ODM-212 / Orion Corp - LARVOL DELTA

Translational in vitro and in vivo evaluation of ODM-212 in solid human cancers (ESMO 2026) - No abstract available

Preclinical • Oncology • Solid Tumor

Novel pan-TEAD inhibitor ODM-212 Demonstrates Broad Combination Potential with KRAS and Pan-RAS Inhibitors in Preclinical Models of Multiple Tumor Types (EORTC-NCI-AACR 2026) - "Abstract will be available as of 4 November (with consent of the author)"

Preclinical • Oncology • KRAS

Dose optimisation in first-in-human Phase I/II trial with pan-TEAD inhibitor ODM-212 (TEADES) in solid tumours (ESMO 2026) - No abstract available

First-in-human • P1/2 data • Oncology • Solid Tumor

Orion Corporation announced 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 (GlobeNewswire) - "The US Food and Drug Administration (FDA) has previously granted Orphan Drug Designation to ODM-212 for the treatment of mesothelioma....ODM-212 is an oral small-molecule pan-TEAD 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."

European regulatory • Orphan drug • Malignant Pleural Mesothelioma • Mesothelioma

3134003: Trial to study the safety and pharmacokinetics of ODM-212 combined with existing cancer treatments (clinicaltrialsregister.eu) - P1/2 | N=13 | Not yet recruiting | Sponsor: Orion Corporation

New P1/2 trial • Oncology • Solid Tumor

First-in-human trial of the TEAD inhibitor ODM-212 in patients with advanced solid tumors (TEADES). (ASCO 2026) - P1/2 | "ODM-212 administration to extensively treated patients with advanced cancer was well tolerated and resulted in some promising tumour responses (particularly in mesothelioma and EHE). The phase 2 portion of TEADES is currently enrolling patients. ClinicalTrials.gov identifier: NCT06725758"

Clinical • First-in-human • Metastases • P1 data • Mesothelioma • Oncology • Renal Disease • Solid Tumor • TEAD1 • WWTR1 • YAP1

Orion Pharma announces first results from Phase 1/2 TEADES trial with TEAD inhibitor ODM-212 in patients with advanced solid tumours (GlobeNewswire) - "Data presented at 2026 ASCO Annual Meeting....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.....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%)....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..."

P1 data • Trial status • Epithelioid Hemangioendothelioma • Malignant Pleural Mesothelioma

Orion Pharma to present its first clinical data from Phase 1/2 TEADES trial of TEAD inhibitor ODM-212 at the 2026 ASCO Annual Meeting (GlobeNewswire) - "The TEADES study is a multi-center, open-label, first-in-human trial designed to evaluate the safety, tolerability and preliminary anti-tumour activity of ODM-212 in patients with advanced solid tumours, including tumour types characterized by dysregulation of the Hippo pathway, such as mesothelioma and epithelioid hemangioendothelioma (EHE)....Data from the phase 1 study will be presented during the conference."

P1 data • Epithelioid Hemangioendothelioma • Mesothelioma

TEADCO: A 2-part Phase 1/2 Open-label Trial on ODM-212 (clinicaltrials.gov) - P1/2 | N=229 | Recruiting | Sponsor: Orion Corporation, Orion Pharma

New P1/2 trial • Lung Cancer • Mesothelioma • Non Small Cell Lung Cancer • Oncology • Pancreatic Adenocarcinoma • Pancreatic Cancer • Solid Tumor • KRAS • PD-L1

Ex vivo trial of ODM-212, a novel pan-TEAD inhibitor, in patients with primary and metastatic solid tumors (AACR 2026) - P1/2 | "ODM-212 shows potent pan-cancer ex vivo efficacy in both primary untreated and heavily pre-treated metastatic tumors. Single agent efficacy correlates with Hippo pathway alterations while encouraging anti-tumor activity is seen also in select patient samples with no known Hippo alterations. This confirms ODM-212 as a potent novel therapeutic to target TEAD transcription factors in solid tumors supporting further clinical development."

