SBIR TOPIC 255 DEVELOPMENT OF ANTICANCER AGENTS

Etubics公司正在将其针对CEA表达癌症的治疗癌症产品转移到第一Inman阶段I/II临床试验。多种癌症都表达CEA，包括结肠癌、乳腺癌和脑癌。新产品由表达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申请将这种治疗方法转移到临床试验。该产品已被报道在幼稚和Ad5免疫动物模型中诱导体液和细胞免疫反应。据报道，该产品的治疗还可以减少已建立的CEA荷瘤的肿瘤体积和重量。该产品是在公司必要且充足的E.C7电池中生产的。在cGMP条件下，已经产生并储存了E.C7细胞的主细胞库。该公司的Ad5[E1-，E2b-]载体主干用途广泛，可用于多种应用。这种载体正在被研究为用于乳腺癌和前列腺癌治疗的其他肿瘤相关抗原的传递平台，以及包括艾滋病毒-1和疟疾在内的传染病靶点。我们将把制造工艺扩展到更多的疾病靶点。该公司准备向FDA交叉提交文件，并通过该合同开始生产用于人体试验的临床级材料。

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.