BI 765063 (OSE-172)

BI 765063 (OSE-172)

In recent years, immunotherapies have driven significant clinical progress and increased hopes for patients suffering from various types of cancer.

Of note, the tumor microenvironment (TME), in particular the presence and immune-status of tumor-associated macrophages (TAM) as well as myeloid and dendritic cells, has been closely linked to tumor activity and responsiveness to T-cell-targeted immunotherapies.

OSE’s R&D team has taken interest in this critical aspect of the TME, focusing on the SIRPα / CD47 pathway which controls the activation of macrophages and dendritic cells.

BI 765063 (OSE-172), a SIRPα an antagonist and first-in-class myeloid checkpoint inhibitor in this area, selectively inhibits SIRPα thus restoring TAM and dendritic cells’ activity in response to tumors:

Pre-clinical studies have demonstrated BI 765063 (OSE-172)’s ability within the TME to inhibit pro-tumorigenic cells while activating anti-tumorigenic ones, generating high interest for this innovative breakthrough approach.

OSE Immunotherapeutics is actively working on several new approaches focused on modulating the tumor microenvironment.


A first-in-man Phase clinical trial 1 is ongoing to evaluate BI 765063 in patients with advanced solid tumors.

The clinical Phase 1 is a dose finding study of monoclonal antibody SIRPα antagonist BI 765063, a myeloid checkpoint inhibitor administered as a single agent and in combination with Boehringer Ingelheim’s monoclonal antibody PD-1 antagonist BI 754091, a lymphocyte T checkpoint inhibitor.

This trial aims to characterize safety, pharmacokinetics, pharmacodynamics and preliminary efficacy in patients with advanced solid tumors.

The study is conducted by OSE Immunotherapeutics as part of a collaboration and license agreement with Boehringer Ingelheim under which Boehringer Ingelheim obtained exclusive rights to BI 765063.