VBI疫苗宣布了1b / 2a期数据和乙肝免疫治疗候选人的进展

StephenW

VBI Vaccines Announces Phase 1b/2a Data and Progress of Hepatitis B Immunotherapeutic Candidate

    Apr 12, 2021 Updated 15 hrs ago

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Apr 12, 2021--

VBI Vaccines Inc. ( Nasdaq: VBIV ) (VBI), a biopharmaceutical company driven by immunology in the pursuit of powerful prevention and treatment of disease, today announced data and next steps from the high-dose cohort of its Phase 1b/2a clinical study of VBI-2601 (BRII-179), the company’s hepatitis B immunotherapeutic candidate, in chronically-infected hepatitis B patients. VBI-2601 (BRII-179) is being developed in collaboration with Brii Biosciences (Brii Bio) as part of a potential functional cure for chronic hepatitis B virus (HBV) infection.

The Phase 1b/2a is a randomized, controlled study designed to assess the safety, tolerability, antiviral and immunologic activity of VBI-2601 (BRII-179) in 46 non-cirrhotic patients with chronic HBV infection on nucleos(t)ide analogue (NUC) therapy. The study is a two-part study to evaluate four doses of VBI-2601 (BRII-179), at either a low (20 µg) or high (40 µg) dose, with and without co-administration of interferon-alpha (IFN-α).

Data to-date from 33 evaluable patients across all study arms suggest:

    VBI-2601 (BRII-179) was well-tolerated at all dose levels with and without IFN-α, with no significant adverse events identified
    Restimulation of T cell immune responses to HBV surface antigens, including S, Pre-S1, and Pre-S2, in ≥ 50% (range: 50% - 78%) of evaluable patients from all VBI-2601 (BRII-179) cohorts – compared to no detectable response in the control, NUC-only arm
    The T cell responses and antibody responses were comparable across the 20µg and 40µg unadjuvanted study arms
    T cell response rates between the adjuvanted and unadjuvanted cohorts were also comparable

VBI and Brii are targeting the presentation of the complete Phase 1b/2a dataset at a scientific conference later in 2021.

Based on the acceptable safety profile and vaccine-induced adaptive immune responses observed to-date, the high dose of VBI-2601 (BRII-179), both with and without IFN-α, was selected to progress into a Phase 2 combination study of VBI-2601 (BRII-179) and BRII-835 (VIR-2218), a novel small interfering ribonucleic acid (siRNA) therapeutic candidate designed to inhibit expression of HBV proteins. Patient screening for the study initiated in March 2021 in New Zealand, and Brii Bio expects to initiate the study in China, Hong Kong, Australia, Taiwan, Singapore, Thailand, and South Korea in the second and third quarter of 2021.

About Hepatitis B

Hepatitis B is one of the world’s most significant infectious disease threats with more than 290 million people infected globally. HBV infection is the leading cause of liver disease and, with current treatments, it is very difficult to cure, with many patients going on to develop liver cancers. An estimated 900,000 people die each year from complications of chronic HBV such as liver decompensation, cirrhosis, and hepatocellular carcinoma.

About VBI-2601 (BRII-179)

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.

StephenW

VBI疫苗宣布了1b / 2a期数据和乙肝免疫治疗候选人的进展

    2021年4月12日，更新15小时前

马萨诸塞州剑桥市-（美国商业资讯）-2021年4月12日-

免疫学驱动的生物制药公司VBI Vaccines Inc.（Nasdaq：VBIV）（VBI）致力于疾病的有力预防和治疗，今天宣布其1b / 2a期临床研究大剂量研究的数据和下一步措施VBI-2601（BRII-179）是该公司的乙型肝炎免疫治疗候选药物，适用于慢性感染的乙型肝炎患者。正在与Brii Biosciences（Brii Bio）合作开发VBI-2601（BRII-179），作为慢性乙型肝炎病毒（HBV）感染的潜在功能疗法的一部分。

1b / 2a期是一项随机，对照研究，旨在评估VBI-2601（BRII-179）在46例经核苷酸（t）ide类似物慢性HBV感染的非肝硬化患者中的安全性，耐受性，抗病毒和免疫活性（ NUC）治疗。这项研究分为两部分，旨在评估低剂量（20 µg）或高剂量（40 µg）的四种剂量的VBI-2601（BRII-179），是否同时使用干扰素-α（IFN） -α）。

迄今为止，来自所有研究部门的33名可评估患者的数据表明：

    在有和没有IFN-α的所有剂量水平下，VBI-2601（BRII-179）都具有良好的耐受性，未发现明显的不良事件
    所有VBI-2601（BRII-179）队列中≥50％（可评估范围：50％-78％）的患者中，对T细胞对HBV表面抗原（包括S，Pre-S1和Pre-S2）的免疫反应进行重新刺激–与对照组中仅NUC的对照组中没有可检测到的反应相比
    在20µg和40µg非佐剂研究组中，T细胞反应和抗体反应相当
    佐剂组和非佐剂组之间的T细胞反应率也相当

VBI和Brii的目标是在2021年下半年的一次科学会议上展示完整的1b / 2a期数据集。

基于可接受的安全性和迄今为止观察到的疫苗诱导的适应性免疫反应，选择了高剂量的VBI-2601（BRII-179），无论有无IFN-α，均已进入2期联合研究VBI-2601（BRII-179）和BRII-835（VIR-2218），一种新型的小干扰核糖核酸（siRNA）治疗候选药物，旨在抑制HBV蛋白的表达。该研究的患者筛查于2021年3月在新西兰开始，Brii Bio预计将于2021年第二和第三季度在中国，香港，澳大利亚，台湾，新加坡，泰国和韩国开始该研究。

关于乙型肝炎

乙型肝炎是世界上最重大的传染病威胁之一，全球感染人数超过2.9亿。 HBV感染是肝病的主要原因，目前的治疗方法很难治愈，许多患者都在继续发展肝癌。每年估计有90万人死于慢性HBV并发症，例如肝脏代偿失调，肝硬化和肝细胞癌。

关于VBI-2601（BRII-179）

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治疗方法的一部分。