Sanaria
Sanaria

Mission Statement

Sanaria's primary mission is to develop and commercialize whole-parasite sporozoite 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.

Foundation for Mission Statement

Malaria is a serious concern for billions of people living in malaria endemic areas and for travelers including military. Plasmodium falciparum (Pf) malaria caused >212 M clinical cases and 429,000-730,500 deaths in 2015, and is thought to be responsible for losses of >$10 B annually in Gross Domestic Product in Africa.

Pf sporozoites (SPZ) are found in mosquitoes and infect humans during mosquito feeding. The excellent protective efficacy in humans of weakened (attenuated) PfSPZ has been known for >40 years. More than 80% of subjects were protected for 10 months when attenuated PfSPZ were administered by ~1,000 mosquito bites. However, mosquito bite immunization cannot be considered a practical vaccine approach.

Sanaria has spent more than a decade addressing the challenges of production, purification and cryopreservation of PfSPZ, and has an extensive domestic and international patent portfolio covering these innovations. PfSPZ have been incorporated into well tolerated, safe, easily injectable PfSPZ-based vaccines; vials of aseptic, purified, cryopreserved PfSPZ-based vaccines that are in compliance with regulatory standards are routinely manufactured. Several candidate vaccines are in development: a) Sanaria® PfSPZ Vaccine, in which PfSPZ are attenuated by irradiation; b) Sanaria® PfSPZ-CVac, in which infectious PfSPZ are attenuated by concomitant administration of an anti-malarial drug; and c) Sanaria® PfSPZ-GA1, in which PfSPZ are attenuated by genetic alteration.

As of August 2017, more than 30 clinical trials of PfSPZ-based products have been conducted in 6 sites in the U.S., and 4 European and 6 African countries; a trial in SE Asia will begin in 2018. 100% protective efficacy against controlled human malaria infection (CHMI) has been shown in five clinical trials of PfSPZ vaccines in the U.S., Germany, Tanzania, and Mali. In double blind, placebo controlled trials in Germany, Mali, Tanzania, and Equatorial Guinea there were no significant differences in adverse events in recipients given PfSPZ Vaccine compared to controls who received saline, and >90% of recipients experienced no pain during and after injection. Protection against CHMI has been demonstrated at 8 months with strains of parasites different from those in the vaccine, and at 14 months with parasite strains that are the same as in the vaccine; sustained protection against natural infection in the field has been demonstrated in two trials in Mali. More than 350 infants have been immunized in Tanzania, Kenya, and Equatorial Guinea.

The entire R&D process is conducted with the collaboration of the International PfSPZ Consortium (I-PfSPZ-C), a group of nearly 200 investigators from ~40 organizations in ~20 countries who are dedicated to development of whole sporozoite malaria vaccines that can be used to prevent malaria in individuals and systematically eliminate malaria from geographically defined areas of the world.

 

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