Plasmodium Falciparum Whole Sporozoite Malaria Vaccine

DESCRIPTION provided by applicant The ideal tool for eliminating Plasmodium falciparum Pf the causative agent of of all malaria deaths would be a highly effective vaccine that prevents blood stage infection and thereby prevents the disease and transmission The only immunogens demonstrated able to induce andgt sustained months protective efficacy in humans are Pf sporozoites SPZ Sanariaandapos s goal is to develop and commercialize a Pf SPZ vaccine that prevents Pf blood stage infection in andgt of recipients The SanariaTM PfSPZ Vaccine is composed of aseptic attenuated purified cryopreserved PfSPZ The platform technology developed to manufacture the PfSPZ Vaccine has facilitated manufacture of PfSPZ for infection of volunteers to test vaccines and drugs PfSPZ Challenge and for vaccination with PfSPZ Challenge under chloroquine protection PfSPZ CVac In late November our collaborators at the Vaccine Research Center NIAID NIH established that IV immunization with PfSPZ Vaccine protected of volunteers against malaria In collaborators in the UK US and Germany demonstrated IM ID and IV administration of PfSPZ Challenge infected of volunteers In October the st clinical trial of PfSPZ CVac began in the Netherlands These products are on an aggressive timeline to commercialization with clinical trials in countries on continents planned for the next months When Sanaria was established many considered it impossible to manufacture PfSPZ that would meet regulatory standards When this was achieved under the first Phase II SBIR of this grant it was argued that PfSPZ could not be manufactured to meet cost of goods standards In the Competitive Renewal of that Phase II SBIR for which we report our Key Results herein we made substantial progress toward reducing cost of goods by innovatively improving the efficiency of manufacturing and release assays Based on that progress we have designed a manufacturing facility to be built within our current space that will conservatively manufacture vials year o x PfSPZ vial at andlt $ vial We previously thought the new facility would have to be at a different site cost $ M and require years to design build and validate Based on our innovations in manufacturing success in the clinic and the increased demand for our PfSPZ products we re designed the facility as an extension of our current Clinical Manufacturing Facility It can be built at a cost of $ M and be operational in andlt years from initiation In tis Competitive Renewal Proposal we will establish the innovations to allow full integration of the scaled up process steps for manufacture of PfSPZ products in the new facility We will translate our innovations and advances into a robust process at a higher scale including refining the equipment tools and processes at each step months Preliminary integration months will be followed by a finalized process in the new facility months This will furthe reduce cost of goods for all of Sanariaandapos s PfSPZ based products and accelerate Phase trials licensure and commercialization by putting manufacturing on track with Sanariaandapos s clinical development efforts PUBLIC HEALTH RELEVANCE Malaria causes million clinical cases and nearly million deaths annually is responsible for andgt loss of GDP in Africa annually and is a serious concern for travelers and military personnel Sanariaandapos s goal is to develop and commercialize a andgt protective malaria vaccine for three primary markets with a potential for andgt $ billion annual revenues Travelers from the developed world to malaria endemic areas military personnel and geographically focused elimination campaigns are the initial markets The eventual goal though continues to be infants and young children in the developing world and eventual eradication of the disease Success in this Phase II SBIR renewal will leave Sanaria ideally placed to design and implement an enhanced manufacturing facility in which the companyandapos s malaria vaccine can be optimally manufactured for pivotal Phase studies licensure and commercial launch