(Chemotherapy Advisor) – Clinical trials have begun for a therapeutic cancer vaccine directed at MUC1, an antigen that is expressed on cells of many malignant tumor types including breast, non-small cell lung, ovarian, colorectal, prostate, pancreatic, gastric, and others. The vaccine’s manufacturer, Oncothyreon, Inc. announced today that it has enrolled its first patient in a Phase 1 trial to evaluate the safety and immunogenicity of the vaccine, which is known as ONT-10.

ONT-10 is designed to elicit both an antibody and a T-cell immune response to identify and destroy cancer cells that express the MUC1 antigen. The vaccine is in a liposomal formulation composed of a 43 amino-acid long glycoprotein segment of MUC1 and the proprietary synthetic adjuvant PET-Lipid A, the latter is a fully synthetic toll like receptor 4 (TLR4) agonist shown to enhance the vaccine’s potency.

Oncothyreon presented preclinical data on the vaccine at the annual conference of the American Association for Cancer Research in 2011. Results of preclinical testing demonstrated that administration of ONT-10 into mice led to strong, specific antibody and cellular immune responses against human MUC1. Tumor growth was also blocked by ONT-10 in the murine model, leaving a high percentage of the vaccinated animals tumor free at the conclusion of the study. In December, 2011, Onthyreon filed an Investigational New Drug application for ONT-10 and recently received the green light to begin clinical trials.

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