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

    View Full Article Hide Full Article
  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

    View Full Article Hide Full Article
  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

    Primary Logo

    View Full Article Hide Full Article
  6. AUSTIN, Texas, Aug. 17, 2020 (GLOBE NEWSWIRE) -- XBiotech Inc. (NASDAQ:XBIT) announced today that it has identified True Human antibodies that could potentially be used as a therapy against SARS-CoV2, the virus that causes COVID-19. The Company discovered these antibodies through a collaboration with BioBridge Global (parent organization of the South Texas Blood & Tissue Center and QualTex Laboratories, one of the largest independent testing laboratories in the United States).

    For the collaboration, BioBridge Global used XBiotech's proprietary COVID-19 screening technology to identify blood donors who had been infected by the novel coronavirus, as part of a program to provide convalescent plasma to treat patients suffering from severe COVID-19…

    AUSTIN, Texas, Aug. 17, 2020 (GLOBE NEWSWIRE) -- XBiotech Inc. (NASDAQ:XBIT) announced today that it has identified True Human antibodies that could potentially be used as a therapy against SARS-CoV2, the virus that causes COVID-19. The Company discovered these antibodies through a collaboration with BioBridge Global (parent organization of the South Texas Blood & Tissue Center and QualTex Laboratories, one of the largest independent testing laboratories in the United States).

    For the collaboration, BioBridge Global used XBiotech's proprietary COVID-19 screening technology to identify blood donors who had been infected by the novel coronavirus, as part of a program to provide convalescent plasma to treat patients suffering from severe COVID-19 infections. In return, BioBridge Global provided XBiotech with blood samples from patients who had been infected with COVID-19. For its antibody discovery process, XBiotech selected blood samples from patients who had recovered rapidly from the virus without serious illness—factors that indicated these donors had antibodies that were highly effective at protecting them against the virus.

    It was only May 21, 2020 that XBiotech received its donor blood and launched its discovery program for COVID-19 True Human antibodies. Today, XBiotech now has a number of True Human antibodies that precisely block the COVID-19 virus' ability to be infectious and at the same time enable the body to naturally clear the virus.

    Dr. Galina Kuzmicheva, Ph.D., XBiotech's Principal Scientist who led the COVID-19 discovery effort, commented, "COVID-19 has resulted in an unprecedented impact on our community. We are pleased to be able to utilize our unique discovery technology to rapidly identify natural human immunity—in the form of True Human antibodies—that can potentially be used to treat the virus infection in humans."

    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

    Primary Logo

    View Full Article Hide Full Article
  7. AUSTIN, Texas, July 22, 2020 (GLOBE NEWSWIRE) -- XBiotech Inc. (NASDAQ:XBIT) announced today it has achieved a crucial milestone in the development of its next generation inflammation-fighting True Human antibodies. The Company is developing a new antibody to replace a previous generation True Human anti-IL-1⍺ antibody that was sold in 2019 for $750 million in cash and up to $600 million in milestone payments. Under terms of the sale, XBiotech was permitted to pursue discovery of new True Human anti-IL-1⍺ antibodies for use in all areas of medicine with the exception of dermatology.

    XBiotech's scientists first discovered and characterized a panel of new anti-IL-1⍺ antibodies from a human donor earlier this year. The team has worked diligently…

    AUSTIN, Texas, July 22, 2020 (GLOBE NEWSWIRE) -- XBiotech Inc. (NASDAQ:XBIT) announced today it has achieved a crucial milestone in the development of its next generation inflammation-fighting True Human antibodies. The Company is developing a new antibody to replace a previous generation True Human anti-IL-1⍺ antibody that was sold in 2019 for $750 million in cash and up to $600 million in milestone payments. Under terms of the sale, XBiotech was permitted to pursue discovery of new True Human anti-IL-1⍺ antibodies for use in all areas of medicine with the exception of dermatology.

    XBiotech's scientists first discovered and characterized a panel of new anti-IL-1⍺ antibodies from a human donor earlier this year. The team has worked diligently through the COVID-19 crisis to clone the genes for the antibodies into cells that can be used for production of these novel therapeutics. The antibody products will be used in human clinical trials and ultimately commercialized. The Research and Development team has now successfully engineered a cell-based production system for the first of its new anti-IL-1⍺ antibodies to enable the Company's drug manufacturing process at its state-of-the-art facility in Austin, Texas.

    Sushma Shivaswamy, the Company's Chief Scientific Officer, said, "Our scientists and all members of the team have worked diligently to overcome the COVID-19 challenges, and to keep us on schedule to re-enter the clinic in 2021. We believe that the new molecule has the potential to be another blockbuster therapeutic with proven industry appeal. Having a production platform is a significant step toward realizing this goal."

    The new antibody targets damaging inflammation by neutralizing interleukin-1alpha (IL-1α), an inflammatory substance produced by the body, which is involved in diseases such as cancer, arthritis and cardiovascular indications. The Company recently announced promising new results that were published in the American Heart Association's journal, Circulation, where antibody therapy targeting IL-1⍺ was found to significantly reduce stroke related brain injury and neurological deficit in animals. This discovery points to a potential blockbuster therapy for the Company's new anti-IL-1⍺ antibody product line.

    Given the retained right to pursue the discovery and development of new True Human™ antibodies targeting IL-1⍺ outside of dermatology, this product candidate is the first in a line of new therapies being developed at XBiotech which will be pursued in major areas of medicine with unmet need.

    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 the 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 the 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.

    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

    Primary Logo

    View Full Article Hide Full Article
  8. AUSTIN, Texas, July 14, 2020 (GLOBE NEWSWIRE) -- XBiotech Inc. (NASDAQ:XBIT) announced today findings published in the prestigious American Heart Association's journal, Circulation. The publication titled, Post-Ischemic Administration of IL-1a Neutralizing Antibody Reduces Brain Damage and Neurological Deficit in Experimental Stroke, points to a use for XBiotech's drug candidate antibody that blocks interleukin-1 alpha (IL-1⍺) for use as a therapeutic to reduce brain damage and neurological deficit after stroke. The research was headed by a world-leading cardiovascular researcher, Dr. Giovanni Camici, Director for the Center for Molecular Cardiology at the University of Zurich in Switzerland. Dr. Camici's research team tested an anti-IL-1⍺…

    AUSTIN, Texas, July 14, 2020 (GLOBE NEWSWIRE) -- XBiotech Inc. (NASDAQ:XBIT) announced today findings published in the prestigious American Heart Association's journal, Circulation. The publication titled, Post-Ischemic Administration of IL-1a Neutralizing Antibody Reduces Brain Damage and Neurological Deficit in Experimental Stroke, points to a use for XBiotech's drug candidate antibody that blocks interleukin-1 alpha (IL-1⍺) for use as a therapeutic to reduce brain damage and neurological deficit after stroke. The research was headed by a world-leading cardiovascular researcher, Dr. Giovanni Camici, Director for the Center for Molecular Cardiology at the University of Zurich in Switzerland. Dr. Camici's research team tested an anti-IL-1⍺ antibody provided by XBiotech to evaluate its ability to reduce brain injury in animals subjected to an experimental stroke and reperfusion injury. About 15 million people worldwide suffer from a stroke each year. Approximately 795,000 of these people are in the United States. Stroke is the second leading cause of death worldwide.

    Dr. Camici commented, "This study demonstrates the importance of IL-1α in mediating the damages caused by ischemic stroke and the efficacy of IL-1α blockade in improving outcome after transient cerebral ischemia in mice. The availability of a clinically approved anti-human IL-1α antibody could offer the possibility to establish new treatment strategies for the management of ischemic stroke patients.  Based on our results, randomized clinical trials should be designed to assess the potential of anti-IL-1α therapy as an adjuvant to interventional or thrombolytic treatment of acute ischemic strokes."

