XBiotech USA, Inc. Announces Results for Its XILONIX&#0153 Treatment of Non-Small Cell Lung Cancer (NSCLC)

Published: May 16, 2013

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AUSTIN, Texas, May 15, 2013 /PRNewswire/ -- XBiotech, a privately held biotechnology company, announced today its recent findings for Non-Small Cell Lung Cancer (NSCLC). Sixteen advanced NSCLC patients were treated at MD Anderson Cancer Center with the Company's True Human Therapeutic Antibody XILONIX. The patients receiving XILONIX had failed all conventional therapy and had progressive disease upon receiving treatment with XILONIX. Over half of the patients treated recovered significant amounts of lean body tissue during treatment; as well, these patients showed a trend toward improved overall physical and functional well-being. A key outcome, however, was the observation that patient overall survival outcomes appeared significantly better than what would be expected for this late stage NSCLC patient population. Stratification of survival outcomes based on patient pretreatment history also provided some interesting findings. Sixty-three percent of the NSCLC patients treated in the study had actually receivedand failedprevious treatment regimens with the anti-cancer agent Tarceva. Surprisingly, these patients appeared to have considerably better survival outcomes than patients with other pre-treatment histories.

Dr. Michael Stecher, XBiotech's Medical Director, says, "We are very encouraged with the response to therapy seen in advanced NSCLC patients. Again we see that XILONIX treatment is associated with recovery from disease, and life extension."

XBiotech was founded in 2005 to commercialize next generation antibody therapeutics. Results to date show a promising treatment for late stage cancer. The Company's lead product candidate, a novel, breakthrough anti-inflammatory, is now in Phase III clinical studies for the treatment of advanced colorectal cancer. The same anti-inflammatory therapeutic has been used by the Company in clinical studies to treat acne, psoriasis, type 2 diabetes and cardiovascular disease. Results suggest that this single agent may be useful in treating multiple disease indications. XBiotech believes that this extraordinary lead product represents what is perhaps the greatest single-product value potential in the therapeutic antibody space.

XBiotech also has a discovery platform for True Human therapeutic antibodies, for which several candidates are in the pre-clinical pipeline. As part of its commercialization strategy, XBiotech has advanced disposable bioreactor manufacturing technology to reduce infrastructure needs, lessen capital requirements and lead times. Low-complexity production capability suggests a new paradigm of cost and development efficiency in the biopharmaceutical space.

XBiotech believes that its unique blend of assets, commercialization platform and cost structure has created the foundation for a unique growth business.

John Simard


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