Sanaria is a biotechnology company developing vaccines protective against malaria and other infectious diseases as well as related products for use in malaria research. Sanaria's vaccines are based on the use of the sporozoite (SPZ) stage of the malaria parasite, Plasmodium, as an immunogen, and as a platform technology for liver-vectored gene delivery. SPZ are normally introduced into humans by mosquito bite where they migrate to the liver and further develop to liver stages, and eventually back into the blood stream where the parasite infects red blood cells (RBC) and causes malaria. Plasmodium falciparum is the species responsible for more than 95% deaths caused by malaria. The WHO estimates there were 247 million clinical cases and 619,000 deaths in 2021 alone.
Sanaria has developed the technology to grow and harvest aseptic, purified Plasmodium falciparum (Pf) SPZ and formulate them as vaccines for human use. Sanaria's first generation vaccine is called Sanaria® PfSPZ Vaccine, and uses radiation attenuated (weakened) SPZ, that cannot divide or cause disease, to induce these protective immune responses in the liver. The next generation vaccines are attenuated differently. Sanaria® PfSPZ-CVac, uses infectious PfSPZ administered along with antimalarial drugs to develop through the liver stage and be killed before infecting RBCs and induce protective immunity. Sanaria® PfSPZ-LARC2 Vaccine is genetically attenuated to arrest (halt development) late in the liver stages of the life cycle. Sanaria is also developing a vaccine that will prevent malaria caused by Plasmodium vivax, the second most important type of malaria parasite worldwide and is expanding its PfSPZ platform to develop vaccines for other diseases where an immune response in the liver may be beneficial, such as chronic hepatitis.
In addition to vaccines, Sanaria produces PfSPZ products for clinical research. Sanaria® PfSPZ Challenge consists of purified, aseptic, infectious PfSPZ and is used for controlled human malaria infections to assess the efficacy of vaccines and drugs against malaria, and acquired or induced immunity and resistance to malaria infection.
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 worldwide and the malaria parasite for which there is the most significant drug resistance. The overall mission includes 1) developing vaccines that prevent all human malaria and using these vaccines to immunize entire populations in geographically defined areas to halt malaria transmission and thereby eliminate malaria and 2) developing vaccines for prevention or treatment of other infectious diseases, and diseases of the liver.
History
Sanaria moved into its first facility in Rockville, MD in July 2003 supported by a phase I Small Business Innovation Research (SBIR) grant from the National Institute of Allergy and Infectious Diseases (NIAID) of the National Institutes of Health (NIH) and subsequently by 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 (BMGF), administered through the PATH Malaria Vaccine Initiative (MVI) which supported the construction of Sanaria's manufacturing facility in Rockville, MD. In 2009, Sanaria received approval from the FDA to test PfSPZ Vaccine in human trials. Sanaria® PfSPZ Vaccine is highly protective against Pf malaria transmitted by controlled human malaria infection (CHMI) and naturally transmitted malaria. PfSPZ Vaccine received FDA Fast Track Designation in 2016. Sanaria's second generation baccine,PfSPZ-CVac (CQ) has shown even stronger protection against CHMI at a much lower dose than PfSPZ Vaccine. Sanaria® PfSPZ-LARC2 Vaccine, developed most recently, has been manufactured and is expected to be assessed in clinical trials in 2023 and 2024.