SAN DIEGO--(BUSINESS WIRE)--Arcturus Therapeutics Holdings Inc. (the “Company”, “Arcturus”, Nasdaq: ARCT), a commercial messenger RNA medicines company focused on the development of infectious disease vaccines and opportunities within liver and respiratory rare diseases, today announced that the U.S.

圣地亚哥--（商业新闻短讯）--Arcturus Therapeutics Holdings Inc.（以下简称“公司”，“Arcturus”，纳斯达克：ARCT），一家商业信使RNA药物公司，专注于传染病疫苗的开发以及肝脏和呼吸道罕见病的机会，今天宣布美国。

Food and Drug Administration (FDA) has issued a “Study Can Proceed” notification for the Company’s Investigational New Drug (IND) application, ARCT-2304, a self-amplifying mRNA (sa-mRNA) vaccine candidate for active immunization to prevent pandemic influenza disease caused by H5N1 virus. The clinical study is funded by Biomedical Advanced Research and Development Authority (BARDA) and designed to enroll approximately 200 healthy adults in the United States..

美国食品和药物管理局（FDA）针对该公司的研究性新药（IND）申请ARCT-2304发布了“研究可以进行”通知，ARCT-2304是一种自我扩增的mRNA（sa mRNA）疫苗候选物，用于主动免疫，以预防由H5N1病毒引起的大流行性流感。该临床研究由生物医学高级研究与发展局（BARDA）资助，旨在招募美国约200名健康成年人。。

“Arcturus is actively engaged with the U.S. government to prepare for the next pandemic, and clearance to proceed into the clinic with our STARR® self-amplifying mRNA technology is a key step in this important process,” said Joseph Payne, President & CEO of Arcturus Therapeutics. “The Phase 1 clinical trial is designed to evaluate the safety, reactogenicity, and immunogenicity of ARCT-2304 as a potential vaccine to protect against the highly pathogenic H5N1 avian influenza.”.

“第一阶段临床试验旨在评估ARCT-2304作为预防高致病性H5N1禽流感的潜在疫苗的安全性，反应原性和免疫原性。”

About ARCT-2304

关于ARCT-2304

ARCT-2304 is a sa-mRNA vaccine candidate formulated within a lipid nanoparticle (LNP). The sa-mRNA vaccine candidate is designed to make many copies of mRNA within the host cell after intramuscular injection to achieve enhanced expression of haemagglutinin (HA) and neuraminidase (NA) antigens, thereby enabling lower doses than conventional mRNA vaccines.

ARCT-2304是在脂质纳米颗粒（LNP）内配制的sa mRNA候选疫苗。sa mRNA疫苗候选物旨在肌肉注射后在宿主细胞内产生许多拷贝的mRNA，以增强血凝素（HA）和神经氨酸酶（NA）抗原的表达，从而使剂量低于常规mRNA疫苗。

Utilizing a mRNA-based platform for pandemic influenza vaccine development offers further options for meeting domestic vaccine manufacturing surge capacity goals. The technology may make vaccines available much sooner than egg- and cell-based technologies. The lyophilized vaccine formulation is stable in refrigerators, thereby simplifying cold-chain storage and reducing distribution risks..

利用基于mRNA的平台开发大流行性流感疫苗为满足国内疫苗生产激增的目标提供了进一步的选择。这项技术可能比基于卵子和细胞的技术更快地提供疫苗。冻干疫苗制剂在冰箱中稳定，从而简化了冷链储存并降低了分销风险。。

About Arcturus

关于Arcturus

Founded in 2013 and based in San Diego, California, Arcturus Therapeutics Holdings Inc. (Nasdaq: ARCT) is a commercial 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，是一家商业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).

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）。