XBIT XBiotech Inc.

18.94
-0.12  -1%
Previous Close 19.06
Open 19.23
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Latest News

  1. 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 



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  2. 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

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  3. 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
  4. 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
  5. 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
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