    Dr. Camici's research team focused on a particular difficult aspect of ischemic stroke, so called reperfusion injury. When patients suffer from a stroke, or a blockage in an artery that provides crucial blood and oxygen to the brain, a portion of the brain typically suffers irreparable damage. However, there is also typically a portion of the brain that has been deprived of oxygen but is functional and may be rescued if the blood clot is removed and normal circulation can be restored. Unfortunately, when the blood clot is removed and blood supply resumes into areas of the brain where oxygen had been deprived, a massive inflammatory response occurs. This ensuing inflammation is believed to be responsible for the so called "reperfusion injury" that is observed with the returning blood supply. The result is widening destruction of brain tissue upon opening of the clogged artery and associated irreparable neurologic deficits. Therefore, decreasing this inflammatory response by inhibiting IL-1⍺ holds promise as an effective treatment for reperfusion injury. There is currently no therapy to treat reperfusion injury.

    Peter Libby, M.D., Mallinckrodt Professor of Medicine at Harvard Medical School and clinical cardiologist at Brigham and Women's Hospital and a contributing author on the publication, and consultant to and XBiotech Director stated, "We urgently need adjunctive therapies to contemporary reperfusion strategies to minimize the potentially devastating brain damage in patients with acute strokes. These events too often rob people of their ability to function independently, to communicate, and can also contribute to cognitive decline.  The benefits of anti-IL-1⍺ therapy, if replicated in humans, could have immense consequences for patients, families, and society at large."

    Dr. Camici's group blocked an artery in the brain in animals to simulate a human stroke. Then after time, researchers reopened the artery to mimic the reperfusion treatment (and subsequent injury) a stroke patient may receive in a hospital. The brains and function of the animals treated with anti-IL-1⍺ antibody were compared to control animals to observe the extent of reperfusion injury. The findings were significant: animals treated with anti-IL-1⍺ antibody had a 36% reduction in brain damage (ie, reduction in reperfusion injury) and these antibody treated animals retained significantly better neurological function, as measured by activity tests, compared to controls.

    XBiotech is developing True Human antibody therapies targeting IL-1a and plans to enter into human clinical studies with a new product candidate for stroke in 2021. Despite the enormous unmet medical need for therapies, there remains today no approved therapy to reduce brain damage caused by reperfusion injury.

    The findings demonstrate a crucial role for IL-1⍺ related inflammation in brain injury, which occurs after a blocked artery in the brain is opened and blood returns to the affected area. In patients that suffer a stroke, the opening of a blocked artery in the brain is performed as soon possible using catheter devices and clot inhibiting drug therapy. However, artery reopening and resumption of blood supply is associated with expanded injury and loss of brain function, such as cognitive or physical impairment.

    In this research, treatment with an antibody that blocks IL-1⍺ was given after artery blockage and just prior to resumption of blood supply to simulate a stroke. The antibody treatment was found to inhibit inflammation in blood vessels and brain cells that had suffered a lack of oxygen supply as a result of the blocked artery. Decreased inflammation caused by IL-1⍺ blockade is believed to be the contributing factor for the reduction in brain damage and improvement in neurological function observed in the animals that received the IL-1a blocking antibody treatment.

    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.

    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

    Primary Logo

    View Full Article Hide Full Article
  9. Donors with Potent Natural Immunity Against the Virus are Identified as the Starting Point for XBiotech's Drug Development Program to Treat COVID-19

    AUSTIN, Texas, May 01, 2020 (GLOBE NEWSWIRE) -- XBiotech Inc. (NASDAQ:XBIT) announced today that human immune donors have now been identified that can support the Company's development of a True Human™ antibody therapy for COVID-19. XBiotech recently developed and transferred screening technology to South Texas Blood & Tissue Center (STBTC), a blood donor organization, that enables blood donors that have COVID-19 immunity to be identified. In collaboration with STBTC, XBiotech scientists have been searching for ideal blood donors with strong natural immunity to COVID-19 to begin its True Human™…

    Donors with Potent Natural Immunity Against the Virus are Identified as the Starting Point for XBiotech's Drug Development Program to Treat COVID-19

    AUSTIN, Texas, May 01, 2020 (GLOBE NEWSWIRE) -- XBiotech Inc. (NASDAQ:XBIT) announced today that human immune donors have now been identified that can support the Company's development of a True Human™ antibody therapy for COVID-19. XBiotech recently developed and transferred screening technology to South Texas Blood & Tissue Center (STBTC), a blood donor organization, that enables blood donors that have COVID-19 immunity to be identified. In collaboration with STBTC, XBiotech scientists have been searching for ideal blood donors with strong natural immunity to COVID-19 to begin its True Human™ antibody discovery process.

    XBiotech scientists have focused their search to find blood donors that have both very high levels of antibodies against COVID-19 and at the same time do not have a history of a serious illness from the virus. XBiotech believes that individuals with evidence of a vigorous antibody response against COVID-19 in the absence of a history of serious illness are ideal for identifying antibodies that could serve as a powerful therapy against the virus. XBiotech scientists are now receiving these exclusive blood samples from STBTC and have begun its proprietary discovery process to isolate the unique genetic information or genes responsible for producing the antibodies in the donors.

    "There is no other research or pharmaceutical organization better prepared with the technology and capabilities of XBiotech to identify and develop antibody therapies derived from natural human immunity" commented John Simard, XBiotech's CEO. He further stated, "The COVID-19 crisis brings into sharp relief the unique position of XBiotech to address existing and emerging unmet medical needs for infectious diseases."

    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.

    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

    Primary Logo

    View Full Article Hide Full Article
  10. AUSTIN, Texas, April 14, 2020 (GLOBE NEWSWIRE) -- 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…

    AUSTIN, Texas, April 14, 2020 (GLOBE NEWSWIRE) -- 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 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.

    Cautionary Note on Forward-Looking Statements
    This 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.

    Contact
    Ashley Otero

    512-386-2930

    Primary Logo

    View Full Article Hide Full Article
  11. AUSTIN, Texas, April 03, 2020 (GLOBE NEWSWIRE) -- XBiotech Inc. (NASDAQ:XBIT) and BioBridge Global today announced their collaboration to participate in a U.S. Food and Drug Administration (FDA) investigational program for U.S. blood centers to begin collecting and distributing convalescent plasma from individuals who have recovered from COVID-19.

    In working toward a potential treatment for COVID-19 patients, XBiotech has developed a clinical test that QualTex Laboratories, a subsidiary of San Antonio-based nonprofit BioBridge Global, will use to identify natural antibodies present in human blood that work against the virus that causes COVID-19. The testing technology will allow QualTex to identify blood that contains naturally neutralizing…

    AUSTIN, Texas, April 03, 2020 (GLOBE NEWSWIRE) -- XBiotech Inc. (NASDAQ:XBIT) and BioBridge Global today announced their collaboration to participate in a U.S. Food and Drug Administration (FDA) investigational program for U.S. blood centers to begin collecting and distributing convalescent plasma from individuals who have recovered from COVID-19.

    In working toward a potential treatment for COVID-19 patients, XBiotech has developed a clinical test that QualTex Laboratories, a subsidiary of San Antonio-based nonprofit BioBridge Global, will use to identify natural antibodies present in human blood that work against the virus that causes COVID-19. The testing technology will allow QualTex to identify blood that contains naturally neutralizing antibodies against the virus in patients who have recovered from COVID-19 (convalescent donors).

    Plasma collected from these donors by the South Texas Blood & Tissue Center (STBTC), which also is a subsidiary of BioBridge Global, could be used to treat patients with serious and/or life-threatening COVID-19 infections.  STBTC will, in return, provide blood samples to XBiotech to enable the development of a candidate True Human™ antibody therapy for the disease.

    XBiotech is in the process of transferring the testing technology to QualTex and training its laboratory professionals to perform the assay in its San Antonio laboratory to enable rapid identification and potential use of the convalescent plasma at medical centers in Texas.

    "XBiotech is working to contribute solutions to reducing the impact of the COVID-19 pandemic," said Dr. Sushma Shivaswamy, Ph.D, XBiotech's Chief Scientific Officer. "Our unique human antibody technology at XBiotech has been developed specifically to address these kinds of issues.

    "We are humbled to be able to support BioBridge Global in its effort to use human convalescent donor blood to provide remedies for patients hospitalized with this deadly disease. XBiotech will continue to use its technology and resources to support the effort against COVID-19."

    Dr. Rachel Beddard, BioBridge Global Medical Director, also commented, "We are excited to be among the first to be able to provide our blood donors with the opportunity to help COVID-19 patients and their families fight this illness."

    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.

