SBIR PHASE I AWARD

Award Information
Agency:
Department of Health and Human Services
Branch
n/a
Amount:
$650,021.00
Award Year:
2011
Program:
SBIR
Phase:
Phase I
Contract:
N43CO110055
Agency Tracking Number:
N43CO110055
Solicitation Year:
2011
Solicitation Topic Code:
NCI
Solicitation Number:
n/a
Small Business Information
GRADALIS, INC.
2545 GOLDEN BEAR DR STE 110, CARROLLTON, TX, 75006-2474
Hubzone Owned:
N
Socially and Economically Disadvantaged:
N
Woman Owned:
N
Duns:
610368925
Principal Investigator:
NANCY TEMPLETON
(214) 220-4304
NTEMPLETON@GRADALISINC.COM
Business Contact:
NANCY TEMPLETON
(214) 220-4304
NTEMPLETON@GRADALISINC.COM
Research Institution:
Stub




Abstract
The objective of this proposal is to define the in vivo effectiveness of a melanoma-targeted nanoparticle for systemic therapeutic delivery. The approach is to utilize a clinically experienced fusogenic bilamellar invaginated vesicle nanoparticle (BIV NP)with a manually extruded DOTAP:cholesterol formulation for the systemic delivery of DNA and RNAi expression plasmids. This will involve the preclinical validation of two recent technological advances: reversible masking and tumor-specific ligand decoration. Reversible masking is a non-toxic alternative to pegylation and involves transient coating with small, uncharged, lipids to bypass non-targeted organs and re-exposure of charge at the target cells for enhanced transfection. Further, the BIV NP will be decorated with low mw, non-immunogenic beta-turn "semi-peptidic" small molecules that mimic secondary structure motifs found at hot-spots in protein-ligand interactions. The small molecule candidate is selected by screening with melanoma cell lines and patient primary cultures for enhanced transgene expression. The project will include: 1) prioritization of low mw ligands that promote BIV-delivered transgene expression; 2) demonstration in nu/nu-hu melanoma xenograft models of the enhanced expression and anti-tumor activity of BIV NPs with pre-established anti-oncogene activities (bi-shSTMN1 payload); and 3) implementation of a GMP manufacturing process for the formulated melanoma-targeted, reversibly-masked bi-shSTMN1-BIV product. These activities will pave the way for future safety/toxicology studies and early phase clinical trials.

* information listed above is at the time of submission.

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