XBiotech, Inc.

XBiotech Inc. (NASDAQ: XBIT) Announces that Hutrukin is being developed by XBiotech as a breakthrough therapy to reduce brain injury after stroke. The last subject in a randomized, open-label, placebo-controlled Phase I dose escalation clinical study has been enrolled. XBiotech discovered, manufactures, and is conducting this clinical study of Hutrukin. The primary objective of the Phase I study is to evaluate safety and pharmacokinetics of Hutrukin in healthy volunteers. Sequential dose escalation was conducted using three cohorts of subjects, each receiving a single intravenous infusion of either placebo or Hutrukin, with eight subjects in each cohort. Hutrukin is a candidate drug being developed to reduce brain injury following ischemic stroke. Globally, one in four people over age 25 will experience a stroke—the leading cause of disability and second leading cause of death in the world. An ischemic stroke occurs when a blood clot obstructs a blood vessel that supplies the blood to the brain. Blockage of blood flow to the brain results in brain injury, loss of brain function, or death. Emergency treatment for stroke includes “clot-busting” drugs or mechanical catheters to re-open arteries, both of which are associated with a phenomenon known as reperfusion injury. Reperfusion injury is the damage that occurs to previously healthy brain tissue after a clot is removed from the artery and blood supply is returned to the healthy but hypoxic brain tissue. This secondary damage is believed to be the result of an inflammatory response resulting from the return of blood cells to the region of the brain that had been previously deprived of blood and oxygen (which is the hypoxic brain tissue). When administered immediately prior to artery-opening procedures, Hutrukin may reduce the inflammatory injuries associated with reperfusion. No drug or treatment is currently available to reduce or prevent reperfusion injury. Hutrukin potentially represents a unique and major advance for stroke victims. About True Human™ Therapeutic Antibodies XBiotech’s True Human™ antibodies are derived without modification from individuals who possess natural immunity to certain diseases. By harnessing the body’s natural immunity to cure disease, True Human™ antibodies have the potential to revolutionize medicine. About XBiotech XBiotech is dedicated to pioneering the development of breakthrough therapies derived from natural human immunity. XBiotech discovered genetic engineering tools that enabled identification of rare antibodies present in human donor blood, and has built a pipeline of antibody therapies, including a candidate therapy that could revolutionize arthritis treatment. Headquartered in Austin, Texas, XBiotech has also lead innovation in biomanufacturing technology. For more information, visit www.xbiotech.com. The content above comes from the network. if any infringement, please contact us to modify.

XBiotech Inc. announced today completion of enrollment of the Phase II portion of its 1-BETTER study—a Phase I/II randomized, double-blind, placebo-controlled clinical study for Natrunix in combination with chemotherapy for treating pancreatic cancer. Natrunix is indistinguishable from a naturally occurring antibody present in a healthy human. Natrunix binds and neutralizes a potent substance, a so called cytokine known as interleukin-1a (IL-1a), that causes connective tissue breakdown, growth of new blood vessels, and recruitment of white blood cells. Malignant tumors, like pancreatic cancer, stimulate the body’s production of IL-1a that induce tumor neovascularization, growth and spread. Additionally, IL-1a acts as an alarm signal when there is body injury (such as when tumors grow), enhancing pain perception, metabolism, appetite, fatigue, and anxiety. The insult from chemotherapy also induces IL-1a production. Adding Natrunix to your chemotherapy regimen may therefore provide numerous benefits, including anti-tumor activity, reduction in chemotherapy side effects, improvement in chemotherapy activity—including increasing the number of cycles of therapy that can be tolerated while improving quality of life. Twenty-two leading cancer centers across the United States have been involved in the Phase I/II study. Pancreatic cancer is the 4th leading cause of cancer death in the United States and the incidence has been increasing steadily since 2000. In 2022, an estimated 50,000 people died from pancreatic cancer in the United States. The Natrunix antibody therapy represents a groundbreaking approach to therapy. The Phase II portion enrolled 65 subjects using the maximum dose studied from the Phase I study that were randomized on a 1:1 basis to receive either Natrunix in combination with ONIVYDE+LV+5-FU (Arm 1), or placebo plus the chemotherapy combination. Key endpoints in the Phase II portion are safety and tolerability, progression-free survival, overall survival and time-to-treatment-failure. About Natrunix Natrunix is a True Human™ antibody that was discovered, developed and manufactured by XBiotech. True Human™ antibodies are derived—without modification—from individuals who possess natural immunity to certain diseases. In many individuals, the body naturally produces antibodies to block pathological inflammation associated with interleukin-1, one of the most extensively studied inflammatory pathways in medicine. Other marketed biological drugs attempt to treat diseases by blocking interleukin-1, however none specifically and exclusively target interleukin-1 alpha (IL-1a). There is also no other marketed monoclonal antibody therapy derived unaltered from a natural human immune response. 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 is currently 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 is also leading the development of innovative biotech manufacturing technologies designed to more rapidly, cost-effectively and flexibly produce therapies urgently needed by patients worldwide. For more information, visit www.xbiotech.com. The content above comes from the network. if any infringement, please contact us to modify.

