Cervical Cancer Prevention Prebiotic Device

预防宫颈癌益生元装置

• 批准号: 10541352
• 负责人: Joanna Elizabeth Ellington
• 金额: $ 5.5万
• 依托单位: GLYCIOME, LLC
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-03-15 至 2022-06-14
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10541352
• 关键词: Acids; Adverse event; Award; Awareness; Bacteria; Businesses; Cessation of life; Clinical; Collaborations; Data; Development; Devices; Ecology; Ecosystem; Education; Educational Curriculum; Ethnic group; Fortune; Funding; Gel; Genital Human Papilloma Virus Infection; Genitourinary system; Grant; HPV-High Risk; Health Personnel; Hour; Human Papillomavirus; Immersion; Individual; Infection; Inflammation; Innovation Corps; Interview; Knowledge; Learning; Link; Malignant neoplasm of cervix uteri; Metabolic; Mucous Membrane; Patients; Persons; Phase; Prevention approach; Recording of previous events; Research; Research Methodology; Resource-limited setting; Sales; Small Business Technology Transfer Research; Technology; Training; Vaccinated; Vagina; Vaginal Gel; Woman; base; cervical cancer prevention; cervicovaginal; commercialization; design; dysbiosis; health care disparity; innovation; insight; instructor; invention; member; microbial; novel; pre-clinical; prebiotics; prevent; product development; programs; prospective; prototype; racial and ethnic; reduce symptoms; tool; tumorigenesis; vaginal microbiota

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.

通过当前I阶段I谓词STTR资金（1R41CA254543-1A1），Glyciome，LLC（女性拥有的 Company），正在完成临床前的概念验证和集成 - 型设计设计，用于新颖的，用户指导， 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）感染是常见的（约4.4亿/年），链接到 500,000例宫颈癌和288,000例死亡/年。高风险HPV和过度生长的持久性 有害的阴道细菌（“营养不良”）导致导致宫颈癌的粘膜和代谢因素。这 所有妇女都可以使用Bibiogyn凝胶（HPV接种疫苗），并专门针对个人 在医疗保健不同的资源设置（“ LRS”）中，以优化阴道生态并预防营养不良， 炎症，HPV持久性和肿瘤发生。现有的营养不良症状缓解疗法（douches， 反酸凝胶）损害阴道生态系统。他们的使用同伴增加了泌尿生殖器的3倍 不良事件，包括感染。相比之下，Bibiogyn提供了益生元，宫颈癌预防 跨种族/族裔妇女的方法，优化内源性，有益的阴道微生物群和 保护性宫颈阴道代谢和粘膜谱。通过补充奖励机制， Glyciome I-Corps团队将参加使用假设驱动的企业家沉浸式课程 客户发现的研究方法，以了解与商业化有关的问题 专有的预科技术。作为本创新课程的一部分，I-Corp团队成员将聚集 通过与潜在客户，战略合作伙伴和其他第三方的强大访谈（n = 100）信息 利益相关者在为期8周的培训期间以25小时的/周/团队成员的努力进行。 Glyciome I-Corps 团队将与教师和其他团队分享他们学到的知识，从而深入了解潜在的 谓词STTR赠款技术的价值主张。 I-Corps计划将加速发展和 Prebiogyn技术的商业化，并协助糖基适应良好的枢轴 精制产品推出计划，使用研究结果来优化宫颈癌预防装置的能力 减轻未满足的临床需求。这些数据将有助于修改Glyciome的商业产品影响NULL- 假设并使已知的技术生态系统多样化，以加速事故的转变 减少宫颈癌死亡的影响，特别是对于LRS中的女性。 Glyciome的I-Corp团队有一个 与已发达的工作流程和项目工具一起建立了产品合作的历史，包括工作 共同介绍产品开发，零售分销和直接消费者的销售以及患者和医疗保健 提供者产品教育/意识。该团队已成功将品牌转变为大型（Fortune 1000） 公司在一起。该团队将从I-Corp的机会中受益，以修改和完善商业化 基于在企业家沉浸式课程中获得的知识的策略。