STTR Phase II: VaxMAP a single dose multivalent vaccine to produce durable and cross-reactive immunity against various coronaviruses

这个小企业技术转让第二阶段项目的广泛影响/商业潜力将解决对更有效疫苗的未得到满足的需求，这些疫苗可以迅速部署，以缩短病原体出现和疫苗开发之间的滞后时间，最大限度地减少社会经济影响，如新冠肺炎大流行中看到的那些影响。这项新的疫苗技术有可能在未来新病原体爆发期间极大地改善美国公民的生活。此外，这项新技术有可能产生积极影响，为全世界提供高价值的美国产品，并在研究领域和生物技术产品制造方面为美国创造就业机会。STTR第二阶段项目的成功完成将使该公司拥有一种具有潜在的多种合作机会的技术，包括生物技术和制药企业，为SARS-CoV-2疫苗开发抗原。通过开发这一新的疫苗平台技术，该公司将能够进入全球疫苗市场的一个重要部分，预计2021年将达到610亿美元，预计到2028年将增长到1250亿美元。这一小企业技术转让(STTR)第二阶段项目将使该公司能够开发一种新的疫苗平台，对新出现的病原体具有强大和持久的疫苗接种反应。尽管现在已经有了有效的新冠肺炎疫苗来抗击2019年开始的全球大流行，但它们面临着重大限制，包括对新的传播变种的效力减弱，需要多次接种，以及由于冷链问题而挑战分销路径。研究目标是在小鼠免疫模型中确定疫苗的最佳剂量，了解其免疫反应的持久性，评估疫苗对不同SARS-CoV-2变种的保护性免疫，评估疫苗的货架期稳定性，并制定监管计划。根据成功的初步数据，预计新产品将通过提供持久的免疫反应来产生对多种SARS-CoV-2变种的保护性免疫，与目前的疫苗相比，这种免疫反应将导致对感染的更持久的保护。此外，新疫苗平台的保质期和储存条件预计将有助于分发和储存，因为预计不会有大规模的冷链物流。这一奖励反映了NSF的法定使命，并通过使用基金会的智力优势和更广泛的影响审查标准进行评估，被认为值得支持。

The broader impact/commercial potential of this Small Business Technology Transfer (STTR) Phase II project will address the unmet need for more effective vaccines that can be rapidly deployed to decrease the lag time between pathogen emergence and vaccine development, minimizing socioeconomic effects such as those seen in the COVID-19 pandemic. This new vaccine technology has the potential to drastically improve the lives of US citizens during future outbreaks of new pathogens. Further, this new technology has the potential to have positive impacts by providing high value US products for the whole world and generating US jobs both in research fields and manufacturing of biotechnology products. Successful completion of this STTR phase II project will position the company with a technology that has potential multiple partnership opportunities including biotechnology and pharmaceutical businesses developing antigens for vaccines against SARS-CoV-2. By developing this new vaccine platform technology, the company will be able to gain access to a significant segment of the global vaccine market estimated at $61 billion in 2021 and projected to grow to $125 billion by 2028. This Small Business Technology Transfer (STTR) Phase II project will enable the company to pursue the development of a new vaccine platform with robust and long-lasting vaccination responses against emergent pathogens. Although effective COVID-19 vaccines are now available to fight the global pandemic that started in 2019, they are facing significant limitations including diminished efficacy against new spreading variants, requirements for multiple doses, and challenging distribution pathways due to cold chain issues. The research objectives are to determine the optimal dose of the vaccine in a murine immunization model, understand the durability of its immune response, assess the vaccine's protective immunity against different SARS-CoV-2 variants, evaluate the vaccine shelf-life stability and develop a regulatory plan. Based on the successful preliminary data, it is anticipated that the new product will generate protective immunity against multiple variants of SARS-CoV-2 by providing a long-lasting immune response that will result in longer-lasting protection against infection when compared to current vaccines. Furthermore, the shelf-life and storage conditions of the new vaccine platform are anticipated to facilitate distribution and stockpiling, as no drastic cold chain logistics are expected.This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the Foundation's intellectual merit and broader impacts review criteria.