WALTHAM, Mass. & SAN DIEGO--(BUSINESS WIRE)--Global biotechnology leader CSL (ASX:CSL; USOTC:CSLLY) and self-amplifying messenger RNA (sa-mRNA) pioneer Arcturus Therapeutics (Nasdaq: ARCT) today announced the results of a head-to-head study demonstrating that self-amplifying (sa-mRNA) COVID-19 vaccine maintained superior immunogenicity compared to the conventional mRNA vaccine Comirnaty® for up to one year against Wuhan-Hu-1, Omicron BA.4-5 and certain other variants, and at one-sixth the dose of the comparator (5 μg vs 30 μg, respectively)..

马萨诸塞州沃尔瑟姆和圣地亚哥——（商业新闻短讯）——全球生物技术领导者CSL（ASX:CSL；USOTC:CSLLY）和自扩增信使RNA（sa mRNA）先驱Arcturus Therapeutics（Nasdaq:ARCT）今天宣布了一项头对头研究的结果，该研究表明，与传统的mRNA疫苗Comirnaty®相比，自扩增（sa mRNA）COVID-19疫苗在长达一年的时间内对武汉Hu-1，Omicron BA.4-5和某些其他变体保持了优异的免疫原性，并且是比较器剂量的六分之一（分别为5μg和30μg）。。

The data, presented as a poster at the OPTIONS XII for the Control of Influenza conference, highlights 12-month follow-up analysis of the Phase 3 trial conducted in Japan by Meiji Seika Pharma, evaluating a booster dose of ARCT-154, showing that the vaccine elicited superior immunogenicity and antibody persistence over Comirnaty® for up to 12 months postvaccination, against multiple SARS-CoV-2 strains and in both younger and older adult age groups..

这些数据作为海报在“控制流感的选择十二”会议上发布，重点介绍了明治精嘉制药公司在日本进行的3期试验的12个月随访分析，评估了ARCT-154的增强剂量，表明该疫苗在接种后12个月内对多种SARS-CoV-2毒株以及年轻和老年成人年龄组的免疫原性和抗体持久性优于Comirnaty®。。

“The 12-month results from the ARCT-154 study continue to establish the durability of immune response from this self-amplifying mRNA vaccine and reinforce the ability of this vaccine to provide protection against COVID-19 at lower doses compared to conventional mRNA vaccines,” said Jonathan Edelman, M.D., Senior Vice President, Vaccines Innovation Unit, CSL.

CSL疫苗创新部门高级副总裁乔纳森·埃德尔曼（JonathanEdelman）医学博士说：“ARCT-154研究的12个月结果继续证实了这种自扩增mRNA疫苗的免疫反应的持久性，并增强了这种疫苗在较低剂量下比传统mRNA疫苗提供针对新型冠状病毒（COVID-19）的保护的能力。”。

“We are proud to showcase at the 2024 OPTIONS conference with these important data about the first sa-mRNA COVID-19 vaccine now approved in Japan.”.

“我们很自豪能在2024年选项会议上展示这些关于日本目前批准的第一种sa mRNA COVID-19疫苗的重要数据。”。

Additional data presented by CSL and Arcturus finds that the bivalent formula, ARCT-2301, developed on the same platform as ARCT-154, induces superior immunogenicity over conventional bivalent mRNA vaccine Comirnaty® that persists against key variants up to six months postvaccination.

CSL和Arcturus提供的其他数据发现，在与ARCT-154相同的平台上开发的二价配方ARCT-2301比传统的二价mRNA疫苗Comirnaty®具有更高的免疫原性，该疫苗可在接种后6个月内持续抵抗关键变体。

“The recent surge in COVID-19 infections and the emerging new variants illustrate the critical need for vaccines that provide a longer duration of protection compared to conventional mRNA vaccines,” said Igor Smolenov, M.D., Ph.D. Chief Development Officer of Arcturus Therapeutics. 'These compelling new studies reaffirm that these sa-mRNA vaccines have the potential to offer potent protection against COVID-19.”.

