New Solid Tumor Treatment Enters Clinical Trial
The first patient has been dosed in a trial for an experimental biologic aimed at advanced solid tumors.
Updated on Oct. 6, 2026 in Cancer
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Orion Pharma has launched a Phase 1/2 clinical trial, known as BICIDES, for their investigational biologic candidate ODM-216. The trial is now evaluating the safety and anti-tumor potential of the therapy in patients living with advanced solid tumors.
Why it matters
This trial marks a shift for Orion Pharma as it expands its research focus from small molecules into the field of biologic therapies. Investigational treatments like ODM-216 aim to provide new options for patients with advanced cancers by targeting specific immune pathways.
The BICIDES trial is a Phase 1/2 study evaluating the safety, pharmacokinetics, and anti-tumor activity of ODM-216 in patients with advanced solid tumors. As a preliminary clinical effort, the study aims to establish initial data on this novel bispecific antibody.
The players
Orion Pharma
A Finland-based pharmaceutical company with 4,000 employees and 1,890 million EUR in 2025 net sales.
The details
ODM-216 is a bispecific antibody designed to target two distinct immune-regulatory pathways: PVRIG and PD-L1. By simultaneously addressing these targets, the drug is intended to activate and enhance the body's anti-tumor immune response. This candidate was developed through research efforts spanning Finland, the UK, and the US.
Timeline
2025: Orion Pharma established a Biologics Research and Development Centre in Cambridge, UK.
October 5, 2026: The first patient was dosed in the BICIDES clinical trial.
Health Landscape
The development of ODM-216 represents a modern approach to cancer immunotherapy by targeting the PVRIG and PD-L1 immune-regulatory pathways. This trial builds on the broader medical shift toward bispecific antibodies to improve immune responses against advanced solid tumors.
This early-stage trial is currently limited to a specific research population and is not a generally available treatment. Patients interested in how such research might eventually impact care options for advanced solid tumors should discuss ongoing trial enrollment criteria with their physician.
The takeaway
Orion Pharma has initiated human testing for its first biologic cancer therapy, which targets two key immune-regulatory pathways. Patients and families can monitor the clinical trial identifier NCT07805252 for future data updates or enrollment criteria through their oncology care team.
Further reading
For more information on the latest developments in oncology research, visit the Cancer section.
More information
To search for details on this and other studies, visit the clinical trial search and lookup portal.
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