XBiotech announced the enrollment of the first patient in a multicenter, randomized clinical study for Natrunix in combination with trifluridine/tipiracil for the treatment of colorectal cancer. The much anticipated clinical study for XBiotech's candidate cancer treatment is being funded by the French National Cancer Institute (INCA). The study is headed by renown oncologists Dr. François Ghiringhelli and Dr. Come Lepage, Professor in Medical Oncology and Director of the INSERM research team at the Georges-Francois Leclerc Cancer Centre, and Professor at the Department of Gastroenterology and Digestive Oncology, University Hospital Dijon, Dijon, France, respectively.

Investigators are combining XBiotech's Natrunix with trifluridine/tipiracil as a new candidate therapy for metastatic colorectal cancer. Subjects receiving the experimental therapy have failed earlier treatment with oxaliplatin, irinotecan, and fluoropyrimidine. Subjects are randomized to receive Natrunix plus trifluridine/tipiracil chemotherapy or placebo plus the chemotherapy.

The study is designed to seamlessly proceed through Phase III development based on achievement of certain efficacy milestones in the Phase I/II portions. Natrunix is a therapeutic monoclonal antibody discovered, manufactured, and undergoing clinical development by XBiotech. The antibody blocks the activity of substance produced by tumors and inflammatory cells that stimulates new blood vessel formation and breaks down connective tissue at the site of the tumor, allowing tumors to grow and spread.

The same substance also activates blood vessels, making them sticky to enhance migration of circulating tumor cells to new sites of metastasis. Natrunix potently blocks the action of the substance, known as IL-1, which is also produced in response to chemotherapy. Colorectal cancer is one of the most common forms of cancer in Europe and the United States, with the American Cancer Society's estimating over 151,000 new cases and over 52,000 deaths annually in the United States alone.