HLX601

HLX601 is a bispecific T-cell engager (TCE) designed to target Delta-like ligand 3 (DLL3) and the CD3 receptor on T cells. Developed by Shanghai Henlius Biotech, it is primarily investigated for the treatment of small cell lung cancer (SCLC), an aggressive neuroendocrine malignancy where DLL3 is highly and selectively expressed on tumor cells but minimally on normal tissues. The drug functions by bridging DLL3-positive tumor cells with cytotoxic T cells, facilitating the formation of an immunological synapse that leads to T-cell activation and subsequent tumor cell lysis. Preclinical studies, including research presented at the AACR Annual Meeting 2026, demonstrate that HLX601 significantly enhances antitumor immune responses, particularly when combined with PD-1 inhibitors like pembrolizumab. This combination therapy has been shown to increase immune cell infiltration and reverse the immunosuppressive tumor microenvironment, providing a strong rationale for clinical evaluation in SCLC patients.

Other names

DLL3-targeted T cell engagerDLL-3-targeted T cell engagerDLL 3-targeted T cell engagerDLL3 TCEDLL-3 TCEDLL 3 TCEanti-DLL3/CD3 bispecific antibody