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2016-07-23

XBiotech, Inc: XBiotech Provides Update on Xilonix(TM) Phase III Programs in US and EU

AUSTIN, Texas, July 22, 2016 (GLOBE NEWSWIRE) -- XBiotech Inc. (NASDAQ:XBIT),
developer of next-generation True Human(TM) antibody therapies, said today
that the Independent Data Monitoring Committee (DMC) for the XCITE Phase III
clinical study of Xilonix(TM) 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(TM) and Interleukin-1 alpha (IL-1alpha)

Xilonix(TM)
is the first monoclonal antibody to specifically target and neutralize
interleukin-1 alpha (IL-1alpha), one of the most potent inflammatory
signaling molecules. The IL-1 pathway in general, and IL-1alpha 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-1alpha 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(TM) Therapeutic Antibodies

Unlike previous generations of antibody therapies, XBiotech's True Human(TM)
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(TM) 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-1alpha 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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This announcement is distributed by NASDAQ OMX Corporate Solutions on behalf of NASDAQ OMX Corporate Solutions clients.
The issuer of this announcement warrants that they are solely responsible for the content, accuracy and originality of the information contained therein.
Source: XBiotech, Inc via Globenewswire

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