XBiotech Inc. (NASDAQ: XBIT) announced today the first meeting of
its Cerebrovascular Medical Advisory Board (CMAB). The CMAB is
comprised of key opinion leaders who specialize in cerebrovascular
diseases including ischemic stroke, which is the third leading
cause of death and second leading cause of disability in the world.
The CMAB is chaired by Clay Johnston, M.D., Ph.D., Dean of Dell
Medical School, Vice President for Medical Affairs, University of
Texas, Austin. Members of the board include Greg Albers, M.D.,
Director of Stanford University Stroke Center, and Brett Cucchiara,
M.D., Director of the Neurovascular Ultrasound Laboratory at the
University of Pennsylvania.
The CMAB is providing expert Medical and
Clinical guidance for XBiotech’s new candidate neuroprotectant,
anti-inflammatory True Human™ antibody therapy to treat stroke. Dr.
Clay Johnston commented, “While we have done a great job in
increasing reperfusion after stroke, we have failed to address the
downstream injury that nearly always occurs. Inflammation is a key
part of that injury and blocking IL-1⍺ has real potential in
further improving outcomes for patients. Once again, I’m excited
about the potential for a neuroprotective agent.”
Together with the CMAB, the Company believes it
has the potential to provide groundbreaking antibody therapies to
patients that will help reduce the impact of strokes and improve
recovery of stroke victims. Currently, no neuroprotectant treatment
has been approved for the damaging effects of reperfusion injury,
representing an extraordinary unmet medical need.
John Simard, President and CEO of XBiotech,
commented, “I am indeed honored to have the support of such
distinguished medical experts assisting XBiotech in developing a
True Human antibody which we believe has unprecedented potential as
a neuroprotectant for patients who experience ischemic strokes. We
plan to expedite clinical development of this unique new drug.”
XBiotech’s Cerebrovascular Medical Advisory
Board Includes:
- Clay Johnston M.D., Ph.D. currently
serves as the inaugural dean of Dell Medical School at the
University of Texas in Austin. As a neurologist specializing in
stroke care and research, he has published extensively in the
prevention and treatment of stroke and transient ischemic attack.
He has led several large cohort studies and three international
multi-center randomized trials. Dr. Johnston is a graduate of
Amherst College and Harvard Medical School. He later received his
Ph.D. in epidemiology from the University of California, Berkeley,
and was a resident in Neurology at UCSF, where he trained in
Vascular Neurology. Dr. Johnston has received national accolades
for his research and was elected to the National Academy of
Medicine in 2019.
- Greg W. Albers, M.D. is a stroke
and vascular neurologist and currently serves as the Director of
the Stanford Stroke Center at Stanford Medical Center. Dr. Albers
is a Coyote Foundation Professor and a Professor, by courtesy, of
Neurosurgery and Neurological Sciences at Stanford University. Dr.
Albers’ primary research focus is the diagnosis, management, and
prevention of ischemic stroke. A prolific and distinguished
researcher, he has authored more than 450 articles on topics
related to cerebrovascular disease in peer-reviewed journals.
- Brett L. Cucchiara M.D. is a
Professor of Neurology and serves as the Director of the
Neurovascular Ultrasound Laboratory at the University of
Pennsylvania. He specializes in cerebrovascular disease and has
extensive experience in stroke clinical trials and biomarker
research. Dr. Cucchiara is a member of the American Board of
Psychiatry and Neurology.
Brain reperfusion, or opening of the clogged
artery, is the cornerstone of emergency treatment for ischemic
stroke. However, opening of a clogged artery is associated with a
rapid induction of inflammation where the returning blood supply
downstream of the clogged artery begins to recirculate in the
brain. The brain injury inflicted by the inflammation can be
devastating. There is presently no approved drug to reduce injury
from reperfusion. XBiotech previously announced a publication, in
animal models of stroke, which described a significant reduction in
brain injury when an IL-1⍺ neutralizing antibody was used to
inhibit inflammation prior to unblocking of the clogged artery.
On December 30, 2019, XBiotech sold a True
Human™ anti-inflammatory antibody in a $1.35 billion transaction.
The Company has since worked vigorously to bring a new line of True
Human™ anti-inflammatory therapies to the clinic in 2021. XBiotech
is now developing a novel True Human™ antibody therapy that
neutralizes interleukin-1 alpha (IL-1⍺) as a neuroprotectant. IL-1⍺
is a trigger in the onset of inflammation. When inflammation is
deregulated, or in situations of acute injury, such as that which
occurs after reperfusion (the resumption of blood flow after
unblocking of an artery), IL-1⍺ enhances the inflammation that
leads to worsening of the injury.
About XBiotechXBiotech 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, and thereby have not been shown to
cause immunogenicity.) 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.
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uncertainties in predicting future results and conditions that
could cause the actual results to differ materially from those
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uncertainties are subject to the disclosures set forth in the "Risk
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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
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after the date of this press release.
Contact
Ashley Oteroaotero@xbiotech.com512-386-2930
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