SAN DIEGO--(BUSINESS WIRE)--Arcturus Therapeutics Holdings Inc. (the “Company”, “Arcturus”, Nasdaq: ARCT), a global late-stage clinical messenger RNA medicines company focused on the development of infectious disease vaccines and opportunities within liver and respiratory rare diseases, today announced the results of a phase 1/2 study showing that a booster dose of a novel, self-amplifying messenger RNA (sa-mRNA) vaccine against COVID-19 induces a robust, broadly cross-reactive, and durable immune response in adults that remains elevated through 12 months after vaccination.

圣地亚哥-（商业线）-Arcturus Therapeutics Holdings Inc.（the“Company”，“Arcturus”，纳斯达克股票代码：ARCT），一家全球晚期临床信使RNA药物公司，专注于开发传染病疫苗和机会今天宣布了一项1/2期研究的结果，该研究显示，一种新型，针对COVID-19的自扩增信使RNA（sa mRNA）疫苗在成人中诱导强烈的，广泛的交叉反应性和持久的免疫应答，其在接种后12个月仍然升高。

Three sa-mRNA vaccines were used in the study, which was presented as a poster at the European Scientific Working Group on Influenza's 9th ESWI Influenza Conference in Valencia, Spain..

该研究中使用了三种sa-mRNA疫苗，该疫苗在西班牙巴伦西亚举行的欧洲流感科学工作组第9届ESWI流感会议上作为海报展示。。

Messenger RNA (mRNA) vaccine technology protects against infectious diseases by instructing cells in the body to make a specific protein, stimulating the immune response, and leaving a blueprint to recognize and fight future infection. However, sa-mRNA also provides the body with instruction to make copies of the mRNA, amplifying the amount of protein made.

Messenger RNA（mRNA）疫苗技术通过指导体内细胞制造特定蛋白质，刺激免疫反应，并留下识别和对抗未来感染的蓝图，从而预防传染病。然而，sa mRNA还为身体提供了制备mRNA拷贝的指示，从而扩增了产生的蛋白质量。

This advanced technology has shown the potential to offer longer duration of immune response at considerably lower doses compared to conventional mRNA vaccines..

与传统的mRNA疫苗相比，这种先进的技术已经显示出以相当低的剂量提供更长的免疫应答持续时间的潜力。。

“Current mRNA technologies provide effective initial immunogenicity against COVID-19, but the results of this study show that our sa-mRNA vaccine platform can offer improvements in duration and breadth of protection against new and emerging variants,” said Igor Smolenov, Chief Development Officer, Arcturus.

首席开发官Igor Smolenov说：“目前的mRNA技术提供了针对COVID-19的有效初始免疫原性，但这项研究的结果表明，我们的sa-mRNA疫苗平台可以改善针对新出现的变体的持续时间和广度。，Arcturus。

“We are proud of the role Arcturus has played, collaborating with CSL, in advancing sa-mRNA vaccine development.”.

“我们为Arcturus与CSL合作在推进sa-mRNA疫苗开发方面发挥的作用感到自豪。”。

CSL’s vaccine business, CSL Seqirus, is Arcturus’ global exclusive partner for the development of novel mRNA vaccines against SARS-CoV-2 (COVID-19), influenza and pandemic preparedness. CSL has a dynamic portfolio of lifesaving medicines, including those that treat hemophilia, hereditary angioedema (HAE) and immune deficiencies, vaccines to prevent influenza, and therapies in iron deficiency and nephrology..

CSL的疫苗业务CSL-Seqirus是Arcturus开发针对SARS-CoV-2（COVID-19），流感和大流行防范的新型mRNA疫苗的全球独家合作伙伴。CSL拥有动态的救生药物组合，包括治疗血友病，遗传性血管性水肿（HAE）和免疫缺陷，预防流感疫苗以及缺铁和肾脏病治疗的药物。。

“We are encouraged by the findings of the study, indicating the sa-mRNA platform’s potential to solve the challenge of mRNA vaccine waning immunity over time, and thereby provide prolonged protection at lower doses,” said Esther Heijnen, M.D., Vice President, Clinical Development, Vaccines Innovation Unit, CSL.

临床开发副总裁Esther Heijnen博士说：“我们对这项研究的结果感到鼓舞，表明sa-mRNA平台有可能解决随着时间推移免疫力下降的mRNA疫苗的挑战，从而以较低剂量提供长期保护。”CSL疫苗创新部。

“Our collaboration with Arcturus on advanced mRNA vaccines is another example of CSL’s relentless pursuit of disruptive innovation when public health and patients can benefit.”.

“我们与Arcturus在先进的mRNA疫苗方面的合作是CSL在公共卫生和患者受益时无情追求颠覆性创新的另一个例子。”。

Study Design and Results

研究设计和结果

For this phase 1/2 randomized, observer-blind study conducted in the US and Singapore, 36 adults previously immunized with approved COVID-19 mRNA vaccines as a primary series were recruited. Participants were randomized 1:1:1 to receive one booster dose on Day 1 of either the ARCT-021, ARCT-154, or ARCT-165 vaccines, all of which encode the SARS-CoV-2 full-length S glycoprotein of, respectively, the ancestral strain in native conformation, a prefusion-stabilized B.1 variant including the D614G mutation, or the Beta variant.

对于在美国和新加坡进行的1/2期随机，观察者盲法研究，招募了36名先前用批准的COVID-19 mRNA疫苗作为主要系列免疫的成人。参与者以1:1:1的比例随机接受ARCT-021，ARCT-154或ARCT-165疫苗第1天的一次加强剂量，所有疫苗均编码SARS-CoV-2全长S糖蛋白，分别为天然构象的祖先菌株，包括D614G突变的融合前稳定的B.1变体或β变体。

Immunogenicity was assessed as neutralizing antibody titers against the SARS-CoV-2 D614G strain, and a panel of SARS-CoV-2 variants measured by pseudoviral microneutralization assay on Days 1, 15, 29, 91, 181, 271, and 366. Solicited adverse events (AE) were assessed up to 7 days, unsolicited AEs up to 28 days, and serious AEs up to 366 days after vaccination..

