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mRNA药物研发商CureVac宣布与葛兰素史克合作开发甲型流感(H5N1)大流行前候选疫苗1/2期联合研究的1期部分

CureVac Announces Start of Combined Phase 1/2 Study in Avian Influenza (H5N1); Development in Collaboration with GSK

BioSpace | 2024-04-24 | 翻译由动脉网AI生成,点击反馈

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Phase 1 part of combined Phase 1/2 study initiated as part of pandemic preparedness against highly pathogenic avian influenza (H5N1) virus, considered to be potential future pandemic threat

作为针对高致病性禽流感(H5N1)病毒的大流行防范措施的一部分,启动了1/2期联合研究的第一阶段,该病毒被认为是未来大流行的潜在威胁

Study will assess monovalent vaccine candidate, encoding an influenza A H5-antigen using proprietary second-generation mRNA backbone

这项研究将评估单价候选疫苗,该候选疫苗使用专有的第二代mRNA骨架编码甲型H5流感抗原

Avian influenza is latest program progressing to clinical trials under broad infectious disease collaboration agreement with GSK

禽流感是根据与葛兰素史克的广泛传染病合作协议进入临床试验的最新项目

TÜBINGEN, GERMANY and BOSTON, MA / ACCESSWIRE / April 24, 2024 / CureVac N.V. (Nasdaq:CVAC) ('CureVac'), a global biopharmaceutical company developing a new class of transformative medicines based on messenger ribonucleic acid ('mRNA'), today announced the start of the Phase 1 part of a combined Phase 1/2 study of an investigational influenza A (H5N1) pre-pandemic vaccine candidate developed in collaboration with GSK.

德国TÜBINGEN和波士顿,MA/ACCESSWIRE/2024年4月24日/CureVac N.V.(纳斯达克:CVAC)(“CureVac”),一家开发基于信使核糖核酸(“mRNA”)的新型转化药物的全球生物制药公司,今天宣布开始与GSK合作开发的研究性甲型流感(H5N1)大流行前候选疫苗的1/2期联合研究的第一阶段。

The H5N1 avian influenza virus is considered a potential future pandemic threat, known to sporadically cross species from its original bird host to other animal hosts and humans. The monovalent vaccine candidate is based on CureVac's proprietary second-generation mRNA backbone and encodes an influenza A H5-antigen..

H5N1禽流感病毒被认为是未来大流行的潜在威胁,已知它偶尔会从原始鸟类宿主跨越物种,传播到其他动物宿主和人类。单价候选疫苗基于CureVac专有的第二代mRNA骨架,编码甲型H5流感抗原。。

'The highly pathogenic avian influenza virus is frequently cited as one of the viruses with high pandemic potential, with cases of animal-to-human transmission of the H5N1 strain already documented. Leveraging our clinically validated mRNA-technology platform and second-generation mRNA backbone, we aim to provide an effective countermeasure to the pandemic threat of potential human-to-human transmission', said Dr.

“高致病性禽流感病毒经常被认为是具有高度大流行潜力的病毒之一,已经记录了H5N1病毒株在动物间传播的病例。利用我们经过临床验证的mRNA技术平台和第二代mRNA骨架,我们旨在为潜在的人与人之间传播的大流行威胁提供有效的对策。

Myriam Mendila, Chief Development Officer of CureVac. 'This clinical milestone, in collaboration with GSK, expands the application of our mRNA technology into an additional indication in infectious diseases and addresses the need to be prepared for potential future pandemics.'.

CureVac首席开发官Myriam Mendila说这一临床里程碑与GSK合作,将我们的mRNA技术的应用扩展到传染病的其他适应症中,并解决了为未来潜在的流行病做好准备的需求。”。

The combined Phase 1/2 study will evaluate the safety, reactogenicity and immunogenicity of an investigational influenza A (H5N1) pre-pandemic vaccine candidate in healthy younger adults aged 18 to 64 and healthy older adults aged 65 to 85. In the initial Phase 1 dose-escalation part of the study, up to five dose levels will be assessed compared to a placebo control.

1/2期联合研究将评估研究性甲型流感(H5N1)大流行前候选疫苗在18至64岁健康年轻人和65至85岁健康老年人中的安全性,反应原性和免疫原性。在研究的第一阶段剂量递增部分,与安慰剂对照相比,将评估多达五个剂量水平。

The study will be conducted in the United States..

这项研究将在美国进行。。

The broad CureVac-GSK infectious disease collaboration was first announced in July 2020. It focuses on applying CureVac's mRNA-technology to the development of new products for infectious disease targets.

broad CureVac-GSK传染病合作于2020年7月首次宣布。它专注于将CureVac的mRNA技术应用于传染病靶标新产品的开发。

About CureVac

关于CureVac

CureVac (Nasdaq:CVAC) is a global biopharmaceutical company in the field of messenger RNA (mRNA) technology, with more than 20 years of expertise in developing, optimizing, and manufacturing this versatile biological molecule for medical purposes. The principle of CureVac's proprietary technology is the use of optimized mRNA as a data carrier to instruct the human body to produce its own proteins capable of fighting a broad range of diseases.

CureVac(纳斯达克股票代码:CVAC)是信使RNA(mRNA)技术领域的全球生物制药公司,在开发,优化和制造这种用于医疗目的的多功能生物分子方面拥有20多年的专业知识。CureVac专有技术的原理是使用优化的mRNA作为数据载体,指导人体产生能够抵抗多种疾病的自身蛋白质。

In July 2020, CureVac entered in a collaboration with GSK to jointly develop new products in prophylactic vaccines for infectious diseases based on CureVac's second-generation mRNA technology. This collaboration was later extended to the development of second-generation COVID-19 vaccine candidates, and modified mRNA vaccine technologies.

2020年7月,CureVac与GSK合作,共同开发基于CureVac第二代mRNA技术的传染病预防性疫苗新产品。这种合作后来扩展到开发第二代COVID-19候选疫苗和改进的mRNA疫苗技术。

Based on its proprietary technology, CureVac has built a deep clinical pipeline across the areas of prophylactic vaccines, cancer therapies, antibody therapies, and the treatment of rare diseases. CureVac N.V. has its headquarters in Tübingen, Germany, and has more than 1,100 employees across its sites in Germany, the Netherlands, Belgium, Switzerland, and the U.S.

基于其专有技术,CureVac在预防性疫苗、癌症治疗、抗体治疗和罕见疾病治疗领域建立了一条深入的临床管道。CureVac N.V.的总部位于德国蒂宾根,在德国、荷兰、比利时、瑞士和美国的工厂拥有1100多名员工。

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