TAS::75 0849 - TOPIC 255 PHASE II, CGMP MANUFACTURE OF A NOVEL CEA EXPRESSING AD5 VIRUS

Award Information
Agency:
Department of Health and Human Services
Branch
n/a
Amount:
$1,499,001.00
Award Year:
2011
Program:
SBIR
Phase:
Phase II
Contract:
N44CO110097
Award Id:
n/a
Agency Tracking Number:
N44CO110097
Solicitation Year:
2011
Solicitation Topic Code:
NCI
Solicitation Number:
n/a
Small Business Information
9715 FREMONT AVE N, SEATTLE, WA, 98103-3140
Hubzone Owned:
N
Minority Owned:
N
Woman Owned:
N
Duns:
154453018
Principal Investigator:
FRANK JONES
(206) 838-5110
FRANK@ETUBICS.COM
Business Contact:
FRANK JONES
(206) 838-5110
FRANK@ETUBICS.COM
Research Institution:
Stub




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.

* information listed above is at the time of submission.

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