Orion Pharma Initiated Phase 1/2 Cancer Trial
The company dosed the first patient in a clinical study for a new bispecific antibody treating solid tumors.
Updated on Oct. 5, 2026 in Cancer
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Orion Pharma has officially launched the BICIDES Phase 1/2 clinical trial by dosing its first patient with ODM-216. This investigative treatment is a bispecific antibody designed to target PVRIG and PD-L1 immune-regulatory pathways in patients with advanced solid tumors.
Why it matters
This study marks the first time Orion Pharma has moved a biologic candidate into clinical testing. It represents a strategic shift for the company, which is expanding its research and development capabilities beyond traditional small-molecule drugs.
The clinical trial, identified as NCT07805252, assesses the safety, pharmacokinetics, and anti-tumor activity of ODM-216 in subjects with advanced solid tumors. This program follows the company's 2025 establishment of a specialized Biologics Research and Development Centre.
The players
Orion Pharma
Orion Pharma is a pharmaceutical company headquartered in Espoo, Finland, that maintains a workforce of approximately 4,000 employees.
The details
ODM-216 is a bispecific antibody engineered to activate anti-tumor immune responses by simultaneously targeting the PVRIG and PD-L1 pathways. The treatment was developed through internal research operations based across Finland, the United Kingdom, and the United States.
Timeline
Orion Pharma established a Biologics Research and Development Centre in 2025.
The first patient was dosed in the clinical trial on October 5, 2026.
The Big Picture
The launch of the BICIDES trial marks the first functional output from the Biologics Research and Development Centre in Cambridge. This transition signals a pivot for the firm as it integrates biologics into its pipeline, departing from a legacy focused primarily on small-molecule chemistry.
The current trial is limited to patients with advanced solid tumors and is not yet available as a public treatment option. Participants in the study will be monitored for safety and pharmacokinetics to determine the potential viability of this new therapeutic approach.
The takeaway
The move into biologics allows pharmaceutical companies to address tumors through multi-pathway immune activation rather than traditional singular targets. Patients and providers should look for future clinical trial data to determine if this platform produces superior therapeutic outcomes.
Further reading
For more context on medical advancements in this field, visit the Cancer section.
More information
For detailed information regarding ongoing studies, please visit the clinical trial search and lookup.
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