Brii Biosciences，Vir Biotechnology和VBI疫苗宣布启动BRII-835（VIR-2218

StephenW

Brii Biosciences, Vir Biotechnology, and VBI Vaccines Announce Initiation of Phase 2 Clinical Trial of BRII-835 (VIR-2218) in Combination with BRII-179 (VBI-2601) for the Treatment of Hepatitis B

Published: Apr 21, 2021
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April 21, 2021 12:00 UTC


– New combination trial of an RNA-targeted therapeutic candidate and an HBV immunotherapeutic candidate aimed at delivering a functional cure for chronic hepatitis B infection –


DURHAM, N.C. & BEIJING & SAN FRANCISCO & CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Brii Biosciences (Brii Bio), Vir Biotechnology, Inc. (Nasdaq: VIR), and VBI Vaccines Inc. (Nasdaq: VBIV) today announced that the first patient has been dosed in a Phase 2 clinical trial evaluating BRII-835 (VIR-2218), an investigational small interfering ribonucleic acid (siRNA) targeting hepatitis B virus (HBV), in combination with BRII-179 (VBI-2601), an investigational HBV immunotherapeutic, for the treatment of chronic HBV infection. This is the first clinical trial in the field to evaluate the combination of these two HBV mechanisms of action.

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The multi-center, randomized, open-label study is designed to evaluate the safety and efficacy of BRII-835 (VIR-2218) compared to the combination of BRII-835 (VIR-2218) and BRII-179 (VBI-2601) with and without interferon-alpha as a co-adjuvant. Both agents have demonstrated proof of mechanism in HBV patients (NCT04507269 BRII-835 China study and ACTRN12619001210167 BRII-179 APEC study). Brii Bio has led the design and implementation of this functional cure proof-of-concept study with the support of VIR and VBI, and is the sponsor of the Phase 2 study (NCT04749368). It will be conducted at sites in Australia, China, Taiwan, Hong Kong Special Administrative Region of China, South Korea, New Zealand, Singapore, and Thailand.

Li Yan, M.D., Ph.D., chief medical officer of Brii Bio, said: “Sustained seroclearance of HBV surface antigen, also known as a functional cure, occurs rarely in the natural history of HBV infection or during the current standard of care treatment. We believe that both viral antigen knockdown with BRII-835 (VIR-2218) and sustained induction of HBV-specific host immune responses by BRII-179 (VBI-2601) are required to remove viral immunosuppression and subsequently break immune tolerance. The combination of these two agents is a step toward developing a functional cure for HBV.”

Phil Pang, M.D., Ph.D., chief medical officer of Vir, said: “This new combination trial represents an important addition to our HBV portfolio approach of combining VIR-2218 with various immunomodulators, including pegylated interferon alpha, VIR-3434 and with a TLR8 agonist, via our previously announced collaboration with Gilead. We look forward to determining if such combinations can stimulate an effective immune response that may result in a finite duration of treatment.”

Francisco Diaz-Mitoma, M.D., Ph.D., VBI’s chief medical officer, said: “We believe that a functional cure for HBV is possible, and will require restoration of HBV-specific immunologic control in addition to viral suppression mechanisms. Data from our previous study suggest BRII-179 (VBI-2601) was able to restimulate both antibody and T cell responses specific to HBV. This combination study represents the first combination of a therapeutic HBV vaccine to restore HBV-immunity with antivirals designed to reduce the levels of HBV surface antigens. We look forward to seeing the outcome of the trial, a milestone that will be meaningful in our collective efforts to provide an effective solution for patients with such a complex and highly infectious virus.”

About BRII-835 (VIR-2218)

BRII-835 (VIR-2218) is an investigational subcutaneously administered HBV-targeting siRNA that has the potential to stimulate an effective immune response and have direct antiviral activity against HBV. 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. VIR-2218 is the first asset in the Company’s collaboration with Alnylam Pharmaceuticals, Inc. to enter clinical trials. Brii Bio licensed exclusive rights to develop and commercialize VIR-2218 for the greater China territory from Vir in 2020.

In addition to the Phase 2 combination trial with BRII-179 (VBI-2601), VIR-2218 is being evaluated in two ongoing trials: as a monotherapy for HBV, and in combination with pegylated interferon-alpha (PEG-IFN-α). Two additional Phase 2 trials of VIR-2218 are expected to start in 2021.

