BI 765049

BI 765049 is a novel immunoglobulin G (IgG)-like bispecific T-cell engager designed to simultaneously bind B7-H6, a member of the B7 family of immune receptors expressed on tumor cells, and CD3 on T cells. This dual binding brings T cells into close proximity with B7-H6-expressing tumor cells, resulting in the formation of a cytolytic synapse that triggers T cell-mediated lysis of the target cancer cell. The mechanism leads to local activation and proliferation of T cells and cytokine secretion, converting non-inflamed ("cold") tumors into inflamed ("hot") tumors. Preclinical studies have shown dose-dependent antitumor activity in humanized colorectal cancer models and increased infiltration by activated T cells. Upregulation of PD-1/PD-L1 pathways has been observed as an adaptive resistance mechanism, providing rationale for combination therapy with PD-1 inhibitors such as ezabenlimab. BI 765049 is being developed primarily for advanced or unresectable solid tumors expressing B7-H6—including gastric cancer, colorectal cancer (CRC), pancreatic ductal adenocarcinoma, hepatocellular carcinoma, head and neck squamous cell carcinoma (HNSCC), and non-small cell lung cancer (NSCLC)—in patients who have progressed on or are ineligible for standard therapies.

Other names

anti-B7-H6/anti-CD3 bispecific antibody BI 765049