Arcturus Therapeutics首席开发官Igor Smolenov医学博士说：“最近新型冠状病毒感染的激增和新出现的变异说明，与传统的mRNA疫苗相比，迫切需要提供更长保护期的疫苗。”这些引人注目的新研究重申，这些sa mRNA疫苗有可能提供针对COVID-19的有效保护。”。

The COVID-19 vaccine from this sa-mRNA platform targeted against the JN.1 variant is approved in Japan for immunization against COVID-19 in adults 18 years and older and is being sold under the trade name KOSTAIVE®.

来自该sa mRNA平台的针对JN.1变体的COVID-19疫苗在日本被批准用于18岁及以上成年人的COVID-19免疫接种，并以商品名KOSTAIVE®出售。

ARCT-154 12-month Study Design and Results

ARCT-154 12个月的研究设计和结果

The randomized, double-blind, active-controlled Phase 3 study was conducted at 11 clinical sites in Japan. The study enrolled 828 adults who had previously been fully immunized with three doses of mRNA vaccine(s). Participants were randomized equally to receive a booster dose of either ARCT-154 or Comirnaty®.

这项随机，双盲，主动对照的3期研究在日本的11个临床地点进行。。参与者被随机分配接受ARCT-154或Comirnaty®的增强剂量。

Immune responses were measured as neutralizing antibodies against the Wuhan-Hu-1 and Omicron BA.4-5 strains in sera obtained at Day 1 before booster vaccination, and Days 29, 91, 181, and 361 after vaccination of participants who were seronegative for SARS-CoV-2 nucleocapsid protein (N-protein), considered to be an indicator of recent COVID-19 infection.

在加强疫苗接种前第1天和接种SARS-CoV-2核衣壳蛋白（N蛋白）血清阴性的参与者接种后第29,91181和361天获得的血清中，测量免疫应答作为针对武汉-Hu-1和Omicron BA.4-5菌株的中和抗体，被认为是近期COVID-19感染的指标。

At the same timepoints neutralizing antibodies against Delta, Omicron BA.2, Omicron BA.2.86, and Omicron XBB.1.5.6 variants were measured in subsets of participants (~30 per group). Responses are expressed as group geometric mean titers (GMT) with 95% confidence intervals, and geometric mean titer ratio (GMTR) between the two vaccine groups at each timepoint..

同时，在参与者的子集中（每组约30个）测量了针对Delta，Omicron BA.2，Omicron BA.2.86和Omicron XBB.1.5.6变体的中和抗体。反应表示为95%置信区间的组几何平均滴度（GMT）和每个时间点两个疫苗组之间的几何平均滴度比（GMTR）。。

At Day 29, neutralizing antibodies (GMTs unadjusted) against the Wuhan-Hu-1 strain in ARCT-154 recipients (n = 378) were superior to those in the Comirnaty® group (n = 374): GMT = 5390 (95% CI: 4899–5931) vs. 3738 (3442–4060), a GMT ratio of 1.44 (1.27–1.64). This advantage persisted through all time points.

在第29天，ARCT-154受体（n=378）中针对武汉Hu-1菌株的中和抗体（未调整的GMT）优于Comirnaty®组（n=374）：GMT=5390（95%CI:4899-5931）对3738（3442-4060），GMT比为1.44（1.27-1.64）。这种优势在所有时间点都持续存在。

At Day 361 (unadjusted) GMTs were 3396 (3019–3821) and 1771 (1532–2047) in ARCT-154 (n = 272) and Comirnaty® (n = 266) groups, a GMT ratio of 1.92 (1.59–2.31). Differences were also observed in responses against Omicron BA.4-5, with GMT ratios of 1.31 (1.07–1.59) at Day 29 and 1.89 (1.42– 2.50) at Day 361.

