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

Description

ABSTRACT Gonorrhea is a genital tract infection caused by Neisseria gonorrhoeaeIt does not induce a state of specific protective immunity and can be acquired repeatedlyDespite public health measuresgonorrhea persists at an unacceptably high frequencyand there is no vaccine against itThe continued emergence of antibiotic resistance threatens to render gonorrhea untreatableOur findings have revealed that Ngonorrhoeae subverts the immune system for its own benefit by inducing high levels of the key immunosuppressive cytokineinterleukinILUsing a mouse model of vaginal gonococcal infectionour preliminary data suggests a novel strategy of immune based therapy aimed at reversing the immunosuppression induced by NgonorrhoeaeNeutralizing antibody against ILhas been encapsulated in biodegradable micro particles for local sustained release to create a proprietary product designated GneXaIntra vaginal administration of GneXain mice with genital gonococcal infection induces T cell and antibody responses against Ngonorrhoeaewhich accelerate clearance of the existing infection and generate resistance to re infection with both homologous and heterologous strainsAdvantages of this treatment include minimal inflammatory potential in the female reproductive tractIn this phase I applicationthe dose regimen of GneXawill be optimizedInitial mechanistic studies related to the role of B cells and duration of protection will be performedWe will also test the ability of GneXato induce protection against re infection in the clinically and commercially relevant context of treatment with antibioticsThis work will provide proof of principle and the scientific underpinnings for GneXaFuture SBIR phase II studies will further elucidate cross protection and validate the expected applicability of scaled up encapsulation methods to anti ILantibodyevaluating yieldbioactivitybatch to batch consistency and shelf stabilityThe CDC has listed drug resistant Ngonorrhoeae asan immediate public health threat that requires urgent and aggressive actionand WHO has called forthe creation and development of new therapeutic optionsThis proposal is part of our company s response to that call to action NARRATIVEPUBLIC HEALTH RELEVANCE STATEMENTGonorrhea is the second most frequentnotifiable infectious disease in the United Statesthe Centers for Disease Control report andgtcases annuallyand world wide incidence is estimated at andgtmillion new infections per yearNo vaccine is available and the emergence of multiple drug resistant strains now raises serious and urgent concerns over future treatment optionsThis proposal seeks to develop a novel strategy of immune intervention against gonorrheaby redirecting the host s immune response to generate effective immunity that eliminates an existing infection and protects against re infection