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CureVac与葛兰素史克合作将季节性流感研究推进到第二阶段,筛选出有前景的广泛覆盖的信使核糖核酸候选疫苗

CureVac Advances Seasonal Flu Study to Phase 2 in Collaboration with GSK Following Selection of Promising mRNA Vaccine Candidate with Broad Coverage

biospace 等信源发布 2023-09-13 02:58

可切换为仅中文


Phase 1 part of combined Phase 1/2 study assessed comprehensive series of flu vaccine candidates, featuring up to eight separate mRNA constructs per candidate

联合1/2期研究的第一阶段部分评估了流感疫苗候选物的综合系列,每个候选物具有多达八个独立的mRNA构建体

Best-performing candidate providing broad antigen coverage against WHO-recommended flu strains selected for Phase 2, following positive data from Phase 1 interim analysis

在第一阶段中期分析的阳性数据之后,针对世卫组织推荐的选择用于第二阶段的流感病毒株提供广泛抗原覆盖的最佳表现候选者

Dosing of first Phase 2 participant anticipated in Q4 2023; Phase 2 to include older adults and standard-of-care comparison

预计在2023季度第一阶段2参与者的剂量;第二阶段包括老年人和护理标准比较

TÜBINGEN, GERMANY and BOSTON, MA / ACCESSWIRE / September 12, 2023 / 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 selection of a promising vaccine candidate for continued clinical development based on positive data from an interim analysis of the ongoing Phase 1 part of a combined Phase 1/2 study, conducted in collaboration with GSK..

德国蒂宾根和马萨诸塞州波士顿/ACCESSWIRE/2023年9月12日/CureVac N.V.(纳斯达克股票代码:CVAC)('CureVac'),一家基于信使核糖核酸('mRNA')开发新型转化药物的全球生物制药公司,今天宣布根据与葛兰素史克合作进行的联合1/2期研究正在进行的1期部分的中期分析的积极数据,选择有希望的候选疫苗继续临床开发。。

The Phase 1 part compared a comprehensive series of multivalent, modified mRNA seasonal flu vaccine candidates with up to eight separate mRNA constructs per candidate, addressing all four WHO-recommended flu strains. The selected vaccine candidate will be advanced to the Phase 2 part of the study, which is expected to dose the first participant in Q4 2023 and will expand to include older adults aged 65 to 85..

第一阶段部分比较了一系列全面的多价,改良的mRNA季节性流感疫苗候选物和每个候选物多达8个独立的mRNA构建体,针对所有四种WHO推荐的流感病毒株。选定的候选疫苗将进入研究的第二阶段,预计将在2023季度为第一批参与者提供剂量,并将扩大到包括65至85岁的老年人。。

'We are very pleased with the interim results from the Phase 1 part of the study, which provided a strong basis to move our clinical development forward into Phase 2,' said Dr. Myriam Mendila, Chief Development Officer of CureVac. 'The power, flexibility and speed of our mRNA technology platform offers tremendous potential to overcome the current challenges associated with providing seasonally updated and highly effective influenza vaccines.

“我们对研究第一阶段的中期结果非常满意,这为将我们的临床开发推进第二阶段提供了坚实的基础,”CureVac首席开发官Myriam Mendila博士说我们的mRNA技术平台的强大功能,灵活性和速度为克服与提供季节性更新和高效流感疫苗相关的当前挑战提供了巨大潜力。

We feel confident that our differentiated vaccine candidate has the potential to offer people broad protection and will advance us on the path to transforming public health.'.

我们相信,我们的差异化候选疫苗有可能为人们提供广泛的保护,并将推动我们走向改变公共卫生的道路。

Vaccine candidates in the Phase 1 part of the combined Phase 1/2 study were tested at different dose levels in 270 healthy younger adults (age 18-50). Interim safety data showed no safety concerns across all tested dose levels for the multivalent candidates. Immunogenicity of all candidates was assessed in parallel with a licensed seasonal flu vaccine comparator.

在270名健康年轻成人(年龄18-50岁)中以不同剂量水平测试组合1/2期研究的1期部分中的候选疫苗。临时安全性数据显示,对于多价候选物,所有测试剂量水平都没有安全性问题。与许可的季节性流感疫苗比较物平行评估所有候选物的免疫原性。

The humoral responses observed supported the selection of a candidate vaccine for further evaluation in Phase 2 in younger and older adults..

观察到的体液反应支持选择候选疫苗,以便在年轻人和老年人的第2阶段进一步评估。。

The CureVac-GSK infectious disease collaboration was first announced in July 2020 and focuses on the development of new products based on CureVac's mRNA technology for different targets in the field of infectious diseases.

