On July 18, 2023 Domain Therapeutics ("Domain" or "the Company"), a clinical-stage biopharmaceutical company developing innovative drug candidates in immuno-oncology targeting G Protein-Coupled Receptors (GPCRs), reported the decision by the European Patent Office to grant a composition of matter European patent providing strong intellectual property protection until October 2040, for its proprietary EP4 receptor antagonist series including the candidate DT-9081 (Press release, Domain Therapeutics, JUL 18, 2023, View Source [SID1234633284]). DT-9081 is currently evaluated in monotherapy in a first-in-human Phase I ascending dose study.
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Dr. Stephan Schann, VP Research at Domain Therapeutics, commented: "After the successful launch of the clinical Phase I study, in late 2022, with our best-in-class EP4 receptor antagonist candidate, DT-9081, the decision to grant this European patent for the EP4 receptor antagonist program across key European territories represents an important step for our proprietary program. Reversing immunosuppression remains an unmet need in many patient populations where new therapeutic options are required. As we work to use our science to unlock new possibilities in cancer, we look forward to continuing our precision research based on a thoughtful biomarker strategy to quantify EP4 receptor target engagement and optimize the selection of subpopulation of patients aiming at having optimal clinical outcomes."
DT-9081 is an orally administered small molecule drug candidate which blocks the EP4 receptor on immune cells and is able to reverse the prostaglandin E2-mediated immunosuppression (PGE2) triggered by certain tumors to bypass the immune system. The findings from preclinical studies with DT-9081, demonstrated significant anti-tumor effects in synergy with immune checkpoint inhibitors, such as anti-PD1 drugs, in multiple models.
The Phase I study, named EPRAD, is a multi-center, open-label study evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy of DT-9081 in adult patients with advanced, recurrent or metastatic solid tumors. Domain has developed a precise biomarker strategy guiding the clinical positioning and monitoring the antagonist activity of the candidate during the patient’s treatment. This precision research enables a differentiated positioning of DT-9081.