I-Corps: Radiotracer Synthesis Commercialization

I-Corps：放射性示踪剂合成商业化

• 批准号: 1157916
• 负责人: Stephen DiMagno
• 金额: $ 5万
• 依托单位: University of Nebraska-Lincoln
• 依托单位国家: 美国
• 项目类别: Standard Grant
• 财政年份: 2011
• 资助国家: 美国
• 起止时间: 2011-10-01 至 2012-03-31
• 项目状态: 已结题
• 来源: https://www.nsf.gov/awardsearch/showAward?AWD_ID=1157916&HistoricalAwards=false
• 关键词: Corps; Radiotracer; Synthesis; Commercialization

The proposed I-Corps project involves bringing advantageous new methodologies for synthesis of [18F]-labeled molecular imaging agents into the clinic. The proposed activity builds upon fundamental discoveries in synthetic chemistry that were made possible by prior NSF funding. In the current project the team assesses the suitability of newly developed and demonstrated technology as the basis for forming a startup enterprise. Activities to be performed during the 6 month funding period will include market assessment, evaluation of the intellectual property surrounding these inventions, and extensive direct contacts with potential customers, licensees, and competitors. These activities will be guided and informed by the curriculum of the I-Corps program. Positron Emission Tomography (PET) is a powerful, noninvasive diagnostic molecular imaging technique. For most PET applications, [18F]fluorinated radiotracers are preferred. The short half-life of this isotope of fluorine (~110 min) requires relatively complex compounds to be prepared and distributed under significant time constraints, while still providing the excellent image quality, compliance with FDA good manufacturing practices, and acceptable radiodosimetry typical of short half-life radionuclides. One such compound, [18F]- 2-fluoro-2-deoxyglucose (FDG), now accounts for the almost all of the [18F]-PET imaging market, estimated to be approximately $500MM/yr in the United States and provides significant support for the clinical management of cancer patients. Unique technology developed in the laboratory will permit rapid and efficient production of additional very high specific activity fluorinated PET compounds for which clinical use has been constrained by the limitations of current radiochemical synthesis methods. The new technology to be advanced in this project provides commercially compatible synthetic pathways and new chemical intermediates for the synthesis of [18F]-labeled imaging agents that can be used to evaluate the pathophysiology of specific cellular receptors in the brain and in the heart, to localize and stage tumors, and to assist in cancer management by monitoring patients' responses to therapy.

拟议的 I-Corps 项目涉及将合成 [18F] 标记分子成像剂的有利新方法引入临床。拟议的活动建立在合成化学的基本发现之上，这些发现是由国家科学基金会先前的资助实现的。在当前项目中，团队评估新开发和演示的技术是否适合作为组建初创企业的基础。 6 个月资助期内将开展的活动包括市场评估、围绕这些发明的知识产权评估以及与潜在客户、被许可方和竞争对手的广泛直接联系。这些活动将受到 I-Corps 计划课程的指导和指导。正电子发射断层扫描 (PET) 是一种功能强大的无创诊断分子成像技术。对于大多数 PET 应用，[18F]氟化放射性示踪剂是首选。这种氟同位素的半衰期短（约 110 分钟），需要在相当长的时间限制下制备和分发相对复杂的化合物，同时仍然提供出色的图像质量、符合 FDA 良好生产规范以及可接受的短周期放射剂量测定。半衰期放射性核素。其中一种化合物，[18F]-2-氟-2-脱氧葡萄糖 (FDG)，现在占据了几乎所有的 [18F]-PET 成像市场，在美国估计每年约为 500MM 美元，并提供了显着的优势。支持癌症患者的临床管理。实验室开发的独特技术将允许快速有效地生产额外的非常高比活性的氟化PET化合物，这些化合物的临床应用受到当前放射化学合成方法的限制。该项目将推进的新技术提供了商业上兼容的合成途径和新的化学中间体，用于合成[18F]标记的显像剂，可用于评估大脑和心脏中特定细胞受体的病理生理学，以对肿瘤进行定位和分期，并通过监测患者对治疗的反应来协助癌症管理。