Award Information
Agency: Department of Health and Human Services
Branch: N/A
Contract: N44CO110097
Agency Tracking Number: N44CO110097
Amount: $1,499,001.00
Phase: Phase II
Program: SBIR
Awards Year: 2011
Solicitation Year: 2011
Solicitation Topic Code: NCI
Solicitation Number: N/A
Small Business Information
9715 FREMONT AVE N, SEATTLE, WA, 98103-3140
DUNS: 154453018
HUBZone Owned: N
Woman Owned: N
Socially and Economically Disadvantaged: N
Principal Investigator
 (206) 838-5110
Business Contact
Phone: (206) 838-5110
Research Institution
Etubics Corporation is clinically testing a new vaccine targeting carcinoembryonic antigen (CEA) expressing cancers in a Phase I/II clinical trials under FDA IND14325. Many cancers express CEA, including colon, breast and pancreatic cancers. It is anticipated that this new biotherapeutic product will complement the armamentarium of existing therapies for the treatment of CEA expressing cancers. The product consists of the Company s novel Adenovirus serotype-5 platform expressing CEA (Ad5 [E1-, E2b-]-CEA) that induces antibodies and cell mediated immune responses that result in anti-tumor activity. The product is manufactured in the necessary and sufficient human E.C7 cell line. A Master Cell Bank has been produced under cGMP conditions. In this Phase II SBIRprogram, we will (1) evaluate the robustness of the manufacturing process, (2) perform an additional GMP manufacturing run to support the next phase clinical trials, (3) perform a product biodistribution study in animals, (4) develop functional assays using the therapeutic product, and (5) perform shelf-life studies of the product. It is expected that completion of these processes and studies will allow us to produce sufficient product to support large-scale clinical trials required to move toward approvalof this new biotherapeutic for active immunotherapy of CEA expressing cancers.

* Information listed above is at the time of submission. *

Agency Micro-sites

SBA logo
Department of Agriculture logo
Department of Commerce logo
Department of Defense logo
Department of Education logo
Department of Energy logo
Department of Health and Human Services logo
Department of Homeland Security logo
Department of Transportation logo
Environmental Protection Agency logo
National Aeronautics and Space Administration logo
National Science Foundation logo
US Flag An Official Website of the United States Government