BI 765063 (OSE-172)

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

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

OSE Immunotherapeutics’ R&D team has taken interest in this critical aspect of research by focusing on SIRPα, on the CD47/SIRPα pathway, a receptor strongly expressed by myeloid and suppressive macrophage cells.

BI 765063 (formerly OSE-172) is an antibody antagonist of SIRPα, a binding partner for the “Don’t eat me“ signal CD47, which is expressed by tumors to escape detection from the immune system. Blocking SIRPα enables tumor associated macrophages and dendritic cells to resume their phagocytosis activity and control / destroy tumor.

In addition, BI 765063, as a SIRPα antagonist and first-in-class myeloid checkpoint inhibitor, inhibits the creation of pro-tumorigenic suppressor cells and restores their function. Pre-clinical studies have demonstrated BI 765063’s ability to inhibit pro-tumorigenic cells while activating anti-tumorigenic ones within the TME, generating high interest for this innovative breakthrough approach.

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


BI 765063 is being evaluated by Boehringer Ingelheim in different combinations in patients with metastatic or recurrent head and neck squamous cell carcinoma (HCC) or hepatocellular carcinoma (HCC) in an international study phase 1b initiated in May 2022 and conducted in the United States, Europe and Asia (NCT05249426). Promising results from the first Phase 1a study of early clinical efficacy data and biomarkers predictive of response and survival (on SIRPα, not CD47) were presented at the AACR Annual Meeting (American Association for Cancer Research) in April 2023


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