SBIR Topic 354: A Novel Predictive Test for Response to Combination Immunotherapies for Patients with non-small cell lung cancer (NSCLC)

在拟议的第二阶段研究中，我们将进一步开发我们的PathMAP®免疫疗法测试，以满足非小细胞肺癌患者群体中未得到满足的临床需求。我们希望创建一种能够准确预测PD-1/PD-L1靶向免疫检查点抑制剂单独和联合化疗的临床反应的测试。我们在第二阶段的开发工作将基于我们在第一阶段执行的初步工作以及我们设计和开发PathMAP测试的丰富经验。PathMAP免疫治疗测试将通过诱导和分类非小细胞肺癌样本对生物相关调节剂和化疗药物的动态生物标记物反应来预测治疗反应。通过这种方式，我们将能够表征每个肿瘤的内在耐药机制，以及这些机制如何影响关键生物标记物的表达能力。SnapPath®癌症诊断系统将使这种体外方法成为可能，该系统可自动化和标准化活的实体肿瘤处理和功能询问，使实体肿瘤患者的高度预测性测试成为可能。据我们所知，PathMAP免疫治疗测试将是第一次将体外技术用于诊断测试，以预测患者对任何免疫治疗药物的反应。

In the proposed Phase II study, we will further develop our PathMAP® Immunotherapy test to address an unmet clinical need within the NSCLC patient population. We hope to create a test that is able to accurately predict clinical response to PD-1/PD-L1 targeted immune checkpoint inhibitors alone and in combination with chemotherapies. Our development work in Phase II will be based on our initial work performed in Phase I and our extensive experience designing and developing PathMAP tests. The PathMAP Immunotherapy test will predict therapeutic response by eliciting and categorizing NSCLC samples’ dynamic biomarker responses to biologically-relevant modulators and chemotherapy agents. In this way, we will be able to characterize each tumor’s intrinsic resistance mechanisms, and how these mechanisms impact key biomarker expression capabilities. This ex vivo approach will be made possible by the SnapPath® Cancer Diagnostics System, which automates and standardizes live solid tumor processing and functional interrogation, to enable highly predictive tests in patients with solid tumors. To our knowledge, the PathMAP Immunotherapy test will represent the first time ex vivo technology has been used in a diagnostic test to predict patient responses to any immunotherapeutic drug.