First-in-human • Metastases • Preclinical • Bladder Cancer • Brain Cancer • Genito-urinary Cancer • Head and Neck Cancer • Lung Cancer • Melanoma • Oncology • Sarcoma • Solid Tumor • Squamous Cell Carcinoma of Head and Neck • KRAS • TEAD1

Orion Corporation…announced the initiation of a Phase 1b/2 basket trial evaluating ODM-212, a potential best-in-class, oral pan-TEAD inhibitor, in combination with standard of care treatments in advanced mesothelioma, KRAS G12C mutated non-small cell lung cancer (NSCLC) and pancreatic cancer (GlobeNewswire) - "The TEADCO trial is a multi-centre, open-label basket trial designed to evaluate the efficacy, safety, dose and tolerability of ODM-212 in combination with standard of care in these indications."

New P1/2 trial • Malignant Pleural Mesothelioma • Non Small Cell Lung Cancer • Pancreatic Cancer

Orion Pharma’s ODM-212 Granted Orphan Drug Designation in Mesothelioma by the US FDA (GlobeNewswire) - "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."

Orphan drug • Malignant Pleural Mesothelioma • Mesothelioma

Orion Pharma announces the initiation of TEADES Phase 2 trial of ODM-212 in Malignant Pleural Mesothelioma (MPM) and Epithelioid Hemangioendothelioma (EHE) (Orion Press Release) - "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....Orion is planning to publish results from the phase 1 part of TEADES trial in an upcoming scientific conference in 2026."

First-in-human • P1 data • Trial status • Epithelioid Hemangioendothelioma • Malignant Pleural Mesothelioma

Preclinical evaluation of the novel TEAD inhibitor ODM-212 (ESMO Asia 2025) - P1/2 | "Preclinical data support ODM-212 as a potent and selective pan-TEAD inhibitor with promising pharmacological and safety characteristics. First-in-Human study (NCT06725758) is currently underway to assess its safety, tolerability, pharmacokinetics, and preliminary antitumor activity in patients with advanced solid tumors."

Preclinical • Mesothelioma • Oncology • Solid Tumor • TEAD1 • TEAD2

TEADES PH1/2 STUDY WITH ODM-212: PRELIMINARY RESULTS IN EHE PATIENTS (CTOS 2025) - "TEAD inhibition with ODM-212 has induced durable tumour regression in EHE, demonstrating proof-of-concept for this targeted approach in a TAZ-fusion driven sarcoma. ODM-212 showed encouraging anti-tumour activity and manageable safety, highlighting the potential of targeting the Hippo–YAP/TAZ–TEAD pathway in EHE."

Clinical • Oncology • Sarcoma • Solid Tumor • CAMTA1 • WWTR1

Two-part, first-in-human study on Novel Pan-TEAD inhibitor ODM-212 in subjects with selected advanced solid tumours (TEADES) (ESMO 2025) - P1/2 | "Legal entity responsible for the study Orion Corporation. Funding Orion Corporation."

Clinical • First-in-human • Metastases • P1 data • Mesothelioma • Oncology • Solid Tumor • TEAD1 • WWTR1 • YAP1

Preclinical characterisation of a novel TEAD inhibitor ODM-212 (ESMO 2025) - P1/2 | "Results ODM-212 binds potently and specifically to all TEAD/TEF transcription factors, inhibiting YAP/TAZ-TEAD complex transcriptional activity. Legal entity responsible for the study Orion Corporation. Funding Orion Corporation."

Preclinical • Mesothelioma • Oncology • Solid Tumor • TEAD1 • TEAD2 • YAP1

TEADES: Two-part, First-in-Human Study on ODM-212 in Subjects with Selected Advanced Solid Tumours (clinicaltrials.gov) - P1/2 | N=315 | Recruiting | Sponsor: Orion Corporation, Orion Pharma

Metastases • New P1/2 trial • Oncology • Solid Tumor