New investment of approximately $50 million from Biomedical Advanced Research and Development Authorityincludes $40 million in Project NextGen funds

来自生物医学高级研究和开发机构的约5000万美元新投资包括NextGen项目基金4000万美元

Contract expands existing support for the development of candidates for prevention and treatment of pathogens of pandemic potential

合同扩大了对开发预防和治疗具有大流行潜力的病原体候选人的现有支持

SAN FRANCISCO, Oct. 03, 2023 (GLOBE NEWSWIRE) -- Vir Biotechnology, Inc. (Nasdaq: VIR) today announced that the Biomedical Advanced Research and Development Authority (BARDA), part of the U.S. Department of Health and Human Services’ (HHS) Administration for Strategic Preparedness and Response (ASPR), has awarded Vir approximately $50 million in new funding to advance the development of novel monoclonal antibody (mAb) candidates and delivery solutions to widen the applicability of mAbs in COVID-19 and in pandemic preparedness and response..

2023年10月3日，旧金山（GLOBE NEWSWIRE）-Vir Biotechnology，Inc。（纳斯达克股票代码：Vir）今天宣布，生物医学高级研究与发展局（BARDA）是美国卫生与公众服务部（HHS）战略准备与响应管理局（ASPR）的一部分，已经为Vir提供了大约5000万美元的新资金，用于推进新型单克隆抗体（mAb）候选物和递送解决方案的开发，以扩大单克隆抗体在COVID-19和大流行防范和应对中的适用性。。

“We are honored to continue to collaborate with the U.S. government as we leverage our world-class antibody platform with the hope of generating powerful new medicines to protect our communities from global infectious disease threats, including pathogens with pandemic potential,” said Marianne De Backer, M.Sc., Ph.D., MBA, Vir’s Chief Executive Officer.

“我们很荣幸继续与美国政府合作，因为我们利用我们的世界级抗体平台，希望能够产生强大的新药来保护我们的社区免受全球传染病威胁，包括具有大流行潜力的病原体，”Marianne De Backer，M.Sc.，Ph.D.，MBA，Vir首席执行官说。

“We are grateful to the U.S. government for its continued support of our innovative technological approaches in mAb research and development as we seek to optimize mAb delivery. We look forward to starting this with VIR-7229, a next-generation COVID-19 mAb that has been shown in preclinical studies to have high potency against historical and currently circulating variants, and that has the potential to be the best in class.”.

“我们感谢美国政府在寻求优化单克隆抗体递送时继续支持我们在单克隆抗体研究和开发方面的创新技术方法。我们期待着从VIR-7229开始，VIR-7229是一种新一代COVID-19单克隆抗体，已在临床前研究中显示出对历史和当前流行的变体具有高效力，并且具有潜力是班上最好的。”。

The new funding will support research and development of novel alternative mAb delivery technologies that have the potential to revolutionize mAb delivery by increasing expression relative to existing technologies. Such delivery could widen the breadth of administration options and shorten development and manufacturing timelines..

新资金将支持新型替代mAb递送技术的研究和开发，这些技术有可能通过增加相对于现有技术的表达来彻底改变mAb递送。这种交付可以拓宽管理选择的范围，缩短开发和制造时间表。。

$40 million of the total funds is part of ‘Project NextGen,’ an initiative by the HHS to advance a pipeline of new, innovative vaccines and therapeutics for COVID-19 and will support the development of VIR-7229 through Phase 1 in the context of developing alternative mAb delivery technologies. The Phase 1 trial is expected to be completed in the second half of 2025.

总资金的4000万美元是“Project NextGen”的一部分，“Project NextGen”是HHS为COVID-19推进新的创新疫苗和治疗方案的倡议，将支持VIR-7229在第一阶段的发展。开发替代mAb递送技术的背景。第一阶段试验预计将于2025年下半年完成。

$10 million of the total funds falls under support from the Division of Chemical, Biological, Radiological and Nuclear (CBRN) medical countermeasures of BARDA which will support the discovery of new mAbs against a second pathogen of pandemic potential in the context of further advancing alternative mAb delivery technologies..