    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 XBiotech
    Ashley Otero

    512-386-2930

    Contact BioBridge Global
    Mary Uhlig

    210-731-5519

    Primary Logo

    View Full Article Hide Full Article
  12. AUSTIN, Texas, Feb. 19, 2020 (GLOBE NEWSWIRE) -- XBiotech Inc. (NASDAQ:XBIT) ("XBiotech") today announced the final results of its "modified Dutch auction" tender offer, which expired at 5:00 p.m., New York City time, on February 12, 2020.

    Based on the final count by American Stock Transfer & Trust Co., LLC, the depositary for the tender offer, a total of 40,007,286 common shares, no par value, were properly tendered and not properly withdrawn at or below the maximum purchase price of $33.00 per share. Not all shares tendered through notice of guaranteed delivery were delivered within the required settlement period.

    XBiotech has accepted for purchase 14,000,000 common shares at a price of $30.00 per share, for an aggregate cost of approximately…

    AUSTIN, Texas, Feb. 19, 2020 (GLOBE NEWSWIRE) -- XBiotech Inc. (NASDAQ:XBIT) ("XBiotech") today announced the final results of its "modified Dutch auction" tender offer, which expired at 5:00 p.m., New York City time, on February 12, 2020.

    Based on the final count by American Stock Transfer & Trust Co., LLC, the depositary for the tender offer, a total of 40,007,286 common shares, no par value, were properly tendered and not properly withdrawn at or below the maximum purchase price of $33.00 per share. Not all shares tendered through notice of guaranteed delivery were delivered within the required settlement period.

    XBiotech has accepted for purchase 14,000,000 common shares at a price of $30.00 per share, for an aggregate cost of approximately $420 million, excluding fees and expenses relating to the tender offer.  These shares represent approximately 32.67 percent of the common shares outstanding.  The final proration factor for shares that XBiotech has purchased pursuant to the tender offer is approximately 33.25 percent.

    To assist shareholders in determining the tax consequences of the tender offer, XBiotech estimates that for purposes of the Income Tax Act (Canada), the paid-up capital per common share was approximately C$8.45 and the "specified amount" (for purposes of subsection 191(4) of the Income Tax Act (Canada)) was C$28.90 as of February 18, 2020. In addition, for purposes of the Income Tax Act (Canada) and any applicable provincial legislation pertaining to eligible dividends, XBiotech designates the entire amount of the deemed dividend arising from its purchase of shares pursuant to the tender offer as an eligible dividend.

    Shareholders who have questions or would like additional information about the tender offer may contact the information agent for the tender offer, D.F. King & Co., Inc., at (212) 269-5550 (banks and brokers) or (866) 856-3065 (all others).

    About True Human™ Therapeutic Antibodies
    XBiotech's True Human™ 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™ 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.

    Contact
    Ashley Otero

    512-386-2930

    Primary Logo

    View Full Article Hide Full Article
  13. AUSTIN, Texas, Feb. 13, 2020 (GLOBE NEWSWIRE) -- This press release corrects a prior version published on February 13, 2020 and is updated to revise the preliminary proration factor.  The corrected press release reads:

    XBiotech Announces Preliminary Results of Tender Offer

    XBiotech Inc. (NASDAQ:XBIT) ("XBiotech") today announced the preliminary results of its "modified Dutch auction" tender offer, which expired at 5:00 p.m., New York City time, on February 12, 2020.

    Based on the preliminary count by American Stock Transfer & Trust Co., LLC, the depositary for the tender offer, a total of 41,164,725 common shares of XBiotech were properly tendered and not properly withdrawn at or below the maximum purchase price of $33.00 per share, including…

    AUSTIN, Texas, Feb. 13, 2020 (GLOBE NEWSWIRE) -- This press release corrects a prior version published on February 13, 2020 and is updated to revise the preliminary proration factor.  The corrected press release reads:

    XBiotech Announces Preliminary Results of Tender Offer

    XBiotech Inc. (NASDAQ:XBIT) ("XBiotech") today announced the preliminary results of its "modified Dutch auction" tender offer, which expired at 5:00 p.m., New York City time, on February 12, 2020.

    Based on the preliminary count by American Stock Transfer & Trust Co., LLC, the depositary for the tender offer, a total of 41,164,725 common shares of XBiotech were properly tendered and not properly withdrawn at or below the maximum purchase price of $33.00 per share, including 2,178,233 shares that were tendered by notice of guaranteed delivery.

    In accordance with the terms and conditions of the tender offer and based on the preliminary count by the depositary, XBiotech expects to accept for payment, at a purchase price of $30.00, approximately 14,000,000 common shares properly tendered at or below the purchase price and not properly withdrawn before the expiration date, at an aggregate cost of approximately $420 million, excluding fees and expenses relating to the tender offer.  The preliminary proration factor for shares that XBiotech expects to purchase pursuant to the tender offer (as corrected) is approximately 31.9 percent, after giving effect to odd lots.

    The number of shares to be purchased and the purchase price are preliminary and subject to change.  The preliminary information contained in this press release is subject to confirmation by the depositary and is based on the assumption that all shares tendered through notice of guaranteed delivery will be delivered within the two trading day settlement period.  The final number of shares to be purchased and the final purchase price will be announced following the expiration of the guaranteed delivery period and completion by the depositary of the confirmation process.  Payment for the shares accepted for purchase under the tender offer, and return of all other shares tendered and not purchased, will occur promptly thereafter.

    D.F. King & Co., Inc. is the information agent for the Offer. Shareholders with questions may call D.F. King at (212) 269-5550 (banks and brokers) or (866) 856-3065 (all others).

    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. The discovery and manufacturing techniques which enable this were designed by and are exclusive to XBiotech. Headquartered in Austin, Texas, XBiotech also leads the development of innovative, proprietary manufacturing technology to reduce the cost and complexity of biological drug production. For more information, visit www.xbiotech.com.

    Cautionary Note Regarding 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
  14. AUSTIN, Texas, Feb. 13, 2020 (GLOBE NEWSWIRE) -- XBiotech Inc. (NASDAQ:XBIT) ("XBiotech") today announced the preliminary results of its "modified Dutch auction" tender offer, which expired at 5:00 p.m., New York City time, on February 12, 2020.

    Based on the preliminary count by American Stock Transfer & Trust Co., LLC, the depositary for the tender offer, a total of 41,164,725 common shares of XBiotech were properly tendered and not properly withdrawn at or below the maximum purchase price of $33.00 per share, including 2,178,233 shares that were tendered by notice of guaranteed delivery.

    In accordance with the terms and conditions of the tender offer and based on the preliminary count by the depositary, XBiotech expects to accept for payment…

    AUSTIN, Texas, Feb. 13, 2020 (GLOBE NEWSWIRE) -- XBiotech Inc. (NASDAQ:XBIT) ("XBiotech") today announced the preliminary results of its "modified Dutch auction" tender offer, which expired at 5:00 p.m., New York City time, on February 12, 2020.

    Based on the preliminary count by American Stock Transfer & Trust Co., LLC, the depositary for the tender offer, a total of 41,164,725 common shares of XBiotech were properly tendered and not properly withdrawn at or below the maximum purchase price of $33.00 per share, including 2,178,233 shares that were tendered by notice of guaranteed delivery.

    In accordance with the terms and conditions of the tender offer and based on the preliminary count by the depositary, XBiotech expects to accept for payment, at a purchase price of $30.00, approximately 14,000,000 common shares properly tendered at or below the purchase price and not properly withdrawn before the expiration date, at an aggregate cost of approximately $420 million, excluding fees and expenses relating to the tender offer.  The preliminary proration factor for shares that XBiotech expects to purchase pursuant to the tender offer is approximately 30.91 percent, before giving effect to odd lots.

    The number of shares to be purchased and the purchase price are preliminary and subject to change.  The preliminary information contained in this press release is subject to confirmation by the depositary and is based on the assumption that all shares tendered through notice of guaranteed delivery will be delivered within the two trading day settlement period.  The final number of shares to be purchased and the final purchase price will be announced following the expiration of the guaranteed delivery period and completion by the depositary of the confirmation process.  Payment for the shares accepted for purchase under the tender offer, and return of all other shares tendered and not purchased, will occur promptly thereafter.

