XBiotech Developing Novel True Human Antibody Targeting Interleukin-1alpha (IL-1⍺)
April 14 2020 - 9:15AM
XBiotech Inc. (NASDAQ: XBIT) announced today that a novel antibody
it has discovered that neutralizes interleukin-1 alpha (IL-1⍺) has
now been advanced as a product candidate for clinical and
commercial development. XBiotech discovered the IgG1 monoclonal
antibody from a healthy donor with natural immunity against IL-1⍺.
Creating medicines from natural human immunity is the hallmark of
XBiotech’s approach to developing a new generation of breakthrough
therapies.
XBiotech recently sold an IL-1⍺ blocking True
Human™ antibody, which it had used successfully in a number of
clinical trials, for $750 million in upfront cash and up to $600
million in potential milestone payments. As part of the sale,
XBiotech agreed not to develop or market anti-IL-1⍺ antibody
treatments for dermatological diseases. However, the Company
retained the right to pursue the discovery and development of new
True Human™ antibodies targeting IL-1⍺ for areas of medicine
outside of dermatology.
The Company believes that the potential unmet
medical need for blocking inflammation through neutralizing IL-1⍺
is unprecedented. IL-1⍺ is produced naturally by the body and is
present on cells such as platelets or white blood cells and can be
released from dead or injured cells. When not properly controlled,
or in situations of traumatic or sustained injury, inflammation
caused by IL-1⍺ is believed to contribute to the progression of
serious illnesses. IL-1⍺ is believed to play a role in stroke,
heart attack, cancer and rheumatological diseases, among others.
Clinical studies conducted by XBiotech and a myriad of scientific
research have shown that blocking IL-1⍺ may have a beneficial
effect in numerous medical conditions.
With the discovery, the Company is on schedule
to reenter the clinic with a new anti-IL-1⍺ therapy in 2021. Since
there is such vast potential for anti-IL-1⍺ therapy in multiple
areas of medicine, the Company believes there is the opportunity to
develop more than one True Human™ antibody, each specialized for
specific areas of medicine. This strategy will potentially allow
XBiotech to maximize value and exclusivity for its True Human™
anti-IL-1⍺ antibodies for various unique medical areas. The Company
expects this will diversify risk for its anti-IL-1⍺ therapies,
allow for multiple potential collaborations, and facilitate greater
resource dedication to each True Human™ anti-inflammatory
therapeutic.
John Simard, XBiotech’s President & CEO,
stated, “We are elated to be able to so quickly advance a new True
Human anti-IL-1⍺ antibody into commercialization. I am very proud
of the extraordinary efforts the XBiotech team continues to make to
advance our important programs in this extremely difficult
environment. There can be no better organization utilizing as good
a technological approach or medical target than what we are
witnessing here at XBiotech, and the True Human antibody program to
target IL-1⍺ mediated inflammation.”
About XBiotech XBiotech is
a fully integrated, global biopharmaceutical company dedicated to
pioneering the discovery, development and commercialization of
therapeutic antibodies. XBiotech currently is advancing a pipeline
of therapies by harnessing naturally occurring antibodies from
patients with immunity to certain diseases. Utilizing natural human
immunity as a source of new medicines offers the potential to
redefine the standards of care for a wide range of diseases.
On December 30, 2019 XBiotech sold an IL-1⍺
blocking True Human™ antibody that had been used successfully in a
number of clinical trials. The sale of the antibody generated $750
million in upfront cash and up to $600 million in potential
milestone payments. The Company retained the right to pursue the
development of True Human™ antibodies targeting IL-1⍺ for all areas
of medicine outside of dermatology. While the Company previously
was focused on a single True Human™ antibody targeting IL-1⍺, it
now plans to develop multiple product candidates, which will target
IL-1⍺ in specific areas of medicine.
In addition to recent sale of its anti-IL-1⍺
antibody, XBiotech now has other revenue sources. Commencing
January 1, 2020 XBiotech began using its proprietary
manufacturing technology to produce clinical drug product for a
major Pharmaceutical Company under a two year supply agreement. In
addition, XBiotech is providing clinical trial contract
research operations to conduct two large, double-blind placebo
controlled Phase II clinical studies. The financial strength
generated from the sale and contract operations is enabling
XBiotech to expand both its anti-IL-1⍺ product development and
infectious disease programs.
To accelerate advance of the Company’s pipeline,
the Company is expanding its existing manufacturing and research
center, and planning to build an additional 30,000ft2 infectious
disease research & development center on its 48-acre property
in Austin, TX which is wholly owned by the Company. The expansion
and new building will be in addition to the present custom-built
33,000ft2 combined manufacturing and R&D facility that
currently exists on the campus. XBiotech owns the 48-acre
campus—and all structures on the property—debt-free and envisions
further expansion of facilities. For more information, visit
www.xbiotech.com.
About True Human™ Therapeutic
AntibodiesXBiotech’s True Human™ antibodies are the
only available antibodies derived without modification from humans
who possess natural immunity to certain diseases. (Unlike all
commercially available antibodies, which are called “Humanized” or
“Fully Human,” XBiotech’s True Human™ antibodies are directly
sourced from the natural human immune response for specific
diseases without modification.) XBiotech’s True Human™ antibodies
have the potential to harness the body’s natural immunity to fight
disease with unprecedented safety, efficacy, and tolerability.
Cautionary Note on Forward-Looking
StatementsThis press release contains forward-looking
statements, including declarations regarding management's beliefs
and expectations, including with respect to XBiotech’s strategic
ambitions, regarding the expected timing of closing of the
transaction with Janssen, filings and approvals relating to the
transaction, the amount and timing of potential future milestone
payments by Janssen, the mechanism of action and potential safety
and efficacy of bermekimab, the anticipated timing of clinical
studies with bermekimab, the progression and results of such
studies, statements regarding the regulatory pathway for bermekimab
and the timing of regulatory filings, and statements regarding any
capital allocation decisions, including as to potential share
repurchases. 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.
ContactAshley
Oteroaotero@xbiotech.com512-386-2930
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