Finland-based Orion (Nasdaq Helsinki: ORNAV, ORNBV) has dosed the first patient in a Phase I/II trial of ODM-216, a PVRIG/PD-L1 bispecific antibody for advanced solid tumours. It is the company’s first biologic and first immuno-oncology candidate to enter clinical testing.
The open-label BICIDES study will assess safety, tolerability, pharmacokinetics, pharmacodynamics and preliminary antitumour activity.
PVRIG is an inhibitory immune checkpoint that suppresses T-cell activity through binding to CD112. ODM-216 combines targeting of this pathway with PD-L1 blockade, aiming to release two brakes on antitumour immunity. Published preclinical research has shown enhanced tumour-growth inhibition when PVRIG and PD-L1 are blocked together, providing a rationale for testing the combination in patients.
Compugen (Nasdaq: CGEN) is also pursuing PVRIG with its antibody COM701. Its ongoing MAIA-ovarian trial evaluates COM701 as maintenance therapy in relapsed platinum-sensitive ovarian cancer, with an interim analysis expected in the first quarter of 2027.