TOPIC 405: INTRATUMORAL BIOSENSING FOR IN VIVO PHARMACOTYPING

主题 405：体内药型分析的瘤内生物传感

• 批准号: 10724131
• 负责人: CHRISTIAN KNOPKE
• 金额: $ 205万
• 依托单位: LODESTONE BIOMEDICAL, LLC
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-09-19 至 2024-09-18
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10724131
• 关键词: Address; Biosensing Techniques; Biosensor; Clinical; Contracts; Dose; Foundations; Future; Glioblastoma; Goals; Immunotherapy; Magnetism; Measures; Metastatic malignant neoplasm to brain; Modeling; Monitor; Patient Selection; Patients; Performance; Phase; Preparation; Quality Control; Reaction Time; Reader; Resistance; Safety; Solid Neoplasm; Survival Rate; System; Testing; Therapeutic; Therapeutic Agents; Work; cancer survival; clinical translation; design; drug candidate; high throughput screening; high throughput technology; in vivo; individualized medicine; melanoma; overtreatment; performance tests; preclinical safety; product development; response; safety testing; treatment optimization; treatment response; tumor; wireless

This project addresses the problem that several rounds of varied immunotherapy treatments over an extended period are often needed to find one that is effective in treating tumors in a particular patient. The proposed solution is an Immunotherapy Response Indication System (IRIS) to monitor treatment response directly in a patient’s own tumor while testing sub therapeutic doses of multiple candidate drugs to determine the best therapeutic option rapidly and safely. The intratumoral monitoring capabilities of the proposed IRIS implantable biosensor and wireless magnetic reader are key to enabling this pharmacotyping strategy. The work plan in this Phase II contract focuses on preclinical safety and performance testing that is foundational to future clinical translation. This pharmacotyping capability enabled by IRIS will allow clinicians to optimize treatment decisions in the early stages of treatment, and during the later stages of treatment in cases of acquired resistance. Our initial clinical product development goal is to track real-time responses within the tumor to immunotherapy in glioblastomas and melanoma brain metastases. Enabling faster selection of patient-specific treatments could increase cancer survival rates in the future

该项目解决了一个问题，即通常需要在长时间内进行几轮不同的免疫疗法治疗，以找到有效治疗特定患者肿瘤的一种。提出的解决方案是一种免疫疗法反应指示系统（IRIS），可以直接在患者自身肿瘤中监测治疗反应，同时测试多种候选药物的亚治疗剂量，以迅速安全地确定最佳的治疗选择。拟议的虹膜植入生物传感器和无线磁性读取器的肿瘤内监测能力是实现此药物分型策略的关键。该第二阶段合同中的工作计划着重于临床前的安全性和绩效测试，这是未来临床翻译的基础。 IRIS启用的这种药物分型能力将使临床医生能够在治疗的早期阶段以及在获得耐药性的情况下优化治疗决策。我们最初的临床产品开发目标是跟踪肿瘤内对胶质母细胞瘤和黑色素瘤脑转移的免疫疗法的实时反应。启用更快的选择 特定于患者的治疗可能会增加癌症的存活率