With the submission of an IND (investigational new drug application) to the ethics committee at the University of Basel, XBiotech is well on its way to starting a second phase I/II clinical trial.  This proposed trial, focusing on the treatment of type 2 diabetes, will be conducted in Switzerland under the direction of a leading expert in the field of Endocrinology and Diabetes.  Diabetes is a disease caused primarily by obesity, and unfortunately the incidence of obesity and diabetes continues to rise industrialized nations.  A chronic inflammatory response has also been observed in diabetes.  This process drives disease progression and the development of disease associated comorbidities.  Blocking the chronic inflammatory process that drives type 2 diabetes may provide a new and more effective treatment option for these patients.

R & D scientists at XBiotech have successfully completed development of new methodology to discover novel antibody sequences from human peripheral blood cells.  The method is designed to capture the crucial “variable regions” that escape identification using traditional approaches. Normally the process of “somatic hypermutation,” which produces the most potent antibodies, also makes these antibodies the most difficult to identify and clone. XBiotech’s new approach is being used to generate antibody “libraries” that more efficiently incorporates sequences with extensive somatic hypermutations. The approach is expected to yield libraries that are superior to those previously constructed. To screen these better libraries, a complementary ‘antibody-display’ system using mammalian cells has also been developed.

Recombinant antibody technology is the fastest growing sector of the pharmaceutical industry. Antigen binding fragments derived from phage display or transgenic mice have been tested been marketed as treatments for a number of illnesses. However, there are certain disadvantages with the current technologies that make discovery of good candidate antibody therapeutics very difficult.

XBiotech will be implementing its new technology into its pipeline discovery program. We expect this technology to yield better antibodies and improve the likelihood of finding these antibodies in human blood samples.

The new platform is rapidly being developed and has already shown other broad applications, including pre-clinical research and development, and clinical pharmacokinetics, where it represents a cell-based alternative to classical ELISA immunoassay.

This study has particular significance, since it is the first ever use of a True Human Antibody in clinical studies. The next generation antibody is intended to block blood vessel growth and reduce the invasive potential of tumors. The study is rather unique also, in that cancer patients will also be closely evaluated for their physical response to therapy, to observe improvement in symptoms of cachexia. There is no current approved drug therapy for the treatment of cachexia.

The MD Anderson study enables treatment of all forms of cancer, including solid and hematopoietic tumors. XBiotech plans to evaluate multiple forms of cancer for safety and response to our novel therapeutic antibody. To find our more about this clinical trial, please go to clinicaltrials.gov.