Successful Phase I Trials [NCI / NIH]
Vaccines based on Aggregon® technology were shown to be highly effective in animal studies of lymphoma and melanoma conducted and published by the Founders and their collaborators. In February 2000 the first clinical trial (Phase Ia) with a personalized cancer vaccine (autologous vaccine) based on the new Aggregon® technology was started in patients with non-Hodgkin’s lymphoma at the US National Institutes of Health (National Cancer Institute). A few years later it was followed by a second trial in patients with follicular lymphoma (Phase Ib). In both clinical trials, the Aggregon® vaccines appeared safe, with strong suggestions of efficacy manifested by induction of potent tumor-specific immune responses, prolongation of chemotherapy-induced remission in many patients and, in two cases, complete objective responses (CR). Such CR responses, characterized by complete disappearance of tumors, attest to the potential of XEME’s cancer vaccines in comparison to most other types of cancer vaccines that are unable to induce CRs.
The scientists involved in the initial development and clinical testing of Aggregon® continued to work on this technology and patented the Intellectual Property at Biomira USA. In 2005, M. Popescu, R. Robb and L. Kwak founded XEME Biopharma Inc. and in 2010, finalized negotiations and licensed the technology from Oncothyreon Inc.(now Cascadian Therapeutics Inc.), the successor of Biomira Inc. In December 2011, through a merger agreement, XEME became a wholly owned subsidiary of TheraTest Laboratories Inc., an established company since 1988, with expertise in manufacturing and marketing immunoassay kits. With financial and administrative help provided by the parent company, XEME built a cGMP manufacturing site and quality control laboratories in preparation for a new round of clinical trials under an Investigational New Drug application that was approved by the US FDA in August 2013 (IND 15639).