Arbutus在2017ICAR上发表多个在研乙肝新药联合用药研究结果

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Arbutus Presents HBV Drug Combination Studies at ICAR
GlobeNewswire•May 22, 2017
Combinations of Arbutus’ RNAi or Capsid Assets with Approved Drugs Demonstrate Complementary Activity
Dr. Michael J. Sofia, Arbutus’ Chief Scientific Officer, Awarded International Society of Antiviral Research Gertrude Elion Award
VANCOUVER, British Columbia and WARMINSTER, Pa., May 22, 2017 (GLOBE NEWSWIRE) -- Arbutus Biopharma Corporation (ABUS), an industry-leading Hepatitis B Virus (HBV) therapeutic solutions company, today presented results from preclinical studies of HBV drugs in three presentations at the 30th International Conference on Antiviral Research (ICAR) held on May 21-25, 2017 in Atlanta, GA. These presentations feature preclinical data from multiple Arbutus pipeline programs that highlight the potential of Arbutus' therapeutic candidates to impair HBV viral functions and demonstrate additive to synergistic activity when combining Arbutus assets with approved HBV therapies.

Arbutus ICAR Presentations
“Systematic In Vitro Evaluation of Current and Experimental Hepatitis B Therapeutics:
Potential Utility for Combinations Exploiting Multiple and Diverse Mechanisms of Action” by Andrea Cuconati, Director of Virology
In preclinical studies, multiple clinical and preclinical Arbutus direct acting antiviral agents tested in combination with nucleoside/nucleotide analogues (NAs) or interferon α-2a (IFN) standard of care therapeutics resulted in either additive or synergistic effects, suppressing multiple elements of HBV including HBsAg, HBeAg and HBV DNA. The results confirm the utility of Arbutus’ agents in clinical combinations with standard of care.  Arbutus RNAi agents ARB-1467 and ARB-1740 are currently in Phase II clinical testing in chronic HBV patients and AB-423, a capsid assembly inhibitor, is in Phase I.
“Activation of STING Mediates Antiviral Effects in a Mouse Model of Chronic Hepatitis B” by Emily Thi, Principal Scientist, In Vivo Pharmacology and Macro-Molecular Discovery
In preclinical studies, STING activation results in control of HBV. Repeated STING activation yielded cumulative reductions in HBV DNA and HBcAg across a 7-day course of study. Type I IFN and cytokine induction may activate innate immune cells and T cell priming to potentially break HBV immune tolerance. These findings provide proof of concept that targeting STING in chronic HBV infection may contribute to viral control and complement the immune modulatory programs underway at Arbutus.
“Viral Hepatitis – The Search for a Cure” by Dr. Mike Sofia, Chief Scientific Officer            
An introduction to the HBV landscape and an overview of the potential new therapies that may overcome the challenge of persistent chronic HBV infection and achieve a functional cure.
Highlights from the Studies Presented:
Our clinical assets ARB-1740, AB-423 and preclinical assets ARB-880, ARB-1820 and ARB-168786, when used in combination with the 'NA and IFN’ standard of care, demonstrate at least additive, and in some cases synergistic, anti-HBV activity.
Preclinical capsid assembly inhibitors ARB-880, ARB-1820 and ARB-168786 show potent and highly selective inhibition of HBV replication. Arbutus expects to nominate a 2nd generation capsid assembly development candidate this year.
These results continue to support Arbutus' combination strategy to develop an HBV cure.            
These presentations can be accessed by visiting the Investor section of www.arbutusbio.com and selecting Events and Presentations.
In conjunction with ICAR, Dr. Michael J. Sofia, Arbutus’ Chief Scientific Officer has been awarded the International Society of Antiviral Research (ISAR) Gertrude Elion Award for his outstanding contributions to the antiviral field through his development of a landmark hepatitis C virus (HCV) treatment.
“It is a great honor to receive the ISAR Gertrude Elion Award for my work that led to the discovery of sofosbuvir, which is the backbone of the curative standard of care for HCV. Arbutus is following a similar pathway by developing multiple therapeutic agents to achieve a cure for chronic HBV,” said Dr. Sofia. “We are pleased to be presenting more encouraging data from our preclinical drug combination studies that support the utility of our proprietary HBV candidates in combination with the current standard of care. We continue to employ a range of HBV models to examine the potential use and mechanistic complementarity of our HBV agents in these combination regimens. Arbutus has built a robust pipeline of HBV product candidates to support this strategy.”
About Arbutus
Arbutus Biopharma Corporation is a biopharmaceutical company dedicated to discovering, developing and commercializing a cure for patients suffering from chronic HBV infection. Arbutus is headquartered in Vancouver, BC, and has facilities in Warminster, PA. For more information, visit www.arbutusbio.com.
Forward-Looking Statements and Information
This press release contains forward-looking statements within the meaning of the Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, and forward looking information within the meaning of Canadian securities laws (collectively, “forward-looking statements”). Forward-looking statements in this press release include statements about the potential of Arbutus' therapeutic candidates to impair HBV viral functions; targeting STING in chronic HBV infection contributing to viral control and complementing the immune modulatory programs underway at Arbutus; nominating a 2nd generation capsid assembly development candidate this year; and discovering, developing and commercializing a cure for patients suffering from chronic HBV infection.
With respect to the forward-looking statements contained in this press release, Arbutus has made numerous assumptions regarding, among other things: the effectiveness and timeliness of clinical trials, and the usefulness of the data; the continued demand for Arbutus’ assets; and the stability of economic and market conditions. While Arbutus considers these assumptions to be reasonable, these assumptions are inherently subject to significant business, economic, competitive, market and social uncertainties and contingencies.
Additionally, there are known and unknown risk factors which could cause Arbutus' actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements contained herein. Known risk factors include, among others: anticipated clinical trials may be more costly or take longer to complete than anticipated, and may never be initiated or completed, or may not generate results that warrant future development of the tested drug candidate; Arbutus may not receive the necessary regulatory approvals for the clinical development of Arbutus' products; economic and market conditions may worsen; and market shifts may require a change in strategic focus.
A more complete discussion of the risks and uncertainties facing Arbutus appears in Arbutus' Annual Report on Form 10-K and Arbutus' continuous disclosure filings, which are available at www.sedar.com and at www.sec.gov. All forward-looking statements herein are qualified in their entirety by this cautionary statement, and Arbutus disclaims any obligation to revise or update any such forward-looking statements or to publicly announce the result of any revisions to any of the forward-looking statements contained herein to reflect future results, events or developments, except as required by law.