About BRII-179 (VBI-2601)

VBI-2601 (BRII-179) is a novel recombinant, protein-based HBV immunotherapeutic candidate that builds upon the 3-antigen conformation of VBI’s prophylactic 3-antigen HBV vaccine candidate, and is designed to target enhanced B-cell and T-cell immunity. VBI-2601 (BRII-179) is being developed in collaboration with Brii Biosciences in the licensed territory of China, Hong Kong, Macau, and Taiwan as part of a potential functional cure for chronic hepatitis B infection.

About Brii Biosciences

Brii Biosciences (Brii Bio) is a multi-national company committed to serving patients’ needs and improving public health by accelerating the development and delivery of breakthrough medicines through partnerships, best-in-class research and development, and the disruptive application of digital and data insight. With operations in the People’s Republic of China and the United States, Brii Bio is poised to serve as a bridge to carry transformative medicines to patients, help create significant growth for our partners and establish an innovation engine to help improve the public health and wellbeing of patients around the world. Brii Bio is developing treatments for illnesses with significant public health burdens, including infectious diseases, liver diseases, and CNS diseases. For more information, visit www.briibio.com.

About Vir Biotechnology

Vir Biotechnology is a clinical-stage immunology company focused on combining immunologic insights with cutting-edge technologies to treat and prevent serious infectious diseases. Vir has assembled four technology platforms that are designed to stimulate and enhance the immune system by exploiting critical observations of natural immune processes. Its current development pipeline consists of product candidates targeting COVID-19, hepatitis B virus, influenza A and human immunodeficiency virus. For more information, please visit www.vir.bio.

About VBI Vaccines Inc.

VBI Vaccines Inc. (“VBI”) is a biopharmaceutical company driven by immunology in the pursuit of powerful prevention and treatment of disease. Through its innovative approach to virus-like particles (“VLPs”), including a proprietary enveloped VLP (“eVLP”) platform technology, VBI develops vaccine candidates that mimic the natural presentation of viruses, designed to elicit the innate power of the human immune system. VBI is committed to targeting and overcoming significant infectious diseases, including hepatitis B, coronaviruses, and cytomegalovirus (CMV), as well as aggressive cancers including glioblastoma (GBM). VBI is headquartered in Cambridge, Massachusetts, with research operations in Ottawa, Canada, and a research and manufacturing site in Rehovot, Israel. For more information, please visit www.vbivaccines.com.

StephenW

Brii Biosciences，Vir Biotechnology和VBI疫苗宣布启动BRII-835（VIR-2218）与BRII-179（VBI-2601）联合治疗乙型肝炎的2期临床试验

发布时间：2021年4月21日
标志标志标志
2021年4月21日12:00 UTC


–靶向RNA的治疗候选物和HBV免疫治疗候选物的新组合试验，旨在为慢性乙型肝炎感染提供功能性治疗–


北卡罗来纳州达勒姆，北京，马萨诸塞州旧金山和坎布里奇-（美国商业资讯）-Brii Biosciences（Brii Bio），Vir Biotechnology，Inc.（Nasdaq：VIR）和VBI Vaccines Inc.（Nasdaq：VBIV）今日宣布第一名患者已在评估BRII-835（VIR-2218）的2期临床试验中服药，BRII-835是针对乙型肝炎病毒（HBV）的研究性小干扰核糖核酸（siRNA），与BRII-179（VBI- 2601），一种研究性的HBV免疫疗法，用于治疗慢性HBV感染。这是该领域中首次评估这两种HBV作用机制组合的临床试验。

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与BRII-835（VIR-2218）和BRII-179（VBI-2601）的组合相比，该多中心，随机，开放标签研究旨在评估BRII-835（VIR-2218）的安全性和有效性。有或没有干扰素-α作为辅助佐剂。两种药物均已证明对HBV患者有作用机制的证据（NCT04507269 BRII-835中国研究和ACTRN12619001210167 BRII-179 APEC研究）。 Brii Bio在VIR和VBI的支持下领导了这项功能性概念验证研究的设计和实施，并且是第二阶段研究（NCT04749368）的赞助商。它将在澳大利亚，中国，台湾，中国香港特别行政区，韩国，新西兰，新加坡和泰国的地点进行。

Brii Bio首席医学官医学博士Li Yan表示：“ HBV表面抗原的持续血清清除（也称为功能性治愈）在HBV感染的自然病史或现行护理标准中很少发生治疗。我们认为，需要用BRII-835（VIR-2218）进行病毒抗原敲除和通过BRII-179（VBI-2601）持续诱导HBV特异性宿主免疫应答来消除病毒免疫抑制并随后破坏免疫耐受。这两种药物的结合是朝着开发乙肝病毒功能性治疗迈出的一步。”

