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.

免疫疗法改变了癌症治疗，但某些肿瘤类型的治疗反应仍然很低。尽管免疫反应性在肿瘤中具有至关重要的意义，但目前尚无用于评估免疫环境和评估治疗反应的非侵入性免疫监测方法。为了满足这种迫切需求，Cellight Technologies正在开发一种针对活化T细胞的宠物剂[18F] F-ARAG，作为免疫疗法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[18F] F-ARAG提供对单声道和组合免疫疗法的反应的早期评估的能力。在第二阶段，我们着重于对临床图像分析和定量的优化和标准化，这是[18F] F-Arag作为免疫疗法反应生物标志物的关键组成部分。在该项目中，我们将确定肺癌患者与治疗无关的可变性，以准确定义一个阈值，该阈值表明治疗引起的信号变化。该阈值将用于对[18F] F-ARAG扫描的自动定量分析，并在接受联合免疫疗法的肺癌患者中创建反应图。计划调查的结果将解决定量图像分析中最关键的一些问题，并强烈推动[18F] F-arag作为对免疫疗法反应的成像生物标志物的发展。