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anti-HER-2004 + hepatitis B surface antigen is an Antibody-Vaccine Engineered Construct (AVEC) designed for the treatment of HER2-positive cancers, particularly ovarian epithelial cancer. Developed by Marek Malecki and the Pharma-Biotech-Medical-Ethical Foundation (PBMEF), the drug consists of a monoclonal antibody (clone anti-HER-2004) targeting the Human Epidermal Growth Factor Receptor 2 (HER2) conjugated to the Hepatitis B surface antigen (HBsAg) virus-like particle (VLP). The therapeutic strategy, termed Redirected, Accelerated, Amplified, Vaccination-Induced Immunotherapy (RAAVIIT), leverages the patient's existing immunity from prior Hepatitis B vaccinations. By anchoring to HER2 on tumor cells, the construct displays HBsAg, which acts as a target for circulating anti-HBsAg antibodies. This recruitment of the adaptive and innate immune systems triggers potent antibody-dependent cell cytotoxicity (ADCC) and complement-dependent cytotoxicity (CDC), resulting in enhanced tumor cell eradication compared to naked anti-HER2 antibodies.
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