April 14 & April 17, 2015
dated April 14, 2015
(Commissioned by XBiotech)
Free-Writing Prospectus filed pursuant to rule 433, dated March 27, 2015; Registration Statement No. 333-201813
All documents, including a transcript of the company video, have been filed with the Securities and Exchange Commission.
XBiotech is a clinical-stage biopharmaceutical company engaged in discovering and developing “True Human” monoclonal antibodies for treating a variety of diseases. True Human monoclonal antibodies are those which occur naturally in human beings—as opposed to being derived from animal immunization or otherwise engineered. We believe that naturally occurring monoclonal antibodies have the potential to be safer and more effective than their non-naturally occurring counterparts. While focused on bringing our lead product candidate, Xilonix, to market, we also have developed a True Human discovery platform as well as a low cost, next generation manufacturing system.
The majority of our efforts to date have been concentrated on developing MABp1 (also known as Xilonix), a therapeutic antibody which specifically neutralizes interleukin-1 alpha (IL-1α). IL-1α is a pro-inflammatory protein produced by leukocytes and other cells, where it plays a key role in inflammation. When unchecked, inflammation can contribute to the development and progression of a variety of different diseases, such as cancer, vascular disease, inflammatory skin disease, and diabetes. Our clinical studies have shown that blocking IL-1α with MABp1 may have a beneficial effect in several diseases.
We completed a Phase I/II clinical trial for MABp1 (Xilonix) as a treatment for cancer at MD Anderson Cancer Center. The results of this study, published in Lancet Oncology in April 2014, found that in the 52 patients with metastatic cancer (18 tumor types) who participated, MABp1 was well tolerated, with no dose-limiting toxicities or immunogenicity. Moreover, within eight weeks of starting therapy many patients began to improve with respect to constitutional symptoms. An imaging method, known as dual energy X-ray absorptiometry (DEXA), revealed that many of the patients improved physically, in terms of gaining lean body mass (LBM); and patient reported outcomes documented that many were recovering from pain, fatigue and appetite loss. Finally, we found that in the patients with colorectal cancer, DEXA-measured recovery was associated with significant improvement in survival.
For the complete company overview, please download the Final Prospectus.
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