Sanaria Inc. Receives U.S. NIH Phase II Small Business Innovation Research Grant for its Malaria Vaccine Manufacturing Process
Sanaria Inc. has received additional support from the National Institute of Allergy and infectious diseases (NIAID) of the National Institutes of Health in the form of a Phase II Small Business Innovation Research (SBIR) Grant. The award for two years isUS$1.99 million. Subject to satisfactory progress by Sanaria, continued funding for a third year will bring the total to nearlyUS$3 million. This new funding will facilitate efforts to increase the efficiency and scale-up of manufacturing and release processes to the levels required for Phase 3 clinical testing, licensure, and commercial launch of Sanaria(TM) PfSPZ, Sanaria's attenuated whole parasite malaria sporozoite vaccine.
Sanaria(TM) PfSPZ Vaccine entered Phase 1 clinical trials of safety and efficacy at the Naval Medical Research Center and the University of Maryland School of Medicine's Center for Vaccine Development in the spring of 2009.
Sanaria(TM) PfSPZ Vaccine consists of live sporozoite-stage Plasmodium falciparum parasites weakened (attenuated) by exposure to radiation. Such sporozoites, delivered to human volunteers by the bite of infected mosquitoes, have been shown to confer protection against malaria. Sanaria has developed novel technologies and facilities to successfully translate research findings from a handful of volunteers receiving mosquito-administered sporozoites to a bona fide vaccine that can be clinically tested and conventionally administered to hundreds of millions of recipients. Although live, attenuated pathogens are commonly used to vaccinate against many viral and bacterial diseases, the Sanaria(TM) PfSPZ Vaccine is unique among vaccines designed to prevent malaria. For the first time, an immunogen conferring high levels of protection against malaria has been formulated as a stable, injectable vaccine candidate that meets regulatory standards.
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