Vir首席医学官Phil Pang博士说：“这项新的联合试验代表了我们将VIR-2218与各种免疫调节剂（包括聚乙二醇化干扰素α，VIR-3434和通过我们先前宣布的与吉利德（Gilead）的合作，与TLR8激动剂一起使用。我们期待确定这种组合是否可以刺激有效的免疫反应，从而可能导致有限的治疗持续时间。”

VBI首席医学官Francisco Diaz-Mitoma博士说：“我们认为，对HBV进行功能性治疗是可能的，除了病毒抑制机制外，还需要恢复HBV特异性免疫控制。来自我们先前研究的数据表明，BRII-179（VBI-2601）能够重新刺激针对HBV的抗体和T细胞反应。这项组合研究代表了一种治疗性HBV疫苗的首次组合，该疫苗可与旨在降低HBV表面抗原水平的抗病毒药恢复HBV免疫力。我们期待看到试验的结果，这是一个里程碑，对我们集体努力为患有如此复杂和高度传染性病毒的患者提供有效的解决方案具有重要意义。”

关于BRII-835（VIR-2218）

BRII-835（VIR-2218）是一种研究性皮下注射的靶向HBV的siRNA，具有刺激有效免疫应答和对HBV具有直接抗病毒活性的潜能。它是临床上首个包含增强稳定化学增强（ESC +）技术的siRNA，可增强稳定性并最大程度地降低脱靶活性，这有可能导致治疗指数的提高。 VIR-2218是公司与Alnylam Pharmaceuticals，Inc.合作进行临床试验的第一项资产。 Brii Bio于2020年从Vir获得了在大中华地区开发和商业化VIR-2218的专有权。

除了与BRII-179（VBI-2601）进行的2期联合试验外，还在两项正在进行的试验中对VIR-2218进行评估：作为HBV的单一疗法，以及与聚乙二醇化干扰素-α（PEG-IFN-α）组合。预计将于2021年开始另外两项VIR-2218的2期试验。

关于BRII-179（VBI-2601）

VBI-2601（BRII-179）是一种新型的基于蛋白质的重组HBV免疫治疗候选药物，它基于VBI预防性3抗原HBV疫苗候选药物的3抗原构象建立，旨在靶向增强的B细胞和T细胞免疫。 VBI-2601（BRII-179）正在与Brii Biosciences合作在中国，香港，澳门和台湾的许可地区开发，作为慢性乙型肝炎潜在功能疗法的一部分。

关于Brii Biosciences

Brii Biosciences（Brii Bio）是一家跨国公司，致力于通过合作伙伴关系，一流的研究与开发以及颠覆性的数字和数字应用来加速突破性药物的开发和交付，从而满足患者的需求并改善公共卫生。数据洞察力。 Brii Bio在中国和美国开展业务，有望成为向患者运送转化药物的桥梁，帮助我们的合作伙伴实现显着增长，并建立创新引擎来帮助改善公众健康和福祉。世界各地的患者。 Brii Bio正在开发具有重大公共卫生负担的疾病的治疗方法，包括传染病，肝病和中枢神经系统疾病。有关更多信息，请访问www.briibio.com。

关于维尔生物技术

Vir Biotechnology是一家临床阶段免疫学公司，致力于将免疫学见识与尖端技术相结合，以治疗和预防严重的传染病。 Vir组装了四个技术平台，旨在通过利用对自然免疫过程的重要观察来刺激和增强免疫系统。其当前的开发流程包括针对COVID-19，乙型肝炎病毒，甲型流感和人类免疫缺陷病毒的候选产品。有关更多信息，请访问www.vir.bio。

关于VBI疫苗公司

VBI Vaccines Inc.（“ VBI”）是一家由免疫学驱动的生物制药公司，致力于有效地预防和治疗疾病。通过创新的病毒样颗粒（“ VLP”）方法，包括专有的包膜VLP（“ eVLP”）平台技术，VBI开发了模仿病毒自然呈递的候选疫苗，旨在激发人类免疫力的先天力量。系统。 VBI致力于针对和克服包括B型肝炎，冠状病毒和巨细胞病毒（CMV）在内的重大传染性疾病，以及包括成胶质细胞瘤（GBM）在内的侵袭性癌症。 VBI的总部位于马萨诸塞州的剑桥，其研究部门位于加拿大渥太华，并在以色列的雷霍沃特设有研究和制造基地。有关更多信息，请访问www.vbivaccines.com。