Sanaria


Sanaria is a biotechnology company developing vaccines protective against malaria, as well as related products for use in malaria research. Sanaria’s vaccines are based on the use of the sporozoite stage of the malaria Plasmodium parasite as immunogen. The SPZ stage of the malaria parasite is inoculated into humans by mosquito bite. Sanaria has developed the technology to grow and harvest aseptic, purified Plasmodium falciparum SPZ and formulate them for use in vaccines for human use. Pf is responsible for the most of the approximately 500,000 deaths caused by malaria annually. Sanaria's most advanced candidate vaccine is called Sanaria® PfSPZ Vaccine, which uses radiation attenuated SPZ, that cannot divide or cause disease, to induce these protective immune responses. Sanaria is developing other PfSPZ vaccines, including Sanaria® PfSPZ-CVac, which uses non-attenuated, infectious PfSPZ administered along with antimalarial drugs to induce protective immunity, and Sanaria® PfSPZ-GA1, which uses genetically attenuated PfSPZ as immunogen. Sanaria is also developing a vaccine that will prevent malaria caused by Plasmodium vivax, the second most important cause of malaria world-wide. Additionally Sanaria produces PfSPZ products for clinical research. Sanaria® PfSPZ Challenge consists of purified, aseptic, non-attenuated PfSPZ and is used for controlled human malaria infections to assess the efficacy of new vaccines and drugs against malaria, and resistance to malaria.

Mission statement

Sanaria's primary mission is to develop and commercialize whole-parasite PfSPZ vaccines that confer high-level, long-lasting protection against Plasmodium falciparum, the malaria parasite responsible for more than 95% of malaria-associated severe illness and death world-wide and the malaria parasite for which there is the most significant drug resistance. The overall mission includes developing vaccines that prevent all human malaria and to use those vaccines to immunize entire populations in geographically defined areas to halt malaria transmission and thereby eliminate malaria.

History

Sanaria moved into its first facility in Rockville, MD in July 2003 supported by a phase I Small Business Innovation Research grant from the National Institute of Allergy and Infectious Diseases of the National Institutes of Health and a $4.09M grant from the United States Army Medical Research Acquisition Activity Group to further develop its vaccine. In 2007, Sanaria received a $29.3-million grant from the Bill and Melinda Gates Foundation, administered through the PATH Malaria Vaccine Initiative which supported the construction of their manufacturing facility in Rockville, MD. In 2009, Sanaria received approval from the FDA to test the vaccine in human trials, the results of which have now been published in multiple high impact and internationally peer reviewed journals. Sanaria® PfSPZ Vaccine has shown high level protection against, both controlled human malaria infection and naturally transmitted malaria, infection by Plasmodium falciparum. Sanaria received FDA Fast Track Designation in 2016.

Clinical Trials

Nineteen clinical trials of PfSPZ Vaccine have been completed or are being conducted in Tanzania, Kenya, Mali, Burkina Faso, Gabon, Equatorial Guinea, Germany, the Netherlands, and the U.S.. Seven clinical trials of PfSPZ-CVac have been conducted in the Netherlands, the U.S., Germany, Equatorial Guinea and Mali. PfSPZ-GA1 is being assessed in its first clinical trial in the Netherlands. PfSPZ Challenge has enabled research teams worldwide to conduct controlled human malaria infection studies in the U.S., the Netherlands, Germany, United Kingdom, Spain, Tanzania, Kenya, Mali, Gabon, Equatorial Guinea, and the Gambia.

i-PfSPZ-C

Sanaria’s entire R&D process is conducted with the collaboration of the International PfSPZ Consortium, a group of ~200 investigators and funders from ~40 organizations in ~20 countries who are dedicated to development of whole PfSPZ malaria vaccines that can be used to prevent malaria in individuals and systematically eliminate malaria from geographically defined areas of the world.
In addition to the U.S. NIAID, U.S. DoD, and the BMGF, significant funding for development of PfSPZ vaccines has come from the Government of Equatorial Guinea and the corporate social responsibility arms of three U.S. energy companies, Top Institute Pharma, universities in Nijmegen and Leiden, the Netherlands, the University of Tübingen, the , the Swiss Tropical Public Health Institute and the Swiss Government, and the Tanzanian Commission on Science and Technology.

Awards