Tobevibart

End of treatment (EOT) data from Cohort 4 of the ENSURE study suggest that patients responding to prior BRII-179 treatment achieved faster and higher rate of surface antigen clearance with curative treatments compared to BRII-179 naïve participants, strengthening the case for a novel enrichment strategy, utilizing BRII-179 to identify and prime patients for improved functional cure outcomes 24 Week follow-up results from Cohorts 1-3 of the ENSURE study demonstrated sustained off-treatment benefits of elebsiran + PEG-IFNα combination therapy vs PEG-IFNα alone DURHAM, N.C. and BEIJING, May 7, 2025 /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 medical need, today announced data from its ongoing Phase 2 ENSURE study as late-breaking posters at the European Association for the Study of the Liver (EASL) Congress 2025 in Amsterdam, the Netherlands. ENSURE (NCT05970289) is a multicenter, open-label Phase 2 study. Cohorts 1-3 were designed to evaluate the contribution of elebsiran, an investigational small interfering ribonucleic acid (siRNA), to the combination treatment with pegylated interferon alpha (PEG-IFNα) in participants with chronic HBV infection with baseline hepatitis B surface antigen (HBsAg) of 100-3,000 IU/mL. Cohort 4 enrolled participants who completed 9 doses of BRII-179, a recombinant protein-based therapeutic vaccine, in combination with elebsiran in a previous APAC study BRII-179-835-001 (NCT04749368) to receive elebsiran and PEG-IFNα combination treatment. These participants were grouped based on their anti-HBs response induced by prior BRII-179 treatment: those with peak anti-HBs titers ≥ 10 IU/L are defined as anti-HBs responders, and those with peak anti-HBs titers < 10 IU/L as non-responders. The design of Cohort 4 as part of this study was based on the insight that BRII-179 could differentiate between immune responders and non-responders, offering the potential to predict future response to therapy. Interim data from Cohort 4 showed that anti-HBs responders achieved a substantially higher rate of HBsAg seroclearance than non-responders. At EOT (Week 48), 61% (11/18) of anti-HBs responders achieved HBsAg seroclearance, compared to 10% (1/10) of non-responders. Among the 11 anti-HBs responders who achieved HBsAg loss, 91% (10/11) had anti-HBs titers ≥ 100 IU/L at EOT. Of note, BRII-179 experienced participants in Cohort 4 achieved HBsAg loss faster than BRII-179 naïve participants in Cohort 2 and 3. 83% (10/12) of HBsAg loss in BRII-179 experienced participants occurred by Week 24, compared to 55% (6/11) in BRII-179 naïve participants. These findings suggest rapid HBsAg seroclearance in subjects with higher anti-HBs titers may translate into durable HBsAg loss and the potential to evaluate shorter treatment durations of PEG-IFNα. Additional data from Cohorts 1-3 of the ENSURE study showed the combination therapy of elebsiran either 100 mg or 200 mg and PEG-IFNα resulted in higher HBsAg loss rate at 24 weeks post EOT compared to PEG-IFNα alone, supporting the additive benefit of siRNA. "The data from Cohort 4 of the ENSURE study are encouraging. We saw in target populations that patients who were immune-responsive through pre-treatment with BRII-179 demonstrated a significant advantage in achieving a higher HBsAg seroclearance rate," said David Margolis, MD, Chief Medical Officer of Brii Bio. "With BRII-179, we may identify patients with less impaired intrinsic immunity and further prime their immune response. This approach may provide more durable HBsAg loss and potentially shorter treatment duration of PEG-IFNα. We are moving full speed ahead with our clinical efforts to deliver a meaningful option to the chronic hepatitis B patients long left waiting." Abstract Number: