On October 5, 2026 Orion Corporation (Orion Pharma) reported that the first patient has been dosed in the BICIDES Phase 1/2 clinical trial evaluating the safety, pharmacokinetics and preliminary anti-tumor activity of ODM-216, an investigational bispecific antibody simultaneously targeting PVRIG and PD-L1 in patients with advanced solid tumors. ODM-216 is Orion Pharma’s first biologic candidate and first immuno-oncology treatment to enter clinical testing in humans. ODM-216 is a key component of Orion Pharma’s immuno-oncology portfolio, including several assets in the pre-clinical pipeline.
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"Treating the first patient in the ODM-216 BICIDES study is a significant achievement for Orion Pharma and an important moment in the evolution of our long-term global R&D strategy to expand our capabilities beyond small molecules and into biologics," said Professor Outi Vaarala, M.D., Ph.D., Executive Vice President, Research & Development at Orion Pharma. "As both our first biologic and first immuno-oncology candidate to reach clinical stage, ODM-216 reflects our team’s commitment to discovering and advancing innovative new treatment approaches that further strengthen our foundation for a diversified future oncology pipeline. We look forward to evaluating ODM-216 in the clinic as we continue our mission for people living with difficult-to-treat cancers."
ODM-216’s advancement is fueled by Orion Pharma’s internal research & development efforts across its global R&D organization located in Finland, the UK and the US, including the company’s Biologics Research & Development Centre in Cambridge, UK, which was established in 2025 to strengthen Orion Pharma’s biologics capabilities.
The Phase 1/2 trial is known as BICIDES and more information can be found on ClinicalTrials.gov using identifier: NCT07805252.
About ODM-216
ODM-216 is an investigational anticancer medicine being developed by Orion Pharma. Designed to activate anti-tumor immune responses, ODM-216 is a bispecific antibody simultaneously targeting PVRIG and PD-L1, two immune-regulatory pathways involved in cancer growth and progression.
(Press release, Orion, OCT 5, 2026, View Source [SID1234673186])