评估免疫原性作为针对SARS-CoV-2D614G菌株的中和抗体滴度，以及在第1,15,29,91181271和366天通过假病毒微中和测定法测量的一组SARS-CoV-2变体。在接种疫苗后7天内评估征求的不良事件（AE），在28天内评估未经请求的AE，在366天内评估严重AE。。

All three vaccines induced robust neutralizing immune response against the D614G variant at Day 29 with geometric mean fold rises (GMFR) from pre-booster levels of 20.0, 36.7 and 23.5 after ARCT-021, ARCT-154, and ARCT-165, respectively. ARCT-154, a leading candidate, induced a broad, cross-neutralizing immune response, which persisted up to one-year post-booster with no further boosting.

在第29天，所有三种疫苗均诱导了针对D614G变体的强力中和免疫应答，分别在ARCT-021，ARCT-154和ARCT-165之后从20.0、36.7和23.5的预加强水平提高了几何平均倍数（GMFR）。领先的候选人ARCT-154诱导了广泛的交叉中和免疫反应，这种反应在加强后持续长达一年，没有进一步的加强。

Similar trends were observed for other SARS-CoV-2 variants including Beta, Delta, Omicron BA.1, Omicron BA.2, and Omicron BA.4/5. Additional exploratory testing confirmed cross-neutralization against emergent BQ.1.1 and XBB.1.5 Omicron sub-lineages with GMFRs of 12.8 and 3.4, respectively, at Day 29 post-booster.

对于其他SARS-CoV-2变体，包括β，δ，Omicron BA.1，Omicron BA.2和Omicron BA.4/5，观察到类似的趋势。另外的探索性测试证实在加强后第29天分别针对GMFR分别为12.8和3.4的紧急BQ.1.1和XBB.1.5 Omicron亚系的交叉中和。

Adverse events were mild or moderate and resolved quickly, and rates of related or severe AEs were low..

不良事件为轻度或中度，迅速消退，相关或严重AE发生率低。。

About Arcturus Therapeutics

关于Arcturus疗法

Founded in 2013 and based in San Diego, California, Arcturus Therapeutics Holdings Inc. (Nasdaq: ARCT) is a global late-stage clinical 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，是一家全球晚期临床mRNA药物和疫苗公司，拥有以下技术：（i）LUNAR®lipid mediated delivery，（ii）STARR®mRNA技术（sa mRNA）和（iii）mRNA药物以及药品制造专业知识。

The Company has ongoing collaborations with CSL Seqirus and Meiji Seika Pharma, and a joint venture with ARCALIS. Arcturus’ pipeline includes RNA therapeutic candidates to potentially treat ornithine transcarbamylase deficiency and cystic fibrosis, along with its partnered mRNA vaccine programs for SARS-CoV-2 (COVID-19) and influenza.

该公司与CSL Seqirus和明治Seika Pharma持续合作，并与ARCALIS合资。Arcturus的管道包括潜在治疗鸟氨酸转氨甲酰酶缺乏症和囊性纤维化的RNA治疗候选药物，以及SARS-CoV-2（COVID-19）和流感的合作mRNA疫苗计划。

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’ technologies are covered by its extensive patent portfolio (patents and patent applications issued in the U.S., Europe, Japan, China, and other countries).

Arcturus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和基因编辑治疗。Arcturus的技术涵盖其广泛的专利组合（在美国，欧洲，日本，中国和其他国家/地区发布的专利和专利申请）。

For more information, visit www.ArcturusRx.com. In addition, please connect with us on Twitter and LinkedIn..

欲了解更多信息，请访问www.ArcturusRx.com。此外，请在Twitter和LinkedIn上与我们联系。。

Forward Looking Statement

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 of success of the Company’s pipeline and partnered programs (including the COVID-19 program partnered with CSL Seqirus), the likelihood that ARCT-154 or any other Arcturus vaccine candidate will be successful or continue to advance, the likelihood that the Phase 1/2 clinical data will be predictive of, or consistent with, future clinical results, the likelihood that the Company’s sa-mRNA vaccine platform will offer improvements in duration and breadth of protection, and the impact of general business and economic conditions.

本新闻稿包含前瞻性声明，其中涉及1995年“私人证券诉讼改革法”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陈述外，任何陈述均为前瞻性陈述，包括有关战略，未来运营，公司渠道成功的可能性以及合作计划（包括与CSL合作的COVID-19计划）的前瞻性陈述。Seqirus），ARCT-154或任何其他Arcturus候选疫苗成功或继续推进的可能性，1/2期临床数据可能预测或与未来临床结果一致的可能性，公司的sa mRNA疫苗平台将提供持续时间和保护范围的改进，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.

Arcturus可能无法实际实现计划，执行意图或满足上述任何前瞻性声明中披露的期望或预测，您不应过分依赖此类前瞻性声明。这些陈述仅是当前的预测或预期，并受到已知和未知的风险，不确定性以及其他可能导致我们或我们行业的实际结果，活动水平，绩效或成就与预期的实质性不同的因素。展望声明，包括在Arcturus的“风险因素”标题下讨论的表格10-K的最新年度报告，以及随后提交给SEC的文件或提交给SEC的文件，这些文件可在SEC的网站www.SEC.gov上找到。

Except as otherwise required by law, Arcturus disclaims any intention.

除法律另有要求外，Arcturus拒绝任何意图。