ezabenlimab + BI 765063

**Ezabenlimab + BI 765063** is a combination of two monoclonal antibodies investigated as a novel dual immune checkpoint blockade strategy for cancer immunotherapy. BI 765063 is a first-in-class monoclonal antibody antagonist targeting **signal-regulatory protein alpha (SIRPα)**, which blocks the interaction between SIRPα and its ligand CD47, thereby preventing the "don't eat me" signal and enhancing phagocytic activity of myeloid cells (such as macrophages and dendritic cells) against tumor cells[1]. Ezabenlimab (also known as BI 754091) is a monoclonal antibody targeting **programmed cell death protein 1 (PD-1)**, blocking the PD-1 pathway to reactivate T-cell mediated immune responses against tumors[1][2]. This combination is being developed mainly for the treatment of advanced solid tumors, particularly for microsatellite stable (MSS) colorectal and endometrial cancers, as well as head and neck squamous cell carcinoma (HNSCC), where checkpoint inhibitor monotherapies are less effective[1][2][10]. Clinical studies show promising safety and early efficacy signals, with manageable side effects and partial response rates in patients with MSS advanced endometrium or colorectal cancer, and in HNSCC[1][2][10]. The drugs are administered by intravenous infusion, typically once every three weeks[1][7]. The combination approach targets both the innate and adaptive immune systems, representing a novel immunotherapeutic strategy for refractory solid tumors[2][6]. Developed by OSE Immunotherapeutics and Boehringer Ingelheim, the combination is currently in Phase 1 clinical trials and ongoing clinical development[1][2][3][4][5][6][7][8][10].

Other names

BI 754091BI754091BI-754091