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Therapeutic Human Hyperimmune Polyclonal Antibodies against Staphylococcal Enterotoxin B

Award Information
Agency: Department of Defense
Branch: Army
Contract: W81XWH-08-C-0004
Agency Tracking Number: A072-154-0249
Amount: $1,159,390.00
Phase: Phase II
Program: SBIR
Solicitation Topic Code: A07-154
Solicitation Number: 2007.2
Solicitation Year: 2007
Award Year: 2008
Award Start Date (Proposal Award Date): 2009-01-15
Award End Date (Contract End Date): 2011-11-14
Small Business Information
Frederick Innovative Technology Center 4539 Metropolitan Ct.
Frederick, MD 21704
United States
DUNS: 601000750
HUBZone Owned: No
Woman Owned: No
Socially and Economically Disadvantaged: No
Principal Investigator
 M. Javad Aman
 President and CSO
 (301) 644-3910
Business Contact
 Mahtab Hekmat
Title: Business Manager
Phone: (301) 360-3505
Research Institution

This Phase II SBIR project addresses the need to develop a treatment for toxic shock induced by staphylococcal Enterotoxin B (SEB), which may be disseminated as an aerosol in a biowarfare scenario. Specifically, we seek to develop a hyperimmune human polyclonal antibody that neutralizes the toxic activity of SEB. SEB has been weaponized and can cause incapacitation and lethality within military and civilian populations. Integrated BioTherapeutics (IBT) has developed a proprietary, cGMP SEB vaccine (STEBVax) that is entering clinical trial sponsored by NIH in summer 2008. In the current proposal, we will use STEBVax to produce hyperimmune globulin (SEB-HIG) in healthy individuals. Feasibility was demonstrated in Phase I in surrogate models. Phase II – a collaborative effort by IBT, Omrix Biopharmaceuticals, and the University of Maryland – involves donor stimulation, plasmapheresis, the purification of SEB-HIG, and tests of therapeutic efficacy in animals. The outcome will be a therapeutic candidate for clinical development. We expect SEB-HIG to reduce the rate of SEB-induced incapacitation and death by >50%, which should make SEB-HIG an essential component of the Strategic National Stockpile. The market could be expanded into the public health sector by combining the product with HIG against other toxins currently in development at IBT.

* Information listed above is at the time of submission. *

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