    D.F. King & Co., Inc. is the information agent for the Offer. Shareholders with questions may call D.F. King at (212) 269-5550 (banks and brokers) or (866) 856-3065 (all others).

    About True Human™ Therapeutic Antibodies

    XBiotech's True Human™ 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™ 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.

    Contact
    Ashley Otero

    512-386-2930

    Primary Logo

    View Full Article Hide Full Article
  15. AUSTIN, Texas, Dec. 30, 2019 (GLOBE NEWSWIRE) -- XBiotech Inc. (NASDAQ:XBIT) announced today closing of the sale of the Company's True Human antibody Bermekimab to Janssen Biotech, Inc. (Janssen), a Janssen Pharmaceutical Company of Johnson & Johnson. Upon closing, Janssen paid XBiotech $750 million, with $75 million held in escrow for 18 months.  Should Janssen pursue bermekimab indications outside of dermatology, XBiotech could also receive up to $600 million in additional payments upon completion of certain commercialization authorizations. In addition to the bermekimab acquisition, Janssen and XBiotech entered into manufacturing supply and clinical services agreements. Revenue from these agreements are expected to generate positive cash…

    AUSTIN, Texas, Dec. 30, 2019 (GLOBE NEWSWIRE) -- XBiotech Inc. (NASDAQ:XBIT) announced today closing of the sale of the Company's True Human antibody Bermekimab to Janssen Biotech, Inc. (Janssen), a Janssen Pharmaceutical Company of Johnson & Johnson. Upon closing, Janssen paid XBiotech $750 million, with $75 million held in escrow for 18 months.  Should Janssen pursue bermekimab indications outside of dermatology, XBiotech could also receive up to $600 million in additional payments upon completion of certain commercialization authorizations. In addition to the bermekimab acquisition, Janssen and XBiotech entered into manufacturing supply and clinical services agreements. Revenue from these agreements are expected to generate positive cash flow for XBiotech over the next two years.

    While Janssen acquired all rights to bermekimab, XBiotech remains free to use its True Human Antibody discovery program to develop new antibody therapeutics targeting IL-1⍺ (the same target as bermekimab) and to commercialize these therapeutics for all non-dermatological diseases. XBiotech plans to re-enter clinical development expeditiously with next generation anti-IL-1⍺ therapeutics.

    The Company plans to use proceeds from the sale and the services agreements to fund discovery and development of its next generation True Human anti-IL-1⍺ antibody program and to advance other antibody therapeutics in the Company's pipeline, including its infectious disease program. The Company will also have sufficient cash to support a significant capital transaction, such as a stock repurchase, subject to final board review and approval.

    John Simard, XBiotech's President & CEO, commented, "We are pleased to have Janssen acquire bermekimab and look forward to seeing superior efficacy and safety of this True Human Antibody in ongoing dermatological clinical trials and beyond. The transaction is an important validation of our True Human platform and the cutting-edge science behind targeting IL-1⍺ and enables us to continue to exploit the vast potential for next generation True Human anti-IL-1⍺ therapeutics outside of dermatology. With the close of the transaction, we are in a stronger position to create extraordinary value for shareholders."

    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.  The discovery and manufacturing techniques which enable this were designed by and are exclusive to XBiotech. Headquartered in Austin, Texas, XBiotech also leads the development of innovative, proprietary 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 unprecedented 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, 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.

    Contact
    Ashley Otero

    512-386-2930

    Primary Logo

    View Full Article Hide Full Article
  16. AUSTIN, Texas, Dec. 17, 2019 (GLOBE NEWSWIRE) -- XBiotech Inc. (NASDAQ:XBIT) announced today that the company was selected for addition to the NASDAQ Biotechnology Index (NASDAQ:NBI). The addition to the NBI will become effective prior to market open on Monday, December 23, 2019.

    The Index is used to designate a set of NASDAQ-listed securities to be acquired as part of index-defined funds to be used in investment portfolios. The biotechnology index is classified according to the Industry Classification Benchmark (ICB). Companies in the biotechnology index must meet eligibility requirements, including minimum market capitalization, average daily trading volume, seasoning as a public company, and other criteria. The index is evaluated annually…

    AUSTIN, Texas, Dec. 17, 2019 (GLOBE NEWSWIRE) -- XBiotech Inc. (NASDAQ:XBIT) announced today that the company was selected for addition to the NASDAQ Biotechnology Index (NASDAQ:NBI). The addition to the NBI will become effective prior to market open on Monday, December 23, 2019.

    The Index is used to designate a set of NASDAQ-listed securities to be acquired as part of index-defined funds to be used in investment portfolios. The biotechnology index is classified according to the Industry Classification Benchmark (ICB). Companies in the biotechnology index must meet eligibility requirements, including minimum market capitalization, average daily trading volume, seasoning as a public company, and other criteria. The index is evaluated annually and serves as the basis for the iShares NASDAQ Biotechnology Index Fund.

    For more information about the NASDAQ Biotechnology Index, including eligibility criteria, visit https://indexes.nasdaqomx.com/.

    About True Human™ Therapeutic Antibodies

    XBiotech's True Human™ 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™ proprietary technology. XBiotech currently is advancing a robust pipeline of antibody therapies to redefine the standards of care in inflammatory 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.

    Contact
    Ashley Otero

    512-386-2930

     

    Primary Logo

    View Full Article Hide Full Article
  17. AUSTIN, Texas, Dec. 07, 2019 (GLOBE NEWSWIRE) -- XBiotech Inc. (NASDAQ:XBIT) announced today that it has entered into a definitive agreement with Janssen Biotech, Inc., a Janssen Pharmaceutical Company of Johnson & Johnson, to sell XBiotech's novel antibody (bermekimab) that neutralizes interleukin-1 alpha (IL-1⍺). IL-1⍺ promotes disease-causing inflammation in a wide range of medical conditions. Janssen will acquire all rights to bermekimab under the terms of the agreement, and XBiotech will be free to use its True Human Antibody discovery program to develop new antibody therapeutics that target IL-1⍺ to treat non-dermatological diseases. XBiotech plans to re-enter clinical development expeditiously with a next generation anti-IL-1⍺ therapeutic…

    AUSTIN, Texas, Dec. 07, 2019 (GLOBE NEWSWIRE) -- XBiotech Inc. (NASDAQ:XBIT) announced today that it has entered into a definitive agreement with Janssen Biotech, Inc., a Janssen Pharmaceutical Company of Johnson & Johnson, to sell XBiotech's novel antibody (bermekimab) that neutralizes interleukin-1 alpha (IL-1⍺). IL-1⍺ promotes disease-causing inflammation in a wide range of medical conditions. Janssen will acquire all rights to bermekimab under the terms of the agreement, and XBiotech will be free to use its True Human Antibody discovery program to develop new antibody therapeutics that target IL-1⍺ to treat non-dermatological diseases. XBiotech plans to re-enter clinical development expeditiously with a next generation anti-IL-1⍺ therapeutic. 

    Following the acquisition, XBiotech will use its proprietary manufacturing technology to produce clinical supplies of bermekimab for Janssen under a supply agreement. In addition, XBiotech will contract with Janssen to provide clinical trial operation services to complete two ongoing Phase II clinical studies evaluating bermekimab in Hidradenitis Suppurativa and Atopic Dermatitis.

    Upon closing, Janssen will make a cash payment of $750 million to XBiotech. In addition, XBiotech may receive up to $600 million in potential milestone payments. XBiotech expects to generate additional revenue from the manufacturing supply agreement and clinical services agreement with Janssen over the next two years.

    XBiotech plans to use a portion of the proceeds from this transaction to fund discovery and development of its next generation True Human anti-IL-1⍺ antibody program. Additionally, a portion of the revenue will be dedicated to advancing other antibody therapeutics in XBiotech's pipeline. The Company is also planning to use part of the proceeds in a capital transaction, such as a stock repurchase, subject to board review and approval.

    John Simard, XBiotech's President & CEO, stated, "We are proud that Janssen has chosen bermekimab as an agent it believes could have an important impact. We believe their acquisition will enable recognition and increase awareness of the full potential of this first-in-class therapeutic. This transaction also provides us the opportunity to showcase our powerful True Human antibody discovery platform, which we are now utilizing to pursue next generation anti-Il-1⍺ antibody therapeutics to treat multiple areas of unmet need outside of dermatology."

