OSE Immunotherapeutics has secured authorisation from the French and Belgian regulatory authorities to conduct a Phase I clinical trial evaluating new myeloid checkpoint inhibitor BI 765063 (previously OSE-172) to treat solid tumours.
The French biotechnology firm is developing selective SIRPα antagonist monoclonal antibody BI 765063 in alliance with Boehringer Ingelheim, which obtained exclusive rights to the molecule.
Acting on SIRPα is intended to prevent the CD47 ligand from binding to and stimulating the cellular inhibitory effects. BI 765063 is expected to boost anti-tumour immunity by improving T cell activity.
In the dose finding Phase I trial, BI 765063 will be studied as a monotherapy and in combination with Boehringer’s lymphocyte T checkpoint inhibitor BI 754091 that is designed as a monoclonal antibody PD-1 antagonist.
The main objective of the trial is to determine safety, pharmacokinetics, pharmacodynamics and preliminary efficacy in patients suffering from advanced solid tumours.
OSE Immunotherapeutics CEO Alexis Peyroles said: “Clinical trial authorisation for this Phase I trial of BI 765063 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.
“These two significant green lights allow us to finalise the clinical entry in premier oncology Phase I European cancer centres.”
The company entered into an exclusive worldwide collaboration and licence agreement with Boehringer in April last year to co-develop BI 765063, and the new Phase I trial forms part of this agreement.
The deal means the trial authorisation and the upcoming first dosing will trigger total milestone payments of €15m from Boehringer to OSE Immunotherapeutics.