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Etubics Awarded $1.5 Million Manufacturing Contract for Breast Cancer Immunotherapeutic


9/27/2013 10:46:15 AM

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SEATTLE (September 26, 2013) – Etubics Corporation, a bio-pharmaceutical company with a proprietary vaccine platform that stimulates a long lasting "active" immune response, announced today that it has received a contract of approximately $1.5 million from Small Business Innovation Research (SBIR) Development Center of the National Cancer Institute (NCI) to manufacture Etubics' breast cancer immunotherapeutic, ETBX-021 (Contract#: HHSN261201300066C).

The contract will generate the data required to support an IND application to the FDA and manufacturing of ETBX-021 GMP product for a Phase I/II clinical trial. ETBX-021 utilizes the Etubics Platform, which is stealth to the immune system and has the ability to deliver a long lasting "active" immune response against cancer targets, educating the immune system's T-cells to act as if the cancer was a simple virus. ETBX-021 targets HER2/neu, which can be found in about one in five breast cancer patients. HER2/neu tumor tends to be more aggressive than other types of breast cancer and also less responsive to hormone and monoclonal antibody treatments.

Pre-clinical studies show that ETBX-021 can induce not only the traditional antibody response but also a potent cell mediated immunity (CMI) against HER2/neu tumors. In addition, ETBX-021 prevented establishment of HER2/neu-expressing tumors and significantly inhibited progression of established tumors in mice models.

More information on Etubics ETBX-021 program can be found in a recently published Nature's Cancer Gene Therapy paper entitled "An Ad5[E1-, E2b-]-HER2/neu vector induces immune responses and inhibits HER2/neu expressing tumor progression in Ad5 immune mice."

Etubics HER2/neu pre-clinical work has been funded through grants and contracts from the NCI under Award Numbers 1R43CA139663-01, HHSN261201100090C and HHSN261201300066C. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.

Since 2006, Etubics Corporation has received federal grant and contract funding in excess of $14.5 million from the National Cancer Institute (NCI), National Institute of Allergy and Infectious Diseases (NIAID), National Institute of Dental and Craniofacial Research (NIDCR) and the Department of Defense (DOD). These grants have helped to further Etubics colon cancer, breast cancer, HPV induced cancer, influenza, and HIV vaccine programs.

About Etubics

Etubics Corporation, based in Seattle, Wash., is a clinical stage bio-pharmaceutical company, which has developed a proprietary platform technology consisting of a next generation Ad5 vector vaccine platform and a manufacturing E.C7 human cell line, collectively the Etubics Platform. Clinical work to date shows that the Etubics Platform overcomes problems associated with existing adenovirus vectors. The Etubics Platform can be used to efficiently and rapidly develop immunotherapeutic drugs and preventive vaccines for a wide range of infectious diseases and cancers. www.etubics.com Statements herein relating to future financial, business performance, conditions or strategies and other financial and business matters, including expectations regarding future revenues and operating expenses, are forward-looking statements within the meaning of the Private Securities Litigation Reform Act. Etubics is a private company. Etubics cautions that these forward-looking statements are subject to numerous assumptions, risks and uncertainties which change over time. Factors that may cause actual results to differ materially from the results discussed in the forward-looking statements or historical experience include risks and uncertainties, including the failure by Etubics to secure and maintain relationships with collaborators; risks relating to the early state of Etubics’s product candidates under development; uncertainties relating to clinical trials; risks relating to the commercialization, if any, of Etubics proposed candidates; dependence on the efforts of third parties; dependence on intellectual property; and risks that it may lack the financial resources and access to capital to fund its operations. Further information on the factors and risks that could affect Etubics business, financial conditions and results of operations, are contained in Etubics’s documents on file at the Company. These forward-looking statements speak only as of the date of this press release and Etubics assumes no duty to update forward-looking statements.

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