    The acquisition of bermekimab provides further validation of the foundational science behind targeting IL-1a as a means to block disease-causing inflammation. Clinical and pre-clinical research suggests blocking IL-1a may be used to treat a number of chronic and acute inflammatory conditions, including skin disease, heart disease, heart attack, stroke, rheumatological disease, gastrointestinal diseases, and cancer.

    Simard further stated, "The cash infusion from the bermekimab transaction will enable XBiotech to accelerate our True Human antibody pipeline. The Company will also have sufficient cash to support a significant capital transaction, which could provide for a non-dilutive liquidity event for our valued shareholders who have supported XBiotech's pioneering work."

    The transaction is subject to customary closing conditions, including clearance under the Hart-Scott-Rodino Antitrust Improvements Act, and is expected to close shortly after HSR approval.

    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. The discovery and manufacturing techniques which enable this were designed by and are exclusive to XBiotech. Headquartered in Austin, Texas, XBiotech also leads the development of innovative, proprietary 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 unprecedented 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, 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.

    Contact
    Ashley Otero

    512-386-2930

    Primary Logo

    View Full Article Hide Full Article
  18. AUSTIN, Texas, Nov. 19, 2019 (GLOBE NEWSWIRE) -- XBiotech Inc. (NASDAQ:XBIT) today announces rapid enrollment in its randomized, double-blind, placebo-controlled Phase 2 clinical study evaluating bermekimab in patients with moderate to severe Hidradenitis Suppurativa (HS). The study is chaired by renowned investigative dermatologist Alice Gottlieb, MD, PhD (Medical Director of Dermatology at the Mount Sinai Beth Israel Campus and Clinical Professor at the Icahn School of Medicine at Mount Sinai) and will enroll approximately 150 patients. XBiotech announced the first patient enrolled in the study on October 23, 2019. Today, XBiotech is already updating status of the study, reporting that 51 patients have now been randomized, or assigned to…

    AUSTIN, Texas, Nov. 19, 2019 (GLOBE NEWSWIRE) -- XBiotech Inc. (NASDAQ:XBIT) today announces rapid enrollment in its randomized, double-blind, placebo-controlled Phase 2 clinical study evaluating bermekimab in patients with moderate to severe Hidradenitis Suppurativa (HS). The study is chaired by renowned investigative dermatologist Alice Gottlieb, MD, PhD (Medical Director of Dermatology at the Mount Sinai Beth Israel Campus and Clinical Professor at the Icahn School of Medicine at Mount Sinai) and will enroll approximately 150 patients. XBiotech announced the first patient enrolled in the study on October 23, 2019. Today, XBiotech is already updating status of the study, reporting that 51 patients have now been randomized, or assigned to an investigational arm of the study.

    Dr. Gottlieb commented, "The very strong participation by clinical sites and by patients is indicative of the substantial need for new therapy and of the favorable view of bermekimab."

    Ms. Ashley Otero, XBiotech's Director of Clinical Operations, stated, "We are extremely excited about the robust enrollment seen to date. After only a few weeks since enrollment of the first patient, we have already randomized over one-third of the intended study population. If this pace continues, we will complete enrollment well ahead of our anticipated timing."

    Bermekimab has been tested in two previous clinical studies. In a recent open label study (n=42), 61% of patients with no prior biological therapy and 63% of patients who had failed previous biological therapy (i.e. adalimumab) achieved a positive HiSCR at 12 weeks. Additionally, the majority of patients in both groups achieved clinically significant reduction in pain from their disease. These results were presented at the American Academy of Dermatology (AAD) in 2019.

    In an earlier double-blind, placebo controlled, randomized study which also evaluated bermekimab in the treatment of HS, the study's primary endpoint was met, demonstrating significant improvement of HiSCR in patients treated with bermekimab compared to control after 12 weeks of therapy (response rate of 60% vs 10%, respectively (p=0.035)). These results have been published in a leading peer reviewed medical journal, the Journal of Investigative Dermatology1

    The primary endpoint for the current study is the percentage of subjects achieving a Hidradenitis Suppurativa Clinical Response (HiSCR) at week 12. Multiple secondary efficacy endpoints will be assessed after 12 and 16 weeks of therapy, including: Numerical Rating Scale (NRS) for pain and itch; Modified Sartorius Score; Dermatology Life Quality Index (DLQI); Hospital Anxiety and Depression Scale (HADS); and Patient Global Impression of Change and Severity (PGI-c, PGI-s). Please visit www.clinicaltrials.gov for a more complete description of the study.

    About Hidradenitis Suppurativa  
    Hidradenitis Suppurativa (HS) is a chronic, inflammatory skin disorder affecting areas rich in apocrine glands. Nodules appear in the affected areas and progressively become swollen with spontaneous rupture and release of pus. This process occurs repeatedly leading to formation of deep sinus tracts and painful dermal abscesses1,[2]. Therefore, HS is often devastating for patients with significant impact on quality of life [3]. The Dermatology Quality Life Index (DQLI) for HS is 8.9, being higher than any other skin disorder4. Traditional treatments comprise of antibiotics, antiandrogens and surgery. The global prevalence for HS is estimated at up to 4% of the population 5.

    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

    __________________

    1 Kanni T et al. MABp1 Targeting Interleukin-1Alpha for Moderate to Severe Hidradenitis Suppurativa not Eligible for Adalimumab: A Randomized Study. J Invest Dermatol. 2017 Nov 9.
    2 Revuz J. Hidradenitis suppurativa. J Eur Acad Dermatol Venereol 2009; 23: 985-998.
    3 Alikhan A, Lynch PJ, Eisen DB. Hidradenitis suppurativa: a comprehensive review. J Am Acad Dermatol. 2009 Apr;60(4):539-61; quiz 562-3. doi: 10.1016/j.jaad.2008.11.911.
    4 Vasquez BG, Alikhan A, Weaver, AL, et al. Incidence of hidradenitis suppurativa and associated factors: a population-based study of Olmsted County, Minnesota. J Invest Dermatol. 2013 Jan;133(1):97-103. doi: 10.1038/jid.2012.255. Epub 2012 Aug 30.
    5 Révuz JE, Canoui-Poitrine F, Wolkenstein P, et al. Prevalence and factors associated with hidradenitis suppurativa: results from two case-control studies. J Am Acad Dermatol 2008; 59: 695-701.

    Primary Logo

    View Full Article Hide Full Article
  19. AUSTIN, Texas, Nov. 12, 2019 (GLOBE NEWSWIRE) -- XBiotech Inc. (NASDAQ:XBIT) has enrolled the first patient in a randomized, double-blind, placebo-controlled Phase 2 clinical study to evaluate its IL-1a blocking antibody therapy in patients with moderate to severe Atopic Dermatitis (AD) (also known as Eczema). Chaired by award-winning dermatologist Seth B. Forman, MD, of ForCare Medical Group in Tampa, FL, the study will assess weekly bermekimab therapy to reduce inflammatory skin lesions, itch, and pain in patients suffering from eczema.

    The study will compare three groups of patients over 16 weeks of treatment: a weekly dosing group, a biweekly dosing group, and a placebo group. Percentage of patients who achieve a 75% reduction in skin…

    AUSTIN, Texas, Nov. 12, 2019 (GLOBE NEWSWIRE) -- XBiotech Inc. (NASDAQ:XBIT) has enrolled the first patient in a randomized, double-blind, placebo-controlled Phase 2 clinical study to evaluate its IL-1a blocking antibody therapy in patients with moderate to severe Atopic Dermatitis (AD) (also known as Eczema). Chaired by award-winning dermatologist Seth B. Forman, MD, of ForCare Medical Group in Tampa, FL, the study will assess weekly bermekimab therapy to reduce inflammatory skin lesions, itch, and pain in patients suffering from eczema.

    The study will compare three groups of patients over 16 weeks of treatment: a weekly dosing group, a biweekly dosing group, and a placebo group. Percentage of patients who achieve a 75% reduction in skin disease after 16 weeks of treatment will be the primary measure of response.  The Eczema Area Severity Index (EASI) scoring system will be used to assess severity of inflammatory skin lesions. Another crucial assessment will be patient itch, which is often severe and unrelenting in this disease. A numeric rating scale (NRS) will be used to assess itch and pain at various timepoints ranging from 4-16 weeks. For more information on this study please visit www.clinicaltrials.gov.

