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2016-07-25

XBiotech Provides Update on Xilonix™ Phase III Programs in US and EU

III Programs in US and EU

AUSTIN, Texas, 2016-07-23 00:45 CEST (GLOBE NEWSWIRE) --
XBiotech Inc. (NASDAQ:XBIT), developer of next-generation True Human™ antibody
therapies, said today that the Independent Data Monitoring Committee (DMC) for
the XCITE Phase III clinical study of Xilonix™ for the treatment of colorectal
cancer, recently recommended study continuation without any amendment to the
study design. The DMC convened as scheduled, subsequent to the enrollment of
400 patients into the study.

The DMC mandate is to “monitor for early evidence of treatment harm and to
routinely recommend to continue, suspend, or otherwise modify enrollment based
on their findings.” The DMC did not have any recommendations for the Company
regarding any need for changes to the study operation. This is viewed as a
positive assessment with respect to safety, as well as to key aspects of study
execution. Another DMC meeting is scheduled to occur either after 600 patients
have been enrolled, or potentially earlier if the study meets its first planned
efficacy analysis milestone. Xilonix has been granted FDA fast-track review and
the XCITE study is on schedule to reach its enrollment milestones in 2016.

The Company’s marketing authorization application for Xilonix for the treatment
of colorectal cancer remains on schedule to achieve a decision in 2016 by the
European Medicines Agency Committee for Medicinal Products for Human Use
(CHMP). The Company recently scheduled an in-person meeting with the CHMP. The
Company believes the meeting will help advance the marketing authorization
process and has agreed with the CHMP for the MAA to be reviewed under the
standard assessment timetable, rather than the accelerated review timeline that
was granted in April 2016. The Company says that the standard timetable will
provide additional time to conduct the MAA process. The standard timetable is
expected to add approximately 60-days to the review proceedings.

About Xilonix™ and Interleukin-1 alpha (IL-1?)
Xilonix™ is the first monoclonal antibody to specifically target and neutralize
interleukin-1 alpha (IL-1?), one of the most potent inflammatory signaling
molecules. The IL-1 pathway in general, and IL-1? in particular, is a desirable
target for anti-cancer therapy because of its potential role in both local and
systemic effects of cancer.i,ii IL-1? in the tumor microenvironment is known to
promote angiogenesis (the growth and spread of tumors), as well as mediate
symptoms such as metabolic dysregulation (e.g., loss of weight and muscle
mass), fatigue and anxiety associated with advanced cancer.

About True Human™ Therapeutic Antibodies
Unlike previous generations of antibody therapies, 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.

i Apte RN, Voronov E. Interleukin-1 a major pleiotropic cyto-kine in tumor-host
interactions. Can Biol. 2002;12:277–290.

ii Dinarello CA. Interleukin-1? neutralisation in patients with cancer.
Lancet Oncol. 2014;15(6):552-553.

Investor Relations
Scott Whitehurst
Phone: 512.386.2993
Email: swhitehurst@xbiotech.com

Media Ex-U.S.
Jonathan Kearney
+44 20 8618 2755

Media U.S.
Ashley Cadle
310.463.0143

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