Orion Pharma announces the initiation of TEADES Phase 2 trial of ODM-212 in Malignant Pleural Mesothelioma (MPM) and Epithelioid Hemangioendothelioma (EHE)
MWN-AI** Summary
On January 8, 2026, Orion Pharmaceuticals announced the launch of the TEADES Phase 2 clinical trial for ODM-212, an innovative oral pan-TEAD inhibitor, aimed at treating Malignant Pleural Mesothelioma (MPM) and Epithelioid Hemangioendothelioma (EHE). MPM is a rare and aggressive cancer primarily linked to asbestos exposure, while EHE is an ultra-rare vascular tumor with no established standard treatment. The Phase 2 trial will focus on evaluating the efficacy, safety, and tolerability of ODM-212 in a population that has limited treatment options and typically poor outcomes.
The study plans to enroll around 300 patients with MPM, EHE, and other solid tumors displaying Hippo pathway dysfunction, particularly those who have progressed after standard treatments. Key endpoints include safety, tolerability, Overall Response Rate, Progression-Free Survival, and Overall Survival. This multi-center, open-label trial is being conducted globally at prominent oncology centers in both the US and Europe.
Dr. Praveen Aanur, Chief Medical Officer of Orion Pharma, expressed optimism over the treatment’s potential, highlighting that encouraging Phase 1 results showed ODM-212's clinical activity as a monotherapy with a manageable safety profile. The company believes ODM-212 possesses the ability to overcome resistance to current and emerging therapies, exciting prospects for combination treatments.
Orion plans to present preliminary results from the Phase 1 TEADES trial at an upcoming scientific conference, further building on the encouraging data reported at the CTOS annual meeting in November 2025. With a longstanding commitment to oncology, Orion aims to advance this promising candidate with urgency and scientific rigor.
MWN-AI** Analysis
Orion Pharma's announcement about the initiation of the TEADES Phase 2 trial for its pan-TEAD inhibitor, ODM-212, marks a significant advancement in its oncology pipeline, focusing on two rare cancers: malignant pleural mesothelioma (MPM) and epithelioid hemangioendothelioma (EHE). Investing in Orion now involves a nuanced study of its trial progress and market potential.
First, investors should note the rarity of MPM and EHE, which leaves a substantial unmet medical need and potential high pricing for successful treatments due to lack of standard therapies. The Phase 1 results indicating manageable safety and clinical activity position ODM-212 favorably within a treatment landscape where patients often have limited options. The design of the Phase 2 trial, with a multi-center approach and 300 patient enrollment, emphasizes Orion’s commitment to robust clinical validation.
Moreover, the focus on secondary endpoints such as Overall Response Rate and Progression-Free Survival could place ODM-212 as a critical player in managing tumors resistant to standard therapy. Should outcomes remain positive, the drug could capture significant attention from oncologists and patients alike, boosting market demand.
As with all pharmaceutical investments, risk factors are inherent. The progression to Phase 2, while promising, hinges on the FDA approval process and competition with emerging therapies. As Orion plans to disseminate Phase 1 findings in 2026, attending upcoming conferences will be crucial for stakeholders to gauge ongoing development momentum and market positioning.
For those considering an investment in Orion Pharmaceutical, closely monitor clinical trial news, partnership opportunities, and responses from the medical community. A positive trajectory in trial results, especially in an urgent market context, could lead to substantial upticks in share value, thereby justifying positioning within a diversified health sector portfolio.
**MWN-AI Summary and Analysis is based on asking OpenAI to summarize and analyze this news release.
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
Contact person for media:
Terhi Ormio, VP, Communications, Orion Corporation
tel. +358 10 426 4646
Contact person for investors:
Tuukka Hirvonen, Head of Investor Relations, Orion Corporation
tel. +358 10 426 2721
Publisher:
Orion Corporation
Communications
Orionintie 1A, FI-02200 Espoo, Finland
http://www.orionpharma.com
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.
FAQ**
How does the initiation of the TEADES Phase 2 trial for ODM-2in MPM and EHE potentially impact the value of Orion Corp New B Shs ORINF, given the significance of addressing rare cancers with limited treatment options?
What are the anticipated milestones for Orion Corp New B Shs ORINF regarding the publication of Phase 1 results from the TEADES trial, and how might this influence investor sentiment?
Considering the competitive landscape for rare cancer therapies, how does Orion Pharma plan to position ODM-212 to enhance the market performance of Orion Corp New B Shs ORINF against alternative treatments?
In light of the promising Phase 1 results for ODM-212, what strategic partnerships or collaborations might Orion Pharma pursue to further bolster the growth potential of Orion Corp New B Shs ORINF in the oncology sector?
**MWN-AI FAQ is based on asking OpenAI questions about Orion Corp New B Shs (OTC: ORINF).
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