Cervical Cancer Prevention Prebiotic Device

In this Phase II SBIR project, Glyciome, a women-owned company, is commercializing ‘PreBioGyn’, a prebiotic intravaginal lubricant designed to prevent bacterial vaginosis (BV), the most common vaginal infection in the world and an established biological risk factor for cervical cancer (CC). There is an urgent need to prevent this cancer (the 4th most common for women globally), which is causing rising death rates in the US for those in low- resource settings (LRS). Our patent-pending, preservative-free therapeutic device offers a disruptive microecological approach to CC prevention for use by anyone - regardless of their human papillomavirus (HPV) vaccination status - to optimize women’s health and reduce public health costs. This is critical in the US, where <60% of teens and fewer adults are fully vaccinated against HPV. About 1 in 4 female Americans (e.g., 34 million people) have BV, resulting in disease-related public health costs of $10B/yr. Current BV treatments include antibiotics and vaginal lubricants (for symptom management), resulting in ~40% disease recurrence rates, with increased HPV infection and CC risks due to iatrogenic vaginal cell and beneficial vaginal microbiome toxicity. PreBioGyn is a preservative-free, therapeutic device that will have first-in-class claims as a pre-coital lubricant to support vaginal ecosystem health for use across reproductive life stages, including subsequent development as the first-ever lubricant in the US cleared for use during pregnancy. The latter is urgently needed, given that half of BV and CC patients are reproductive-aged women. The beachhead market for PreBioGyn’s approach to BV and CC prevention, as a lubricant to optimize vaginal health, will offer benefits to anyone, including those who have received the HPV vaccine, those already infected with HPV, and those who refuse vaccines. The Phase I studies of PreBioGyn provided a solid foundation for this Phase II SBIR with in vitro product proof-of- concept established for vaginal cell and vaginal microbiome safety as compared to existing BV-relief lubricants (with the US current market leader having $60MM/yr. in sales). Phase II Aims will support sequential regulatory clearances for PreBioGyn for use across reproductive stages with an initial product launch within two years, including the completion of the following tasks: Specific Aim 1 Finalize manufacturing of PreBioGyn in commercial enclosures for Phase II Aims and launch. Specific Aim 2 Complete biocompatibility assays for FDA clearance for PreBioGyn as a gamete-safe lubricant for fertility patients and design the pathway for subsequent product clearance for use during pregnancy. Specific Aim 3 Conduct a safety and feasibility randomized clinical trial (RCT) of PreBioGyn in at least 70 LRS subjects recently treated for BV. Commercial Application. The PreBioGyn market will intersect with two US retail categories: personal lubricants (US sales $325MM/yr., global sales $2B/yr.) and feminine symptom treatments (US sales $350MM/yr). PreBioGyn sales of $75MM/yr. will provide near-term CC prevention across local healthcare systems and grow Glyciome’s presence in the $127B/yr personal care industry.