Papillomavirus-like Particles (VLP) as Broad Spectrum Human Papillomavirus (HPV) Vaccines

Project Summary The goal of this SBIR Fast Track project is to further the commercialization of PathoVax s bi valent RGVaxTM as a broad spectrum Human PapillomavirusHPVvaccine that targets all clinically relevant HPVsCurrent HPV vaccines provide type restricted protection that focuses only on sexually transmitted HPVs resulting in an unexpected STD stigma that directly affects uptake ratesBy targeting additional HPVs especially non sexual types that causes diseases such as recalcitrant anogenitalcutaneous wartsand life threatening laryngeal papilloma sRGVaxoffers the potential to be marketed as a general public health vaccineThis provides the opportunity to sidestep current social stigma and potentially increase market uptakeThis unique advantage will attract strategic partners that PathoVax will work with to bring RGVaxinto the clinicPathoVax has licensed the underlying prototype technology based on a HPV virus like particleVLPplatform that displayscopies of the highly conservedstable HPV epitopeRGAnimal vaccination studies utilizing this prototype have confirmed broad spectrum protection againstHPVsa dramatic improvement over current HPV vaccine that only protectstypes at bestGiven the broad protectionthis prototype was awarded an NCI PREVENT grant that supports manufacturing and IND enabling studiesTo enhance the odds of market success for this innovationPathoVax has developed an improved bi valent RGVaxTM formulation as the final commercial product to satisfy FDA mandated antibody titer standards and provide comprehensive HPVdisease protectionIn this SBIR Fast TrackPhasespecific aims focuses on benchmarking our finalized formulation to obtain competitive profiling data against Gardasilthe current standard of care for HPV preventionThis will be done in the same animal models used to validate the current Gardasil vaccine franchise owned by MerckAimOnce we have demonstrated RGVax s superioritywe will transition into phasespecifics aims whereby PathoVax will demonstrate RGVax s efficacy data in animal models that simulates immune suppressionso as to develop pivotal preclinical data to support PathoVax s clinical strategy by demonstrating RGVaxTM s ability to prevent skin HPV disease in organ transplant recipientsOTRsas a first indication for marketing approvalAimAdditionallyPathoVax will provide the FDA with a GMP manufacturing strategy to produce the bi valent RGVaxTM formulation by working with a vaccine contract manufacturerCMOto develop a production and purification processAimAand also demonstrate this process produces RGVax vaccine particles that are superior or equivalent to current laboratory produced particlesBThe timely development of this data package is critical for both our upcoming pre IND FDA discussionfund raising to investor groups and initiating our IND enabling program for a bi valent phaseba clinical trial PROJECT NARRATIVE PathoVax s RGVaxoffers the opportunity to prevent various forms of HPV associated cancers and disease that have continued to impose a significant burden on patient s personal lives as well as their healthcare systemsThe scientific and commercial merits of RGVaxwill 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 cancerpreventative vaccine as well as the need for regular Pap screening being diminished