Drug intelligence / Profile preview

pembrolizumab + BI 765063

Development stage
Unknown
Lead developer
Boehringer Ingelheim
Modality
Monoclonal Antibodies → Antibody-Based Therapeutics
Administration
Intravenous
01

Overview

This is a **combination therapy** consisting of **pembrolizumab**, a marketed anti-PD-1 monoclonal antibody, and **BI 765063**, an investigational first-in-class monoclonal antibody antagonist of **SIRPα**. Pembrolizumab blocks the programmed cell death protein 1 (**PD-1**) on T-cells to enhance anti-tumor immune responses. BI 765063 targets **SIRPα** on myeloid cells, preventing it from engaging CD47, thus blocking a "don't eat me" signal and promoting macrophage-mediated phagocytosis of tumor cells. This combination aims to enhance anti-tumor immunity via simultaneous checkpoint inhibition of T cells (PD-1) and myeloid cells (SIRPα). Clinical development has focused on the **neoadjuvant treatment of resectable colorectal cancer**, with ongoing investigation in a Phase I study to assess safety, feasibility, and preliminary efficacy as a pre-surgical intervention in early-stage disease[1][2].

Other names
pembrolizumab and BI 765063 combination
02

Targets

SIRPA (Signal-regulatory protein alpha)PDCD1 (Programmed cell death protein 1 receptor)

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