吉利德和维尔生物技术公司建立临床合作伙伴关系，以探索

StephenW

Gilead and Vir Biotechnology Establish Clinical Collaboration to Explore Combination Strategies for Functional Cure for Chronic Hepatitis B Virus
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January 12, 2021 08:00 ET | Source: Vir Biotechnology, Inc.

– First Phase 2 clinical trial to combine immunomodulation and antigen suppression approaches in HBV cure research –

FOSTER CITY, Calif. and SAN FRANCISCO, Jan. 12, 2021 (GLOBE NEWSWIRE) -- Gilead Sciences, Inc. (NASDAQ: GILD) and Vir Biotechnology, Inc. (NASDAQ: VIR) today announced that the companies have entered into a clinical collaboration to evaluate novel therapeutic combination strategies aimed at developing a functional cure for chronic hepatitis B virus (HBV).

The companies plan to initiate a Phase 2 trial evaluating combination therapy for both treatment-experienced and treatment-naïve people living with HBV. The multi-arm trial will evaluate different combinations of selgantolimod, Gilead’s investigational TLR-8 agonist; VIR-2218, Vir’s investigational small interfering ribonucleic acid (siRNA); and a commercially-sourced, marketed PD-1 antagonist. People in the trial with HBV treatment experience may also receive Gilead’s Vemlidy® (tenofovir alafenamide fumarate, TAF). The primary outcome of the study will be the proportion of patients achieving a functional cure, defined as an off-therapy loss of hepatitis B surface antigen (HBsAg) and HBV DNA from the serum.

Both companies retain full rights to their individual product candidates and will discuss the potential path forward for any future combination studies based on the outcome of the Phase 2 trial.

“Gilead has a two-decade commitment to people with hepatitis B and we have worked tirelessly to bring new treatments forward with the goal of helping to improve their lives,” said Anuj Gaggar, vice president, Clinical Research, Virology at Gilead Sciences. “We believe that selgantolimod and VIR-2218 have the potential to be best-in-class therapeutics and could provide a compelling new combination approach to a functional cure for HBV.”

“We are enthusiastic about this collaboration,” said Phil Pang, M.D., Ph.D., chief medical officer of Vir Biotechnology. “We believe a functional cure for the majority of patients will require a reduction of the levels of circulating viral proteins together with an immune boost to stimulate the production of new T-cells that can bring the infection under control. We believe that this collaboration with Gilead adds a novel and significant new combination to our efforts to find a cure for HBV.”

HBV affects more than 290 million people worldwide. Globally, HBV is a leading cause of liver cancer and each year it is estimated that more than 800,000 people die of HBV-related liver disease. While current antiviral therapies result in sustained HBV viral suppression, they rarely completely clear the virus and therefore people with HBV require lifelong therapy.

The safety and efficacy of selgantolimod and VIR-2218 have not been established. They are investigational compounds, not approved by the U.S. Food and Drug Administration (FDA) or any other regulatory authority.

StephenW

吉利德和维尔生物技术公司建立临床合作伙伴关系，以探索联合治疗慢性乙型肝炎病毒的策略
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美国东部时间2021年1月12日08:00 |资料来源：Vir Biotechnology，Inc.。

–结合免疫调节和抗原抑制方法进行HBV治愈研究的第2期临床试验–

2021年1月12日（加利福尼亚州福斯特市和旧金山）-吉利德科学公司（纳斯达克股票代码：GILD）和维尔生物技术有限公司（纳斯达克股票代码：VIR）今天宣布，两家公司已达成临床合作以评估旨在开发功能性治愈慢性乙型肝炎病毒（HBV）的新型治疗组合策略。

该公司计划启动一项针对治疗经验丰富和未接受过治疗的HBV患者联合治疗的2期临床试验。这项多臂试验将评估吉利德研究性TLR-8激动剂selgantolimod的不同组合； VIR-2218，Vir研究中的小型干扰核糖核酸（siRNA）；以及市售的PD-1拮抗剂。具有HBV治疗经验的试验人员也可能会使用吉利德的Vemlidy®（替诺福韦alafenamide富马酸酯，TAF）。该研究的主要结果将是达到功能治愈的患者比例，该功能治愈定义为血清中乙型肝炎表面抗原（HBsAg）和HBV DNA的治疗后损失。

两家公司均保留各自候选产品的全部权利，并将根据第二阶段试验的结果讨论未来任何组合研究的潜在途径。

Gilead Sciences病毒学临床研究副总裁Anuj Gaggar表示：“吉列德（Gilead）对乙型肝炎患者有两个十年的承诺，我们一直在不懈地努力，以期提出新疗法，以帮助改善他们的生活。 “我们认为，selgantolimod和VIR-2218有可能成为同类最佳疗法，并可能为功能性治疗HBV提供令人信服的新组合方法。”

“我们对这项合​​作充满热情，” Vir Biotechnology首席医学官医学博士Ph。Pang说。 “我们认为，对大多数患者进行功能性治疗将需要降低循环病毒蛋白的水平，并增强免疫力，以刺激新的T细胞的产生，从而使感染得到控制。”我们相信与Gilead的合作为我们寻找HBV的方法增添了新颖而重要的新组合。”

HBV影响全球超过2.9亿人。在全球范围内，HBV是导致肝癌的主要原因，据估计，每年有80万人死于HBV相关的肝病。尽管目前的抗病毒疗法可导致持续的HBV病毒抑制，但它们很少能完全清除病毒，因此HBV患者需要终生治疗。

尚未确定selgantolimod和VIR-2218的安全性和有效性。它们是研究性化合物，未经美国食品药品监督管理局（FDA）或任何其他监管机构的批准。

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