Tobevibart

Preliminary data from Cohort 4 of the ENSURE study supports a novel enrichment strategy to utilize BRII-179 to identify patients who are immune responders and have the potential to achieve higher HBsAg loss at EOT 48-week EOT data from Cohort 1-3 of the ENSURE study clearly suggests the added benefits of elebsiran towards achieving a higher rate of HBsAg loss in combination with PEG-IFNα DURHAM, N.C. and BEIJING, China, March 30, 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 needs, announced new data from its ongoing Phase 2 ENSURE study as a late-breaking oral presentation at the 34th Annual Meeting of Asian Pacific Association for the Study of the Liver (APASL 2025) in Beijing, China. 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), in combination 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. Participants who completed 9 doses of BRII-179, a recombinant protein-based therapeutic vaccine, in combination with elebsiran (BRII-835) in a previous APAC study BRII-179-835-001 (NCT04749368) were enrolled to Cohort 4 of this study and received elebsiran and PEG-IFNα combination treatment. The design of Cohort 4 as part of this study was based on insight from previous studies that a significant proportion of the chronic HBV patients fail to generate a sufficient immune response after receiving multiple doses of BRII-179, and therefore unlikely to have the immune support to achieve sustainable functional cure. Emerging data from Cohort 4 showed that participants who previously had BRII-179 induced anti-HBs response achieved a substantially higher rate of HBsAg seroclearance than those who did not. At Week 24, more than half of the BRII-179 responders (55.6% [10/18]) achieved HBsAg seroclearance, compared to only 10.0% (1/10) in non-responders. These latest data suggest that BRII-179 can serve as a predictive tool for enriching patients more likely to respond to curative therapies. Additional data from Cohorts 1-3 of the ENSURE study showed that higher end of treatment (EOT) HBsAg loss and seroconversion rates in participants receiving elebsiran in combination with PEG-IFNα than those receiving PEG-IFNα alone. "The positive Cohort 4 data from the ENSURE study opens new doors for HBV functional cure," said Dr. Grace Lai-Hung Wong, Professor of Gastroenterology and Hepatology at CUHK Medical Data Analytics Centre (MDAC) and Department of Medicine and Therapeutics in Hong Kong SAR, China. "Previous studies have suggested that BRII-179 may offer a unique opportunity to identify CHB patients who are able to elicit the necessary HBsAg antibody response. I believe these new findings provide clear evidence supporting such value proposition and further substantiate the role of BRII-179 in shaping future combination therapies." "We are encouraged that the Cohort 4 from the ENSURE study continue to support our enrichment strategy in developing a functional cure for chronic HBV in target populations," said David Margolis, MD, Chief Medical Officer of Brii Bio. "The results underscore the potential of BRII-179 in identifying patients who are more likely to respond to regimens aimed at functional cure, thereby enhancing functional cure rates in the target population while reducing exposure to costly therapies for those with a lower probability of cure. We are committed to advancing BRII-179 in combination with various