多获益，从而获得更高功能性治愈率 由公司及其合作伙伴开展的多项联合研究数据将继续支持公司的策略，即通过正确的联合治疗方案在更广泛的患者群体中实现HBV功能性治愈 公司在11月15日至19日于美国加利福尼亚州圣地亚哥举行的美国肝病研究学会（AASLD）年会上，以最新突破（late-breaking）口头报告的形式公布了其正在进行的2期ENSURE研究的最新数据。 ENSURE是一项阳性对照、随机、2期研究，旨在评估试验性小干扰核糖核酸（siRNA）elebsiran（BRII-835，VIR-2218）联合聚乙二醇干扰素α（PEG-IFNα）对乙型肝炎表面抗原（HBsAg）基线为100-3,000 IU/mL的慢性HBV感染者的作用。该研究排除了HBsAg基线水平较低（<100 IU/mL）的HBV患者，以研究在更广泛患者群体中的潜在疗效。ENSURE 48周治疗结束（EOT）数据显示，在治疗结束时，接受200mg或100mg elebsiran联合PEG-IFNα治疗的参与者中分别有26.3%（5/19）或33.3%（6/18）实现HBsAg血清清除，而接受PEG-IFNα单药治疗的参与者中只有5.6%（1/18）实现HBsAg血清清除。 首都医科大学附属北京友谊医院肝病研究中心主任贾继东教授表示： ENSURE研究的EOT数据非常明确。既往研究显示，siRNA联合PEG-IFNα是最有希望获得更高HBsAg血清清除的疗法之一。ENSURE研究首次为siRNA在已有的PEG-IFNα疗法基础上对实现功能性治愈的作用提供了证据。我们相信，elebsiran有望对提高HBV功能性治愈率产生重要影响。 这项试验数据令我们备受鼓舞，它将继续支持我们在目标人群中开发慢性HBV功能性治愈疗法的目标。该结果凸显了elebsiran作为目前正在开展的多项临床研究中进行评估的联合治疗方案核心的潜力。我们期待着通过正在进行的2期研究，将elebsiran与其他疗法相结合，以为全球2.54亿慢性HBV感染者提供更高的功能性治愈率。 摘要编号 5008 最新突破口头报告标题 Elebsiran（BRII-835）联合聚乙二醇干扰素α（PEG-IFNα）对比 PEG-IFNα 在病毒学抑制的慢性乙型肝炎病毒（HBV）感染者中的疗效和安全性的初步结果 讲者 贾继东教授 首都医科大学附属北京友谊医院肝病中心主任 在治疗结束时，elebsiran 200 mg + PEG-IFNα队列和elebsiran 100mg + PEG-IFNα队列的HBsAg血清清除率分别为26.3%（5/19）和33.3%（6/18），明显高于PEG-IFNα单药治疗队列（5.6%）。 在HBsAg基线为100-1,500 IU/mL的亚组中，接受elebsiran 200 mg或100 mg联合PEG-IFNα治疗后分别有31.3%（5/16）或40.0%（6/15）的参与者实现了HBsAg血清清除。 Elebsiran + PEG-IFNα队列在治疗结束时的HBsAg下降幅度（平均值[SE]：elebsiran 200 mg或100 mg分别为-2.47 [0.28]或-3.01 [0.28] log10 IU/mL）大于 PEG-IFNα队列（-1.02 [0.30] log10 IU/mL）。 在HBsAg基线水平为100-3,000 IU/mL的参与者中，elebsiran 200 mg和100 mg剂量联合PEG-IFNα可实现相似的HBsAg血清清除率和HBsAg降幅。 在病毒学抑制的慢性HBV感染参与者中，elebsiran联合PEG-IFNα治疗总体安全且耐受性良好。 治疗后随访仍在进行中，将在治疗结束后继续随访24周。 作为腾盛博药开发HBV功能性治愈独特方法的一部分，公司及其合作伙伴正在积极推进我们差异化产品组合的多项联合研究，包括elebsiran、针对HBV的在研广谱中和性单克隆抗体tobevibart，以及重组蛋白HBV免疫治疗药物BRII-179。我们将在2025年的科学会议上分享关键数据。 关于乙型肝炎 乙型肝炎病毒（HBV）感染是世界上最重大的感染性疾病威胁之一，全球感染人数超过2.54亿。1慢性HBV感染是肝脏疾病的主要原因，每年约有82万人死于慢性HBV感染的并发症。1中国慢性HBV感染人数达8,700万，非常值得关注。2 关于Elebsiran（BRII-835，VIR-2218） Elebsiran是一种经皮下注射给药的靶向乙型肝炎病毒（HBV）的小干扰核糖核酸（siRNA）研究性药物，旨在降解HBV RNA转录本及限制乙型肝炎表面抗原的产生，其具有针对HBV及丁型肝炎病毒（HDV）的直接抗病毒活性。其是首个进入临床的采用增强稳定化学增强技术的siRNA，以增强稳定性并最大程度地减少脱靶活性，从而有可能提高治疗指数。腾盛博药于2020年从Vir Biotechnology, Inc. 获得了在大中华地区开发和商业化elebsiran的独家权益。 关于腾盛博药 腾盛博药（股票代码：2137.HK）是一家生物技术公司，致力于针对存在巨大未被满足的患者需求、治疗手段有限，以及给患者带来严重社会歧视的重大公共卫生挑战开发创新疗法。公司专注于感染性疾病和中枢神经系统疾病，正在推进一条涵盖多种独特候选药物的产品管线，重点包括针对乙型肝炎病毒（HBV）感染的领先项目。在富有远见卓识和经验丰富的领导团队带领下，公司在位于罗利-达勒姆、旧金山湾区、北京和上海的主要生物技术中心开展业务。欲了解更多信息，请点击阅读原文。

DURHAM, N.C. and BEIJING, May 13, 2024 /PRNewswire/ -- Brii Biosciences Limited ("Brii Bio" or the "Company", stock code: 2137.HK), a biotechnology company developing therapies to improve patient health and choice across diseases with high unmet need, today announced that the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) granted Breakthrough Therapy Designations for BRII-877 (tobevibart), an investigational broadly neutralizing monoclonal antibody targeting hepatitis B virus (HBV) and BRII-835 (elebsiran), an investigational HBV-targeting small interfering ribonucleic acid (siRNA). This represents another milestone in the Company's pursuit of a functional cure for HBV, following