LB25123/ LBP-018 Title: Chronic hepatitis B virus infected participants responding to prior BRII-179 treatment achieved faster and higher rate of hepatitis B virus surface antigen seroclearance on elebsiran plus pegylated interferon-alfa: end of treatment data from ENSURE study Presenter: Grace Lai-Hung Wong, MBChB (CUHK), MD (CUHK), FRCP (Lond, Edin), FHKCP, FHKAM (Medicine), Professor of Gastroenterology and Hepatology at CUHK Medical Data Analytics Centre (MDAC) and Department of Medicine and Therapeutics in Hong Kong SAR, China A total of 28 participants with baseline HBsAg > 100 and ≤ 3000 IU/mL were analyzed. 18 and 10 participants had peak anti-HBs titer ≥ 10 IU/L (defined as anti-HBs responders) and < 10 IU/L (defined as non-responders) induced by BRII-179 in the previous study, respectively. Median [range] HBsAg at the time of initiating elebsiran + PEG-IFNα was numerically higher in anti-HBs responders (539.4 [106.7-2165.0] IU/mL) than in non-responders (219.3 [106.7-671.5] IU/mL). At EOT (Week 48), 61% (11/18) of anti-HBs responders achieved HBsAg seroclearance, compared to 10% (1/10) of non-responders. Among the anti-HBs responders who lost HBsAg, 91% (10/11) had anti-HBs titers ≥ 100 IU/L at EOT. BRII-179 experienced participants achieved HBsAg loss faster than BRII-179 naïve participants, with 83% (10/12) of HBsAg loss occurring by Week 24 (vs 55% [6/11] in BRII-179 naïve participants). Elebsiran + PEG-IFNα was generally safe and tolerated in BRII-179 experienced participants. Abstract Number: LB25115/ LBP-016 Title: Efficacy and safety of elebsiran and pegylated interferon alfa combination therapy versus pegylated interferon alfa in participants with chronic hepatitis B virus infection: follow-up results from the ongoing phase 2, randomized, open-label ENSURE study Presenter: David Margolis, MD, MPH, Chief Medical Officer of Brii Biosciences At Week 72 (24 weeks post EOT), higher HBsAg loss rate was observed in participants on combination therapy of either elebsiran 200mg or 100 mg and PEG-IFNα compared to PEG-IFNα alone (21.1% [4/19] or 33.3% [6/18] vs 5.6% [1/18]). All the 11 participants with HBsAg loss had baseline HBsAg < 1500 IU/mL. Incidence of treatment emergent adverse events (TEAEs) was comparable between combination therapy cohorts and PEG-IFNα alone cohort. Most TEAEs were consistent with known side effects of PEG-IFNα. As part of Brii Bio's unique approach to developing a functional cure for HBV, the Company and its partners are actively progressing multiple combination studies with our differentiated portfolio, including BRII-179 being evaluated in multiple combination studies with elebsiran led by Brii Bio; elebsiran being evaluated in combination with PEG-IFNα in studies led by Brii Bio; and tobevibart, an investigational broadly neutralizing monoclonal antibody targeting HBV, being evaluated in multiple Phase 2 and 3 tobevibart and elebsiran combination studies led by Vir Biotechnology. Key data readouts will be shared in the coming months at scientific conferences throughout 2025. About Hepatitis B Hepatitis B virus (HBV) infection 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 infection each year.[1] HBV is of exceptional concern in China, where 87 million people are chronically infected.[2] 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. In November 2023, the Center for Drug Evaluation (the "CDE") of the National Medical Products Administration (the "NMPA") granted BRII-179 Breakthrough Therapy Designation. About Elebsiran (previously known as BRII-835, VIR-2218) Elebsiran is an investigational subcutaneously administered HBV-targeting siRNA designed to degrade hepatitis B virus RNA transcripts and limit the production of hepatitis B surface antigen. It has the potential to have direct antiviral activity against HBV and HDV. It is the first siRNA in the clinic to include Enhanced Stabilization Chemistry Plus 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 elebsiran for the Greater China territory from Vir Biotechnology, Inc. in 2020. 