Smallpox subunit vaccine in the C-PERL expression system

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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.