Cervical Cancer Prevention Prebiotic Device

通过目前的第一阶段预测STTR资金(1R41CA254543-1A1)，Glyciome，LLC(一家妇女拥有的 公司)，正在完成临床前概念验证和集成原型设计，这是一种以用户为导向的、 益生素阴道凝胶(“PreBioGyn”)通过优化健康的阴道微生物和 粘膜功能。全球生殖器人类乳头瘤病毒(HPV)感染很常见(约4.4亿/年)，与 每年有50万例宫颈癌和28.8万例死亡。高危型HPV持续存在与HPV过度生长 有害的阴道细菌(“生物失调”)会导致导致宫颈癌的粘膜和代谢因素。这个 PreBioGyn凝胶将对所有女性开放(无论是否接种HPV疫苗)，并专门针对个人 在医疗保健中，为了优化阴道生态和防止生物失调， 炎症、HPV持久性和肿瘤发生。现有的缓解生物失调症状的疗法(冲洗， 非处方酸凝胶)损害阴道生态系统。它们的使用与泌尿生殖系统的3倍增长有关 不良事件，包括感染。相比之下，PreBioGyn提供了一种益生菌，预防宫颈癌 跨种族/民族妇女优化内源性、有益的阴道微生物区系和 具有保护性的宫颈阴道代谢和粘膜特征。通过补充奖励机制， Glyciome I-Corps团队将参加一个使用假设驱动的企业家沉浸式课程 客户发现的研究方法，以深入了解与商业相关的问题 专有的PreBioGyn技术。作为这个创新课程的一部分，i-Corp团队成员将聚集在 通过与潜在客户、战略合作伙伴和其他第三方进行深入访谈(n=100)获得信息 利益攸关方在为期8周的培训期间每周25小时/团队成员的努力。Glyciome I-Corps 团队将与讲师和其他团队分享他们所学到的知识，以获得对未来的洞察 谓词STTR授权技术的价值主张。I-Corps计划将加快发展和 将PreBioGyn技术商业化，并协助Glyciome调整消息灵通的支点 完善的产品推广计划，利用研究成果优化宫颈癌预防设备的能力 以缓解未得到满足的临床需求。这些数据将有助于修改Glyciome的商业产品影响为空- 假设，并使已知的技术生态系统多样化，以加速发明转化为 对减少宫颈癌死亡的影响，特别是对LRS的妇女。Glyciome的i-Corp团队有一个 通过开发的工作流程和项目工具(包括工作)建立了富有成效的协作历史 共同致力于产品开发、零售分销和直接面向消费者的销售，以及患者和医疗保健 供应商产品教育/意识。这个团队已经成功地将品牌转变为大型品牌(财富1000强) 公司在一起。该团队将受益于i-Corp修改和完善商业化的机会 PreBioGyn的战略，基于在创业沉浸式课程中获得的知识。

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.