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Human monoclonal antibodies as countermeasures for T-2 mycotoxin

Award Information
Agency: Department of Defense
Branch: Office for Chemical and Biological Defense
Contract: W911QY-16-P-0050
Agency Tracking Number: C152-003-0012
Amount: $149,964.61
Phase: Phase I
Program: SBIR
Solicitation Topic Code: CBD152-003
Solicitation Number: 2015.2
Solicitation Year: 2015
Award Year: 2016
Award Start Date (Proposal Award Date): 2015-12-22
Award End Date (Contract End Date): 2016-09-30
Small Business Information
321 Jones Boulevard
Pottstown, PA 19464
United States
DUNS: 962964990
HUBZone Owned: No
Woman Owned: No
Socially and Economically Disadvantaged: No
Principal Investigator
 Rolf Swoboda
 (610) 990-7531
Business Contact
 Hiep Tran
Phone: (610) 990-7531
Research Institution

Mycotoxins are fungal toxins to which exposure frequently results in incapacitation or even in death. Natural outbreaks of mycotoxin poisoningare common worldwide. Due to its physical-chemical properties, high toxicity and relative ease to produce, mycotoxin T-2 is classified as apotential biological warfare agent. Currently there are no FDA approved medical countermeasures available for T-2 mycotoxin exposure. In thisproject, neutralizing human antibodies to T-2 will be developed using Abzymes proprietary in vivo Self-Diversifying Antibody Library (SDALib)platform,. SDALib will provide a diverse array of antibodies, without the need for animal immunization and subsequent necessary humanization ofthe antibody. Since this is a non-animal system, the platform can generate human antibodies against toxins, pathogens, self-antigens, and the likewhich are by nature difficult to obtain. In Phase I, high-affinity T-2 neutralizing human antibodies will be developed and validated using an in vitrosystem. In Phase II, antibody candidates will be further evaluated as a medical countermeasure in a small mammal study. Selected clones will beused to generate high-yield producer stable mammalian cell lines for antibody production in large quantity. Non-clinical GLP pharmacokinetic andpharmacodynamics data will be obtained laying the foundation for subsequent Phase III studies.

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

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