VBI疫苗和Brii Biosciences发起了慢性乙型肝炎感染患者的BRII-179

StephenW

VBI Vaccines and Brii Biosciences Initiate Phase 1b/2a Study of BRII-179 (VBI-2601) in Patients with Chronic Hepatitis B Infection
Business Wire


November 14, 2019
8:00 AM EST

– Novel recombinant, protein-based immuno-therapeutic for the treatment of chronic hepatitis B virus (HBV) infection

– Two-part, dose-escalation study expected to enroll up to 65 patients

– Initial data expected in H2 2020

CAMBRIDGE, Mass. & BEIJING & DURHAM, N.C. — VBI Vaccines (NASDAQ: VBIV) (“VBI”), a commercial-stage biopharmaceutical company developing next-generation infectious disease and immuno-oncology vaccines, and Brii Biosciences (“Brii Bio”), a clinical-stage company committed to serving patients’ needs and improving public health in China and around the world, today announced the first patient dosed in a Phase 1b/2a proof-of-concept study of BRII-179 (VBI-2601), a novel recombinant, protein-based immuno-therapeutic candidate in development for the treatment of chronic hepatitis B virus (HBV) infection.

“Chronic HBV has long been considered one of the most challenging viral infections to treat, due to its complex life cycle once it takes hold in the liver,” said Jeff Baxter, President and CEO of VBI. “There is growing consensus in the scientific community that a functional cure for HBV is possible and that it will require restoration of HBV immunity to ensure the body’s own ability to control the viral infection. We believe BRII-179 (VBI-2601) has the potential to be a critical and differentiated component of a functional cure for HBV.”

“Alleviating the disease burden of HBV through a functional cure would be transformational for individuals and societies around the world,” said Zhi Hong, Ph.D., co-founder, and CEO of Brii Bio. “We, together with our colleagues at VBI, are pleased to announce the start of this clinical study of BRII-179 (VBI-2601) as we work hard to address this unmet need, and we look forward to sharing the initial human proof-of-concept results from this study in the second half of 2020.”

BRII-179 (VBI-2601) is uniquely formulated to target both B-cell and T-cell immunity through multiple mechanisms of action, including neutralizing the circulating hepatitis B virus, blocking hepatitis B infection of hepatocytes mediated through Pre-S1, and enabling immune-mediated clearance of HBV-infected hepatocytes. Where many investigational agents work inside the infected liver cells downstream of transcription, BRII-179 (VBI-2601) is designed to impact the key extracellular steps in the HBV lifecycle in order to restore immunologic control over the infection.

The Phase 1b/2a clinical study of BRII-179 (VBI-2601) is a randomized, controlled study designed to assess the safety, tolerability, and antiviral activity of BRII-179 (VBI-2601) in patients with chronic HBV infection. The study is designed as a two-part dose-escalation study assessing different dose levels of BRII-179 (VBI-2601), and is expected to enroll up to 65 patients.

Initial human proof-of-concept data from the Phase 1b/2a clinical study are expected in the second half of 2020.

The study is sponsored by Brii Bio and will be conducted at multiple study sites in New Zealand, Australia, Thailand, South Korea, Hong Kong SAR, and China.

StephenW

VBI疫苗和Brii Biosciences发起了慢性乙型肝炎感染患者的BRII-179（VBI-2601）1b / 2a期研究
美国商业资讯


十一月14，2019
美国东部标准时间上午8:00

–新型的基于蛋白质的重组免疫疗法，用于治疗慢性乙型肝炎病毒（HBV）感染

–分为两部分的剂量递增研究预计将招募多达65位患者

–预计将于2020年下半年发布初始数据

马萨诸塞州剑桥和北卡罗来纳州北卡罗来纳州— VBI疫苗（纳斯达克股票代码：VBIV）（“ VBI”）是一家商业级生物制药公司，致力于开发下一代传染病和免疫肿瘤疫苗以及Brii Biosciences（“ Brii Bio” ）是一家致力于在中国乃至世界范围内满足患者需求并改善公共健康的临床阶段公司，今天宣布其第一位患者接受了BRII-179（VBI-2601）1b / 2a期概念验证研究一种新型的基于蛋白质的重组重组免疫治疗候选药物，正在开发中，用于治疗慢性乙型肝炎病毒（HBV）感染。

VBI总裁兼首席执行官Jeff Baxter说：“长期以来，慢性HBV被认为是最具挑战性的病毒感染治疗方法，因为它一旦进入肝脏，生命周期就会复杂。” “科学界越来越多地达成共识，认为有可能治愈HBV，并且需要恢复HBV免疫力以确保机体控制病毒感染的能力。我们相信BRII-179（VBI-2601）具有可能成为HBV功能性治疗的关键和差异化组成部分。”

Brii Bio的共同创始人兼首席执行官Zhi Hong博士说：“通过功能性治疗减轻HBV的疾病负担将对世界各地的个人和社会产生变革。” “我们和VBI的同事们很高兴宣布BRII-179（VBI-2601）的这项临床研究已经开始，因为我们正在努力解决这一未得到满足的需求，我们期待与大家分享最初的人类证据- 2020年下半年这项研究得出的概念结果。”

BRII-179（VBI-2601）的独特配方可通过多种作用机制同时针对B细胞和T细胞免疫，包括中和循环中的乙型肝炎病毒，阻断由Pre-S1介导的肝细胞的乙型肝炎感染，以及乙肝病毒感染的肝细胞的免疫介导清除。在转录下游受感染的肝细胞内部有许多研究药物起作用的地方，设计了BRII-179（VBI-2601）以影响HBV生命周期中的关键细胞外步骤，以恢复对感染的免疫控制。

BRII-179（VBI-2601）的1b / 2a期临床研究是一项随机对照研究，旨在评估BRII-179（VBI-2601）在慢性HBV感染患者中的安全性，耐受性和抗病毒活性。该研究被设计为分为两部分的剂量递增研究，评估BRII-179（VBI-2601）的不同剂量水平，预计可招募65位患者。

预计2020年下半年将获得1b / 2a期临床研究的初步人类概念验证数据。

这项研究由Brii Bio赞助，并将在新西兰，澳大利亚，泰国，韩国，香港特别行政区和中国的多个研究地点进行。