在第361天（未调整），ARCT-154（n=272）和Comirnaty®（n=266）组的GMT分别为3396（3019-3821）和1771（1532-2047），GMT比为1.92（1.59-2.31）。对Omicron BA.4-5的反应也存在差异，第29天的GMT比率为1.31（1.07-1.59），第361天的GMT比率为1.89（1.42-2.50）。

A subset of subjects who were seronegative for N-protein displayed similar differences in immune responses between ARCT-154 and Comirnaty® against the Delta, Omicron BA.2, BA.2.86, and XBB.1.5.6 variants at Day 361. The GMT ratios were 1.88 (0.79–4.49) against Delta, 2.34 (1.06–5.17) against Omicron BA.2, 2.51 (1.00–6.31) against Omicron BA.2.86 and 2.81 (1.09–7.28) against Omicron XBB.1.5.6..

在第361天，对N蛋白呈血清阴性的一部分受试者在ARCT-154和Comirnaty®之间对Delta，Omicron BA.2，BA.2.86和XBB.1.5.6变体的免疫应答方面表现出相似的差异。GMT与Delta的比值为1.88（0.79–4.49），与Omicron BA的比值为2.34（1.06–5.17）。与Omicron BA的比值为2.51（1.00–6.31）。与Omicron BA.2.86的比值为2.81（1.09–7.28），与Omicron XBB的比值为1.5.6。。

Bivalent 6-month Study Design and Results

二价6个月的研究设计和结果

In this randomized, multicenter, Phase 3, observer-blind, active-controlled trial in Japan, fully-immunized (3‒5 doses of mRNA vaccine) adults were randomized 1:1 to receive a booster dose of ARCT-2301 or Comirnaty® Original/BA.4-5. The primary objective was to demonstrate non-inferiority of the immunogenicity of ARCT-2301 vs.

在日本的这项随机，多中心，3期，观察者盲，主动对照试验中，完全免疫（3-5剂mRNA疫苗）的成年人以1:1的比例随机接受增强剂量的ARCT-2301或Comirnaty®Original/BA.4-5。主要目的是证明ARCT-2301与。

Comirnaty® Original/BA.4-5 at Day 29 as neutralizing antibody GMT and seroresponse rates (SRR) against Omicron BA.4-5. Key secondary outcomes included titers of neutralizing antibodies against Wuhan-Hu-1 and Omicron XBB.1.5..

Comirnaty®Original/BA.4-5在第29天作为针对Omicron BA.4-5的中和抗体GMT和血清反应率（SRR）。关键的次要结果包括针对武汉Hu-1和Omicron XBB.1.5的中和抗体滴度。。

Between September and November 2023, 930 men and women (19‒80 years) with at least three prior mRNA COVID-19 vaccinations were enrolled at nine medical centers in Japan and administered ARCT-2301 (n = 465) or Comirnaty® Original/BA.4-5 (n = 465) boosters. At Day 29 ARCT-2301 (n = 398) induced superior neutralizing antibody responses vs.

2023年9月至11月，日本9家医疗中心招募了930名男性和女性（19-80岁），其中至少有三次接种过新型冠状病毒肺炎疫苗，并使用了ARCT-2301（n=465）或Comirnaty®Original/BA.4-5（n=465）助推器。在第29天，ARCT-2301（n=398）诱导了优异的中和抗体反应。

Comirnaty® (n = 405) against Omicron BA.4-5 (GMT ratio 1·49 [95% CI: 1.26–1.76], SRR difference 7.2% [95% CI: 0.6–13.7]), and against Wuhan-Hu-1 (GMT ratio 1.45 [1.28–1.63], SRR difference 12.5% [5.9–19.0]). The difference persisted through six months with GMT ratios of 2.17 (95% CI: 1.75-2.69) and 1.98 (95% CI: 1.69-2.31), respectively.

Comirnaty®（n=405）对Omicron BA.4-5（GMT比1.49[95%CI:1.26-1.76]，SRR差异7.2%[95%CI:0.6-13.7]）和对武汉胡-1（GMT比1.45[1.28-1.63]，SRR差异12.5%[5.9-19.0]）。这种差异持续了六个月，GMT比率分别为2.17（95%CI:1.75-2.69）和1.98（95%CI:1.69-2.31）。

Antibody responses against Omicron XBB.1.5 were also higher after ARCT-2301 vs. Comirnaty® (GMT ratio 1.63 [1.36–1.94], SRR difference 16.7% [10.1–23.2])..