the Breakthrough Therapy Designation granted for BRII-179, a recombinant protein-based HBV immunotherapeutic, in November 2023. The Breakthrough Therapy Designation for BRII-877 (tobevibart) was supported by Phase 1 and 2 studies conducted by Vir Biotechnology ("Vir", Nasdaq: VIR) and Brii Bio. As of September 2023, more than 350 people living with HBV have received treatment of BRII-877 (tobevibart). Data has shown BRII-877 (tobevibart) to be well-tolerated and to have resulted in marked decreases in HBsAg levels suggesting the potential for BRII-877 (tobevibart) to be an important part of a treatment regimen for people living with chronic HBV infection and chronic hepatitis D virus (HDV) infection. The Breakthrough Therapy Designation for BRII-835 (elebsiran) was supported by Phase 1 and 2 studies conducted by Brii Bio and its partner Vir. As of September 2023, more than 570 people living with HBV have participated in clinical studies where BRII-835 (elebsiran) has been shown to be well-tolerated and has demonstrated direct antiviral activity against HBV in participants with chronic HBV and HDV infection. "Receiving Breakthrough Therapy Designations for BRII-877 and BRII-835 as well as the earlier Breakthrough Therapy Designation for BRII-179 further supports our long-held scientific rationales in the development of functional cure combination regimens for patients with chronic HBV infection," said Dr. Qing Zhu, Head of China R&D, Brii Bio. "Brii Bio and our partner Vir Biotechnology have conducted numerous clinical trials over the past five years, from which we have gained comprehensive clinical safety and efficacy data as well as critical insight towards our late-stage development plan and achieving potentially higher rates of HBV functional cure in broader patient populations." Having three breakthrough therapeutic modalities puts the Company in a unique position to address the broader populations of HBV infections including co-infection with HDV. As part of Brii Bio's approach to developing a functional cure for HBV, the Company and its partner Vir are progressing plans to initiate multiple combination studies in 2024 to further optimize the curative regimens that will inform the Company's registration strategy to bring the best regimens to HBV patients. About Hepatitis B Hepatitis B viral infection (HBV) is one of the world's most significant infectious disease threats with more than 254 million people infected globally.1 Chronic HBV infection is the leading cause of liver disease and an estimated 820,000 people die of complications from chronic HBV each year.1 HBV is of exceptional concern in China, where 87 million people are infected.2 About Hepatitis D Hepatitis D is a liver inflammation caused by the hepatitis D virus (HDV), which relies on hepatitis B virus (HBV) for replication. This infection can only occur in the presence of HBV. The combination of HDV-HBV co-infection is considered the most severe form of chronic viral hepatitis, leading to a quicker progression