Evaluate Therapeutic Potential of Novel Immunomodulator, Imprime

Award Information
Agency:
Department of Health and Human Services
Branch
n/a
Amount:
$159,140.00
Award Year:
2010
Program:
SBIR
Phase:
Phase I
Contract:
N43CO201000118
Award Id:
96390
Agency Tracking Number:
N43CO201000118
Solicitation Year:
n/a
Solicitation Topic Code:
NCI
Solicitation Number:
n/a
Small Business Information
BIOTHERA, 3388 MIKE COLLINS DR, EAGAN, MN, 55121-2410
Hubzone Owned:
N
Minority Owned:
N
Woman Owned:
N
Duns:
177980927
Principal Investigator:
MARY ANTONYSAMY
Business Contact:
(651) 675-0300
Research Institute:
n/a
Abstract

Pancreatic cancer is a "rare" and fata l disease, with few treatment options. Currently, promising antitumor strategies utilize combination therapies, with each agent targeting separate aspects of oncogenesis. Disappointingly, combination of anti- EGFR monoclonal antibody (MAb), cetuximab, with standard-of-care, gemcitabine, failed to improve survival in this disease. Although EGFR is over-expressed in >90% of pancreatic carcinomas -90% also contain KRAS mutations. We herein propose a strategy that could overcome resistance of KRAS mutations to anti-EGFR MAbs. Biothera is developing Imprime-PGG¿, a beta 1,3/1,6 glucose polymer, as an adjunct to MAbs for cancer treatment. The proprietary agent, Imprime, induces neutrophil-mediated cellular cytotoxicity, where Imprime 'primes' neutrophils (comprise -50%-70% of human immune cells) to recognize and kill MAb targeted tumors. Preclinically, Imprime has shown therapeutic efficacy as an adjunct to MAbs in various tumor models, including KRAS-mutated lung and colon carcinoma models. This coupled wi th the safety and recent efficacy data from a Phase 1 b/2 metastatic CRC study supports Imprime to be a safe and effective drug. Overall objective is to establish preclinical proof of concept for this novel treatment approach in pancreatic cancer xenografts; both KRAS-wild type and KRASmutant tumors will be studied, and subsequently evaluate therapeutic potential in the clinic.

* information listed above is at the time of submission.

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