CureVac-GSK传染病合作组织于2020年7月首次宣布,重点开发基于CureVac mRNA技术的新产品,用于传染病领域的不同目标。

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,优化和制造用于医疗目的的这种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,指导人体产生能够对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与葛兰素史克合作,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。这项合作后来扩展到开发第二代COVID-19候选疫苗和改良的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等领域建立了深入的临床渠道。CureVac N.V.总部设在德国蒂宾根,在德国,荷兰,比利时,瑞士和美国的各地拥有1100多名员工。

Further information can be found at www.curevac.com..

更多信息请访问www.curevac.com。。

CureVac Media and Investor Relations Contact

CureVac媒体与投资者关系联系人

Dr. Sarah Fakih, Vice President Corporate Communications and Investor Relations

Sarah Fakih博士,公司通讯和投资者关系副总裁

CureVac, Tübingen, Germany

CureVac,Tübingen,Germany

T: +49 7071 9883-1298

T: +4970719883-1298

M: +49 160 90 496949

M: +4916090496949

sarah.fakih@curevac.com

sarah.fakih@curevac.com

Forward-Looking Statements CureVac

前瞻性声明CureVac

This press release contains statements that constitute 'forward looking statements' as that term is defined in the United States Private Securities Litigation Reform Act of 1995, including statements that express the opinions, expectations, beliefs, plans, objectives, assumptions or projections of CureVac N.V.

本新闻稿包含1995年“美国私人证券诉讼改革法案”中定义的构成“前瞻性声明”的声明,包括表达CureVac N.V.的意见,期望,信念,计划,目标,假设或预测的声明。

and/or its wholly owned subsidiaries CureVac SE, CureVac Manufacturing GmbH, CureVac Inc., CureVac Swiss AG, CureVac Corporate Services GmbH, CureVac RNA Printer GmbH, CureVac Belgium SA and CureVac Netherlands B.V. (the 'company') regarding future events or future results, in contrast with statements that reflect historical facts.

和/或其国有子公司CureVac SE,CureVac Manufacturing GmbH,CureVac Inc.,CureVac Swiss AG,CureVac Corporate Services GmbH,CureVac RNA Printer GmbH,CureVac Belgium SA和CureVac Netherlands B.V.(该“公司”)关于未来事件或未来结果,与反映历史事实的陈述形成对比。

Examples include discussion of the potential efficacy of the company's vaccine and treatment candidates and the company's strategies, financing plans, growth opportunities and market growth. In some cases, you can identify such forward-looking statements by terminology such as 'anticipate,' 'intend,' 'believe,' 'estimate,' 'plan,' 'seek,' 'project,' or 'expect,' 'may,' 'will,' 'would,' 'could,' 'potential,' 'intend,' or 'should,' the negative of these terms or similar expressions.

例子包括讨论公司疫苗和治疗候选人的潜在功效以及公司的战略,融资计划,增长机会和市场增长。在某些情况下,您可以通过“预期”,“意图”,“相信”,“估计”,“计划”,“寻求”,“项目”或“期望”等术语来识别此类前瞻性陈述。这些术语或类似表达式的否定性。

Forward-looking statements are based on management's current beliefs and assumptions and on information currently available to the company. However, these forward-looking statements are not a guarantee of the company's performance, and you should not place undue reliance on such statements. Forward-looking statements are subject to many risks, uncertainties and other variable circumstances, including negative worldwide economic conditions and ongoing instability and volatility in the worldwide financial markets, ability to obtain funding, ability to conduct current and future preclinical studies and clinical trials, the timing, expense and uncertainty of regul.

前瞻性声明基于管理层当前的信念和假设以及公司当前可用的信息。但是,这些前瞻性陈述并不能保证公司的业绩,您不应该过分依赖这些陈述。前瞻性陈述受到许多风险,不确定性和其他可变情况的影响,包括全球经济状况负面,全球金融市场持续不稳定和波动,获得资金的能力,进行当前和未来临床前研究和临床试验的能力,时机,费用和不确定性。

For further information, please reference the company's reports and documents filed with the U.S. Securities and Exchange Commission (SEC). You may get these documents by visiting EDGAR on the SEC website at www.sec.gov.

有关详细信息,请参阅本公司提交给美国证券交易委员会(SEC)的报告和文件。您可以访问SEC网站www.SEC.gov上的EDGAR获取这些文件。

SOURCE: CureVac

来源:CureVac

View source version on accesswire.com:

在AccessWire.com上查看源版本:

https://www.accesswire.com/783216/curevac-advances-seasonal-flu-study-to-phase-2-in-collaboration-with-gsk-following-selection-of-promising-mrna-vaccine-candidate-with-broad-coverage

https://www.accesswire.com/783216/curevac-advances-seasonal-flu-study-to-phase-2-in-collaboration-with-gsk-following-selection-of-promising-mrna-vaccine-candidate-with-broad-coverage