Cervical Cancer Prevention Prebiotic Device

通过目前的I期同品种器械STTR资助（1 R41 CA 254543 - 1A 1），Glyciome，LLC（一家女性拥有的 公司），正在完成临床前概念验证和集成原型设计，用于一种新颖的，用户导向的， 益生元阴道凝胶（“PreBioGyn”），通过优化健康的阴道微生物和 粘膜功能全球生殖器人乳头瘤病毒（HPV）感染很常见（约4.4亿/年），与 500，000例宫颈癌和288，000例死亡。高危型HPV的持续存在和 有害的阴道细菌（“生态失调”）导致引起宫颈癌的粘膜和代谢因素。的 PreBioGyn凝胶适用于所有女性（接种HPV疫苗或未接种），并且专门针对个人 在医疗保健不同的低资源环境（“LRS”）中，为了优化阴道生态并防止生态失调， 炎症、HPV持久性和肿瘤发生。用于生态失调的现有疗法-缓解（灌洗， 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疾病的3倍增加有关。 不良事件，包括感染。相比之下，PreBioGyn提供益生元，预防宫颈癌 为不同种族/民族的女性提供优化内源性有益阴道微生物群的方法， 保护子宫颈阴道代谢和粘膜特征。通过补充奖励机制， Glyciome I-Corps团队将参加一个创业沉浸式课程，该课程使用假设驱动的 客户发现的研究方法，以深入了解与商业化相关的问题， 专有的PreBioGyn技术。作为这一创新课程的一部分，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的深入访谈（n=100）获得信息 在为期8周的培训期间，每名团队成员每周工作25小时。Glyciome I军团 团队将与讲师和其他团队分享他们所学到的知识， 等同STTR授权技术的价值主张。I-Corps计划将加速发展， PreBioGyn技术的商业化，并协助Glyciome适应信息灵通的枢轴， 完善产品推广计划，利用研究成果优化宫颈癌预防设备的功能 以缓解未满足的临床需求。这些数据将有助于修改Glyciome的商业产品影响无效- 假设，并使已知的技术生态系统多样化，以加速发明的转化， 减少宫颈癌死亡率的影响，特别是对LRS的妇女。Glyciome的I-Corp团队有一个 与开发的工作流程和项目工具建立了富有成效的协作历史，包括 在产品开发、零售分销和直接面向消费者的销售，以及患者和医疗保健方面， 提供商产品教育/意识。该团队已成功地将品牌转变为大型（财富1000强） 公司在一起。该团队将受益于I-Corp的机会，以修改和完善商业化 PreBioGyn的战略，基于在创业沉浸课程中获得的知识。

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.