VBI Vaccines 宣布加拿大卫生部批准 PreHevbrio™ 用于预防成人乙

StephenW

VBI Vaccines 宣布加拿大卫生部批准 PreHevbrio™ 用于预防成人乙型肝炎

2022 年 12 月 8 日 | 新闻稿

VBI Vaccines Inc.（纳斯达克股票代码：VBIV）(VBI) 是一家受免疫学驱动，追求强大的疾病预防和治疗能力的生物制药公司，今天宣布加拿大卫生部已批准 PreHevbrio™ [3 抗原乙型肝炎疫苗（重组）] 用于针对 18 岁及以上成年人的所有已知乙型肝炎 (HBV) 病毒亚型引起的感染进行主动免疫。 可以预期丁型肝炎也可以通过 PreHevbrio 免疫接种来预防，因为丁型肝炎（由 δ 因子引起）在没有乙型肝炎感染的情况下不会发生。

“我们很高兴地宣布加拿大卫生部的批准，这是该疫苗的第四次监管批准，这是我们努力提供广泛使用我们的 3 抗原乙型肝炎疫苗的又一有意义的成就，”VBI 总裁兼首席执行官 Jeff Baxter 说。 首席执行官。 “正如我们多次说过的那样，我们相信 PreHevbrio 有可能成为一种有意义的差异化工具，可以帮助医疗保健提供者在根除乙型肝炎的斗争中发挥作用，我们期待着支持加拿大的公共卫生倡议，以 促进这一点。”

该批准基于新药提交 (NDS) 中的临床数据，该数据强调了两项关键、随机、双盲、对照的 3 期临床研究 PROTECT 和 CONSTANT 的积极结果。 这些研究的数据分别发表在 2021 年 5 月的《柳叶刀传染病》和 2021 年 10 月的《美国医学协会网络期刊》上。这两项研究都将 PreHevbrio 与单抗原 HBV 疫苗 Engerix-B 进行了比较。 PROTECT 研究的结果表明，PreHevbrio 在所有 18 岁以上的受试者中引起了更高的血清保护率（91.4% 对 76.5%），包括 45 岁以上的成年人（89.4% 对 73.1%）。 PROTECT 研究结果还表明，PreHevbrio 在糖尿病患者（83.3% 对 58.3%）以及体重指数 (BMI) 超过 30 的患者（89.22% 对 68.11%）中诱导了更高的血清保护率。 两项研究的综合安全性分析表明具有良好的耐受性，没有意外的反应原性。 所有年龄组中最常见的不良事件是注射部位疼痛和压痛、肌痛和疲劳，所有这些通常在 1-2 天内无需干预即可解决。

关于 PreHevbrio™

VBI 的乙肝疫苗是唯一的三抗原乙肝疫苗，由乙肝病毒的三种乙肝表面抗原——S、pre-S1 和 pre-S2 组成。 它获准在加拿大、美国、欧盟/欧洲经济区、英国和以色列使用。 该疫苗的品牌名称是：PreHevbrio™（美国、加拿大）、PreHevbri™（欧盟/欧洲经济区、英国）和 Sci-B-Vac®（以色列）。

完整的产品专论，包括加拿大 PreHevbrio 的患者用药信息，将在加拿大政府的药品数据库中提供。



关于 VBI 疫苗公司。
VBI Vaccines Inc. (“VBI”) 是一家受免疫学驱动的生物制药公司，致力于有效预防和治疗疾病。 通过其对病毒样颗粒（“VLP”）的创新方法，包括专有的包膜 VLP（“eVLP”）平台技术，VBI 开发了模仿病毒自然呈现的候选疫苗，旨在激发人类免疫的先天力量 系统。 VBI 致力于针对和克服重大传染病，包括乙型肝炎、冠状病毒和巨细胞病毒 (CMV)，以及包括胶质母细胞瘤 (GBM) 在内的侵袭性癌症。 VBI 总部位于马萨诸塞州剑桥市，在加拿大渥太华设有研究机构，在以色列雷霍沃特设有研究和制造基地。

联系方式
妮可安德森
企业传讯及投资者关系总监
电话：(617) 830-3031 x124
电子邮件：[email protected]

StephenW

VBI Vaccines Announces Health Canada Approval for PreHevbrio™ for the Prevention of Hepatitis B in Adults

December 8, 2022 | Press Releases

VBI Vaccines Inc. (Nasdaq: VBIV) (VBI), a biopharmaceutical company driven by immunology in the pursuit of powerful prevention and treatment of disease, today announced that Health Canada has approved PreHevbrio™ [3-antigen Hepatitis B Vaccine (Recombinant)] for active immunization against infection caused by all known subtypes of hepatitis B (HBV) virus in adults 18 years of age and older. It can be expected that hepatitis D will also be prevented by immunization with PreHevbrio as hepatitis D (caused by the delta agent) does not occur in the absence of hepatitis B infection.

“We are excited to announce Health Canada’s approval, a fourth regulatory approval for this vaccine, and an achievement that is another meaningful step in our effort to provide broad access to our 3-antigen hepatitis B vaccine,” said Jeff Baxter, VBI’s President and CEO.  “As we’ve said many times, we believe PreHevbrio has the potential to be a meaningful and differentiated tool that can help healthcare providers make a difference in the fight to eradicate hepatitis B, and we look forward to supporting public health initiatives in Canada to facilitate this.”

The approval was based on clinical data in the new drug submission (NDS), which highlighted the positive results from two pivotal, randomized, double-blind, controlled Phase 3 clinical studies, PROTECT and CONSTANT. Data from these studies were published, respectively, in The Lancet Infectious Diseases in May 2021 and The Journal of the American Medical Association Network Open in October 2021. Both studies compared PreHevbrio to Engerix-B, a single-antigen HBV vaccine. Results from the PROTECT study showed that PreHevbrio elicited higher rates of seroprotection in all subjects age 18+ (91.4% vs. 76.5%), including in adults age 45+ (89.4% vs. 73.1%). The PROTECT study results also showed that PreHevbrio induced higher rates of seroprotection in subjects with diabetes (83.3% vs. 58.3%) as well as in subjects with body mass index (BMI) over 30 (89.22% vs. 68.11%). The integrated safety analysis of both studies demonstrated good tolerability with no unexpected reactogenicity. The most common adverse events in all age groups were injection site pain and tenderness, myalgia, and fatigue, all which generally resolved without intervention in 1-2 days.

About PreHevbrio™

VBI’s hepatitis B vaccine is the only 3-antigen hepatitis B vaccine, comprised of the three hepatitis B surface antigens of the hepatitis B virus – S, pre-S1, and pre-S2. It is approved for use in Canada, the United States, European Union/European Economic Area, United Kingdom, and Israel. The brand names for this vaccine are: PreHevbrio™ (US, Canada), PreHevbri™ (EU/EEA, UK), and Sci-B-Vac® (Israel).

The full product monograph including patient medication information for PreHevbrio in Canada will be made available on the Government of Canada's Drug Product Database.

 

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.

VBI Contact
Nicole Anderson
Director, Corporate Communications & IR
Phone: (617) 830-3031 x124
Email: [email protected]