ATHENS, Ga. & SAN JOSE, Calif.--(BUSINESS WIRE)--CyanVac LLC, a clinical-stage biotechnology company developing intranasal vaccines using a transformational parainfluenza virus 5 (PIV5)-based vector, announced today that it received federal Project NextGen funding to support a comparative Phase 2b study of CVXGA, the company’s PIV5-based vaccine candidate designed to protect against COVID-19..

佐治亚州雅典市和加利福尼亚州圣何塞市——（商业新闻短讯）——CyanVac LLC是一家临床阶段的生物技术公司，使用基于转化型副流感病毒5（PIV5）的载体开发鼻内疫苗，今天宣布，它获得了联邦项目NextGen资助，以支持CVXGA的2b期比较研究，CVXGA是该公司基于PIV5的候选疫苗，旨在预防COVID-19。。

Project NextGen is an initiative of the U.S. Department of Health and Human Services (HHS) to advance new, innovative vaccines and therapeutics providing broader and more durable protection for COVID-19. The award is one of the first made through the Rapid Response Partnership Vehicle, a consortium funded by the Biomedical Advanced Research and Development Authority (BARDA) part of the Administration for Strategic Preparedness and Response (ASPR) within HHS, to accelerate product and technology development..

NextGen项目是美国卫生与公众服务部（HHS）的一项倡议，旨在推进新的创新疫苗和治疗方法，为新型冠状病毒提供更广泛和更持久的保护。该奖项是第一个通过快速反应伙伴关系机构（Rapid Response Partnership Vehicle）获得的奖项之一，该机构是由卫生和公众服务部战略准备与反应管理局（ASPR）下属的生物医学高级研究与发展局（BARDA）资助的财团，旨在加速产品和技术开发。。

The Phase 2b study of PIV-5-based CVXGA intranasal COVID-19 vaccine will be conducted through BARDA’s clinical studies network.

基于PIV-5的CVXGA鼻内COVID-19疫苗的2b期研究将通过BARDA的临床研究网络进行。

'This award will accelerate the development of our PIV5-based intranasal COVID-19 vaccine, building on our very promising Phase 1 and preliminary Phase 2a clinical trial results,” said Biao He, Ph.D., founder and CEO of CyanVac. “PIV5 is a novel intranasal vaccine vector that has been shown to replicate safely in humans in clinical trials and stimulates all three pillars of immunity – cellular, mucosal, and humoral – with minimal uncomfortable side effects.

CyanVac创始人兼首席执行官Biao He博士说：“这个奖项将加速我们基于PIV5的鼻内新型冠状病毒肺炎疫苗的开发，建立在我们非常有希望的第一阶段和初步2a期临床试验结果的基础上。”。“PIV5是一种新型鼻内疫苗载体，在临床试验中已被证明可在人体内安全复制，并刺激细胞，粘膜和体液这三大免疫支柱，且副作用最小。

The successful development of an intranasal COVID-19 vaccine using this new vector will demonstrate the capabilities of our PIV5 platform and benefit the development of PIV5-based vaccines for other emerging infectious diseases.”.

使用这种新载体成功开发鼻内新型冠状病毒肺炎疫苗将证明我们的PIV5平台的能力，并有利于开发针对其他新兴传染病的基于PIV5的疫苗。”。

Under the award, CyanVac will be the sponsor for a 10,000 participant, randomized double-blinded Phase 2b study that will compare the efficacy, safety and immunogenicity of CyanVac’s next-generation intranasal COVID-19 vaccine candidate to a U.S. Food and Drug Administration (FDA)-approved mRNA-based COVID-19 vaccine.

根据该奖项，CyanVac将成为10000名参与者的随机双盲2b期研究的赞助商，该研究将比较CyanVac下一代鼻内新型冠状病毒肺炎候选疫苗与美国食品和药物管理局（FDA）批准的基于mRNA的新型冠状病毒肺炎疫苗的疗效，安全性和免疫原性。

The study will be conducted through BARDA's Clinical Studies Network and will evaluate the vaccine in a subset of participants at higher risk of severe disease. The study is expected to start in the fall of 2024 and will evaluate the efficacy of CVXGA in preventing not only severe COVID-19 infections, but also asymptomatic infections..