modalities through our ongoing studies and collaborations with strategic partners, aiming to deliver higher functional cure rates to 254 million patients worldwide living with chronic HBV infection." Abstract Number: OP0335 Presentation Title: Responders to Prior BRII-179 Treatment Achieved Faster and Higher Rate of HBsAg Seroclearance Following Treatment of Elebsiran and PEG-IFNα in Participants with Chronic Hepatitis B Virus Infection: Preliminary 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 Among the 28 of the 31 participants enrolled in Cohort 4 with baseline HBsAg ≥ 100 IU/mL being analyzed, 18 participants with peak anti-HBs ≥ 10 IU/L induced by prior BRII-179 treatment were defined as BRII-179 responders and 10 participants with peak anti-HBs < 10 IU/L were defined as non-responders. At Week 24 of treatment with elebsiran + PEG-IFNα, 39.3% (11/28) of the Cohort 4 participants achieved HBsAg seroclearance. The rate of HBsAg seroclearance at Week 24 in the BRII-179 responders was 55.6% (10/18), notably higher compared to the non-responders at 10% (1/10). Responders to prior BRII-179 treatment appeared to achieve a faster HBsAg seroclearance compared to BRII-179 naïve participants receiving elebsiran + PEG-IFNα as previously reported. Elebsiran and PEG-IFNα combination therapy was generally safe and well tolerated in participants with virally suppressed chronic HBV infection. Treatment with elebsiran + PEG-IFNα is ongoing for 48 weeks. Abstract Number: LB0009 Presentation Title: Higher end of treatment (EOT) HBsAg loss and seroconversion rates in participants with chronic HBV infection receiving elebsiran (BRII-835) and pegylated interferon alfa-2a (PEG-IFNα) compared to PEG-IFNα alone: Week 48 results from ongoing ENSURE study Presenter: Jidong Jia, M.D., Ph.D., Professor of Medicine at the Liver Research Centre, Beijing Friendship Hospital, Capital Medical University in Beijing, China The rates of HBsAg seroclearance at EOT in elebsiran 200 mg + PEG-IFNα and elebsiran 100 mg + PEG-IFNα cohorts were 26.3% (5/19) and 33.3% (6/18), respectively, notably higher compared to PEG-IFNα alone cohort (5.6%) in participants with baseline HBsAg levels 100-3,000 IU/mL. Greater HBsAg reductions at EOT were observed in elebsiran + PEG-IFNα combination cohorts (mean [SE]: -2.47 [0.28] or -3.01 [0.28] log10 IU/mL in elebsiran 200 mg or 100 mg, respectively) than in PEG-IFNα cohort (-1.02 [0.30] log10 IU/mL). Elebsiran in combination with PEG-IFNα at both 200 mg and 100 mg doses achieved similar HBsAg reductions and seroclearance rates. Elebsiran and PEG-IFNα combination therapy was generally safe and well tolerated in participants with virally suppressed chronic HBV infection. Post-treatment follow-up is ongoing and will continue for 24 weeks after discontinuation of treatment. 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, a recombinant protein-based HBV immunotherapeutic 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 the 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 (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的初步数据支持一项新颖的富集策略，利用BRII-179识别免疫应答患者，使其有望在治疗结束时（EOT）实现更高的HBsAg清除率 ENSURE研究队列1-3的48周EOT数据清楚表明，elebsiran联合PEG-IFNα治疗可实现额外获益，达到更高的HBsAg清除率 中国北京和美国北卡罗来纳州达勒姆 2025年3月30日 /美通社/ -- 腾盛博药生物科技有限公司（"腾盛博药"或"公司"，股票代码：2137.HK），一家致力于针对患者需求未被满足的疾病开发治疗方案，以改善患者健康状况和治疗选择的生物技术公司，今日宣布，在中国北京举行的第34届亚太肝病学会年会（APASL 2025）上，公司以最新突破口头报告的形式公布了其正在进行的ENSURE 2期研究的最新数据。 