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TAS::75 0849 - TOPIC 255 PHASE II, CGMP MANUFACTURE OF A NOVEL CEA EXPRESSING…

Award Information

Agency:
Department of Health and Human Services
Branch:
N/A
Award ID:
Program Year/Program:
2011 / SBIR
Agency Tracking Number:
N44CO110097
Solicitation Year:
2011
Solicitation Topic Code:
NCI
Solicitation Number:
Small Business Information
ETUBICS CORPORATION
9715 FREMONT AVE N SEATTLE, WA 98103-3140
View profile »
Woman-Owned: No
Minority-Owned: No
HUBZone-Owned: No
 
Phase 2
Fiscal Year: 2011
Title: TAS::75 0849 - TOPIC 255 PHASE II, CGMP MANUFACTURE OF A NOVEL CEA EXPRESSING AD5 VIRUS
Agency: HHS
Contract: N44CO110097
Award Amount: $1,499,001.00
 

Abstract:

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.

Principal Investigator:

Frank Jones
206-838-5110
FRANK@ETUBICS.COM

Business Contact:

Frank Jones
206-838-5110
FRANK@ETUBICS.COM
Small Business Information at Submission:

ETUBICS CORP
9715 FREMONT AVE N SEATTLE, WA 98103-3140

EIN/Tax ID: 200035202
DUNS: N/A
Number of Employees: N/A
Woman-Owned: No
Minority-Owned: No
HUBZone-Owned: No