About

XBiotech is developing a first-in-class monoclonal antibody (MABp1) to inhibit chronic inflammation. Chronic (sterile) inflammatory responses are involved in the progression of many serious and common diseases. Thus commercialization of MABp1 represents a unique blockbuster-potential impact to medicine and industry.

The MABp1 product candidate had its historic launch at MD Anderson Cancer Center in February 2010, where it has since been used in a Phase 1/2 study to treat various forms of cancer, including lung, colorectal, endocrine, sarcoma and lymphoma. Based on these results, the Company believes that MABp1 has exhibited anti-tumor activity. MABp1 is also being investigated in other important areas of medicine, including: leukemia (Phase 1); Type 2 diabetes (Phase2); Psoriasis (Phase 2); and vascular disease (Phase 2).

MABp1 is a True Human™ antibody cloned from a natural human immune response and—unlike currently marketed antibodies—it has not undergone any modification to alter its function. XBiotech thus believes that True Human™ monoclonal antibodies will exhibit the best potential tolerability and safety. Clinical results to date with MABp1 support this thinking. The Company has a proprietary discovery platform for True Human™ antibodies.

XBiotech has established a current good manufacturing practices (cGMP) program to commercialize its lead product candidate, and presently operates a total bioreactor capacity of 1,000L. The manufacturing process uses disposable technology that reduces infrastructure and go-forward operating costs, compared to existing stainless steel bioreactors. The Company has purchased land and designed a commercial-scale plant with 25,000L total bioreactor capacity. Construction of the facility is planned to commence in 4th quarter 2011.