SBIR Diagnostic Method to Identify approved drugs as treatment options in individuals with rare cancer

SBIR 诊断方法用于识别已批准药物作为罕见癌症个体的治疗选择

• 批准号: 10931987
• 负责人: GITTE PEDERSEN
• 金额: $ 34.03万
• 依托单位: GENOMIC EXPRESSION, INC.
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-02-28 至 2024-02-27
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10931987
• 关键词: Antineoplastic Agents; Award; Biological Assay; Cancer Patient; Clinical; DNA Repair Gene; Data; Detection; Device or Instrument Development; Diagnosis; Diagnostic; Drug Combinations; Drug Targeting; ERBB2 gene; Exhibits; FDA approved; Gene Expression; Genes; Genomics; Malignant Childhood Neoplasm; Malignant Neoplasms; Malignant neoplasm of ovary; Messenger RNA; Methods; Oncologist; Pharmaceutical Preparations; Pharmacotherapy; Poly(ADP-ribose) Polymerase Inhibitor; Reverse Transcriptase Polymerase Chain Reaction; Services; Small Business Innovation Research Grant; clinically actionable; improved outcome; innovation; mRNA Expression; mRNA sequencing; ovarian neoplasm; overexpression; programmed cell death ligand 1; rare cancer; response biomarker; targeted biomarker; tumor

The long term objective of this proposal is to improve outcomes for ovarian cancer patients in the frontline setting. Few effective drug treatment options exist for ovarian cancer and other rare cancers whereas 300+ drugs have been approved by the FDA to treat non-rare cancers. Analysis of tumor mRNA gene expression has the potential to identify over expression of approved drug targets, such as HER2, AR, and PD-L1, and silencing of DNA repair genes that make ovarian tumors more responsive to PARP inhibitors. In this project, a proprietary tumor mRNA sequencing method called “OneRNA” will be analytically validated in 30 clinically annotated de-identified ovarian tumors by (1) comparing relative mRNA expression levels (tumor vs normal) to reverse transcriptase PCR (RT-PCR) (2) evaluating concordance of aberrantly expressed genes detected with the OneRNA assay with FDA approved immunohistochemical (IHC) assays. Based on preliminary data, we expect to identify at least one clinically actionable aberrantly expressed gene in over 90% of tumors. The resulting data will support the launch of an ovarian tumor expression analysis service by the Genomic Expression CLIA lab to help oncologists identify which drugs and drug combinations are likely to benefit ovarian cancer patients.

该提案的长期目标是改善一线卵巢癌患者的预后。 对于卵巢癌和其他罕见癌症，几乎没有有效的药物治疗选择，而300多种药物已经被用于治疗卵巢癌和其他罕见癌症。 经FDA批准用于治疗非罕见癌症。肿瘤mRNA基因表达分析有可能识别 批准的药物靶点（如HER 2、AR和PD-L1）的过度表达，以及使 卵巢肿瘤对PARP抑制剂更敏感。 在该项目中，一种名为“OneRNA”的专有肿瘤mRNA测序方法将在30年内进行分析验证。 通过（1）比较相对mRNA表达水平（肿瘤与正常）与 逆转录酶PCR（RT-PCR）（2）评价用 OneRNA检测与FDA批准的免疫组织化学（IHC）检测。根据初步数据，我们预计 在超过90%的肿瘤中鉴定至少一种临床上可操作的异常表达基因。 由此产生的数据将支持基因组表达研究所推出卵巢肿瘤表达分析服务。 CLIA实验室帮助肿瘤学家确定哪些药物和药物组合可能使卵巢癌患者受益。