ARCT-2301与Comirnaty®相比，针对Omicron XBB.1.5的抗体反应也更高（GMT比1.63[1.36-1.94]，SRR差异16.7%[10.1-23.2]）。。

About sa-mRNA

关于sa mRNA

mRNA vaccines help protect against infectious diseases by providing a blueprint for cells in the body to make a protein to help our immune systems recognize and fight the disease. Unlike standard mRNA vaccines, self-amplifying mRNA vaccines instruct the body to make more mRNA and protein to boost the immune response..

mRNA疫苗通过为体内细胞提供蓝图，使其产生蛋白质，帮助我们的免疫系统识别和抗击疾病，从而有助于预防传染病。与标准的mRNA疫苗不同，自我扩增的mRNA疫苗指导身体产生更多的mRNA和蛋白质来增强免疫反应。。

About CSL

关于CSL

CSL (ASX:CSL; USOTC:CSLLY) is a global biotechnology company with a dynamic portfolio of lifesaving medicines, including those that treat hemophilia and immune deficiencies, vaccines to prevent influenza, and therapies in iron deficiency and nephrology. Since our start in 1916, we have been driven by our promise to save lives using the latest technologies.

CSL（ASX:CSL；USOTC:CSLLY）是一家全球生物技术公司，拥有一系列充满活力的救生药物，包括治疗血友病和免疫缺陷的药物，预防流感的疫苗以及缺铁和肾脏病的疗法。自1916年成立以来，我们一直致力于使用最新技术拯救生命。

Today, CSL – including our three businesses: CSL Behring, CSL Seqirus and CSL Vifor – provides lifesaving products to patients in more than 100 countries and employs 32,000 people. Our unique combination of commercial strength, R&D focus and operational excellence enables us to identify, develop and deliver innovations so our patients can live life to the fullest.

如今，CSL（包括我们的三大业务：CSL Behring、CSL Sequirus和CSL Vifor）为100多个国家的患者提供救生产品，拥有32000名员工。我们独特的商业实力、研发重点和卓越运营相结合，使我们能够识别、开发和提供创新，使我们的患者能够过上最充实的生活。

For inspiring stories about the promise of biotechnology, visit CSLBehring.com/Vita and follow us on Twitter.com/CSL. For more information about CSL, visit www.CSL.com..

有关生物技术前景的鼓舞人心的故事，请访问CSLBehring.com/Vita，并在Twitter.com/CSL上关注我们。有关CSL的更多信息，请访问www.CSL.com。。

About Arcturus

关于大角星

Founded in 2013 and based in San Diego, California, Arcturus Therapeutics Holdings Inc. (Nasdaq: ARCT) is a global mRNA medicines and vaccines company with enabling technologies: (i) LUNAR® lipid-mediated delivery, (ii) STARR® mRNA Technology (sa-mRNA) and (iii) mRNA drug substance along with drug product manufacturing expertise.

Arcturus Therapeutics Holdings Inc.（纳斯达克股票代码：ARCT）成立于2013年，总部位于加利福尼亚州圣地亚哥，是一家全球mRNA药物和疫苗公司，拥有以下技术：（i）LUNAR®脂质介导的递送，（ii）STARR®mRNA技术（sa mRNA）和（iii）mRNA药物以及药品制造专业知识。

Arcturus developed KOSTAIVE®, the first self-amplifying messenger RNA (sa-mRNA) COVID vaccine in the world to be approved. Arcturus has an ongoing global collaboration for innovative mRNA vaccines with CSL Seqirus, and a joint venture in Japan, ARCALIS, focused on the manufacture of mRNA vaccines and therapeutics.

