Cervical Cancer Prevention Prebiotic Device

Through current Phase I predicate STTR funding (1R41CA254543-1A1), Glyciome, LLC (a women-owned company), is completing preclinical proof-of-concept and integrated-prototype design for a novel, user-directed, prebiotic vaginal gel (“PreBioGyn”) to prevent cervical cancer by optimization of healthy vaginal microbial and mucosal function. Global genital human papillomavirus (HPV) infections are common (~440 million/yr), linking to 500,000 cases of cervical cancer and 288,000 deaths/yr. Persistence of high-risk HPV and overgrowth of harmful vaginal bacteria (“dysbiosis”) result in mucosal and metabolic factors that cause cervical cancer. The PreBioGyn gel will be accessible to all women (HPV vaccinated or not), and is specifically targeted to individuals in healthcare disparate, Low Resource Settings (“LRS”), to optimize vaginal ecology and prevent dysbiosis, inflammation, HPV persistence and oncogenesis. Existing therapies for dysbiosis symptom-relief (douches, over-the counter acid-gels) harm the vaginal ecosystem. Their use associates with 3-fold increases in urogenital adverse events, including infection. In contrast, PreBioGyn offers a prebiotic, cervical cancer prevention approach for women across racial/ethnic groups to optimize endogenous, beneficial vaginal microbiota and protective cervicovaginal metabolic and mucosal profiles. Through the supplemental award mechanism, the Glyciome I-Corps team will participate in an Entrepreneurial Immersion course that uses a hypothesis-driven research method of customer discovery to gain insights into the issues associated with commercialization of the proprietary PreBioGyn technology. As part of this innovative curriculum, the I-Corp team members will gather information through robust interviews (n=100) with potential customers, strategic partners, and other third-party stakeholders, in a 25-hours/week/team-member effort during the 8-week training period. The Glyciome I-Corps team will share what they have learned with instructors and other teams, gaining insights into the prospective value proposition of the predicate STTR grant technology. The I-Corps program will accelerate development and commercialization of the PreBioGyn technology, and assist Glyciome in adapting well-informed pivots for a refined product rollout plan, using research findings to optimize the cervical cancer prevention device’s capability to alleviate unmet clinical needs. These data will help modify Glyciome’s commercial product impact null- hypothesis, and diversify the known technology ecosystem, to accelerate transformation of the invention for impact in reducing cervical cancer deaths, especially for women in LRS. Glyciome’s I-Corp team has an established history of productive collaboration with developed workflows and project tools, including working together on product development, retail distribution and direct-to-consumer sales, and patient and healthcare provider product education/awareness. This team has successfully transitioned brands to large (Fortune 1000) companies together. The team will benefit from the I-Corp opportunity to modify and refine the commercialization strategy for PreBioGyn, based on knowledge gained during the Entrepreneurial Immersion course.Glyciome, LLC (a women-owned small business) proposes an established collaborative three-person team to participate in the I-Corps Entrepreneurial Immersion course, to complete hypothesis-driven research for customer discovery into issues associated with commercialization of their proprietary, cervical cancer prevention prebiotic device (“PreBioGyn” gel). The team members will gather information (spending 25-hours/week/team member over the 8-week curriculum) in a large number of interviews with potential customers, strategic partners, and other third-party stakeholders regarding their proprietary technology as described in the predicate STTR Phase 1 (Award #1R41CA254543-1A1). The Glyciome I-Corps team will share what they learn with instructors and other teams, gaining new insights into the prospective impact of their disruptive, user-directed technology to prevent cervical cancer (currently causing close to 300,000 deaths/yr globally) by reducing vaginal dysbiosis and optimizing healthy vaginal microbial and mucosal function.