总资金中有1000万美元得到了巴达化学，生物，放射性和核（CBRN）医疗对策司的支持，该司将支持在进一步推进替代方案的背景下发现针对大流行潜力的第二种病原体的新单克隆抗体。单克隆抗体递送技术。。

The new investment falls under Vir’s existing Other Transaction Authority (OTA), a multi-year contract BARDA awarded Vir in 2022. This OTA allows for a potential total investment of up to $1 billion to support Vir’s development of future pandemic influenza mAbs as well as the potential development of up to 10 emerging infectious disease or CBRN medical countermeasure candidates.

新投资属于Vir现有的其他交易管理局（OTA），这是一项在2022年授予Vir的多年合同BARDA。该OTA允许潜在的总投资高达10亿美元，以支持Vir开发未来的大流行性流感单克隆抗体，以及潜在开发多达10种新出现的传染病或CBRN医疗对策候选人。

The balance of the potential funding is subject to BARDA exercising up to 12 options in further support of the development of pre-exposure prophylactic antibodies for the prevention of influenza illness or supporting medical countermeasures for other pathogens of pandemic potential..

潜在资金的平衡取决于BARDA行使多达12种选择，以进一步支持开发用于预防流感疾病的暴露前预防性抗体或支持其他具有大流行潜力的病原体的医疗对策。。

Vir is also receiving approximately $11 million in additional BARDA funding that will be applied to wind down activities for the BARDA-supported Phase 2 PENINSULA trial evaluating the investigational prophylactic mAb VIR-2482 for the prevention of symptomatic influenza A illness.

Vir还将获得大约1100万美元的额外BARDA资金，用于BARDA支持的2期PENINSULA试验的结束活动，评估用于预防症状性甲型流感的研究性预防性mAb Vir-2482。

These programs have been funded in whole or in part with federal funds from the Department of Health and Human Services; Administration for Strategic Preparedness and Response (ASPR); Biomedical Advanced Research and Development Authority (BARDA), under OT number: 75A50122C00081.

这些计划全部或部分由卫生和人类服务部的联邦资金资助；战略准备和响应管理（ASPR）；生物医学高级研究与发展局（BARDA），编号：75A50122C00081。

About VIR-7229

关于VIR-7229

VIR-7229 is a potent preclinical monoclonal antibody that has shown the ability to broadly neutralize COVID-19 variants in vitro. VIR-7229 is designed as a prophylactic for COVID-19 and was identified using Vir’s proprietary mAb discovery platform. VIR-7229 incorporates Xencor, Inc.’s Xtend™️ technology and is affinity matured using machine learning to increase its effectiveness in binding to SARS-CoV and SARS-CoV-2 variants..

VIR-7229是一种有效的临床前单克隆抗体，已显示出在体外广泛中和COVID-19变体的能力。VIR-7229被设计为COVID-19的预防剂，并使用VIR专有的mAb发现平台进行鉴定。VIR-7229合并了Xencor，Inc.的Xtend™️ 技术，并使用机器学习进行亲和力成熟，以提高其与SARS-CoV和SARS-CoV-2变体结合的有效性。。

About VIR-2482

关于VIR-2482

VIR-2482 is an investigational hemagglutinin targeting, intramuscularly administered influenza A-neutralizing monoclonal antibody. In vitro, it has been shown to cover all major strains of influenza A that have arisen since the 1918 flu pandemic. VIR-2482 is designed as a prophylactic for influenza A.

VIR-2482是研究性血凝素靶向，肌内施用的甲型流感中和单克隆抗体。在体外，已显示涵盖自1918年流感大流行以来出现的所有主要甲型流感病毒株。VIR-2482被设计为甲型流感的预防剂。

VIR-2482 incorporates Xencor’s Xtend™ and was identified using Vir’s proprietary mAb discovery platform..