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Arbutus在2017ICAR上发表多个在研乙肝新药联合用药研究结果
来源：肝脏巴士（HeparBus）微信时间：2017-05-23



业界领先的慢乙肝治疗解决方案公司 Arbutus 近日宣布，公司在2017年5月21日至25日在美国佐治亚州亚特兰大举办的第30届国际抗病毒研究会议(ICAR)上发表了3项关于慢乙肝在研新药的临床前研究结果。这些发布的临床前数据结果是来自多个 Arbutus 管道项目，凸显了 Arbutus 的治疗候选物在损伤HBV病毒功能方面的潜力，并且在将 Arbutus 的产品与经批准的HBV治疗药物联合应用时表现出叠加和协同作用。

Arbutus 在此次ICAR上发表的三份研究摘要分别为

1.Systematic In Vitro Evaluation of Current and Experimental Hepatitis B Therapeuticsotential Utility for Combinations Exploiting Multiple and Diverse Mechanisms of Action

在多个临床前研究中，Arbutus 的直接作用抗病毒药物在联合核苷（酸）类似物或聚乙二醇干扰素α-2a 使用的多个临床前和临床研究中表现出了叠加的和协同的作用，抑制了HBV 病毒的多个成分，包括 HBsAg, HBeAg 和 HBV DNA。这些结果证实了 Arbutus 的药物在联合目前标准抗病毒药物时的有效性。Arbutus 的 RNAi药物 ARB-1467 和 ARB-1740目前正在慢乙肝患者中进行 Phase II 期临床测试，而衣壳组装抑制剂 AB-423 目前也在进行 Phase I期临床。

2.Activation of STING Mediates Antiviral Effects in a Mouse Model of Chronic Hepatitis B

在多个临床前研究中，干扰素基因刺激蛋白(STING)的激活可以导致HBV受到控制。反复的干扰素基因刺激蛋白(STING)激活在7天的疗程中使得 HBV DNA 和 HBcAg 出现累积降低。I型IFN和细胞因子诱导可激活先天性免疫细胞和T细胞进而潜在地引发打破HBV免疫耐受。 这些发现提供了概念验证，在慢性HBV感染中靶向STING可能有助于病毒控制和对 Arbutus 正在进行的免疫调节项目进行补充。

3.Viral Hepatitis — The Search for a Cure

这份摘要主要是介绍 HBV 前景，以及可能克服持续性慢性HBV感染的挑战并实现功能治愈的潜在新疗法的概述。

发表研究的重点内容：

1.Arbutus 正在临床研究的药物 ARB-1740, AB-423 以及在做临床前研究的药物 ARB-880, ARB-1820 和 ARB-168786 在跟标准的药物核苷（酸）类似物和IFN联合应用时，至少表现出叠加，有些甚至表现出协同的抗HBV 活性。

2. 处于临床前研究阶段的衣壳组装抑制剂  ARB-880, ARB-1820 和 ARB-168786 表现出强力和高选择性的抑制HBV复制。Arbutus 希望在今年提起第二代衣壳组装抑制剂的研发工作。

3.这些研究结果继续支持 Arbutus 在治愈HBV感染上的联合用药战略。

与ICAR一同，Michael J. Sofia 博士，Arbutus 的首席科学家因为开发出了一种具有里程碑意义的抗丙型肝炎病毒药物，为表彰其在抗病毒领域做出的杰出贡献，国际抗病毒研究学会（ISAR）决定授予其 Gertrude Elion 奖。

“获得ISAR授予的 Gertrude Elion 奖是非常荣幸的，因为我在工作中对索菲布韦（sofosbuvir）（索菲布韦是目前标准的治愈HCV感染的支柱）的发现。Arbutus 正在紧随着相似的途径通过研发多种治疗方案以期实现HBV感染的治愈，”Sofia 博士说道。“我们非常乐意发表更多的具有鼓励性的数据，从我们的临床前药物联合研究中，这些将对我们专有的 HBV 候选产品在跟现有标准的药物联合应用时的有效性形成支撑。我们继续使用一系列HBV模型来检查这些联合方案中我们HBV药物的潜在用途和机制互补性。Arbutus 已经建立了一个强大的HBV候选产品管道来支持这一策略。”

kite2002005

这个博士伟大，提供银行账号，只要能治好我的乙肝，说个数 乙肝最好也许也是联合疗法

齐欢畅2

马克