Therapeutic Human Hyperimmune Polyclonal Antibodies against Staphylococcal Enterotoxin B

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.