SBIR TOPIC 229, PHASE II: PHARMACODYNAMIC ASSAY FOR AKT FOR USE WITH PI3K/AKT/MTOR INHIBITORS

Award Information
Agency:
Department of Health and Human Services
Amount:
$999,002.00
Program:
SBIR
Contract:
N44CO110087
Solitcitation Year:
2011
Solicitation Number:
N/A
Branch:
N/A
Award Year:
2011
Phase:
Phase II
Agency Tracking Number:
N44CO110087
Solicitation Topic Code:
NCI
Small Business Information
ROCKLAND, INC.
650 ENGLESVILLE RD, BOYERTOWN, PA, 19512-8407
Hubzone Owned:
N
Woman Owned:
Y
Socially and Economically Disadvantaged:
N
Duns:
058999129
Principal Investigator
 DAVID CHIMENTO
 (800) 656-7625
 CHIMENTO@ROCKLAND-INC.COM
Business Contact
 DAVID CHIMENTO
Phone: (800) 656-7625
Email: CHIMENTO@ROCKLAND-INC.COM
Research Institution
 Stub
Abstract
In response to this NCI solicitation, Rockland proposes to develop a novel method to assay the pharmacodynamic (PO) properties of anti-cancer small molecules targeting the PI3K/mTOR/AKT signaling pathway by quantitatively and independently measuring the phosphorylation of each unique AKT isoform in a validated multiplex immunoassay. The developed PD-AKT-ELISA would offer improved personalized medicine, whereby physicians would prescribe a dosage according to the pharmacodynamic effects of anti-cancer drugson individual patients, or modify therapeutic modality based on the feedback for each individual Akt isoform. We plan to use a number of anti-cancer drug candidates in this study and to produce reagents, including monoclonal antibodies to measure inactiveand active AKT isoforms suitable for a fit-for-use theranostic quantitative biomarker ELISA for AKT. The PO-AKT-ELISA and associated reagents will be produced, optimized, validated and applied to both solid tumor and soft tumor xenograft tissue. The reagents and validated assay will measure all AKT isoforms in its active and inactive states to fill a need not currently addressed by products or technologies commercially available to researchers and clinicians. The end result will be a multiplex assay thatcan be used by most existing immunoassay readers in both a research and high through-put clinical environment. Assay results will allow physicians to more precisely target dosages or types of drugs that modulate the PI3K/mTOR/AKT pathway, and will ultimately lower treatment costs by more accurately prescribing effective doses of anticancer drugs and potentially shortening the duration of drug treatment regimens.

* information listed above is at the time of submission.

Agency Micro-sites

US Flag An Official Website of the United States Government