GelVac Stable, Dry-Powder Nasal Recombinant VLP-Based Bivalent Norovirus Vaccine

DESCRIPTION provided by applicant Noroviruses are a group of enteropathogenic viruses belonging to the taxonomic family Caliciviridae which causes approximately of epidemic non bacterial outbreaks of gastroenteritis around the world and may be responsible for of all foodborne outbreaks of gastroenteritis in the US In developing countries according to a estimate by CDC researchers up to children less than years old die of norovirus infection each year There is no vaccine against norovirus and no specific antiviral drugs to treat infections To be safe and effective a vaccine must protect humans against two serotypes of Norovirus currently causing epidemics Nanotherapeutics and its collaborators propose to conduct BLA enabling preclinical development of a stable dry powder nasal norovirus vaccine that will form the basis for initiation of Phase I clinical studies The vaccine consists of the GelVacandquot dry powder formulation in combination with recombinant virus like particle rVLP antigens of two dominant norovirus genotypes G III manufactured in green plants using a transient viral expression system The powder vaccine is packaged in an established disposable nasal powder inhaler Valois Monopowder MK IV ready for nasal administration The GelVacandquot dry powder formulation is a novel in situ gelling nasal powder vaccine delivery platform based on GelSite R polymer a distinct and inert ionic polysaccharide polygalacturonic acid that enhances the immune response through prolonged nasal residence sustained antigen release by an in situ gelation mechanism and stabilization of vaccine antigens The GelVacandquot dry powder approach addresses the storage and administration shortcomings of the current NoV oral approach The G I VLP antigen produced using the plant expression system has been successfully formulated with GelVacandquot dry powder and a series of preclinical immunogenicty studies have been conducted with the vaccine formulation at Arizona State Universityandapos s ASU These studies have demonstrated that the antigen is stable in the GelVacandquot dry powder and nasal administration of the GelVacandquot dry powder with G I antigen induced strong mucosal and humroal responses including a robust IgA response in intestinal tract In addition the response levels generated with GelVacandquot dry powder was comparable or better than those with formulations containing a variety of TLR agonists as adjuvants These studies formed a solid basis for the proposed fast track development of GelVacandquot dry powder NoV vaccine containing both G I and G II antigens that is designed to provide protection against two dominant norovirus genotypes Noroviruses are a group of enteropathogenic viruses belonging to the taxonomic family Caliciviridae which causes approximately of epidemic non bacterial outbreaks of gastroenteritis around the world and may be responsible for of all foodborne outbreaks of gastroenteritis in the US The GelVacandquot dry powder formulation is a novel in situ gelling nasal powder vaccine delivery platform based on GelSite R polymer a distinct and inert ionic polysaccharide polygalacturonic acid that enhances the immune response through prolonged nasal residence sustained antigen release by an in situ gelation mechanism and stabilization of vaccine antigens These studies formed a solid basis for the proposed fast track development of GelVacandquot dry powder NoV vaccine containing both G I and G II antigens that is designed to provide protection against two dominant norovirus genotypes