Malaria causes >250 million clinical cases and ~1 million deaths annually, is responsible for >1% loss of GDP in Africa and is a serious concern for travelers and military personnel. A highly effective vaccine is desperately needed and radiation-attenuated Plasmodium falciparum (Pf) sporozoites (SPZ) and non- attenuated PfSPZ with chloroquine chemoprophylaxis (ChemoProphylaxis with Sporozoites, CPS), administered by mosquito bites, induce the most efficacious (>90%) and long lasting (10-28 months) protection against malaria in humans. In its most recent clinical trial, Sanaria's PfSPZ Vaccine, consisting of radiation attenuated, aseptic, purified, cryopreserved PfSPZ, protected 6/6 (100%) of volunteers 6/9 subjects who received the highest and second highest dose of PfSPZ intravenously (IV), unparalleled in the history of malaria vaccine development. PfSPZ Vaccine will undergo rigorous testing during the next year in clinical trials targeting individuals in the U.S., Germany, Tanzani, Mali, and Equatorial Guinea towards licensure in ~4 years for mass administration elimination campaigns in Africa and prevention of malaria in travelers. Also, based on the demonstration that Sanaria's non-attenuated, infectious PfSPZ (PfSPZ Challenge) can infect 100% of volunteers in Europe and the US, PfSPZ Challenge in conjunction with chemoprophylaxis is Sanaria's 2nd vaccine product, PfSPZ-Chemoprophylaxis (C) Vaccine (Vac) (PfSPZ-CVac). The accelerated path to licensure requires scale-up efforts to meet projected market needs. Although the absolute number of PfSPZ required/yr will depend on the numbers of PfSPZ/dose, and the numbers of PfSPZ that can be obtained per mosquito, we anticipate soon needing to process 10^7, then 10^8 and finally >2x10^8 mosquitoes/yr. Manual dissection of 10^7 mosquitoes/yr is achievable with a 2-fold expansion within our current manufacturing facility however, automation can facilitate a further 5 to 10-fold increase (5x10^7 -10^8 mosquitoes/yr) in throughput within the same physical space. In contrast dissection of 10^8 mosquitoes per year by hand will require sizeable expansion in order to house a hugely expanded dissector taskforce. Modeling of projected cost curves also indicates that the price of the vaccine will drop progressively with each increment manufactured only if automation is put in place, but not with manual-dissection. In fact after processing the first 10^7 mosquitoes, the cost/vial of vaccine drops >50%. Based on preliminary development of automatable prototypes we propose to construct the first integrated automated mosquito microdissection system (AMMS) and fine-tune performance parameters and materials compliance for high throughput cGMP processing at an industrial scale. Successful completion of these goals will put Sanaria's manufacturing progress on track with its clinical development and commercialization plans, allow for greatly enhanced production from current facilities without a need for significant expansion and thereby facilitate more immediate widespread use of a whole PfSPZ vaccine for the hundreds of millions who suffer from this disease.

Public Health Relevance

Malaria causes >300 million clinical cases and approximately 1 million deaths annually, is responsible for >1% loss of GDP in Africa and is a serious concern for travelers and military personnel. Sanaria was founded to transform mosquito-administered sporozoites (SPZ) that comprise the most highly efficacious method of immunizing humans against malaria, into practical, easily-administered human vaccines for preventing and eliminating malaria. Fundamental to this translation is the dissection of mosquito salivary glands that harbor the SPZ stage of the malaria parasite, a procedure that is efficiently performed by highly-skilled human operators. However, automating this procedure and dissociating it from limitations of human capability, endurance, and training can result in quantum improvements in the throughput, implementation and long-term sustainability of the process. As a result, production of the radiation-attenuated Plasmodium falciparum (Pf) SPZ vaccine (termed PfSPZ Vaccine), infectious PfSPZ (PfSPZ Challenge) for inducing human malaria in drug and vaccine efficacy trials, and, infectious PfSPZ chemoprophylaxis (C) Vaccine (Vac ) termed PfSPZ-CVac, can be easily scaled up to meet projected market needs. Moreover, automation of the most human- intensive procedure in our production process will also allow concomitant large-scale manufacturing of a variety of live, purified, cryopreserved SPZ from various species of Plasmodium that have resulted from Sanaria's technological innovation and which have already generated significant revenue as research reagents.

National Institute of Health (NIH)
National Institute of Allergy and Infectious Diseases (NIAID)
Small Business Innovation Research Grants (SBIR) - Phase I (R43)
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Special Emphasis Panel (ZRG1-IMST-M (13))
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MO, Annie X Y
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Sanaria, Inc.
United States
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