SBIR TOPIC 255 DEVELOPMENT OF ANTICANCER AGENTS

SBIR 主题 255 抗癌药物的开发

• 批准号: 7946181
• 负责人: Frank R. Jones
• 金额: $ 15万
• 依托单位: ETUBICS CORPORATION
• 依托单位国家: 美国
• 财政年份: 2009
• 资助国家: 美国
• 起止时间: 2009-09-30 至 2010-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7946181
• 关键词: SBIR; TOPIC; 255; DEVELOPMENT; ANTICANCER

Etubics Corporation is moving its therapeutic cancer product targeting CEA expressing cancers into first-inman Phase I/II clinical trials. Multiple cancers express CEA including colon, breast and brain. The new product consists of the novel Ad5 gene platform expressing CEA. Pre-clinical studies have been performed and the data supports an IND application to move this treatment into clinical trials. The product has been reported to induce humoral and cell-mediated immune responses in naive and Ad5 immune animal models. Treatment with the product has also been reported to reduce tumor volume and weight in established CEA bearing tumors. The product is manufactured in the Company's necessary and sufficient E.C7 cells. A Master Cell Bank of the E.C7 cells has been produced and banked under cGMP conditions. The Company's Ad5 [E 1-, E2b-] vector backbone is versatile and can be used in many applications. This vector is being investigated as a delivery platform for other tumor associated antigens for breast cancer and prostate cancer treatment, as well as infectious disease targets including HIV-1 and malaria. We will extend the manufacturing process to additional disease targets. The Company is prepared to cross-file with the FDA and initiate manufacture of clinical grade material for human trials via this contract.

Etubics公司正在将其针对CEA表达癌症的治疗性癌症产品进入I/II期临床试验。包括结肠癌、乳腺癌和脑癌在内的多种癌症都表达CEA。新产物由表达CEA的新型Ad5基因平台组成。已经进行了临床前研究，数据支持IND申请将该治疗转入临床试验。据报道，该产品在幼稚和Ad5免疫动物模型中诱导体液和细胞介导的免疫反应。据报道，用该产品治疗已确定的CEA荷瘤可减少肿瘤体积和重量。该产品是在公司的必要和充足的E.C7电池中制造的。在cGMP条件下制备并储存了E.C7细胞的主细胞库。该公司的Ad5 [e1 -， E2b-]矢量主干是通用的，可用于许多应用。目前正在研究这种载体作为其他肿瘤相关抗原的递送平台，用于治疗乳腺癌和前列腺癌，以及包括HIV-1和疟疾在内的传染病靶点。我们将把生产过程扩展到更多的疾病目标。该公司准备与FDA交叉备案，并通过该合同开始生产用于人体试验的临床级材料。