TAS::75 0849::TAS TOPIC 255 DEVELOPMENT OF GB13 AS A NOVEL GLIOBLASTOMA THERAPY

Award Information
Agency:
Department of Health and Human Services
Amount:
$199,785.00
Program:
SBIR
Contract:
N43CO110092
Solitcitation Year:
2011
Solicitation Number:
N/A
Branch:
N/A
Award Year:
2011
Phase:
Phase I
Agency Tracking Number:
N43CO110092
Solicitation Topic Code:
NCI
Small Business Information
TARGEPEUTICS, INC
475 W GOVERNOR RD, HERSHEY, PA, 17033-1517
Hubzone Owned:
N
Woman Owned:
N
Socially and Economically Disadvantaged:
N
Duns:
080755650
Principal Investigator
 STEPHEN ABRAMSON
 (717) 533-7772
 ABRAMSON@LIFESCIPARTNERS.NET
Business Contact
 STEPHEN ABRAMSON
Phone: (717) 533-7772
Email: ABRAMSON@LIFESCIPARTNERS.NET
Research Institution
 Stub
Abstract
This Phase I SBIR contract is to (1) produce multiple lots of GB13 to establish the quality and reproducibility of the manufacturing process, (2) characterize biochemical properties of GB13, including affinity to target cells, (3) qualify a live cell-basedbioassay with multiple product lots, (4) develop a plan for Phase II SBIR preclinical development activities, including anmial efficacy and toxicity investigations to support the filing of an IND for human clinical trials. High-Grade astrocytomas (HGAs) are aggressive CNS tumor with median survival:::::: 14 months using the current standard of care. About 80% of HGAs overexpress an IL-13 receptor subunit [GB-13Ra(2)] that is virtually absent in healthy CNS tissue. GB 13 is a recombinant targeted cytotoxic fusion protein being developed to treat recurrent HGAs. Its targeting moiety, a single mutant human IL-13.E13K [Glu(13)-+Lys] binds GB-13Ra{2) with 50-fold higher affinity than native IL-13 and has low affinity for IL-13 receptor s of healthy tissue. It is linked to a mutant Pseudomonas endotoxin (PE4E), that is unable to bind its normal target cell receptor and can kill only cells that recognize IL 13.E13K. GB13 is a potent killer of cultured animal GBM cells in vitro. Targepeutics seeks funds to(1) produce multiple lots of GB13 to establish the quality and reproducibility of the manufacturing process, (2) characterize biochemical properties of GB13, including affinity to target cells, (3) qualify a live cell-based bioassay with multiple product lots, (4) develop a plan for Phase" SBIR preclinical development activities, including animal efficacy and toxicity investigations to support the filing of an IND for human clinical trials.

* information listed above is at the time of submission.

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