M802

M802 is a bispecific antibody designed to target both HER2 (human epidermal growth factor receptor 2) and CD3. It consists of a monovalent unit against HER2 and a single-chain unit against CD3, enabling it to bind simultaneously to HER2-positive tumor cells and CD3-positive T cells. This dual targeting recruits T cells to the tumor microenvironment, promoting immune-mediated cytotoxicity against HER2-expressing cancer cells. Preclinical studies have shown that M802 is more cytotoxic than trastuzumab (Herceptin) in both high- and low-HER2-expressing cell lines, as well as in trastuzumab-resistant models. The drug retains antitumor signaling pathway activity similar to Herceptin but demonstrates enhanced efficacy due to its ability to recruit effector immune cells via its anti-CD3 component. Developed for the treatment of advanced solid tumors with HER2 overexpression, clinical development has focused on evaluating safety, tolerability, pharmacokinetics/pharmacodynamics, immunogenicity, and preliminary efficacy in this patient population[1][2].