Broad Spectrum Thermostable Single dose Papillomavirus-like Particles (VLP) for the prevention of all HPV-associated cancers.

Project Summary The goal of PathoVax s SBIR Phaseproject is to further develop the potential and global applicability of RGVaxTMa broad spectrum universal HPV vaccineRGVaxTM is currently a single chimeric HPV virus like particleVLPplatform that displayscopies of the highly conservedneutralizing HPV epitopeRGAnimal vaccination studies confirmed broad spectrum protectionvia RGcross neutralizing antibodiesagainst clinically relevantHPVsThis dramatic improvement over licensed HPV vaccines led to an National Cancer InstituteNCIPREVENT award that funds GMPtoxicology and an IND application for Phaseexpected QTo enhance the odds of market successPathoVax sought discussions with HPV key opinion leaders and has learnt that the practical impact of RGVax upon licensure can be compromised by vaccine implementation challenges such asmultiple immunizations andinstability due to refrigeration requirementsAs suchPathoVax is furthering the current RGVaxTM formulation via a Thermostablizing Atomic Layer DepositionTALDprocessTALD first converts aluminum adjuvanted RGVaxTM into a thermostable lyophilized glassy powderThis powder is subsequently utilized as a core which undergoes at least anothercycles of nanometer thick layering of aluminium adjuvant on its surface via Atomic Layer DepositionALDSubsequentlya secondouter layer of lyophilized RGVax may be adsorbed to the aluminum coated RGVax particlesThis new formulationtermedTALD RGVaxcan then be administered as a single injection whereby the outer layer of antigen and the aluminum based coating will act as the conventional primary doseFollowingdaystunable by adjusting the number of coatssufficient coating will dissolveallowing release of the core antigen to serve to as a boosterTALD is able to convert aluminum adjuvant formulated vaccine into a thermostable form without compromising immunogenicitymost lyophilization processes require freezing and this affects the stability of pre formulated adjuvant vaccinesAdditionallyalthough administered as a single injectionby virtue of the ALD process TALD RGVax provides a prime and boost vaccinationAimis focused on developing a robust primary protocol to readily generate TALD RGVaxwith different parameterse gdifferent ALD coating depositsand study it s subsequent in vitro conformation and temperature stabilityand in murine models its immunogenicityAimfocuses on benchmarking the toplead TALD RGVax formulations based on the parameters and findings in AimEfficacy of these lead TALDcandidates will be tested against Gardasilthe current standard of care for HPV preventionVaccination studies will be performed using animal models which validated the current Gardasil vaccine franchiseTogetherthese studies will systematically define key TALD RGVax parameters that will eventually lead to an optimized TALD RGVax formulation and process strategy for SBIR phasePROJECT NARRATIVE PathoVax is developing the world sst single immunizationthermostablebroad spectrum universal Human PapillomavirusHPVVaccineThe scientific and commercial merits of RGVaxwill offer the opportunity toprevent various forms of HPV associated cancers and disease andaddress vaccine implementation issues such as cold chain storage and patient compliance which burden both developed and developing country s healthcare systemsThis vaccine will potentially also drive up immunization rates for future generations to be free from HPV infectionsand one may envision a healthcare system where there is no controversial stigma towards a cancer preventative vaccine as well as the need for regular Pap screening being diminished