Immutep's lead candidate enters Ph I trial

French drugmaker Immutep SA's lead product candidate, ImmuFact IMP321, has entered a Phase I clinical trial in disease-free melanoma. The natural human T cell immunostimulatory factor is designed to amplify the T cell immune response and can be used as an immunopotentiator in therapeutic vaccines, alone, or in combination with chemotherapy.

The open-label four-arm trial will compare a selected set of eight HLA-A2 melanoma peptide antigens, with or without IMP321 and/or Montanide. The primary objectives of the study are to determine whether immunization with the peptides in PBS, or emulsified in Montanide, results in detectable cytotoxic T lymphocyte responses and to establish safety of the addition of IMP321 to these two peptide formulations. Secondary objectives are to analyze the kinetics of any detectable CTL response and disease-free survival.