BLUEWILLOW BIOLOGICS INC — Department of Health and Human Services SBIR Phase II: R

Description

ABSTRACT Genital herpes simplex virusHSVinfections are a major public health problem affecting rtmillion people in the United States and rtmillion globallyHSVinfection causes recurringgenital sores that are painful and result in considerable psychological distressTransmission can occur during sexual contact and from mother to child during birth with fatal consequencesThere is no effective vaccine to prevent HSVNanoBio Corporation is developing a novelintranasal nanoemulsionNEvaccine that elicits serum neutralizing activitya Thresponseand Thcells for mucosal immunitythereby offering protection systemically and at the site of HSVentry through the mucosal surfaceThe proprietary oil in water NE has been shown to incorporatedeliver and adjuvant multiple different antigen types when administered by the intranasal routethus enabling broad protection against both respiratory and sexually transmitted diseasesThe NE adjuvant was formulated with protective gBand gDantigens for evaluation in the HSVguinea pig challenge modelData generated from two studies in this model demonstrated thatiIntranasal immunization conferred favorable protection following HSVchallenge compared tointramuscular administrationiiRobust protection was conferred even though intranasal immunization elicited lower serum antibody levelsindicating that additional mucosal immunity determinants are involvediiiIncorporation of two glycoproteinsgBand gDinto the NE vaccine was superior to gDantigen alonea finding not observed with previous intramuscular vaccine candidatesandivIntranasal immunization of the NE gBgDvaccine showed superior efficacy in the guinea pig model forprevention of infectionsheddingchronic recurrenceand viral latencyas compared to a conventionalintramuscular gDvaccine formulated in alum and monophosphoryl lipid AMPLThese data support the development of an intranasal NE gBgDvaccine to achieve protection against HSVIn this Direct Phase II SBIR programNanoBio will develop the research cell banks and the viral stock for production of gBand gDantigensand develop upstream and downstream processes for antigen productionpurification and scale up to producevaccine dosesgram purified antigenNanoBio simultaneously will develop the analytical methods required for final drug product releaseA pre IND meeting will be conducted with the FDAAfter completion of this SBIR projectfunding will be sought out to perform cGMP compliant production of the vaccineand an IND will be filed with the FDA to enable phase I II clinical trials to assess safetyimmunogenicity and preliminary efficacy of the NE vaccine to prevent HSVinfection in humansA prophylactic NE gBgDgenital herpes vaccine that induces both mucosal and systemic immunity will have great medical benefit in preventing HSVinfection in the United States and throughout the world