New In Vitro 3D Functional Model of Tumorigenesis

描述（由申请人提供）：在我们最初的研发工作中，我们成功地证明了一种新型人体生物基质系统（HuBiogel）在设计用于体外检查肿瘤发生过程的3D生物测定系统中的可行性。总体目标是开发和商业化这些人类生物测定系统。第一阶段的工作明确确立了新的测定模型表现出许多优势，传统的单层细胞培养和动物源性生物基质系统。确定生物活性或环境的HuBiogel测定用于实时分析肿瘤生长和血管生成。基于项目的临床相关性，我们还与两位著名的癌症研究人员展开了积极的合作。有了这项有前途的技术，我们提出了三个扩展任务，以充分实现我们的研发目标。它们是：1）使用自动化技术建立商业规模的生物基质生产、分析和配制的有效方案; 2）使用人乳腺和脑肿瘤细胞模型完成3D肿瘤生长、侵袭和血管生成测定平台的开发; 3）通过已建立的细胞和分子分析技术验证HuBiogel测定的功能特性。我们的集成技术将允许精确的实时分析肿瘤发生级联。新的3D检测技术将提供更多的临床相关性，因为它模拟了人类肿瘤样生物学和功能。这种先进的生物测定系统将有助于早期到晚期肿瘤发生阶段的终点分析，特异性阳性和阴性调节剂的平行评价以及肿瘤细胞或活检的表型分析。因此，及时完成这一有前途的研发项目将对癌症生物学、药物发现和治疗研究市场产生积极影响。项目相关性：目前不存在可接受的商业肿瘤试验模型，其使用天然或确定的人类生物基质系统。VBI将开发可重复使用和一次性的3D肿瘤生长，侵袭和血管生成检测平台。HuBiogel的销售、预包装检测试剂盒和内部药物检测服务将在基础、生物医学和癌症研究领域拥有重要的全球市场。

DESCRIPTION (provided by applicant): In our initial R&D effort we successfully demonstrated the feasibility of a novel human biomatrix system (HuBiogel) in designing 3D bioassay system for in vitro examination of tumorigenesis process. The overall goal was and is to develop and commercialize these human bioassay systems. Phase I work definitely established that new assay models exhibit many advantages over conventional monolayer cell cultures and animal-derived biomatrix systems. HuBiogel assays of defined bioactivity or environment are established for real-time analysis of tumor growth and angiogenesis. Based on project's clinical relevance, we also initiated active collaborations with two renowned cancer researchers. With this promising technology, we propose three extended tasks to fully accomplish our R&D goals. They are: 1) Establish efficient protocols for biomatrix production, analysis and formulation at commercial scale using automated technologies; 2) Complete the development of 3D tumor growth, invasion and angiogenesis assay platform using human breast and brain tumor cell models; 3) Validate functional properties of HuBiogel assays by established cellular and molecular analysis techniques. Our integrated technology will allow precise real-time analysis of tumorigenesis cascade. New 3D assay technology will provide more clinical relevance as it emulates human tumor-like biology and function. This advanced bioassay system will be useful for endpoint analysis of early to late tumorigenesis stages, parallel evaluation of specific positive and negative regulators and phenotypic profiling of tumor cells or biopsies. Thus, the timely completion of this promising R&D project will positively impact cancer biology, drug discovery and therapeutic research markets. Project Relevance: No acceptable commercial tumor assay model currently exists which utilizes a natural or defined human biomatrix system. VBI will develop reusable and disposable 3D tumor growth, invasion and angiogenesis assay platforms. Sale of HuBiogel, pre-packed assay kits and in-house drug testing services would have a significant world-wide market in basic, biomedical and cancer research fields.