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。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（BRII-835）给药的参与者被纳入该研究的队列4，并接受elebsiran和PEG-IFNα联合治疗。本研究队列4的设计基于既往研究的见解，即很大一部分慢性HBV患者在接受治疗性疫苗的多次治疗后未能产生足够的免疫应答，因此不太可能获得免疫支持以实现持久的功能性治愈。 队列4的最新数据显示，过往产生BRII-179诱导的乙肝表面抗体（抗-HBs）应答的参与者，其HBsAg血清清除率显著高于未产生应答的参与者。第24周时，超过半数的BRII-179应答者（55.6% [10/18]）实现了HBsAg血清清除，而无应答者只有10.0%（1/10）实现了HBsAg血清清除。本次公布的数据表明，BRII-179有潜力成为一种预测工具，用于筛选出更可能对治愈方法产生应答的患者。 此次公布的ENSURE研究中队列1-3额外数据显示，与接受PEG-IFNα单药治疗的参与者相比，接受elebsiran联合PEG-IFNα治疗的参与者在治疗结束 (EOT) 时有更高的HBsAg清除率和血清转换率。 黄丽虹教授（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）表示："ENSURE研究队列4的积极数据为HBV功能性治愈打开了新的大门。既往研究表明，BRII-179可能为识别能够产生必要的HBsAg抗体应答的慢性乙型肝炎 （CHB）患者提供新路径。我相信，这次的新数据为BRII-179在筛选治疗获益人群方面的价值提供了有力的证据，进一步确立了BRII-179在未来联合疗法格局中的地位。" 腾盛博药首席医学官David Margolis博士表示："ENSURE研究队列4的数据继续支持我们在目标人群中开发慢性HBV功能性治愈的富集策略，这令我们备受鼓舞。研究结果进一步凸显了BRII-179在识别更可能对功能性治愈疗法产生应答的患者方面的潜力，通过患者富集策略能提高目标人群的功能性治愈率，同时有助于降低治愈概率较低人群的治疗成本负担。我们致力于通过正在开展的临床研究以及与战略合作伙伴的合作，将BRII-179与多种疗法结合使用，以期为全球2.54亿慢性HBV感染患者实现更高的功能性治愈率。" 摘要编号： OP0335 报告标题： 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 和 PEG-IFNα 治疗后可获得更快更高的HBsAg清除：来自ENSURE研究的初步数据 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 在队列4中入组的31例参与者中，有28例基线HBsAg ≥ 100 IU/mL的参与者被纳入分析。其中，18例通过先前BRII-179治疗诱导的抗-HBs峰值≥10 IU/L的受试者被定义为BRII-179应答者，10例抗-HBs峰值<10 IU/L的受试者被定义为无应答者。 在elebsiran + PEG-IFNα治疗第24周时，队列4参与者中有39.3%（11/28）实现了HBsAg血清清除。 第24周时，BRII-179应答者的HBsAg血清清除率为55.6%（10/18），明显高于无应答者的10%（1/10）。 与此前报告的接受elebsiran + PEG-IFNα治疗但未经BRII-179治疗的参与者相比，既往接受BRII-179治疗的应答者似乎可以实现更快的HBsAg血清清除。 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。 Elebsiran + PEG-IFNα治疗会持续48周。 摘要编号： LB0009 报告标题： 与单用 PEG-IFNα 相比，接受 elebsiran 和PEG-IFNα治疗的慢性 HBV 感染者在治疗结束 (EOT) 时 HBsAg 清除率和血清转换率更高： 正在进行的ENSURE研究第48周结果 主讲人： 贾继东教授，M.D.，Ph.D.，首都医科大学附属北京友谊医院肝病研究中心主任，中国北京 EOT时，在基线HBsAg水平为100-3,000 IU/mL的参与者中，elebsiran 200 mg + PEG-IFNα队列和elebsiran 100 mg + 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%）。 与PEG-IFNα队列（-1.02 [0.30] log 10 IU/mL）相比，elebsiran + PEG-IFNα队列在EOT时的HBsAg下降幅度更大（平均值[SE]：elebsiran 200 mg或100 mg分别为-2.47 [0.28]或-3.01 [0.28] log 10 IU/mL）。 Elebsiran联合PEG-IFNα治疗（剂量分别为200 mg和100 mg），在HBsAg下降幅度和血清清除率方面均表现出相似的效果。在病毒学抑制的慢性HBV感染参与者中，elebsiran联合PEG-IFNα疗法总体安全且耐受性良好。 治疗后随访仍在进行中，并将持续随访至治疗终止后第24周。 作为腾盛博药开发HBV功能性治愈的独特疗法的一部分，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（一种重组蛋白HBV免疫治疗候选药物，由腾盛博药开展 elebsiran 和 BRII-179 联合疗法的研究） 、elebsiran（由腾盛博药开展 elebsiran 和 PEG-IFNα 联合研究）以及tobevibart（一种靶向HBV的研究性广泛中和单克隆抗体，Vir Biotechnology正就tobevibart和elebsiran联合疗法开展多项 2 期和 3 期研究 ）。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-179 BRII-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。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（BRII-835，VIR-2218） Elebsiran是一种经皮下注射给药的靶向HBV的siRNA研究性药物，旨在降解乙型肝炎病毒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，请访问 www.briibio.com 。 [1] World Health Organization. (April 2024). Global hepatitis report 2024: action for access in low- and middle-income countries. World Health Organization. Retrieved from https://www-who-int.libproxy1.nus.edu.sg/publications/i/item/9789240091672 [2] World Health Organization. Hepatitis. World Health Organization. Retrieved from https://www-who-int.libproxy1.nus.edu.sg/china/health-topics/hepatitis#:~:text=There%20are%2087%20million%20people,living%20with%20chronic%20hepatitis%20C .