Boehringer Ingelheim and OSE Immunotherapeutics SA announce that the first patient has been dosed in the first-in-human Phase 1 clinical trial evaluating BI 765063, formerly OSE-172, a first-in-class monoclonal antibody antagonist of SIRPα, being studied in patients with advanced solid tumors. The Phase 1 study is a dose finding study of 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 T-lymphocyte checkpoint inhibitor.
“We are very pleased with the progress achieved on BI 765063’s program and having the first patient dosed marks a significant milestone in the product’s development. The advancement of a myeloid cell checkpoint blocking monoclonal antibody into the clinic exemplifies Boehringer Ingelheim’s commitment to the next wave of innovation in cancer immunology therapies, with the goal of meaningfully improving outcomes for patients with difficult-to-treat cancers,” said Jonathon Sedgwick, Ph.D., Senior Vice President and Global Head, Cancer Immunology & Immune Modulation Research at Boehringer Ingelheim.
“We are excited to begin first-in-human testing with this novel SIRPα-targeting compound, which we believe has first-in-class potential in the treatment of solid tumors,” said Alexis Peyroles, Chief Executive Officer of OSE Immunotherapeutics. “This marks one of many anticipated milestones in the collaboration agreement with our partner Boehringer Ingelheim, and we look forward to advancing rapidly this potentially transformative treatment through the clinic. Milestones such as this one for the novel compounds our R&D teams develop have provided OSE with a stable financial base to grow steadily our first-in-class immuno-oncology pipeline.”
The study is conducted by OSE Immunotherapeutics as part of a collaboration and license agreement under which Boehringer Ingelheim obtained exclusive rights to BI 765063. Under the terms of the collaboration and license agreement, the clinical trial authorization obtained in March 2019 and dosing of the first patient in this Phase 1 trial triggers milestone payments of a total of €15 million to OSE Immunotherapeutics from Boehringer Ingelheim. This trial aims to characterize safety, pharmacokinetics, pharmacodynamics and preliminary efficacy of the immunotherapy in patients with advanced solid tumours.