towards hepatocellular carcinoma and liver-related death. Globally, nearly 5% of individuals with chronic HBV infection are affected by HDV. HDV infection can occur through either simultaneous infection with both hepatitis B and D (co-infection) or acquiring hepatitis D after already having hepatitis B (super-infection).3 About BRII-877 (Tobevibart) BRII-877 (tobevibart) is an investigational subcutaneously administered neutralizing monoclonal antibody designed to block entry of HBV and HDV into hepatocytes and also to reduce the level of virions and subviral particles in the blood. BRII-877 (tobevibart), which incorporates Xencor's Xtend™ and other Fc technologies, has been engineered to potentially function as a T-cell vaccine against HBV and HDV, as well as to have an extended half-life. Brii Bio licensed exclusive rights to develop and commercialize BRII-877 (tobevibart) for the greater China territory from Vir Biotechnology, Inc. ("Vir") in 2022. About BRII-835 (Elebsiran) BRII-835 (elebsiran) is an investigational subcutaneously administered HBV-targeting siRNA that has the potential to stimulate an effective immune response and has direct antiviral activity against HBV and HDV. It is the first siRNA in the clinic to include Enhanced Stabilization Chemistry Plus (ESC+) technology to enhance stability and minimize off-target activity, which potentially can result in an increased therapeutic index. Brii Bio licensed exclusive rights to develop and commercialize BRII-835 (elebsiran) for the greater China territory from Vir Biotechnology, Inc. ("Vir") in 2020. About BRII-179 BRII-179 is a novel recombinant protein-based HBV immunotherapeutic candidate that expresses the Pre-S1, Pre-S2, and S HBV surface antigens, and is designed to induce enhanced and broad B-cell and T-cell immunity. Brii Bio licensed BRII-179 from VBI Vaccines, Inc. ("VBI") in December 2018 and has extended the exclusive license to global rights since July 2023. About Brii Bio Brii Biosciences Limited ("Brii Bio", stock code: 2137.HK) is a biotechnology company developing therapies to address major public health challenges where patients experience high unmet medical needs, limited choice and significant social stigmas. With a focus on infectious and central nervous system diseases, the Company is advancing a broad pipeline of unique therapeutic candidates with lead programs against hepatitis B viral infection (HBV). The Company is led by a visionary and experienced leadership team and has operations in key biotech hubs, including Raleigh-Durham, the San Francisco Bay Area, Beijing and Shanghai. For more information, visit . [1] World Health Organization. (April 2024). Global hepatitis report 2024: action for access in low- and middle-income countries. World Health Organization. Retrieved from [2] World Health Organization. Hepatitis. World Health Organization. Retrieved from . [3] World Health Organization. (July 2023). Hepatitis D. World Health Organization. Retrieved from SOURCE Brii Biosciences Limited