DEL_OSE Immunotherapeutics ((DEL_0RAD)), OSE Immunotherapeutics ((DE:6OP)) announced an update on their ongoing clinical study.
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The clinical study titled An Open-label Phase I Dose Finding Study of BI 765063, a Monoclonal Antibody (mAb) Antagonist of SIRPα, as Single Agent and in Combination With BI 754091, a Programmed Death-1 (PD-1) mAb, to Characterize Safety, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy in Patients With Advanced Solid Tumours aims to evaluate the safety and efficacy of BI 765063 alone and in combination with BI 754091 in patients with advanced solid tumors. This study is significant as it explores new treatment avenues for challenging cancer types.
The interventions being tested are BI 765063, a monoclonal antibody targeting the SIRPα receptor, and BI 754091, a monoclonal antibody targeting the PD-1 receptor. These drugs are designed to inhibit specific immune checkpoints, potentially enhancing the body’s immune response against tumors.
The study follows an interventional design with a randomized allocation and a sequential intervention model. It is open-label, meaning there is no masking, and its primary purpose is treatment-focused. The study consists of two phases: a dose escalation phase and an expansion phase.
The study began on April 16, 2019, and was last updated on June 23, 2025. The primary completion date is not specified, but the study is marked as completed, indicating that data collection for primary outcomes is finished.
This update could positively impact OSE Immunotherapeutics’ stock performance by demonstrating progress in their clinical pipeline, potentially enhancing investor confidence. The involvement of Boehringer Ingelheim as a collaborator adds credibility and may influence industry dynamics, as competitors watch the outcomes closely.
The study is ongoing, with further details available on the ClinicalTrials portal.