Orion Pharma announces the initiation of TEADES Phase 2 trial of ODM-212 in Malignant Pleural Mesothelioma (MPM) and Epithelioid Hemangioendothelioma (EHE)

ORION CORPORATION
PRESS RELEASE
8 JANUARY 2026 at 12.00 EET

Orion Pharma announces the initiation of TEADES Phase 2 trial of ODM-212 in Malignant Pleural Mesothelioma (MPM) and Epithelioid Hemangioendothelioma (EHE)

Orion Corporation (Orion Pharma) announces initiation of a Phase 2 trial evaluating ODM-212, a potential best-in-class, oral pan-TEAD inhibitor, as a monotherapy in malignant pleural mesothelioma (MPM) and epithelioid hemangioendothelioma (EHE), which are rare and difficult to treat cancers. The Phase 2 study is designed to further evaluate the efficacy, safety, dose and tolerability of ODM-212 in a patient population with significant unmet need where current treatment options are limited and outcomes remain poor. The first patient in the study was treated in December 2025.

The TEADES trial is a Phase 2 multi-center, open-label study that will enroll approximately 300 patients with MPM, EHE or other solid tumors with dysfunction in Hippo pathway. The trial will include patients who have progressed after receiving standard treatments and have no further treatment options. The primary endpoints of the study are safety and tolerability with secondary endpoints including Overall Response Rate, Progression Free Survival and Overall Survival. This is a global trial conducted at leading oncology centers in the US and Europe.

“Treating the first patient in this Phase 2 study represents an important milestone for ODM-212 clinical development program and more importantly for patients,” said Praveen Aanur, MD, MPH, MBA, Chief Medical Officer, Oncology Therapy Area, Orion Pharma. “The encouraging Phase 1 results demonstrated clinical activity as monotherapy with manageable safety profile across different doses and schedules that were tested. We are also excited for the potential of combination treatments with ODM-212 given its mechanism to overcome resistance in standard therapies and emerging therapies in multiple tumor types. Building on the promising Phase 1 data, we are advancing ODM-212 with urgency and scientific rigor as monotherapy and combination therapy for patients across multiple cancers.”

Orion is planning to publish results from the phase 1 part of TEADES trial in an upcoming scientific conference in 2026. Preliminary results in EHE patients were presented at the CTOS annual meeting held in Miami, US in November 2025.

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.

About Malignant Pleural Mesothelioma
Malignant Pleural Mesothelioma (MPM) is a rare and aggressive cancer that originates in the pleura—the thin membrane lining the lungs and chest wall. It accounts for about 80–90% of all mesothelioma cases and is strongly linked to asbestos exposure. Current treatments mainly include chemotherapy and immunotherapy.

About Epithelioid Hemangioendothelioma
Epithelioid Hemangioendothelioma (EHE) is an ultra-rare vascular tumor or abnormality that arises from the cells lining the blood vessels. It is estimated that less than one per million people are living with this rare cancer. Currently there is no standard treatment for EHE.

Orion Corporation

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Orion 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 and active pharmaceutical ingredients. Orion has 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 Orion are used to treat cancer, neurological diseases and respiratory diseases, among others. In 2024 Orion's net sales amounted to EUR 1,542 million and the company employed about 3,700 professionals worldwide, dedicated to building well-being. Orion's A and B shares are listed on Nasdaq Helsinki.