XBiotech USA Engages In Research For Heart Attack Antibody Therapy

XBiotech Inc. (NASDAQ: XBIT), developer of True Human™ therapeutic antibodies, announced today the signing of a Material Transfer Agreement (MTA) with Brigham and Women’s Hospital and Massachusetts General Hospital. XBiotech will provide Antibodies to block the inflammatory mediator interleukin 1 alpha while Novartis Pharmaceuticals will provide an interleukin 1 beta antibody to a research team headed by cardiovascular medicine specialist Dr. Peter Libby. The research team will conduct pre-clinical studies to assess the potential of these antibodies to reduce injury to the heart muscle after heart attack and to calm inflammation in atherosclerotic plaques.

Dr. Libby, a cardiovascular medicine specialist at Brigham and Women’s Hospital (BWH) and the Mallinckrodt Professor of Medicine at Harvard Medical School (HMS), is the principal investigator of the research project. He has authored more than 370 peer-reviewed articles related to his interest in atherosclerosis and preventative cardiology. Dr. Libby’s research includes studying the messengers created by the body that may produce arterial plaque and blockages. Dr. Libby has received research recognitions on four continents including the highest basic research awards from the American Heart Association and American College of Cardiology, the Gold Medal of the European Society of Cardiology, and the Anitchkow award from the European Atherosclerosis Society.

Dr. Libby stated “I have researched IL-1’s cardiovascular actions for many years, and am excited about the opportunity to be able to inhibit selectively IL-1 isoforms experimentally to define their roles and thus inform the design of future clinical trials targeting IL-1 in cardiovascular diseases.”

John Simard, the Company’s Chief Executive Officer, commented, “Dr. Libby’s pioneering work to explore the role of inflammation in cardiovascular disease has been inspirational to our endeavors. Indeed the body of evidence he has generated during his remarkable career forms a key basis to XBiotech’s rationale for using its inflammation-blocking antibody therapy to treat vascular disease. This collaboration is intended to extend these observations by evaluating the role of antibody therapy in reducing injury to heart muscle associated with heart attacks.”

MABp1 has been in a number of human clinical trials. XBiotech has reported that the antibody therapy has shown promising results in a Phase II randomized study, where the therapy was used to reduce major adverse cardiovascular events and restenosis to the blood vessel after revascularization procedures. The therapy has been Fast Tracked by the US FDA for clinical development in this indication. The animal analogue, FLO1 is a monoclonal antibody that neutralizes the same inflammatory target, IL-1a, as MABp1, but specifically targets the murine form of IL-1a. The use of FLO1 allows it to be well tolerated and function within the animal immune system in a way that is analogous to MABp1 in humans.

ABOUT XBIOTECH

XBiotech is pioneering a new era in the discovery and development of targeted antibodies based on its True Human™ technology. The Company's mission is to rethink the way antibody medicines are discovered and commercialized by advancing its robust pipeline of truly natural human antibodies for treating serious diseases such as cancer, inflammatory conditions and infectious diseases. XBiotech's most advanced product, Xilonix™, is a potential breakthrough antibody therapy that is currently the subject of two pivotal Phase III clinical studies for treating advanced colorectal cancer. Xilonix™ specifically targets and neutralizes interleukin-1 alpha (IL-1a), a molecule known to promote angiogenesis, growth and spread of tumors, as well as mediate symptoms such as metabolic dysregulation, fatigue and anxiety associated with advanced cancer. XBiotech believes that its broad pipeline of True Human antibodies will be able to potentially deliver unmatched safety and efficacy because they are cloned directly from individual donors who possess natural immunity against certain targeted diseases. As such, XBiotech expects that True Human antibodies will retain their natural physiology and tolerance profile, having passed the rigors of immune selection in the body.

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