History & Direction

XBiotech was founded based on the premise that pharmacologically relevant antibodies were present in humans that could be cloned and used as therapeutics. XBiotech expects these human derived antibodies to offer the best possible safety and tolerability. The potential resource of using human-sourced antibodies was recognized as a largely undeveloped opportunity; and thus, commercialization of a True Human™ antibody was deemed to represent a first-in-class product in the rapidly growing business of therapeutic antibodies

XBiotech was founded in 2005 to assemble the core technology and expertise to source True Human™ antibodies and to establish a discovery program. XBiotech was thus conceived around the notion that the next logical—and ultimate step—for these biologics should be the emergence of True Human™ antibody therapeutics.

The True Human™ derivation of these products was expected to improve safety and efficacy of antibody therapy, and thus broaden acceptance and further expand market opportunities for these next-generation products. The Company now has a True Human™ Antibody (MABp1) that targets—a “master regulator” of chronic inflammation—interleukin-1 alpha (IL-1α). MABp1 Clinical data so far support the original premise of extraordinary safety and tolerability.

XBiotech has operations in Canada, the United States and Switzerland with the vast majority of operations at its facilities in Austin, Texas. Research and development work continues for a number of different antibody targets—with ongoing screening of human blood for new candidate therapeutics. However, much of the Company’s resources are now devoted to commercializing its lead product candidate MABp1.

The company has established an in-house clinical regulatory program, which is enabled by in-house cGMP drug manufacturing, product formulation, and a fill-finish operation to supply all clinical drug product needs.

Dynamic drug production and clinical trial capabilities are at the heart of XBiotech’s rapid value creation effort and aggressive commercialization plan. The Company has launched numerous clinical trials to study its core therapeutic technology—blocking chronic (sterile) inflammation—in important disease areas.

XBiotech plans to proceed with pivotal studies in one or more indications, including a possible orphan drug indication. This is based in part on observations that MABp1 has exhibited anti-tumor activity and excellent safety in an ongoing clinical trial at MD Anderson Cancer center in Houston, Texas.

XBiotech is pioneering cutting-edge technology to commercialize its drug product. This includes the engineering of simple, robust bioreactors to support cost-effective, commercial-scale manufacturing. A 48-acre parcel of land has been purchased about 10 minutes from downtown Austin, Texas. Plans have been drawn and submitted for approval to build a 25,000L total bioreactor-capacity production facility. This operation is estimated to be capable of producing about 2,000,000 doses annually of antibody, and will enable launch into the market place as early as 2014.