    Dr. Forman commented, "We are now understanding that IL-1alpha (IL-1⍺) plays a primary role in inflammatory skin diseases. Earlier Phase 2 results using the IL-1⍺ blocker, bermekimab, showed unprecedented treatment effects such as reduction of inflammatory lesions, itch, and pain in patients with eczema.  I look forward to the outcome of this study."

    Bermekimab was previously tested in a clinical study of patients with moderate to severe AD. Those results were previously presented at the annual conferences of the American Academy of Dermatology (AAD) and the European Academy of Dermatology and Venerology (EADV) by renowned dermatologists Dr. Eric Simpson and Dr. Alice Gottlieb, respectively. The findings showed that after only 8 weeks of bermekimab therapy, 75% of patients had achieved 75% improvement in disease severity as assessed by EASI score (the current standard of care for biological therapy involves a 16 week treatment regimen and is associated with 44-51% of patients achieving 75% improvement). Bermekimab therapy was also associated with a dramatic reduction in itch and pain, with three fourths of patients achieving clinically significant reduction in itch, and 86% achieving clinically significant reduction in pain after only 8 weeks of treatment.

    John Simard, the Company's President and CEO, stated, "I am grateful to Dr. Forman for leading this important study. Results from our earlier study suggest that bermekimab has the potential to change the paradigm for treating moderate to severe AD and to improve quality of life for millions of patients suffering from this disease."

    Inflammation plays a major role in the induction and progression of several skin diseases, including eczema or atopic dermatitis1. Bermekimab blocks the action of the potent inflammatory substance IL-1⍺ found in skin. It has been demonstrated that IL-1⍺ is necessary for inducing chronic skin inflammation through aberrant stores of intracellular IL-1⍺ in keratinocytes, which constitute approximately 90% of skin cells. IL-1⍺ secretion has shown not only to be necessary component in driving skin inflammation, but by itself sufficient to do so2. Therefore, neutralizing IL-1⍺ activity through an inhibitor such as bermekimab has promise to resolve chronic skin inflammation and looks to be a key target for treating atopic dermatitis, along with other inflammatory skin diseases.

    About Atopic Dermatitis
    Atopic dermatitis (AD) is an inflammatory skin disease affecting as much as 20% of the population in western industrial societies. Chronic eczema in AD and associated pruritus can be a significant cause of morbidity and impact life quality. Disease pathogenesis is complex but ultimately converges on a pathological inflammatory process that disrupts the protective barrier function of the skin. Keratinocytes are a major reservoir of IL-1⍺ and may be a key source of inflammatory stimulus in AD. IL-1⍺ is present on leukocytes, where its role in leukocyte trafficking and infiltration may represent a key step in the chronic inflammation of AD. IL-1⍺ is a key inducer of matrix metalloproteinases activity which could be directly involved in the epithelial barrier breakdown in AD3. Loss of regulation of IL-1 results in systemic inflammation with extensive skin involvement4.

    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.

    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

    _______________________________

    1 Bou-Dargham MJ Et al. The Role of Interleukin-1 in Inflammatory and Malignant Human Skin Diseases and the Rationale for Targeting Interleukin-1 Alpha. Med Res Rev. 2017 Jan;37(1):180-216. doi: 10.1002/med.21406. Epub 2016 Sep 8.
    2 Archer NK et al. Injury, dysbiosis, and filaggrin deficiency drive skin inflammation through keratinocyte IL-1a release. J Allergy Clin Immunol. 2019 Apr;143(4):1426-1443.e6. doi: 10.1016/j.jaci.2018.08.042. Epub 2018 Sep 19.
    3 Han et al. Interleukin-1alpha-induced proteolytic activation of metalloproteinase-9 by human skin. Surgery. 2005 Nov;138(5):932-9.
    4 Askentijevich et al. An autoinflammatory disease with deficiency of the interleukin-1-receptor antagonist. N Engl J Med. 2009 Jun 4;360(23):2426-37.

    Primary Logo

    View Full Article Hide Full Article
  20. AUSTIN, Texas, Oct. 23, 2019 (GLOBE NEWSWIRE) -- XBiotech Inc. (NASDAQ:XBIT) announced today that the first patient was enrolled in its randomized, double-blind, placebo-controlled Phase 2 clinical study evaluating bermekimab in patients with moderate to severe Hidradenitis Suppurativa (HS). The multi-center, international study will enroll approximately 150 patients into three arms: two bermekimab dosing regimens versus a placebo arm over sixteen (16) weeks of therapy. The study is chaired by renowned investigative dermatologist Alice Gottlieb, MD, PhD, Medical Director of dermatology at the Mount Sinai Beth Israel Campus and Clinical Professor at the Icahn School of Medicine at Mount Sinai.

    The study's primary endpoint is the percentage…

    AUSTIN, Texas, Oct. 23, 2019 (GLOBE NEWSWIRE) -- XBiotech Inc. (NASDAQ:XBIT) announced today that the first patient was enrolled in its randomized, double-blind, placebo-controlled Phase 2 clinical study evaluating bermekimab in patients with moderate to severe Hidradenitis Suppurativa (HS). The multi-center, international study will enroll approximately 150 patients into three arms: two bermekimab dosing regimens versus a placebo arm over sixteen (16) weeks of therapy. The study is chaired by renowned investigative dermatologist Alice Gottlieb, MD, PhD, Medical Director of dermatology at the Mount Sinai Beth Israel Campus and Clinical Professor at the Icahn School of Medicine at Mount Sinai.

    The study's primary endpoint is the percentage of subjects achieving Hidradenitis Suppurativa Clinical Response (HiSCR) at week 12. Multiple secondary efficacy endpoints will be assessed after 12 and 16 weeks of therapy, including: Numerical Rating Scale (NRS) for pain and itch; Modified Sartorius Score; Dermatology Life Quality Index (DLQI); Hospital Anxiety and Depression Scale (HADS); and Patient Global Impression of Change and Severity (PGI-c, PGI-s). Please visit www.clinicaltrials.gov for a more complete description of the study.

    Dr. Gottlieb commented, "With bermekimab we now have a potential new tool in the toolbox to treat diseases like hidradenitis suppurativa. Targeting IL-1⍺ represents a new class of medication. I am pleased that we are underway with a large randomized study that we can expect will provide definitive findings for this novel therapy."

    John Simard, XBiotech CEO, stated, "HS is a cornerstone for our bermekimab dermatology franchise. We are excited to launch this large randomized study.  We expect this study will corroborate the promising safety and efficacy results seen in our previous clinical trials of bermekimab to treat HS, including rapid and dramatic reduction of pain. Our True Human antibody platform harnesses the human body's natural antibody response to disease, and we hope that in the case of HS, bermekimab will offer an effective, safe relief to people with this difficult condition."

    Bermekimab has demonstrated its safety and efficacy treating HS in two previous clinical studies. A recent open label study demonstrated that weekly bermekimab is an effective therapy, as measured by improvement in disease according to HiSCR, the key measure of disease in HS.  In the study, 61% of patients with no prior biological therapy achieved positive HiSCR at 12 weeks1, and 63% of patients who had failed previous biological therapy (i.e. adalimumab) achieved a positive HiSCR at 12 weeks. Another unrivaled finding in the study was a significant treatment-related reduction of pain in HS patients. Reducing pain is widely recognized among experts as a key objective for HS treatment, but this symptom has been largely unaddressed by available drugs. Pain was assessed with a patient questionnaire using a numerical rating scale from 0 to 10. A 30% and ≥1-unit reduction in pain score is considered a clinically important relief from pain, and no approved monotherapy for HS has elicited a clinically significant effect on pain2.  Remarkably, a substantial majority of patients treated with weekly bermekimab achieved this endpoint: 67% and 72% at week 12 who had prior or no prior anti-TNF therapy, respectively.

