Discovery

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 NAtural (True) Human Monoclonal AntiBody (NATHMAB™) therapeutics. The first step in generating NATHMAB™ involves screening individuals to find naturally occurring antibodies present that may be relevant as therapeutics. Once relevant antibodies have been identified, cells and genetic material are isolated from the individual in order to clone the antibody gene. Once cloned, a monoclonal antibody can be used to develop 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 what we believe are clinically relevant antibodies—identified 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 our NATHMAB™ discovery program. Antibodies in the pipeline require further key technical development and validation milestones before being considered as clinical trial candidates. Nonetheless, we believe the NATHMAB™ approach to therapeutic antibody development represents a key program in the future of antibody drug development.