XBIT XBiotech Inc.

18.8
-0.67  -3%
Previous Close 19.47
Open 19.52
52 Week Low 8.72
52 Week High 21.48
Market Cap $550,099,524
Shares 29,260,613
Float 14,543,457
Enterprise Value $317,520,647
Volume 75,276
Av. Daily Volume 120,745
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Latest News

  1. AUSTIN, Texas, Jan. 21, 2021 (GLOBE NEWSWIRE) -- 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…

    AUSTIN, Texas, Jan. 21, 2021 (GLOBE NEWSWIRE) -- 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 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 30,000ftinfectious 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 Antibodies

    XBiotech'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.

    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.

    Contact

    Ashley Otero



    512-386-2930



    Primary Logo

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  2. AUSTIN, Texas, Jan. 19, 2021 (GLOBE NEWSWIRE) -- 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…

    AUSTIN, Texas, Jan. 19, 2021 (GLOBE NEWSWIRE) -- 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 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 Antibodies

    XBiotech'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.

    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.

    Contact

    Ashley Otero



    512-386-2930



    Primary Logo

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  3. AUSTIN, Texas, Nov. 19, 2020 (GLOBE NEWSWIRE) -- XBiotech Inc. (NASDAQ:XBIT) announced today new data for its breakthrough candidate therapy for treating infections of influenza and COVID-19. The Company continues to analyze components of its so-called FLUVID™ therapy as it develops manufacturing capability for a product candidate. The True Human antibodies targeting the virus causing COVID-19 were found to effectively neutralize a test virus at concentrations about four-times better than the antibodies the FDA is now considering for emergency use authorization. Ongoing research has also found that the True Human antibodies in this therapeutic cocktail that target influenza are capable of rescuing 100% of animals that receive an otherwise…

    AUSTIN, Texas, Nov. 19, 2020 (GLOBE NEWSWIRE) -- XBiotech Inc. (NASDAQ:XBIT) announced today new data for its breakthrough candidate therapy for treating infections of influenza and COVID-19. The Company continues to analyze components of its so-called FLUVID™ therapy as it develops manufacturing capability for a product candidate. The True Human antibodies targeting the virus causing COVID-19 were found to effectively neutralize a test virus at concentrations about four-times better than the antibodies the FDA is now considering for emergency use authorization. Ongoing research has also found that the True Human antibodies in this therapeutic cocktail that target influenza are capable of rescuing 100% of animals that receive an otherwise lethal dose of flu virus. The latest research findings suggest the FLUVID™ therapy, designed to be effective against all known strains of influenza in addition to the COVID-19 virus, could provide a uniquely effective therapy for treating complex infections from one or more of these viruses. There is no other therapy available to treat both COVID-19 and Influenza infections that occur together.

    With the resurgence of the COVID-19 virus during this oncoming flu season, we are faced with the likelihood that many people will be infected by both influenza and COVID-19 viruses. Co-infections, or "superinfections", may increase severity of disease and further complicate treatment. A therapy that could treat COVID-19+Influenza co-infections is urgently needed.

    While the COVID-19 pandemic has only recently emerged, the FLUVID™ candidate therapy is the result of years of Research and Development at XBiotech, incorporating extraordinary influenza True Human antibodies that have been systematically evaluated for their ability to target virtually all known strains of influenza viruses. Whereas the True Human COVID-19 antibodies were derived from patients who recovered rapidly without serious illness and therefore should have potent neutralizing capability against the virus.

    The influenza strains that will be targeted by FLUVID include: seasonal H1N1 and H3N2 strains; pandemic strains H1N1, H2N2, H3N2; avian influenza strains H5N1, H5N2 and H7N9; and even H9N2 and H10N8, which are currently in poultry but are believed to have pandemic potential in humans.

    Dr. Sushma Shivaswamy, Ph.D., XBiotech's Chief Scientific Officer, commented, "We continue to see outstanding data as we move this unique and critical therapy toward the clinic. Unlike any other Research and Development program, our pipeline is focused on delivering therapies to the vulnerable demographic that is most in need of the FLUVID™ therapy. We believe strongly in the potential of this product candidate."