    An earlier double-blind, placebo controlled, randomized study also evaluated bermekimab in the treatment of HS. The study met its primary endpoint, demonstrating significant improvement of HiSCR in patients treated with bermekimab compared to control after 12 weeks of therapy (response rate of 60% vs 10%, respectively (p=0.035))3. These results have been published in the Journal of Investigative Dermatology

    About Hidradenitis Suppurativa  
    Hidradenitis Suppurativa (HS) is a chronic, inflammatory skin disorder affecting areas rich in apocrine glands. Nodules appear in the affected areas and progressively become swollen with spontaneous rupture and release of pus. This process occurs repeatedly leading to formation of deep sinus tracts and painful dermal abscesses4,5. Therefore, HS is often devastating for patients with significant impact on quality of life6. The Dermatology Life Quality Index (DLQI) for HS is 8.9, being higher than any other skin disorder7. Traditional treatments comprise of antibiotics, antiandrogens and surgery. The global prevalence for HS is estimated at up to 4% of the population5.

    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

    ______________________________
    1  HiSCR response rates at week 12 were 42% and 59% in the so called PIONEER I and PIONEER II Phase III studies with the FDA-approved drug adalimumab, respectively. Only 28% and 46% of patients achieved clinically relevant pain reduction (as defined above) in the PIONEER I and PIONEER II studies, respectively. In the PIONEER II study, patients received adalimumab as a combination therapy with antibiotics. Pain reduction results were not significant (compared to placebo) in PIONEER I.
    2 Only 34 of 122 (28%) of patients treated weekly with adalimumab achieved this endpoint at week 12 in the PIONEER I monotherapy study.
    3 Kanni T et al. MABp1 Targeting Interleukin-1Alpha for Moderate to Severe Hidradenitis Suppurativa not Eligible for Adalimumab: A Randomized Study. J Invest Dermatol. 2017 Nov 9.
    4 Revuz J. Hidradenitis suppurativa. J Eur Acad Dermatol Venereol 2009; 23: 985-998.
    5 Alikhan A, Lynch PJ, Eisen DB. Hidradenitis suppurativa: a comprehensive review. J Am Acad Dermatol. 2009 Apr;60(4):539-61; quiz 562-3. doi: 10.1016/j.jaad.2008.11.911.
    6 Vasquez BG, Alikhan A, Weaver, AL, et al. Incidence of hidradenitis suppurativa and associated factors: a population-based study of Olmsted County, Minnesota. J Invest Dermatol. 2013 Jan;133(1):97-103. doi: 10.1038/jid.2012.255. Epub 2012 Aug 30.
    7 Révuz JE, Canoui-Poitrine F, Wolkenstein P, et al. Prevalence and factors associated with hidradenitis suppurativa: results from two case-control studies. J Am Acad Dermatol 2008; 59: 695-701.

    Primary Logo

    View Full Article Hide Full Article
  21. AUSTIN, Texas, Oct. 02, 2019 (GLOBE NEWSWIRE) -- XBiotech (NASDAQ:XBIT) announced the first patient was enrolled in a clinical study evaluating bermekimab therapy in adults with systemic sclerosis (SSc), otherwise known as scleroderma, a devastating inflammatory syndrome characterized by chronic inflammation in the blood vessels, skin, and other organs. The randomized double-blind, placebo-controlled trial will evaluate efficacy of weekly bermekimab monotherapy versus placebo. The primary endpoint of the study will be measured at 12 weeks, and will assess SSc disease severity using a combination of rheumatological, clinical, and physiological measures. The study will randomize patients 1:1 to receive either weekly subcutaneous injections of…

    AUSTIN, Texas, Oct. 02, 2019 (GLOBE NEWSWIRE) -- XBiotech (NASDAQ:XBIT) announced the first patient was enrolled in a clinical study evaluating bermekimab therapy in adults with systemic sclerosis (SSc), otherwise known as scleroderma, a devastating inflammatory syndrome characterized by chronic inflammation in the blood vessels, skin, and other organs. The randomized double-blind, placebo-controlled trial will evaluate efficacy of weekly bermekimab monotherapy versus placebo. The primary endpoint of the study will be measured at 12 weeks, and will assess SSc disease severity using a combination of rheumatological, clinical, and physiological measures. The study will randomize patients 1:1 to receive either weekly subcutaneous injections of bermekimab or placebo. The study will also include an open label weekly bermekimab treatment regimen during weeks 13-24, where patients will continue to be evaluated using the same endpoints.

    SSc is characterized by systemic inflammation that results in injury to blood vessels, and fibrosis of the skin and internal organs1. Skin lesions can be severe, resulting in disfiguration and debilitating pain. In addition, patients suffering from SSc have substantially reduced life expectancy due to the fibrosis that occurs in vital organs and chronic inflammation of the blood vessels2.

    While the cause of SSc is unknown, pathogenesis of the disease is understood to involve errant activation of fibroblasts. In normal organs and tissues, fibroblast cells play a crucial role in building the structural framework of connective tissue that holds the organs and tissues together. Fibroblasts produce the extracellular matrix substances that actually enable the organ structure. When fibroblasts are errantly activated in SSc, they become hyperactive and produce excessive extracellular matrix, which is the basis for fibrosis.

    An initial step in the SSc disease process is believed to be the release of the potent inflammatory cytokine interleukin-1 alpha (IL-1⍺) from keratinocytes in the epidermis3. The release of IL-1⍺ results in the production of a myriad of other inflammatory cytokines, including IL-6, TNF, IL-8, IL-10, and others from surrounding tissues4,5,6,7. Blocking IL-1⍺ could abrogate the pathological cascade that occurs in this disease.  Bermekimab specifically binds and neutralizes IL-1⍺.

    Errant IL-1⍺ production has been repeatedly shown to occur in cells of patients with SSc (8,9). IL-1⍺ levels are elevated in SSc patients10,11, including in the skin and in lung fluids of SSc patients with pulmonary fibrosis; and when IL-1⍺ production is induced in normal fibroblasts, these take on the characteristics of SSc fibroblasts12.

    Evangelos Giamarellos-Bourboulis, MD, PhD, Professor of Internal Medicine, Attikon University Hospital and principle investigator of the study, commented, "We have long suspected a role for IL-1⍺ in the pathogenesis of systemic sclerosis. There are thus strong fundamental principles behind our use of bermekimab in treating the disease. We hope that this study will finally lead to an effective treatment approach for patients with systemic sclerosis."

    The most common affected organs in SSc are the skin, the gastrointestinal tract, the lungs, and the heart. Capillary endothelium is involved, leading to ischemia and digital necrosis. Patients develop an interstitial lung disease (ILD) prototype dominated by pulmonary hypertension (PHA) and failed gas exchange. Almost all patients also have signs of intestinal dysmotility leading to gastrointestinal reflux and bloating13. Hallmarks of SSc are fibrosis of the skin and internal organs and vasculopathy. SSc is the only rheumatic disorder accompanied by substantial lethality; so far no specific treatment targeting the mechanism of pathogenesis is available.

    About True Human™ Therapeutic Antibodies
    XBiotech's True Human™ 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™ 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.

    Contact
    Ashley Otero

    512-386-2930

    __________________________________
    1 Varga J, Abraham D (2007) Systemic sclerosis. A prototypic multisystem fibrotic disorder. J Clin Invest 117:557–67.
    2 Steen VD, Medsger TA Jr. Severe organ involvement in systemic sclerosis with diffuse scleroderma. Arthritis Rheum 2000; 43: 2437–2444.
    3 Werner S, Krieg T, Smola H. Keratinocyte-fibroblast interactions inwound healing. J Invest Dermatol 2007; 127: 998 1008.
    4 Engelhardt E, Toksoy A, Goebeler M, Debus S, Bröcker EB, Gillitzer R. Chemokines IL-8, GROa, MCP-1, IP-10, and Mig are sequentially and differentially expressed during phase-specific infiltration of leukocyte subsets in human wound healing. Am J Pathol 1998; 153: 1849–1860.
    5 Uchi H, Terao H, Koga T, Furue M. Cytokines and chemokines in the epidermis. J Invest Dermatol 2000; 24S: 529-538.
    6 Gillitzer R, Goebeler M. Chemokines in cutaneous wound healing. J Leukoc Biol 2001; 69: 513–521.
    7 Gillitzer R, Goebeler M. Chemokines in cutaneous wound healing. J Leukoc Biol 2001; 69: 513–521.
    8 Kawaguchi Y, Hara M, Wright TM. Endogenous IL-1a from systemic sclerosis fibroblasts induces IL-6 and PDGF-A. J Clin Invest 1999; 103: 1253–1260.
    9 Kawaguchi Y. IL-1a gene expression and protein production by fibroblasts from patients with systemic sclerosis. Clin Exp Immunol 1994; 97: 445–450.
    10 Duan H, Fleming J, Pritchard DK et al. (2008) Combined analysis of monocyte and lymphocyte messenger RNA expression with serum protein profiles in patients with scleroderma. Arthritis Rheum 58:1465–74.
    11 Maekawa TJinnin MOhtsuki MIhn H. Serum levels of interleukin-1α in patients with systemic sclerosis. J Dermatol. 2013 Feb;40(2):98-101. doi: 10.1111/1346-8138.12011. Epub 2012 Oct 18.
    12 Kawaguchi Y, McCarthy SA, Watkins SC, Wright TM. Autocrine activation by interleukin 1a induces the fibrogenic phenotype of systemic sclerosis fibroblasts. J Rheumatol 2004; 31: 1946– 1954.
    13 Denton CP, Khanna D, Systemic sclerosis. Lancet 2017; 390: 1685-1699.

