XBiotech Candidate True Human™ COVID-19 Therapy Found to Target Highly Infectious Emerging Strain
January 21 2021 - 8:15AM
XBiotech Inc. (NASDAQ: XBIT) announces that its COVID-19 candidate
True Human™ antibody therapy may also be used for treating the
COVID-19 mutant virus that recently emerged in the UK and is now
rapidly spreading across the US. The mutant COVID-19 virus has
alterations to the spike protein that reportedly make the virus
more contagious, and these mutations might also enable the virus to
escape existing vaccines or therapies. XBiotech’s candidate therapy
specifically targets the so-called spike protein of the virus and
potently neutralizes the virus’ ability to infect cells. The
company analyzed its candidate COVID-19 therapy for its ability to
bind the spike protein of the mutant COVID-19 virus and was found
to have the same high affinity for spike protein of both the
original COVID-19 and mutant COVID-19 viruses. These findings
provide quick and convincing evidence that XBiotech’s candidate
True Human™ therapy, which was potently effective in neutralizing
the original strain of COVID-19, could be expected to be similarly
effective at neutralizing the mutant strain of the virus.
The new mutant COVID-19 virus has undergone
changes that include small differences in the so-called spike
protein of the virus. Scientists at XBiotech used a
state-of-the-art method employing bio-layer interferometry to
analyze binding of its COVID-19 True Human™ antibody to the spike
protein of the mutant strain. These studies showed the antibody
bound to the mutant spike protein with same high affinity as it
does to the original COVID-19 virus.
Sushma Shivaswamy, Ph.D., XBiotech’s Chief
Scientific Officer, commented, “We are extremely excited that our
antibody therapy has the capability of treating this new, even more
contagious, strain of the virus. I applaud the hard work and
dedication of our scientists who are tirelessly working to address
emerging needs of this pandemic while keeping us on track to pursue
other important diseases.”
The Company previously announced that its
candidate True Human™ therapy for COVID-19—isolated from an actual
patient that had recovered from the infection—was found to
neutralize the virus at concentrations about four-times better than
antibodies currently FDA approved under emergency use
authorization.
The higher rate of transmission of the mutant
COVID-19 virus means that it could quickly become the dominant form
of the virus in the US. The CDC in fact predicts the new variant
will be the main cause of COVID infections in the USA by March,
2021. A therapy that could be used to treat both COVID-19 and the
mutant strains of the virus could be of crucial importance as the
mutant virus spreads. The Company has engineered production capable
cell lines and is prepared to establish manufacturing processes for
clinical development as necessary.
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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development of the industry in which we operate, may differ
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after the date of this press release.
ContactAshley
Oteroaotero@xbiotech.com512-386-2930
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