这项研究将通过BARDA的临床研究网络进行，并将在患有严重疾病风险较高的参与者中评估疫苗。该研究预计将于2024年秋季开始，并将评估CVXGA在预防严重COVID-19感染以及无症状感染方面的疗效。。

'Many vaccines including COVID-19 vaccines are quite effective at preventing serious illness and death, but there is a need for vaccines that can also block transmission of a pathogen to other people,” said Dr. Henry Radziewicz, Chief Medical Officer of CyanVac. “Our intranasal vaccine is delivered to mucosal surfaces, a key focus area for Project NextGen by BARDA because such vaccines have the potential to reduce the spread of disease.”.

“包括新型冠状病毒肺炎疫苗在内的许多疫苗在预防严重疾病和死亡方面非常有效，但也需要能够阻止病原体向他人传播的疫苗，”CyanVac首席医疗官亨利·拉齐维茨博士说。“我们的鼻内疫苗被输送到粘膜表面，这是BARDA NextGen项目的一个关键重点领域，因为这种疫苗有可能减少疾病的传播。”。

“We are excited to work with BARDA on this large-scale trial and are grateful for their support,” added Dr. He.

何博士补充道：“我们很高兴能与BARDA合作进行这项大规模试验，并感谢他们的支持。”。

The project is being funded with federal funds from HHS, ASPR, BARDA, under Other Transaction (OT) number 75A50123D00005.

该项目由美国卫生与公众服务部（HHS）、澳大利亚公共资源管理局（ASPR）、巴尔达（BARDA）的联邦资金资助，其他交易（OT）编号为75A50123D00005。

About CVXGA

关于CVXGA

CVXGA is a clinical-stage COVID-19 vaccine candidate based on a proprietary parainfluenza virus 5 (PIV5) vector that encodes the spike (S) protein of SARS-CoV-2. The PIV5 vector was developed at the University of Georgia and is based on a respiratory virus that is not known to cause disease in humans which has been commonly administered to dogs as part of combination distemper/kennel cough vaccines for decades.

CVXGA是基于专有副流感病毒5（PIV5）载体的临床阶段COVID-19候选疫苗，该载体编码SARS-CoV-2的尖峰蛋白。PIV5载体是在佐治亚大学开发的，基于一种呼吸道病毒，这种病毒不知道会引起人类疾病，几十年来，这种病毒通常作为犬瘟热/犬瘟热咳嗽联合疫苗的一部分用于狗。

CyanVac and its affiliate, Blue Lake Biotechnology, are developing CVXGA as a single-dose, intranasal vaccine to prevent SARS-CoV-2 infection and serious complications associated with COVID-19. Preclinical studies have demonstrated that CVXGA is immunogenic and protective and prevents transmission of SARS-CoV-2.

CyanVac及其附属公司Blue Lake Biotechnology正在开发CVXGA作为单剂量鼻内疫苗，以预防SARS-CoV-2感染和与COVID-19相关的严重并发症。临床前研究表明，CVXGA具有免疫原性和保护性，可防止SARS-CoV-2的传播。

Phase 1 data has shown that subjects dosed with CVXGA showed robust mucosal, cellular and humoral immune responses with limited or no reactogenicity and no serious events assessed as related to the vaccine..

第一阶段的数据显示，服用CVXGA的受试者表现出强大的粘膜，细胞和体液免疫反应，反应原性有限或无反应，并且没有评估与疫苗相关的严重事件。。

About CyanVac and Blue Lake Biotechnology

关于CyanVac和Blue Lake Biotechnology

CyanVac LLC and its affiliate, Blue Lake Biotechnology, Inc., are developing intranasal vaccines that harness the full breadth of the immune system to keep people healthy, prevent serious infectious diseases, and protect the health of vulnerable populations. Our platform uses a proprietary parainfluenza virus 5 vector into which a foreign gene from a targeted pathogen is inserted.

CyanVac LLC及其附属公司蓝湖生物技术有限公司（Blue Lake Biotechnology，Inc.）正在开发鼻内疫苗，利用免疫系统的全方位来保持人们的健康，预防严重的传染病，并保护弱势人群的健康。我们的平台使用专有的副流感病毒5载体，将来自靶向病原体的外源基因插入其中。

We have generated a robust clinical-stage pipeline of best-in-class vaccines designed to overcome the limitations of existing vaccine technologies. Our lead product candidates have demonstrated potential for high efficacy and durability with few vaccine-related side effects..

我们已经建立了一个强大的临床阶段最佳疫苗管道，旨在克服现有疫苗技术的局限性。我们的主要候选产品已证明具有高效性和耐用性的潜力，几乎没有与疫苗相关的副作用。。

Learn more at CyanVac and Blue Lake Biotechnology.

在CyanVac和Blue Lake Biotechnology了解更多信息。