ORION CORPORATION
PRESS RELEASE
30 MAY 2026 at 21:30 EEST
Orion Pharma announces first results from Phase 1/2 TEADES trial with TEAD inhibitor ODM-212 in patients with advanced solid tumours
- Data presented at 2026 ASCO® Annual Meeting show ODM-212 was well tolerated, with proteinuria being the most common treatment related adverse event (TRAE)
- ODM-212 showed early efficacy in Hippo pathway dysregulated tumours, such as mesothelioma and EHE (epithelioid hemangioendothelioma)
- A clinical development program is underway investigating ODM-212 as a monotherapy and in combination with standard of care treatments in various solid tumours
Orion Pharma today announced first Phase 1 results from the ongoing Phase 1/2 multi-site, open-label, first-in-human TEADES trial evaluating the safety, tolerability and preliminary efficacy of ODM-212, a small molecule oral pan-TEAD inhibitor in patients with advanced solid tumours. According to the results, ODM-212 was well tolerated. Dose limiting toxicities (DLT) were not reported and the maximum tolerated dose (MTD) was not reached. The most frequent treatment-related adverse event (TRAE) was proteinuria (19.7%), which was reversible and resulted in treatment adjustment in 7.9% of patients. Other common TRAE's were increased lipase (15.8%) and nausea (10.5%).
Treatment responses by RECIST 1.1 were observed across multiple doses (overall response rate1, ORR 15.6%), predominantly in patients with mesothelioma (ORR 27.8%, disease control rate2, DCR 77.8%) and EHE (ORR 22.2%, DCR 100%). The new data were presented during the 2026 American Society of Clinical Oncology Annual Meeting, taking place in Chicago, IL, United States, from May 29-June 2, 2026.
"We are encouraged by the safety profile and early signs of clinical activity observed with ODM-212, particularly in mesothelioma and EHE, where treatment options remain limited", said Professor Outi Vaarala, Executive Vice President, Research & Development at Orion Pharma. "These results support continued clinical development of ODM-212 both as a monotherapy and in combination settings."
Phase 2 of the TEADES trial is ongoing. The trial will enroll up to 300 patients with malignant pleural mesothelioma (MPM), EHE or other solid tumours with dysfunction in Hippo pathway, and who have progressed despite available standard treatments and with limited further treatment options. Another ongoing Phase 1/2 trial TEADCO is evaluating ODM-212 in combination with standard of care treatments in advanced mesothelioma, KRAS G12C mutated non-small cell lung cancer (NSCLC) and pancreatic cancer.
About the TEADES study
The TEADES trial is a Phase 1/2 multi-center, open-label study that will enroll up to 300 patients with MPM, EHE or other solid tumours with dysfunction in Hippo pathway. The trial will include patients who have progressed despite available standard treatments and with limited 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.
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 tumour 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.
Contact person for media:
Christina Weber-Villumsen, Vice President, Corporate Communications, Brand & Public Affairs
Tel. +358 50 4635247
Contact person for investors:
Tuukka Hirvonen, Head of Investor Relations
Tel. +358 10 426 2721
Abbreviations
1 ORR: The Overall Response Rate (ORR) is defined as the share of patients who experience either a complete response (CR) or a partial response (PR) to a treatment. Complete response is defined by disappearance of all detectable evidence of a tumor. Partial response is defined by a reduction in tumor size.
2 DCR: Disease Control Rate (DCR) in oncology refers to the percentage of patients whose cancer shrinks or remains stable after treatment, representing the sum of complete responses (CR), partial responses (PR), and stable disease (SD).
Publisher:
Orion Corporation
Communications
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https://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.
