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XBiotech Inc. develops True Human™ monoclonal antibodies derived from human donors for inflammatory, oncology, neurologic, and infectious disease applications. Company news centers on its antibody platform, Natrunix, an anti-interleukin-1alpha candidate studied in pancreatic cancer and rheumatology, and Hutrukin, a candidate therapy for reducing brain injury after ischemic stroke.
Recurring developments include clinical study results, program-prioritization decisions, FDA-related clinical authorizations, enrollment updates, and the company’s Austin campus operations, including GMP manufacturing, research laboratories, infectious disease facilities, quality control, and clinical operations.
XBiotech Inc. has initiated a randomized, open-label, placebo-controlled clinical study for Hutrukin, a novel therapy aimed at reducing brain injury from ischemic stroke. With over 10 million cases of ischemic strokes annually, the need for effective treatments is critical. Hutrukin seeks to mitigate reperfusion injury, a common complication following clot-removal procedures, by targeting inflammation before blood flow is restored. The Phase I study will evaluate three dosing levels for safety and pharmacokinetics, with results guiding further research phases. XBiotech leverages its proprietary True Human™ antibody technology to explore innovative treatments across various diseases.
XBiotech has announced the launch of the TASKIN Study, a Phase I/II/III clinical trial for Natrunix in combination with trifluridine/tipiracil, aimed at treating metastatic colorectal cancer. Funded by the French National Cancer Institute (INCA), this study will take place at 20 medical centers in France. The trial aims to evaluate the efficacy of Natrunix in patients who have failed prior treatments. With colorectal cancer accounting for over 151,000 new cases annually in the U.S., this study could have significant implications for treatment options.
XBiotech Inc. (NASDAQ: XBIT) has successfully completed the Phase I portion of its 1-BETTER study assessing the anti-cancer drug Natrunix combined with chemotherapy for pancreatic cancer. Thirty leading cancer centers participated in the study, which showed that Natrunix was well-tolerated without any dose-limiting toxicities. The Phase II portion is now starting, enrolling 60 subjects to evaluate key endpoints like progression-free survival and overall survival. Pancreatic cancer remains a significant health challenge, with about 50,000 deaths expected in the U.S. in 2022.
XBiotech announced the approval of its candidate cancer treatment Natrunix by the French National Agency for the Safety of Medicines and Health Products (ANSM) for a multicenter Phase-I-III clinical study. This study aims to evaluate Natrunix in combination with trifluridine/tipiracil for treating metastatic colorectal cancer in patients who haven't responded to prior treatments. Funded by a grant from the French National Cancer Institute (INCA), the study will enroll at least 160 subjects across 20 leading medical centers in France.
XBiotech has announced a Manufacturing Agreement with Janssen Research & Development, extending its support for the production of Bermekimab until December 2023. This follows the sale of Bermekimab to Janssen in December 2019. Although contract manufacturing is not a core part of XBiotech's strategy, the company is leveraging its advanced manufacturing technology and facilities in Austin, Texas to facilitate this arrangement. XBiotech aims to use the generated revenue to further develop its pipeline of therapeutic antibodies.
XBiotech has enrolled the first patient in a randomized clinical study for Natrunix-SQ, a promising therapy targeting arthritis. The Phase I study will evaluate safety and pharmacokinetics while assessing blood levels at increasing doses. Natrunix-SQ aims to neutralize interleukin-1, a key inflammation driver, specifically targeting IL-1a, potentially redefining anti-inflammatory treatments. Following successful Phase I results, multiple Phase II studies are planned. This development marks a significant step in advancing treatments for rheumatological diseases.
XBiotech Inc. (NASDAQ: XBIT) has received FDA authorization to initiate clinical development for Natrunix, its novel True Human™ antibody therapy targeting rheumatological diseases. This breakthrough therapy aims to treat inflammatory joint diseases, including osteoarthritis and rheumatoid arthritis (RA), without causing general immunosuppression. With an increasing number of patients diagnosed—projected to rise to 67 million in the U.S. by 2030—Natrunix's Phase I study will begin with dosing for subcutaneous injections, followed by Phase II studies in RA.
XBiotech (NASDAQ: XBIT) has announced its plan to initiate a Phase I/II randomized, placebo-controlled clinical study for a new True Human™ antibody therapy aimed at reducing brain injury after stroke. The study will take place at leading U.S. medical centers and targets ischemia-reperfusion injury, a consequence of inflammation that follows the reopening of blocked arteries. With stroke contributing to high mortality and disability worldwide, this therapy could represent a significant advancement in neurology.
On September 8, 2021, XBiotech (NASDAQ: XBIT) announced Dr. Benjamin Musher will chair its clinical program for Natrunix™, a novel cancer drug targeting pancreatic cancer. This drug aims to reduce tumor growth by blocking tumor blood supply and minimizing chemotherapy toxicity. The 1-BETTER study will evaluate Natrunix™ alongside existing treatments at multiple cancer centers, generating crucial data on survival rates and quality of life for patients. John Simard, CEO, expressed optimism about the upcoming results from this promising clinical trial.
XBiotech Inc. (NASDAQ: XBIT) has appointed Dr. Mark Ziats as Medical Director, enhancing its clinical team focused on developing its drug candidates for diseases like cancer and cardiovascular conditions. Dr. Ziats brings extensive medical experience, having trained at Baylor College and the University of Cambridge. CEO John Simard emphasized that Dr. Ziats’ expertise will strengthen XBiotech’s mission of utilizing True Human antibodies, derived from individuals with natural immunity, to treat various diseases. XBiotech continues to advance its therapeutic antibody pipeline aimed at redefining standard care practices.