DNA Vaccine Technology to Rapidly Produce Cocktails of Polyclonal Antibodies to Neutralize Lethal Viruses of Military Importance

Award Information
Agency:
Department of Defense
Branch
Army
Amount:
$411,035.00
Award Year:
2013
Program:
STTR
Phase:
Phase II
Contract:
W81XWH-13-C-0041
Award Id:
n/a
Agency Tracking Number:
A2-5417
Solicitation Year:
2012
Solicitation Topic Code:
A12a-T028
Solicitation Number:
2012.A
Small Business Information
3233 15th Street South, Fargo, ND, 58104-6147
Hubzone Owned:
N
Minority Owned:
N
Woman Owned:
N
Duns:
048764943
Principal Investigator:
John Ballantyne
Chief Scientific Officer
(701) 297-9256
jb@aldevron.com
Business Contact:
Michael Jablon
Program Manager
(701) 297-9256
mjablon@aldevron.com
Research Institute:
University of North Dakota
David S Bradley, Ph.D.
501 North Columbia Road
Stop 9037
Grand Forks, ND, 58202-9037
(701) 777-2214
Nonprofit college or university
Abstract
In this Phase II STTR proposal we will demonstrate the scalability and ruggedness of the production system necessary for the commercialization of the goose egg-derived immunoglobulin product that is a countermeasure to the lethal (40 %) Hantavirus Pulmonary Syndrome caused by Andes Virus (ANDV). A major objective will be creating a Quality System (QS) around the global process that aligns it with standards commensurate with FDA guidance. Related objectives will be the development of critical assays and the harmonization of the related Standard Operating Procedures into the QS. Pharmacokinetic and repeat dose studies will be performed that will allow us to better evaluate the quantities to be used and routes of delivery for the anti-ANDV product in the challenge study. Endpoints as measures of success would be the reproducible production of 5 g lots of low impurity anti-ANDV and the use of such lots affording clinically significant protection up to five days after challenge. These results would indicate the commercial viability of a platform that is based on the use of genetic immunization in geese as a means of creating therapies for Category-A pathogens for which no countermeasures or vaccines exist.

* information listed above is at the time of submission.

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