XBiotech is pioneering the development of first-in-class True Human™ therapeutic antibodies. True Human™ antibodies are cloned from a human gene involved in a natural human immune response. In the human body, genes that encode antibodies undergo “rearrangement.” This “rearrangement” results in billions of antibodies. Once a unique antibody is made, it must undergo a process of “selection.” The selection process ensures that a unique antibody exhibits good functionality and does not cause adverse reactions in the body.
This process is complex and species specific and cannot be completely mimicked through artificial systems or other animal models. Based on the basic biology of antibodies, XBiotech believes that True Human™ antibodies offer the best safety, efficacy and thus commercial value compared to earlier generation antibody therapeutics. Accordingly, the Company believes that its True Human™ antibodies represent the first of a new class of antibody therapy.
The Company has a discovery pipeline for True Human™ monoclonal antibodies. The first step in discovery of these naturally occurring antibodies involves screening of individual human blood samples. Once relevant antibodies have thus been identified, protein, cells and genetic material are isolated from the individual in order to clone the antibody gene. Once cloned, a production cell line can be developed for the manufacture of the monoclonal antibody as a therapeutic product.
The Company has screened thousands of donors using a Super High Stringency Antibody Mining technology (SHSAM™). SHSAM™ has enabled us to identify clinically relevant antibodies—discovered from literally trillions of irrelevant background antibody molecules in the blood of donors. From this program, the Company has archived hundreds of samples and identified positive antibody reactivity against known, medically important targets.
XBiotech believes that its lead product represents one of the most significant drugs in development in the world today. Yet we continue to pursue a discovery program that we believe has very important implications for the future development of therapeutic antibodies.