Arcturus开发了KOSTAIVE®，这是世界上第一个被批准的自扩增信使RNA（sa mRNA）新型冠状病毒疫苗。Arcturus正在与CSL-Seqirus进行创新mRNA疫苗的全球合作，并在日本成立了一家合资企业ARCALIS，专注于mRNA疫苗和治疗剂的生产。

Arcturus' pipeline includes RNA therapeutic candidates to potentially treat ornithine transcarbamylase (OTC) deficiency and cystic fibrosis (CF), along with its partnered mRNA vaccine programs for SARS-CoV-2 (COVID-19) and influenza. Arcturus' versatile RNA therapeutics platforms can be applied toward multiple types of nucleic acid medicines including messenger RNA, small interfering RNA, circular RNA, antisense RNA, self-amplifying RNA, DNA, and gene editing therapeutics.

Arcturus的管道包括可能治疗鸟氨酸转氨甲酰酶（OTC）缺乏症和囊性纤维化（CF）的RNA治疗候选物，以及针对SARS-CoV-2（COVID-19）和流感的合作mRNA疫苗计划。大角星的多功能RNA治疗平台可应用于多种类型的核酸药物，包括信使RNA，小干扰RNA，环状RNA，反义RNA，自扩增RNA，DNA和基因编辑疗法。

Arcturus' technologies are covered by its extensive patent portfolio (over 400 patents and patent applications in the U.S., Europe, Japan, China, and other countries). For more information, visit www.ArcturusRx.com. In addition, please connect with us on Twitter and LinkedIn..

大角星的技术涵盖了其广泛的专利组合（在美国、欧洲、日本、中国和其他国家有400多项专利和专利申请）。。。

Forward-Looking Statements

前瞻性声明

This press release contains forward-looking statements that involve substantial risks and uncertainties for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. Any statements, other than statements of historical fact included in this press release, are forward-looking statements, including those regarding strategy, future operations, the likelihood that KOSTAIVE will provide a longer duration of protection, the likelihood and timing of future approvals of KOSTAIVE anywhere in the world including Europe, the plans to submit additional regulatory filings and timing thereof, that preclinical or clinical data will be predictive of future clinical results, and the impact of general business and economic conditions.

本新闻稿包含前瞻性声明，涉及1995年《私人证券诉讼改革法案》提供的安全港的重大风险和不确定性。除本新闻稿中包含的历史事实声明外，任何声明均为前瞻性声明，包括有关战略、未来运营、KOSTAIVE提供更长保护期的可能性、KOSTAIVE未来在世界任何地方（包括欧洲）获得批准的可能性和时间、提交额外监管文件的计划及其时间安排、临床前或临床数据将预测未来临床结果以及一般商业和经济状况的影响。

Arcturus may not actually achieve the plans, carry out the intentions or meet the expectations or projections disclosed in any forward-looking statements such as the foregoing and you should not place undue reliance on such forward-looking statements. These statements are only current predictions or expectations, and are subject to known and unknown risks, uncertainties, and other factors that may cause our or our industry’s actual results, levels of activity, performance or achievements to be materially different from those anticipated by the forward-looking statements, including those discussed under the heading 'Risk Factors' in Arcturus’ most recent Annual Report on Form 10-K, and in subsequent filings with, or submissions to, the SEC, which are available on the SEC’s website at www.sec.gov.

大角星可能无法实际实现上述任何前瞻性声明中披露的计划、意图或期望或预测，您不应过度依赖此类前瞻性声明。这些声明仅是当前的预测或预期，并受到已知和未知的风险、不确定性和其他因素的影响，这些因素可能导致我们或我们行业的实际业绩、活动水平、绩效或成就与前瞻性声明所预期的大不相同，包括Arcturus最新年度报告（表10-K）中“风险因素”标题下讨论的内容，以及随后向美国证券交易委员会提交的文件或提交给美国证券交易委员会的文件，这些文件可在美国证券交易委员会网站www.SEC.gov上查阅。

Except as otherwise required by law, Arcturus disclaims any intention or obligation to update or revise any forward-looking statements, which speak only as of the date they were made, whether as a result of new information, future .

除非法律另有规定，大角星不承担更新或修订任何前瞻性声明的任何意图或义务，这些声明仅在做出之日起生效，无论是由于新信息、未来。