    Primary Logo

    View Full Article Hide Full Article
  22. AUSTIN, Texas, Sept. 27, 2019 (GLOBE NEWSWIRE) -- XBiotech (NASDAQ:XBIT) announced today that Dr. Alice Gottlieb will be presenting clinical findings for bermekimab in the treatment of atopic dermatitis (AD) at the European Academy of Dermatology and Venereology (EADV) Congress being held in Madrid Spain October 9-13th.  Dr. Gottlieb will present data from a multicenter, phase 2 study in which bermekimab monotherapy showed rapid and dose dependent improvement in AD. The presentation will be given during the October 12th morning session for late breaking clinical data, Chaired by Professor Brigitte Dreno. A subset of these data were presented at the American Academy of Dermatology conference in Washington, D.C. in March of this year.

    A highlight…

    AUSTIN, Texas, Sept. 27, 2019 (GLOBE NEWSWIRE) -- XBiotech (NASDAQ:XBIT) announced today that Dr. Alice Gottlieb will be presenting clinical findings for bermekimab in the treatment of atopic dermatitis (AD) at the European Academy of Dermatology and Venereology (EADV) Congress being held in Madrid Spain October 9-13th.  Dr. Gottlieb will present data from a multicenter, phase 2 study in which bermekimab monotherapy showed rapid and dose dependent improvement in AD. The presentation will be given during the October 12th morning session for late breaking clinical data, Chaired by Professor Brigitte Dreno. A subset of these data were presented at the American Academy of Dermatology conference in Washington, D.C. in March of this year.

    A highlight of the data to be reported is the observation that after only 8 weeks of bermekimab therapy, three-fourths of patients achieved 75% improvement in their Eczema Area and Severity Index (EASI 75) scores, a key measure of disease severity in AD. The current standard of care and the only approved biological therapy for AD involves a 16 week treatment regimen, which clinical trials have shown to result in 44-51% of patients achieving 75% improvement in EASI score. Another key finding to be reported in the bermekimab study was a dramatic reduction in itch, which can be debilitating in eczema patients. An overall reduction of ≥4 points based on the Numerical Rating Scale for itch is considered clinically significant. Seventy-five percent of patients achieved ≥4 point reduction in 8 weeks.

    Atopic dermatitis, commonly referred to as eczema, is characterized by chronic inflammation of the skin, which results in a breakdown of the skin barrier and leads to dry, thickened, scaly skin, redness, and itching, the latter which can be debilitating and result in significant sleep disturbances and loss of quality of life. There's an estimated 18 million people with AD in the United States and the incidence is believed to be increasing in industrialized countries. Nearly 7 million persons in the U.S. are believed to have atopic dermatitis that is considered moderate to severe, which is the disease severity of subjects treated in the present study. The economic impact of AD is significant, with an estimate of nearly $40 billion in costs annually.

    About True Human™ Therapeutic Antibodies
    XBiotech's True Human™ 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™ 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.

    Contact
    Ashley Otero
     
    512-386-2930

    Primary Logo

    View Full Article Hide Full Article
  23. AUSTIN, Texas, Sept. 20, 2019 (GLOBE NEWSWIRE) -- XBiotech Inc. (NASDAQ:XBIT) announced today that the Canadian Patent Office has granted XBiotech a patent (Patent Number 56003542-6CA) covering the use of bermekimab in the treatment of inflammatory skin diseases. The patent describes studies showing that antibodies which specifically neutralize the activity of interleukin-1alpha (IL-1α), such as bermekimab, reduce skin inflammation and treat inflammatory skin diseases. XBiotech has conducted a number of clinical trials in dermatology using bermekimab, including studies in hidradenitis suppurativa, atopic dermatitis, and psoriasis vulgaris (plaque psoriasis). The company has also published clinical findings for the treatment of psoriasis and…

    AUSTIN, Texas, Sept. 20, 2019 (GLOBE NEWSWIRE) -- XBiotech Inc. (NASDAQ:XBIT) announced today that the Canadian Patent Office has granted XBiotech a patent (Patent Number 56003542-6CA) covering the use of bermekimab in the treatment of inflammatory skin diseases. The patent describes studies showing that antibodies which specifically neutralize the activity of interleukin-1alpha (IL-1α), such as bermekimab, reduce skin inflammation and treat inflammatory skin diseases. XBiotech has conducted a number of clinical trials in dermatology using bermekimab, including studies in hidradenitis suppurativa, atopic dermatitis, and psoriasis vulgaris (plaque psoriasis). The company has also published clinical findings for the treatment of psoriasis and acne. The development of bermekimab for the treatment of inflammatory skin disorders is an important part of XBiotech's commercialization programs.

    Stanley Kim, Ph.D., J.D., XBiotech's Corporate Vice President of Intellectual Property, stated, "I am pleased that the Canadian Patent Office acknowledged the significance of XBiotech's contribution to this field by granting this patent with broad claims. As a pioneer in IL-1α research, XBiotech has developed a significant worldwide patent portfolio for the use of anti-IL-1α antibody to prevent and treat inflammatory skin diseases as well as other conditions involving sterile inflammation."

    This patent issuance in Canada further broadens XBiotech's patent portfolio as it relates to bermekimab and its potential to treat inflammatory skin disorders through IL-1 alpha blockade. The company has previously successfully completed clinical studies evaluating bermekimab for treatment of atopic dermatitis, psoriasis1, acne2, pyoderma gangrenosum, and hidradenitis suppurativa3.

    The grant of this patent in Canada is in addition to patents granted in the U.S., Europe, Australia, and Japan. The Company's patent portfolio also includes several pending U.S. and foreign applications  directed to dermatologic pathologies. XBiotech plans to continue to pursue inflammatory skin disorder indications as it further strengthens its clinical pipeline.

    About 85 million Americans (approximately one in four) sought treatment from a physician for skin disease in 2013—with an estimated direct health care cost of $75 billion, a number which continues to grow. The economic impact and prevalence of skin disease is on a similar magnitude as the other major diseases affecting the U.S. population, including diabetes and cardiovascular disease. Consequently, revenues from new biological drugs to treat skin diseases are growing rapidly. XBiotech believes bermekimab has the potential to emerge as a leading therapy for skin disease.

    About True Human™ Therapeutic Antibodies
    XBiotech's True Human™ 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™ 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.

    Contact
    Ashley Otero

    512-386-2930

    1 Coleman KM et al. Open-Label Trial of MABp1, a True Human Monoclonal Antibody Targeting Interleukin 1⍺, for the Treatment of Psoriasis. JAMA Dermatol. 2015 May;151(5):555-6.

    2 Carrasco D et al. An Open Label, Phase 2 Study of MABp1 Monotherapy for the Treatment of Acne Vulgaris and Psychiatric Comorbidity. J Drugs Dermatol. 2015 Jun;14(6):560-4.

    3 Kanni T et al. MABp1 Targeting Interleukin-1Alpha for Moderate to Severe Hidradenitis Suppurativa not Eligible for Adalimumab: A Randomized Study. J Invest Dermatol. 2017 Nov 9.

    Primary Logo

    View Full Article Hide Full Article