ABZYME THERAPEUTICS LLC — Department of Defense SBIR Phase I: CBD152-003

Description

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.