On June 23, 2026 Orion Corporation (Orion Pharma) reported that its investigational drug ODM-212 has received Orphan Designation from the European Commission, based on the recommendation from the European Medicines Agency’s (EMA) Committee for Orphan Medicinal Products (COMP), for the treatment of malignant mesothelioma, which is a rare and difficult to treat cancer. The US Food and Drug Administration (FDA) has previously granted Orphan Drug Designation to ODM-212 for the treatment of mesothelioma.
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ODM-212 is an oral small-molecule pan-TEAD (Transcriptional Enhanced Associate Domain) inhibitor being tested in a Phase 2 clinical study (TEADES) for the treatment of malignant pleural mesothelioma (MPM), epithelioid hemangioendothelioma (EHE) and other solid tumors with dysfunction in Hippo pathway. The trial includes patients who have progressed after receiving standard treatments and have no further treatment options. This is a global trial conducted at leading oncology centers in the US and Europe. For more information on the TEADES Phase 2 clinical study, please visit ClinicalTrials.gov and reference identifier NCT06725758.
"The Orphan Designation for ODM-212 is an important milestone for Orion Pharma. It highlights the need for new treatments in mesothelioma and reinforces our commitment to developing innovative therapies for patients with rare cancers," said Praveen Aanur, MD, MPH, MBA, Chief Medical Officer, Oncology Therapy Area, Orion Pharma.
About Orphan Designation in the EU
The EMA grants Orphan Designation to medicines intended for the treatment, prevention or diagnosis of life-threatening or chronically debilitating rare diseases, defined as having a prevalence of no more than 5 in 10,000 in the EU. Additionally, for a medicine to be granted Orphan Designation there should be no satisfactory method of diagnosis, prevention or treatment of the condition concerned, or, if such a method exists, the medicine must be of significant benefit to those affected by the condition.
With this designation for ODM-212, Orion Pharma, the sponsor, is now qualified for incentives including protocol assistance, fee reductions for certain regulatory activities, and eligibility for a 10-year period of market exclusivity following approval. Orphan Designation neither shortens the development time or regulatory review time of a drug nor gives the drug any advantage in the regulatory review or approval process.
About ODM-212
ODM-212 is an oral small-molecule pan-TEAD (Transcriptional Enhanced Associate Domain) inhibitor developed by Orion Pharma. It targets the Hippo signaling pathway, which regulates cell growth and organ size. Dysregulation of this pathway—particularly through YAP/TAZ activation—can lead to uncontrolled tumor growth and resistance to cancer therapies. ODM-212 works by blocking TEAD transcription factors, disrupting YAP-TEAD protein-protein interactions, and inhibiting TEAD auto-palmitoylation, which is essential for TEAD activity.
(Press release, Orion, JUN 23, 2026, View Source [SID1234668913])