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XBiotech Announces Publication of Post-Hoc Analysis for Phase III Colorectal Cancer Study

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Biomarkers Predict Significantly Higher Rates of Treatment Response to Bermekimab in Advanced Cancer Patients

AUSTIN, Texas, Dec. 13, 2018 (GLOBE NEWSWIRE) -- XBiotech Inc. (NASDAQ: XBIT) announced today the publication of findings on key biomarker analysis of colorectal cancer patients treated with bermekimab in its European Phase III study. The manuscript, entitled, “Interleukin-1 Receptor Antagonist (IL-1ra) Levels Predict Favorable Outcome after Bermekimab, a First-in-Class True Human Interleukin-1α Antibody,  in a Phase III Randomized Study of Advanced Colorectal Cancer”, has been published online in the journal OncoImmunology.

The findings report that patients with relatively low levels of IL-1ra or IL-6 were more likely to respond to bermekimab therapy and achieve the study’s primary endpoint. The study’s primary endpoint measured a combination of physical symptoms—pain, fatigue, anorexia and muscle wasting—which tend to worsen with advanced cancer, to assess whether these symptoms stabilized or improved with treatment. Patients that achieved the primary endpoint in the Phase III study had one-fifth as many serious adverse events, were twice as likely to have no tumor growth, improved significantly with all life quality measures, and had almost three-fold increase in survival compared to failures.

Results from Dr. Razelle Kurzrock’s analysis found that for patients with relatively low IL-1ra levels at the start, 41% of those treated with bermekimab achieved the primary endpoint, compared to only 33% of patients for the entire bermekimab treatment group (19% of placebo patients achieved the primary endpoint). However, in the publication it is reported that for those with relatively low pretreatment levels of both IL-1ra and IL-6, 46% of patients in the bermekimab group versus only 17% in placebo achieved the primary endpoint (p<0.01). About 28% of patients in the study met the criteria of low IL-1ra and low IL-6.

Dr. Razelle Kurzrock, lead author of the publication, is Chief, Division of Hematology and Oncology, and Director, Center of Personalized Cancer Therapy at Moores Cancer Center UC San Diego.  Dr. Kurzrock  commented, “These findings help us better identify patients with advanced cancer who can benefit from a targeted therapy that interrupts the inflammatory process, thereby decreasing tumor growth and cancer-related morbidity. We hope that these results will help lead us to the effective use of bermekimab in cancer therapy.”

About Razelle Kurzrock, M.D.
Dr. Kurzrock is a medical oncologist and a renowned expert in precision medicine. She is a thought leader in the use of anti-cytokine therapies for the treatment of cancer and one of the first to recognize the importance of the interleukin-1 pathway in cancer. While at the University of Texas MD Anderson Cancer Center, Dr. Kurzrock built one of the most successful Phase 1 clinical trials programs in the nation, and was the senior author in the pioneering study for XBiotech’s colorectal cancer study. Dr. Kurzrock currently serves as: Senior Deputy Director for Clinical Science, Murray Professor of Medicine, Director for the Center for Personalized Cancer Therapy and Clinical Trials Office, and a Team Leader for Experimental Therapeutics at the Moores Cancer Center at UC San Diego. Dr. Kurzrock is also Chief of the Hematology & Oncology Division in the UC San Diego School of Medicine. Dr. Kurzrock serves on XBiotech’s Scientific Advisory Board.

About True Human™ Therapeutic Antibodies
XBiotech’s True Human™ antibodies are derived without modification from individuals who possess natural immunity to certain diseases. With discovery and clinical programs across multiple disease areas, XBiotech’s True Human antibodies have the potential to harness the body’s natural immunity to fight disease with increased safety, efficacy and tolerability.

About XBiotech
XBiotech is a fully integrated global biosciences company dedicated to pioneering the discovery, development and commercialization of therapeutic antibodies based on its True Human™ proprietary technology. XBiotech currently is advancing a robust pipeline of antibody therapies to redefine the standards of care in oncology, inflammatory conditions and infectious diseases. Headquartered in Austin, Texas, XBiotech also is leading the development of innovative biotech manufacturing technologies designed to more rapidly, cost-effectively and flexibly produce new therapies urgently needed by patients worldwide. For more information, visit www.xbiotech.com.

Cautionary Note on Forward-Looking Statements

This press release contains forward-looking statements, including declarations regarding management's beliefs and expectations that involve substantial risks and uncertainties. In some cases, you can identify forward-looking statements by terminology such as "may," "will," "should," "would," "could," "expects," "plans," "contemplate," "anticipates," "believes," "estimates," "predicts," "projects," "intend" or "continue" or the negative of such terms or other comparable terminology, although not all forward-looking statements contain these identifying words. Forward-looking statements are subject to inherent risks and uncertainties in predicting future results and conditions that could cause the actual results to differ materially from those projected in these forward-looking statements. These risks and uncertainties are subject to the disclosures set forth in the "Risk Factors" section of certain of our SEC filings. Forward-looking statements are not guarantees of future performance, and our actual results of operations, financial condition and liquidity, and the development of the industry in which we operate, may differ materially from the forward-looking statements contained in this press release. Any forward-looking statements that we make in this press release speak only as of the date of this press release. We assume no obligation to update our forward-looking statements whether as a result of new information, future events or otherwise, after the date of this press release.

Contact
Ashley Otero
aotero@xbiotech.com
512-386-2930

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