XBIT XBiotech Inc

XBiotech Inc. (NASDAQ: XBIT) has enrolled the first patient in its 1-BETTER study, a randomized, double-blind, placebo-controlled clinical study to evaluate XB2001 in combination chemotherapy for treatment of Pancreatic Cancer.

XBiotech’s novel anti-cancer agent, XB2001, is being assessed in combination with ONIVYDE + 5-FU/LV chemotherapy regimens. Safety and tolerability of the regimen, as well as progression-free survival, overall survival and time-to-treatment-failure will be assessed in the study.

XB2001 blocks inflammation pathways turned on by tumors that help tumors vascularize, spread and cause collateral damage to healthy tissues. By using XB2001 to block inflammation in pancreatic cancer, investigators also hope to see a reduction in serious adverse events and reduced hospitalizations of subjects. Moreover, the anti-inflammatory effects of XB2001 may make the chemotherapy more effective and less toxic.

The study is also investigating a novel clinical endpoint that XBiotech calls the “clinical benefit response”, which involves radiological assessment of muscle mass and patient reported measures of pain, fatigue and appetite. In earlier clinical studies in advanced cancer patients, XBiotech discovered that subjects with preserved muscle mass and stabilization or improvement of these symptoms, had dramatically improved overall survival. The Company previously validated this endpoint in a phase III study in colorectal cancer patients and will explore this endpoint now with its new drug in pancreatic cancer.

The current study will commence with a Phase 1 portion to establish safety, tolerability and dosing of XB2001 in combination with ONIVYDE+5-FU/LV. The Phase I portion will serve to establish a recommended Phase 2 dose, which will involve enrollment of 60 patients randomized to receive either placebo+ONIVYDE+5-FU/LV or XB2001+ONIVYDE+5-FU/LV for up to 12 cycles.

Dr. Carl Gray, Principal Investigator at Community Cancer Trials of Utah, site of first patient enrollment, commented, “Pancreatic cancer remains an aggressive and difficult form of cancer to treat. If we can use XB2001 to improve outcomes and increase the tolerability of chemotherapy, this would be an exciting advance.”

John Simard, chairman and CEO of XBiotech stated, “Chemotherapy and paraneoplastic-related acute and chronic inflammatory responses play a key role in tumor progression and is a cause of significant morbidity with chemotherapy. Currently there is no approved therapy to specifically target this fundamental aspect of tumor biology or these effects of chemotherapy.”

About True Human™ Therapeutic Antibodies XBiotech’s True Human™ antibodies are derived without modification from individuals who possess natural immunity to certain diseases. XBiotech is undertaking discovery and clinical development 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 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.

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Kaitlyn Hopkinskhopkins@xbiotech.comTel. 737-207-4600