XBiotech USA, Inc. (NASDAQ:XBIT) announced today that it has obtained an exclusive, worldwide license from CT Atlantic AG (CTA), a Swiss biotechnology company.  Under the terms of the license agreement, XBiotech will use its proprietary manufacturing technology to advance the development of the True HumanTM anti-NY-ESO-1 monoclonal antibody, 12D7.  Accordingly, XBiotech will now begin to establish the production capability to enable 12D7 clinical development.

The 12D7 antibody targets NY-ESO-1, a cancer-related protein commonly found in many kinds of aggressive tumors. The therapeutic use of 12D7 offers the potential to target advanced tumors by activating cellular immunity or antibody directed immune responses against tumors. A 12D7 therapy may be combined with other therapies that unleash the immune system to produce anti-cancer responses.

John Simard, President & CEO of XBiotech, commented, “The 12D7 antibody was isolated from a human immune response against cancer and is therefore a logical fit with our pipeline of human-derived antibodies. 12D7 offers the potential to be used as a therapy with minimal side effects—and safely in combinations with other agents, including checkpoint inhibitors—to help direct a patient’s immune response against their cancer.”

Simard further commented, “Although NY-ESO-1 has been the subject of an enormous amount of scientific investigation, pointing to its association with tumors and anti-tumor immunity, the 12D7 antibody has yet to be evaluated in clinical trials. 12D7 is a good example of how our unique manufacturing technology can be used to help advance promising candidates discovered elsewhere.”

Prof. Alex Knuth, M.D., member of the Board of Directors at CTA, Medical Director and Chief Executive Officer of the National Center for Cancer Care and Research (NCCCR) and Chairman of Cancer Services at Hamad Medical Corporation, commented, “I am excited to bring this NY-ESO-1 specific True Human antibody to the clinic with the advanced technologies and expert guidance of XBiotech. NY-ESO-1 is the most immunogenic human cancer antigen known to date. The 12D7 antibody comes from a melanoma patient with a remarkably favourable disease course despite advanced metastasis. NY-ESO-1 immunity appears to predict a better response to immune checkpoint interventions and the 12D7 antibody has been shown to support conventional treatments like chemotherapy with better outcomes in animal models; and in combination with radiotherapy, 12D7 may also amplify immune responses against cancer cells.”