    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 based on harnessing naturally occurring antibodies from patients with immunity to certain diseases. The approach to use natural human immunity as a source of new medicines offers the potential to redefine the standards of care a wide range of diseases. Headquartered in Austin, Texas, XBiotech also is leading the development of innovative manufacturing technology to reduce the cost and complexity of biological drug production. For more information, visit www.xbiotech.com.

    About True Human™ Therapeutic Antibodies

    XBiotech'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.

    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.

    Contact

    Ashley Otero



    512-386-2930 



    Primary Logo

    View Full Article Hide Full Article
  4. AUSTIN, Texas, Sept. 21, 2020 (GLOBE NEWSWIRE) -- XBiotech Inc. (NASDAQ:XBIT) announced today it is developing a new breakthrough candidate therapy it calls FLUVID™ for treating illness caused by combined infections with influenza and COVID-19. With the global spread of the novel COVID-19 virus, there will be added risk during flu seasons that people may be infected by both influenza and COVID-19 viruses. Co-infections with the two viruses, or superinfections, may increase severity of disease and further complicate treatment. FLUVID therapy will combine XBiotech's breakthrough influenza True Human antibodies together with its recently discovered COVID-19 antibodies into one treatment. As flu season approaches amid concerns over a potential

    AUSTIN, Texas, Sept. 21, 2020 (GLOBE NEWSWIRE) -- XBiotech Inc. (NASDAQ:XBIT) announced today it is developing a new breakthrough candidate therapy it calls FLUVID™ for treating illness caused by combined infections with influenza and COVID-19. With the global spread of the novel COVID-19 virus, there will be added risk during flu seasons that people may be infected by both influenza and COVID-19 viruses. Co-infections with the two viruses, or superinfections, may increase severity of disease and further complicate treatment. FLUVID therapy will combine XBiotech's breakthrough influenza True Human antibodies together with its recently discovered COVID-19 antibodies into one treatment. As flu season approaches amid concerns over a potential deadly "twindemic", FLUVID is an urgently needed and potential breakthrough therapy to treat combined infections with influenza and COVID-19 viruses. FLUVID could be used to provide immunity to infection or to treat infections once they have occurred.

    FLUVID is the culmination of years of research and development. It incorporates extraordinary influenza antibodies that target all known strains of influenza, combined with the Company's recently discovered COVID-19 antibody, passive immunity derived from patients who recovered rapidly from the virus without serious illness. FLUVID harnesses the best in human immunity to provide what is expected to be a safe and effective therapy against both deadly viruses.

    Multiple strains of influenza are responsible for the seasonal illnesses and pandemics experienced around the globe. However, among these multiple influenza strains, there are small portions of the virus that are common among all the strains. For years, XBiotech scientists diligently screened human donors for antibodies capable of targeting these regions shared among influenza viruses. By identifying antibodies that target the shared areas of the influenza viruses, XBiotech is able to develop a single therapy that could be used to treat virtually all known strains.

    XBiotech's vision paid off with the discovery of the IH201 and IH302 antibodies. Together, these two influenza antibodies neutralize seasonal H1N1 and H3N2 influenza strains as well as pandemic influenza strains, including: H1N1 Spanish Flu, which infected 500 million people and killed 50 million worldwide; H2N2 Asian Flu; H3N2 Hong Kong flu, which killed 4 million people; the more recent H1N1 California virus; the Hong Kong (H3N2) virus which has been prevalent since 2014; and the sporadic but persistent avian influenza strains H5N1, H5N2 and H7N9. In addition, the IH201 and IH302 True Human antibodies target the influenza strains H9N2 and H10N8, which are currently widespread in poultry and are speculated to have future pandemic potential in humans. XBiotech's influenza antibodies therefore target virtually all of the known influenza strains and sub-types that have caused widespread disease over the past century, and are even expected to neutralize the avian influenza strains that are predicted to have potential to infect humans in the future. FLUVID will contain IH201 and IH302 antibodies along with the Company's anti-COVID-19 antibody.

    John Simard, XBiotech President & CEO, commented, "We believe a combination antibody therapy is the best way to prepare for flu season or a larger influenza pandemic outbreak that may occur in combination with COVID-19. XBiotech's discovery program is unlike any other, and we now have candidate therapeutics to treat real-world infections which will involve multiple pathogens and co-infections."