AUSTIN, Texas, Aug. 08, 2023 (GLOBE NEWSWIRE) -- xBiotech USA, Inc. (NASDAQ: XBIT) today began treating the first patient in a phase II, double-blind, placebo-controlled, randomized clinical study to evaluate Natrunix as a new treatment for Arthritis. Natrunix blocks a key cause of inflammation involved in pain and joint destruction in rheumatoid arthritis (RA). The primary endpoint of the Phase II is the American College of Rheumatology (ACR) 20% Response (ACR 20) rate at 12 weeks. Secondary and exploratory endpoints include ACR 50, ACR 70, numerical rating scale (NRS) for pain score, inflamed and painful joint counts, Health Assessment Questionnaire Disability Index (HAQ-DI), Routine Assessment of Patient Index Data 3 (RAPID-3), Clinical Disease Activity Index (CDAI) and safety. These endpoints reflect the expectation that Natrunix may provide needed improvement with respect to pain, tenderness, mobility of joints and quality of life. Approximately 210 subjects will be enrolled into three different arms in the study. All subjects will receive methotrexate (MTX) and be randomized to receive either one of two doses of Natrunix or placebo. Natrunix is a monoclonal antibody indistinguishable from a naturally occurring antibody from a human donor. Natrunix binds and neutralizes the action of one of the most potent inflammation-causing substances known—interleukin-1. For decades, interleukin-1 was seen as the key target for drugs to treat RA. However, to date, drugs that block interleukin-1 have not lived up to expectations as therapies for RA. XBiotech believes it has solved this puzzle. Interleukin-1 actually describes two separate and distinct molecules—IL-1a and IL-1b—that are produced at different times and places in the body. XBiotech is the first to develop candidate therapies—like Natrunix—that directly and specifically neutralize IL-1a. In recent years, world-class research has shown that in many cases IL-1a may be the crucial target for blocking disease-causing activities of the interleukin-1 inflammatory pathway. Natrunix thus holds promise as a new generation anti-inflammatory therapy for arthritis. As a naturally derived human antibody, it is also by design expected to be among the safest and best tolerated medicines ever developed. One in four adults, or over 50 million people in the United States are currently affected by Rheumatoid Arthritis, including 33% of those between the ages of 45-64 and 50% of person over 65 years of age. The number of persons affected by RA is expected to increase, with the CDC predicting that by the year 2040, 78.4 million adults, will suffer from RA in the United States. In addition, it is expected that 300,000 children will suffer from juvenile arthritis (Arthritis Foundation, 2023). About True Human™ Therapeutic Antibodies Natrunix was discovered by XBiotech researchers at the Company’s headquarters in Austin, Texas. XBiotech’s True Human™ antibodies are derived without modification from individuals who possess natural immunity to certain diseases. By harnessing the body’s natural immunity to cure disease, True Human™ antibodies have the potential to revolutionize medicine. About XBiotech XBiotech is dedicated to pioneering the development of breakthrough therapies derived from natural human immunity. XBiotech discovered genetic engineering tools that enabled identification of rare antibodies present in human donor blood, and has built a pipeline of antibody therapies, including a candidate therapy that could revolutionize arthritis treatment. Headquartered in Austin, Texas, XBiotech has also lead innovation in biomanufacturing technology. For more information, visit . 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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 Wenyi Wei wwei@xbiotech.com Tel. 737-207-4600