Characterization of tumor vaccines during product development

The term tumor vaccines encompasses a wide variety of diverse agents capabl e of interacting with the imune system to product local inflammation. delay ed type hypersensitivity reaction and/or tumor regression and, hopefully, a therapeutic effect. These vaccines may be grouped into the following gener al areas: (1) Cell-based vaccines such as manipulated tumor cells, activate d peripheral blood or bone marrow-derived lymphocytes, dendritic cells or o ther antigen presenting cells (APC) and gene-modified tumor cells or other cells engineered to express cytokines, growth factors or tumor antigens. (2 ) Antigen preparations, such as synthetic peptides. purified antigens and t umor cell lysates. (3) Viral and plasmid vectors expressing therapeutic gen es. (4) Liposome containing antigen, peptides, plasmids encoding tumor anti gens. While no tumor vaccine has been licensed by the FDA, numerous clinica l trials are ongoing and some products have advanced to Phase III pivotal s tages of development. However, as with many novel products, major regulator y and scientific issues associated with clinical use of tumor vaccines rema in to be addressed. In this paper, we address issues associated with differ ent types of tumor Vaccines and provide recommendations for the characteriz ation of these vaccines at various stages of development. Published by Else vier Science Ltd.