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 diseases, the Company is advancing a broad pipeline of unique therapeutic candidates with lead programs against hepatitis B virus (HBV) infection. 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 . SOURCE Brii Biosciences Limited WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

ENSURE研究队列4的治疗结束（EOT）数据表明，对既往BRII-179治疗有应答的患者在接受治愈性治疗后相较BRII-179未经治患者实现了更快、更高的表面抗原清除率，强调了利用BRII-179识别和免疫激活患者，以提高功能性治愈结果的新型富集策略ENSURE研究队列1-3的24周随访结果表明，与PEG-IFNα单药相比，elebsiran + PEG-IFNα联合治疗具有持续的非治疗性获益公司今日宣布，在荷兰阿姆斯特丹举行的2025年欧洲肝病研究协会（EASL）会议上以最新突破壁报的形式公布其正在进行的ENSURE 2期研究数据。ENSURE（NCT05970289）是一项多中心、开放性2期研究。队列1-3旨在评估elebsiran（一种研究性小干扰核糖核酸（siRNA））在与聚乙二醇干扰素α（PEG-IFNα）联合治疗慢性乙型肝炎病毒（HBV）感染者（基线乙肝表面抗原（HBsAg）水平为100-3,000 IU/mL）中的作用。队列4入组了在先前的亚太地区研究BRII-179-835-001（NCT04749368）中接受过9剂BRII-179（一种基于重组蛋白的治疗性疫苗）联合elebsiran给药的参与者，接受elebsiran与PEG-IFNα联合治疗。这些参与者根据他们之前接受BRII-179 治疗后产生的抗HBs应答进行分组：抗HBs滴度峰值≥ 10 IU/L的参与者被定义为抗HBs应答者，抗HBs滴度峰值< 10 IU/L 的参与者被定义为无应答者。本研究队列 4 的设计基于BRII-179可以区分免疫应答者和无应答者的一种见解，从而为预测未来的治疗应答提供了可能。队列4的中期数据显示，，抗HBs应答者的HBsAg血清清除率显著高于无应答者。EOT（第48周）时，61%（11/18）的抗HBs应答者达到HBsAg血清清除，而无应答者为10%（1/10）。在11名HBsAg转阴的抗HBs应答者中，91%（10/11）在EOT时的抗HBs滴度≥100 IU/L。值得注意的是，队列4中的BRII-179经治参与者比队列2和队列3中BRII-179未经治参与者更快实现HBsAg清除，第24周时在BRII-179经治参与者中已有83%（10/12）的参与者实现HBsAg清除，而BRII-179未经治参与者为55% （6/11）。这些发现表明，快速的HBsAg血清清除率和较高的抗HBs滴度可转化为持久的HBsAg清除，以及评估缩短PEG-IFNα疗程的可能性。ENSURE研究队列1-3的其他数据表明，与PEG-IFNα单药治疗相比，100或200毫克elebsiran与PEG-IFNα联合治疗在EOT24周后均可实现更高的HBsAg清除率，支持siRNA的额外获益。ENSURE研究队列4的数据令人鼓舞。我们在目标人群中发现，经过BRII-179预治疗产生免疫应答的患者在实现较高的HBsAg血清清除率方面表现出显著优势。借助BRII-179，我们可以识别内在免疫受损程度较低的患者，并进一步增强其免疫应答。这种方法可使HBsAg清除更持久，并有可能缩短PEG-IFNα的治疗时间。我们正在全速推进临床工作，以期为目标慢性乙型肝炎患者提供有意义的可选方案。摘要编号LB25123/ LBP-018标题对既往BRII-179治疗产生应答的慢性乙型肝炎病毒感染者在接受elebsiran + 聚乙二醇干扰素α治疗后可获得更快更高的乙型肝炎表面抗原清除率：来自ENSURE研究的治疗结束时数据主讲人黄丽虹教授MBChB（CUHK），MD（CUHK），FRCP（Lond, Edin），FHKCP，FHKAM（Medicine）香港中文大学医学数据分析中心（MDAC）及香港中文大学内科及药物治疗学系肠胃及肝病科专科教授中国香港特别行政区共分析了28例基线HBsAg > 100和≤ 3000 IU/mL的参与者。在既往研究中，BRII-179诱导的18例参与者的抗HBs滴度峰值≥ 10 IU/L（定义为抗HBs应答者）和10例参与者< 10 IU/L（定义为无应答者）。在开始elebsiran + PEG-IFNα治疗时，抗HBs应答者（539.4 [106.7-2165.0] IU/mL）的HBsAg中位数（范围）在数值上高于无应答者（219.3 [106.7-671.5] IU/mL）。EOT（第48周）时，61%（11/18）的抗HBs应答者达到HBsAg血清清除，而无应答者为10%（1/10）。在HBsAg转阴的抗HBs应答者中，91%（10/11）在EOT时的抗HBs滴度≥100 IU/L。BRII-179经治参与者比BRII-179未经治参与者更快实现HBsAg清除，第24周时已有83%（10/12）的参与者实现HBsAg清除（BRII-179未经治参与者为55% （6/11））。Elebsiran + PEG-IFNα联合治疗在BRII-179经治的参与者中总体安全且可耐受。摘要编号LB25115/ LBP-016标题Elebsiran 和 PEG-IFNα联合治疗与PEG-IFNα治疗慢性乙型肝炎病毒感染参与者的有效性和安全性：正在进行的2期、随机、开放性ENSURE研究的随访结果主讲人David MargolisM.D.，MPH腾盛博药首席医学官第72周（EOT后24周）时，与PEG-IFNα单药治疗相比，在接受elebsiran 200 mg或100 mg与PEG-IFNα联合治疗的参与者中观察到更高的HBsAg转阴率（21.1% [4/19]或33.3% [6/18] vs 5.6% [1/18]），所有11例实现HBsAg清除的参与者基线HBsAg < 1500IU/mL。联合治疗队列和PEG-IFNα单药治疗队列之间治疗中出现的不良事件（TEAE）的发生率相当。大多数TEAE与PEG-IFNα的已知副作用一致。作为腾盛博药开发HBV功能性治愈的独特方法的一部分，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BRII-179（正在腾盛博药领导的多项elebsiran联合疗法中进行评估）；elebsiran（正在腾盛博药领导的PEG-IFNα联合疗法中进行评估）；以及tobevibart（一种靶向HBV的研究性广泛中和单克隆抗体，正在Vir Biotechnology领导的在多项2期和3期tobevibart和elebsiran联合疗法中进行评估）。在2025年接下来的几个月，我们将在各大科学会议上持续分享关键数据。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BRII-179BRII-179是一种基于重组蛋白质的新型HBV 免疫治疗候选药物，可表达HBV的Pre-S1、Pre-S2和S表面抗原，旨在诱导增强和广泛的B细胞和T细胞免疫应答。腾盛博药于2018年12月从VBI Vaccines, Inc.（“VBI”）引进了BRII-179，还自2023年7月起，将BRII-179的独家许可扩展至全球市场。2023年11月，中国国家药品监督管理局（NMPA）药品审评中心（CDE）授予BRII-179突破性治疗认定。关于Elebsiran(曾用名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，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。