Boehringer Ingelheim and OSE Immunotherapeutics have dosed the first patient in a Phase I clinical trial of BI 765063 to treat patients with advanced solid tumours.
BI 765063, which was formerly known as OSE-172, is a first-in-class monoclonal antibody antagonist of SIRPα.
It is administered in combination with Boehringer’s monoclonal antibody PD-1 antagonist and a T-lymphocyte checkpoint inhibitor, BI 754091.
The first-in-human trial aims to characterise the safety, pharmacokinetics, pharmacodynamics, and preliminary efficacy of BI 765063 in patients with advanced solid tumours.
Boehringer Ingelheim senior vice-president and Cancer Immunology & Immune Modulation Research global head Jonathon Sedgwick said: “We are very pleased with the progress achieved on BI 765063’s programme 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.”
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OSE is conducting the study as part of a partnership and licence agreement that granted Boehringer exclusive rights to BI 765063.
Under the agreement, the clinical trial authorisation was obtained in March this year.
OSE secured authorisation from the French and Belgian regulatory authorities in March this year for the Phase I clinical trial evaluating BI 765063.
With the dosing of the first patient in this Phase I trial, OSE will receive a total of €15m in milestone payments from Boehringer.
OSE Immunotherapeutics CEO Alexis Peyroles said: “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.”