    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 based on harnessing naturally occurring antibodies from patients with immunity to certain diseases. The approach to use natural human immunity as a source of new medicines offers the potential to redefine the standards of care a wide range of diseases. Headquartered in Austin, Texas, XBiotech also is leading the development of innovative manufacturing technology to reduce the cost and complexity of biological drug production. For more information, visit www.xbiotech.com.

    About True Human™ Therapeutic Antibodies

    XBiotech'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.

    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.

    Contact

    Ashley Otero



    512-386-2930

    Primary Logo

    View Full Article Hide Full Article
  5. FDA has Authorized Use of Antibody-Rich COVID-19 Therapy Derived from Convalescent Patients

    Under Collaboration BioBridge Global Will Be Using XBiotech's COVID-19 Antibody Test to Identify the Convalescent Blood Products

    AUSTIN, Texas, Aug. 24, 2020 (GLOBE NEWSWIRE) -- XBiotech Inc. (NASDAQ:XBIT) announced today that the U.S. Food and Drug Administration (FDA) issued an emergency use authorization (EUA) for COVID-19 Convalescent Plasma (CCP) as a COVID-19 treatment, opening the door for XBiotech's antibody screening technology used to identify CCP. XBiotech collaborated with BioBridge Global to develop a test to accurately detect human antibodies present in patient blood that specifically attack the COVID-19 virus. BioBridge Global, which…

    FDA has Authorized Use of Antibody-Rich COVID-19 Therapy Derived from Convalescent Patients

    Under Collaboration BioBridge Global Will Be Using XBiotech's COVID-19 Antibody Test to Identify the Convalescent Blood Products

    AUSTIN, Texas, Aug. 24, 2020 (GLOBE NEWSWIRE) -- XBiotech Inc. (NASDAQ:XBIT) announced today that the U.S. Food and Drug Administration (FDA) issued an emergency use authorization (EUA) for COVID-19 Convalescent Plasma (CCP) as a COVID-19 treatment, opening the door for XBiotech's antibody screening technology used to identify CCP. XBiotech collaborated with BioBridge Global to develop a test to accurately detect human antibodies present in patient blood that specifically attack the COVID-19 virus. BioBridge Global, which provides blood products to hospitals through its subsidiary, the South Texas Blood & Tissue Center, is using XBiotech's test to identify human bloods from patients that have recovered from COVID-19—so called convalescent plasma. BioBridge utilizes the convalescent plasma to produce naturally immune blood products as treatment for patients hospitalized with the virus.

    While XBiotech's testing technology will be used as the first step in the production of anti-COVID-19 convalescent blood products, XBiotech has also used the convalescent blood samples supplied by BioBridge to identify the precise genetic information present in individuals producing these natural antibodies against COVID-19. The Company recently announced it had in fact successfully discovered candidate True Human therapeutic antibodies based on this effort.

    The decision by the FDA to approve use of convalescent plasma (or blood with natural anti-COVD-19 antibodies from patients that recovered from the infection) comes from the Agency's extensive review of scientific data developed over the past several months. These preliminary findings show that convalescent plasma is safe and effective in treating COVID-19, such that a 35% better survival rate has been observed in patients 30 days after receiving plasma treatment. Furthermore, there have been approximately 70,000 patients treated to date with no concerning safety signals.

    This data strongly supports XBiotech's approach and technology for identifying therapeutic antibodies—which it does for a variety of diseases—from convalescent blood. By identifying and manufacturing the actual antibodies from convalescent patients, the Company is able to produce candidate drug products with highly concentrated purified antibody. This approach allows the Company to harness the body's immune response to the virus and make targeted therapies that could potentially be safe and effective.

    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 Antibodies

    XBiotech'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.

    About BioBridge Global

    BioBridge Global is a San Antonio-based 501(c)(3) nonprofit corporation that offers diverse services through its subsidiaries – the South Texas Blood & Tissue Center, QualTex Laboratories, GenCure and The Blood & Tissue Center Foundation. BBG provides products and services in blood resource management, cellular therapy, donated umbilical cord blood and human tissue as well as testing of blood, plasma and tissue products for clients in the United States and worldwide. BBG is committed to saving and enhancing lives through the healing power of human cells and tissue. It enables advances in the field of regenerative medicine by providing access to human cells and tissue, testing services and biomanufacturing and clinical trials support. Learn more at BioBridgeGlobal.org.

    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.

    Contact XBiotech

    Ashley Otero



    512-386-2930

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