IMU-131 + pembrolizumab

IMU-131 + pembrolizumab is an investigational combination therapy for metastatic or advanced HER2/neu-overexpressing gastric or gastroesophageal junction adenocarcinoma. IMU-131 (HER-Vaxx) is a B-cell peptide-based vaccine targeting the HER2 receptor, constructed from three B-cell peptides including the binding epitope of trastuzumab and formulated as a hybrid peptide conjugated to CRM197 (a non-toxic diphtheria toxin variant), and mixed with Montanide ISA51 as an adjuvant. It induces polyclonal HER2-specific IgG and IgG1 antibodies, mediates antibody-dependent cellular cytotoxicity, inhibits HER2 signaling, and reduces immunosuppressive FOXP3+ regulatory T cells, resulting in antitumor responses. Pembrolizumab is a monoclonal antibody checkpoint inhibitor targeting PD-1, which blocks its interaction with PD-L1, thereby enhancing T-cell mediated immune responses against tumors. This combination is being evaluated for efficacy and safety in patients who progressed after trastuzumab-containing regimens, specifically those naïve to prior checkpoint inhibition. IMU-131 is given intramuscularly on a defined schedule, and pembrolizumab is administered intravenously every three weeks. Preclinical data support a synergistic mechanism targeting both HER2/neu and the PD-1/PD-L1 axis, and the clinical study is designed to assess immunogenic, antitumor, and safety outcomes[1][2][3].

Brand names

HER-Vaxx

Other names

IMU-131 + pembrolizumabHER-Vaxx + pembrolizumab