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HER2-CD3-Fc mRNA-LNPs is an experimental therapeutic consisting of lipid nanoparticles (LNPs) encapsulating messenger RNA (mRNA) that encodes a novel bispecific antibody (bsAb). This bsAb is designed with binding domains for the tumor-associated antigen HER2 (Human Epidermal Growth Factor Receptor 2) and the T-cell marker CD3, along with an Fc region for stability and extended half-life. Upon administration, the LNPs transfect host cells, which then express and secrete the bispecific antibody. The secreted bsAb facilitates the recruitment and activation of T cells against HER2-overexpressing tumor cells, inducing potent T-cell-directed cytotoxicity and the secretion of inflammatory cytokines such as IFN-γ and TNF-α. Preclinical studies have demonstrated significant antitumor activity and complete tumor growth blockage in various HER2-positive cancer models, including ovarian, breast, and lung cancers.
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