TG4010: a vaccine with a therapeutic role in cancer.

One of the strategies to enhance immune response against tumors has been the use of vaccines against tumor-associated antigens (TAAs). MUC1 is a TAA that is overexpressed in many malignancies being linked to worse prognosis. Moreover, tumor MUC1 is hypoglycosylated revealing new epitopes that are antigenic and potential T-cell targets. TG4010 is a recombinant viral vaccine targeting MUC1, also encoding for IL-2. TG4010 has been tested in Phase I-II trials demonstrating a consistent safety profile with mild local reactions as main side effect. These studies have confirmed immune responses to the vaccine product. Clinical efficacy has been observed mainly in patients with non-small-cell lung cancer in combination with chemotherapy. Peripheral activated NK cells are currently being validated as biomarkers of response.