SBIR TOPIC 255 DEVELOPMENT OF ANTICANCER AGENTS

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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.