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THERATOPE (STn-KLH) is an active specific immunotherapy (cancer vaccine) developed by Biomira Inc. It consists of a synthetic sialyl-Tn (STn) carbohydrate epitope, a tumor-associated antigen frequently overexpressed on the mucins of various adenocarcinomas, covalently linked to the immunogenic carrier protein keyhole limpet hemocyanin (KLH). The vaccine is typically formulated with an adjuvant, such as Detox-B (a stable emulsion containing monophosphoryl lipid A and mycobacterial cell wall skeleton) or QS-21, to enhance the immune response. Its mechanism involves inducing a humoral response, specifically STn-specific IgM and IgG antibodies, to recognize and target STn-positive tumor cells. While it showed promise in early-phase trials for breast, ovarian, and colorectal cancers, a large pivotal Phase 3 trial in metastatic breast cancer failed to meet its primary endpoints of time to progression and overall survival, leading to the discontinuation of its clinical development.
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