Smallpox subunit vaccine in the C-PERL expression system

描述(由申请人提供)：切萨皮克Perl(C-Perl)是一家重组蛋白制造公司，该公司建议开发一种基于牛痘重组蛋白的天花疫苗，并在C-Perl的专有幼虫表达系统中表达。拟议的疫苗将针对数百万无法接种天花活病毒疫苗的人。C-Perl系统是一种专有的自动化杆状病毒介导的系统，能够产生从克到公斤级别的重组蛋白质。一些在痘病毒和亚单位疫苗方面的世界领先专家将协助C-Perl执行这项工作。建议的疫苗已经在相关的早期动物模型中进行了测试，并被证明有效。C-Perl拥有在亚单位疫苗中使用这些蛋白质的独家许可证，并已证明其专有系统可以生产大量高质量、功能性的重组蛋白质，并可在可扩展的、符合cGMP的过程中生产。该申请分为三个里程碑：(1)开发生产亚单位疫苗的符合cGMP的工艺；(2)使用C-PERL幼虫系统生产的蛋白质完成小鼠痘苗挑战模型和猴痘猴子模型；(3)批准IND用于亚单位疫苗的L/11期人体试验。这三个里程碑的成功将使L/11期人体试验取得快速进展，并最终在普通人群中使用该疫苗。

DESCRIPTION (provided by applicant): Chesapeake PERL (C-PERL), a recombinant protein manufacturing company, proposes to develop a smallpox vaccine based on recombinant proteins from vaccinia and expressed in C-PERL's proprietary larval expression system. The proposed vaccine will be targeted for the millions of people who cannot take the live virus vaccines for smallpox. The C-PERL system is a proprietary, automated baculovirus mediated system capable of producing recombinant proteins from the gram to the kilogram level. Some of the world's leading experts in both poxviruses and subunit vaccines will assist C-PERL in performing the work. The proposed vaccine has been tested and proved effective in a relevant, early phase animal model. C-PERL has an exclusive license for using the proteins in a subunit vaccine, and has demonstrated that its proprietary system can produce large quantities of high quality, functional recombinant proteins and in a scaleable, cGMP compliant process. The application is separated into thee milestones: (1) Development of a cGMP compliant process for the production of the subunit vaccine; (2) Completion of a mouse vaccinia challenge model and a monkey pox monkey model using protein produced in the C-PERL larval system; (3) Approval of an IND for testing of the subunit vaccine in a Phase l/ll human trial. Success in these three milestones will allow rapid progress towards Phase l/ll human trials and toward eventual use of the vaccine in the general population.