SAR443216

SAR443216 is a novel trispecific monoclonal antibody and T-cell engager designed to target HER2-expressing tumors. It binds simultaneously to three targets: human epidermal growth factor receptor 2 (HER2), CD3, and CD28. By engaging both CD3 and CD28 on T cells while binding HER2 on tumor cells, it activates T cells for cytolysis of HER2-positive cancer cells, including those with low or mutant HER2 expression. The drug has demonstrated the ability to stimulate regression of breast cancers in preclinical models through both direct cytotoxicity (primarily via CD8+ T cell-mediated lysis) and indirect antiproliferative effects mediated by CD4+ T cells that block tumor cell cycle progression at G1/S phase. Clinical studies are ongoing in patients with advanced solid tumors expressing HER2, including breast, ovarian, and gastric cancers[1][5][7][8].