SBIR PHASE II - TOPIC 396 - IMAGING FOR CANCER IMMUNOTHERAPIES

SBIR 第二阶段 - 主题 396 - 癌症免疫疗法的成像

• 批准号: 10706239
• 负责人: JELENA LEVI
• 金额: $ 199.52万
• 依托单位: CELLSIGHT TECHNOLOGIES, INC.
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-09-16 至 2024-09-15
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10706239
• 关键词: Address; Advanced Development; Biological Markers; Cancer Patient; Combination immunotherapy; Image Analysis; Immune; Immunologic Monitoring; Immunotherapy; Investigation; Malignant neoplasm of lung; Maps; Methods; Non-Small-Cell Lung Carcinoma; Phase; Platinum; Positron-Emission Tomography; Pre-Clinical Model; Scanning; Signal Transduction; Small Business Innovation Research Grant; Standardization; T-Lymphocyte; Technology; Testing; anti-PD-1; anti-PD-L1; cancer imaging; cancer immunotherapy; cancer therapy; chemotherapy; clinical imaging; imaging biomarker; quantitative imaging; response; response biomarker; treatment response; tumor

Immunotherapy has transformed cancer treatment, but therapy response remains low for certain tumor types. Despite the vital significance of immune activity within tumors, there are currently no non-invasive immunomonitoring methods for assessment of immune contexture and assessment of response to therapy. To address this urgent need, Cellsight Technologies is developing a PET agent specific for activated T cells, [18F]F-AraG, as an imaging biomarker of immunotherapy response. In Phase I we demonstrated in preclinical models the ability of [18F]F-AraG to provide an early assessment of response to both mono and combinatorial immunotherapy. In Phase II we focus on optimization and standardization of clinical image analysis and quantitation as the crucial components of [18F]F-AraG’s suitability to serve as a biomarker of immunotherapy response. In this project, we will determine treatment-independent variability in lung cancer patients to accurately define a threshold that indicates therapy-induced signal changes. This threshold will be used for automated quantitative analysis of [18F]F-AraG scans and creation of response maps in lung cancer patients undergoing combinatorial immunotherapy. The results of the planned investigations will address some of the most critical issues in quantitative image analysis and strongly advance development of [18F]F-AraG as an imaging biomarker for response to immunotherapies.

免疫疗法已经改变了癌症治疗，但对某些肿瘤类型的治疗反应仍然较低，尽管肿瘤内的免疫活性具有重要意义，但目前还没有用于评估免疫状况和评估治疗反应的非侵入性免疫监测方法。为了满足迫切需要，Cellsight Technologies 正在开发一种针对活化 T 细胞的 PET 试剂，[18F]F-AraG，作为免疫治疗反应的成像生物标志物，在第一阶段，我们在临床前模型中证明了其能力。 [18F]F-AraG 对单一和组合免疫疗法的反应提供早期评估 在第二阶段，我们重点关注临床图像分析和定量的优化和标准化，作为 [18F]F-AraG 适合性的关键组成部分。在这个项目中，我们将确定肺癌患者的治疗独立变异性，以准确定义指示治疗引起的信号变化的阈值。 [18F]F-AraG 扫描并在接受强组合免疫治疗的肺癌患者中创建反应图计划的研究结果将解决定量图像分析和推进 [18F]F-AraG 开发中的一些最关键问题。免疫疗法反应的成像生物标志物。