SANARIA INC. — Department of Health and Human Services SBIR Phase I: NIAID

Description

DESCRIPTION Malaria causes andgt million clinical cases and million deaths annually is responsible for andgt 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 andgt and long lasting months protection against malaria in humans In its most recent clinical trial Sanariaandapos s PfSPZ Vaccine consisting of radiation attenuated aseptic purified cryopreserved PfSPZ protected of volunteers 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 years for mass administration elimination campaigns in Africa and prevention of malaria in travelers Also based on the demonstration that Sanariaandapos s non attenuated infectious PfSPZ PfSPZ Challenge can infect of volunteers in Europe and the US PfSPZ Challenge in conjunction with chemoprophylaxis is Sanariaandapos s nd 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 ^ then ^ and finally andgt x ^ mosquitoes yr Manual dissection of ^ mosquitoes yr is achievable with a fold expansion within our current manufacturing facility however automation can facilitate a further to fold increase x ^ ^ mosquitoes yr in throughput within the same physical space In contrast dissection of ^ 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 ^ mosquitoes the cost vial of vaccine drops andgt 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 Sanariaandapos 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 andgt million clinical cases and approximately million deaths annually is responsible for andgt 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 Sanariaandapos s technological innovation and which have already generated significant revenue as research reagents