VIR-2482结合了Xencor的Xtend™ 并使用Vir专有的mAb发现平台进行识别。。

About Vir Biotechnology

关于Vir生物技术

Vir Biotechnology, Inc. is an immunology company focused on combining cutting-edge technologies to treat and prevent infectious diseases and other serious conditions. Vir has assembled two technology platforms that are designed to stimulate and enhance the immune system by exploiting critical observations of natural immune processes.

Vir Biotechnology，Inc。是一家免疫学公司，专注于结合尖端技术来治疗和预防传染病和其他严重疾病。Vir组装了两个技术平台，旨在通过利用对自然免疫过程的批判性观察来刺激和增强免疫系统。

Its current clinical development pipeline consists of product candidates targeting hepatitis B and hepatitis delta viruses, influenza A and B, human immunodeficiency virus and COVID-19. Vir has several preclinical candidates in its pipeline, including those targeting RSV/MPV and HPV. Vir routinely posts information that may be important to investors on its website..

其目前的临床开发流程包括针对乙型肝炎和乙型肝炎病毒，甲型和乙型流感，人类免疫缺陷病毒和COVID-19的候选产品。Vir有几个临床前候选人，包括针对RSV/MPV和HPV的候选人。Vir通常会在其网站上发布对投资者可能重要的信息。。

Forward-Looking Statements

前瞻性声明

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as “may,” “will,” “plan,” “potential,” “aim,” “expect,” “anticipate,” “promising” and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements.

本新闻稿包含1995年“私人证券诉讼改革法”含义内的前瞻性声明。诸如“可能”，“将会”，“计划”，“潜力”，“目标”，“期望”，“预期”，“有希望”和类似表达（以及引用未来事件，条件或情况的其他单词或表达）旨在确定前瞻性陈述。

These forward-looking statements are based on Vir’s expectations and assumptions as of the date of this press release. Forward-looking statements contained in this press release include, but are not limited to, statements regarding Vir’s strategy and plans; the potential benefits of VIR-7229 to protect against historical and currently circulating COVID-19 variants and the potential benefits of alternative mAb delivery technologies in pandemic preparedness and response; wind down activities of VIR-2482 for the prevention of symptomatic influenza A illness; the potential benefits, safety, and efficacy of Vir’s investigational therapies; and risks and uncertainties associated with drug development and commercialization Many important factors may cause differences between current expectations and actual results, including uncertainty as to whether the anticipated benefits of the BARDA collaboration can be achieved; unexpected safety or efficacy data or results observed during clinical trials or in data readouts; the timing and outcome of Vir’s planned interactions with regulatory authorities; difficulties in obtaining regulatory approval; uncertainty as to whether the anticipated benefits of Vir’s collaborations with other companies can be achieved; difficulties in collaborating with other companies; challenges in accessing manufacturing capacity; clinical site activation rates or clin.

这些前瞻性声明基于本新闻稿发布之日Vir的期望和假设。本新闻稿中包含的前瞻性声明包括但不限于有关Vir战略和计划的声明；VIR-7229防止历史和目前流行的COVID-19变体的潜在益处以及替代mAb递送技术在大流行防范和响应中的潜在益处；VIR-2482用于预防有症状的甲型流感病毒的结束活动；Vir研究疗法的潜在益处，安全性和有效性；与药物开发和商业化相关的风险和不确定性许多重要因素可能会导致当前预期与实际结果之间的差异，包括不确定是否可以实现BARDA合作的预期收益；在临床试验或数据读数期间观察到的意外安全性或有效性数据或结果；Vir与监管机构计划互动的时间和结果；难以获得监管部门的批准；Vir与其他公司合作的预期收益是否可以实现的不确定性；与其他公司合作的困难；获得制造能力的挑战；临床部位激活率或临床。

Contacts: Media Carly Scaduto Senior Director, Media Relations cscaduto@vir.bio +1-314-368-5189 Investors Sasha Damouni Ellis Executive Vice President, Chief Corporate Affairs Officer sdamouni@vir.bio

联系人：Media Carly Scaduto媒体关系高级总监cscaduto@vir.bio+1-314-368-5189投资者Sasha Damouni Ellis公司首席公司事务官员执行副总裁sdamouni@vir.bio