Monoclonal antibodies (mAb) were a transformational scientific innovation designed to enhance the immune system's ability to regulate cell functions. They are designed to bind to a very specific epitope (area) of an antigen or cell surface target and can bind to almost any selected target. mAbs have the unique ability to alert the immune system to attack and kill specific cancer cells (as in the case of Yervoy®) or block certain biochemical pathways (such as those leading to rheumatoid arthritis, as in the case of Remicade®). In contrast, polyclonal antibodies, which are generated by the body through natural exposure to an antigen or through vaccination, target multiple epitopes. They are effective at binding to antigens but tend to be less potent and less specific than monoclonal antibodies. Monoclonal antibodies, with their designer capabilities and potency, have consequently become a powerful class of products against cancers, autoimmune diseases such as rheumatoid arthritis, and neurological diseases such as multiple sclerosis.
However, mAb technology does have limitations. Delivered by passive administration, meaning they are manufactured outside the body, they typically require costly large-scale laboratory development and production. Additional limitations include the necessity for repeat administrations and their limited length of in vivo potency.
The paradigm shift of Inovio's technology is that the DNA for a monoclonal antibody is encoded in a DNA plasmid, delivered directly into cells of the body using electroporation, and the mAbs are "manufactured" by these cells. Using this approach, the published data from this study demonstrated that a single administration of a highly optimized DNA-based monoclonal antibody in mice generated antibody molecules in the bloodstream possessing desirable functional activity including high antigen-binding and HIV-neutralization capabilities against diverse strains of HIV viruses for at least 7 days. Importantly, this DNA delivery strategy resulted in a rapid increase (i.e. in as little as 24 to 48 hours) in antibody levels in mice. All of these feats were not previously achievable with other DNA-based or viral delivery technologies. Although the published proof-of-concept experiments were specifically conducted with a VRC01 monoclonal antibody for HIV, Inovio's transformational approach could be applied to develop active monoclonal antibody products against multiple therapeutically important diseases, including cancers as well as inflammatory and infectious diseases. Combined with the significantly favorable cost structure of Inovio's DNA-based technology in comparison to conventional monoclonal antibody technology, active in-body generation of functional monoclonal antibodies in humans has the potential to significantly expand the range of targetable diseases.
"Inovio is one of the most innovative and scientifically productive biotechnology companies in our industry. Since the merger that created
"What makes me particularly excited about this new published data is that, although early, the results clearly demonstrate the utility and potential of Inovio's patented DNA plasmid and electroporation technology to generate and develop a new class of active monoclonal antibody products with tremendous therapeutic and market potential. These advancements represent a new area of value enhancement for Inovio stakeholders and we are now developing multiple important monoclonal product candidates."
Monoclonal antibodies have become one of the most valuable therapeutic technologies of recent years. In 2012, global sales value of monoclonal antibodies exceeded
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