Orion Oyj

Orion Pharma announces first patient dosed in Phase 1/2 clinical trial of ODM-216, the company’s first biologic candidate to reach clinical testing

ORION CORPORATION
PRESS RELEASE
05 OCTOBER 2026 at 8:00am ET

Orion Pharma announces first patient dosed in Phase 1/2 clinical trial of ODM-216, the company’s first biologic candidate to reach clinical testing 
Milestone marks Orion Pharma’s entry into clinical-stage biologics (large molecules) and advances the company’s immuno-oncology portfolio

ESPOO, Finland, CAMBRIDGE, United Kingdom and CAMBRIDGE, M.A., October 5, 2026 – Orion Corporation (Orion Pharma) today announced 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.

“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.

Media contact:
Maddie Davidshofer, Lead, Scientific & Pipeline Communications
tel. +1 857 529 0169

Investor contact:
Tuukka Hirvonen, Head of Investor Relations
tel. +358 10 426 2721                                                 

Publisher:
Orion Corporation
Communications
Orionintie 1A, FI-02200 Espoo, Finland
http://www.orionpharma.com

Orion Pharma is a globally operating Nordic pharmaceutical company – a builder of well-being for over a hundred years. We develop, manufacture and market human and veterinary pharmaceuticals as well as active pharmaceutical ingredients, combining our trusted expertise with continuous innovation. We have an extensive portfolio of proprietary and generic medicines and consumer health products. The core therapy areas of our pharmaceutical R&D are oncology and pain. Proprietary products developed by us are used to treat cancer, respiratory diseases and neurological diseases, among others. In 2025 our net sales amounted to EUR 1,890 million, and we employ about 4,000 professionals worldwide, dedicated to building well-being.