OSE Immunotherapeutics Announces Authorization for Phase I Clinical Trial for its Checkpoint Inhibitor

March 8, 2019

OSE Immunotherapeutics has been granted authorization to commence a Phase I clinical trial for checkpoint inhibitor BI 765063 (previously OSE-172).

OSE Immunotherapeutics, a clinical stage biotechnology company, has been granted authorization from the French National Agency for Medicines and Health Products Safety (ANSM) and by the Belgian Federal Agency for Medicines and Health Products (FAMHP) to commence a Phase I clinical trial for checkpoint inhibitor BI 765063 (previously OSE-172).

It was revealed in a Mar. 5, 2019 press release that the clinical trial will be a dose finding study of BI 765063 (a selective SIRPα antagonist monoclonal antibody), 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. The study will be conducted by OSE Immunotherapeutics and forms part of a collaboration and license agreement with Boehringer Ingelheim. 

Under the terms of the agreement, Boehringer Ingelheim has exclusive rights to CI 765063 and as a result of the clinical trial authorization and upcoming first patient dosing, milestone payments of €15 million will be paid to OSE Immunotherapeutics from Boehringer Ingelheim.

“Clinical trial authorization for this Phase I trial of BI 765063 (OSE-172) as a monotherapy and in combination marks a major step of investigation into the potential of the anti-SIRPα checkpoint inhibitor with PD-1 blockade,” said Alexis Peyroles, CEO of OSE Immunotherapeutics. “We are very pleased by the rapid progression of our innovative program. These two significant green lights allow us to finalize the clinical entry in premier oncology Phase I European cancer centers.”

Source: OSE Immunotherapeutics