Orion Pharma Announces First Results: ODM-212
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Orion Pharma announced first results from the Phase 1/2 TEADES trial of TEAD inhibitor ODM-212 in advanced solid tumours. The drug was well tolerated with no dose-limiting toxicities and a 15.6% overall response rate.
Orion Pharma announces first results from the Phase 1/2 TEADES trial of oral pan-TEAD inhibitor ODM-212 in advanced solid tumours. At ASCO 2026, the company reported no DLTs, ORR 15.6% overall, and stronger early activity in mesothelioma and epithelioid hemangioendothelioma.
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Key Takeaways
- No DLTs reported; MTD not reached in the disclosed Phase 1 TEADES readout.
- ORR 15.6% overall; mesothelioma ORR 27.8% (DCR 77.8%); EHE ORR 22.2% (DCR 100%).
- Top TRAEs: proteinuria 19.7%, increased lipase 15.8%, nausea 10.5%.
- Registry IDs: TEADES NCT06725758; combination program TEADCO NCT07563738.
What did Orion Pharma announce as first results?
On May 30, 2026, Orion Pharma said first Phase 1 results from the ongoing TEADES trial of ODM-212 were presented at the 2026 ASCO Annual Meeting in Chicago (May 29–June 2, 2026).
ODM-212 is described as a small-molecule oral pan-TEAD inhibitor targeting the Hippo pathway in patients with advanced solid tumours. The trial is multi-site, open-label, and first-in-human.
Primary: Orion TEADES first results — GlobeNewswire.
Which efficacy and safety numbers are in the release?
Orion reported ODM-212 was well tolerated. Dose-limiting toxicities were not reported, and the maximum tolerated dose was not reached.
The most frequent treatment-related adverse event was proteinuria (19.7%), described as reversible and leading to treatment adjustment in 7.9% of patients. Other common TRAEs were increased lipase (15.8%) and nausea (10.5%).
Responses by RECIST 1.1 were seen across multiple doses (ORR 15.6%), mainly in mesothelioma (ORR 27.8%, DCR 77.8%) and EHE (ORR 22.2%, DCR 100%).
Where is TEADES registered, and what is the design?
ClinicalTrials.gov lists TEADES as NCT06725758: a Phase 1/2 first-in-human study of ODM-212 in subjects with selected advanced solid tumours. Status is recruiting, with estimated enrollment around 315 participants and Orion Pharma as sponsor.
The registry describes a two-part dose-escalation and dose-expansion design focused on tumours with Hippo pathway alterations and related biology.
Registry: NCT06725758 — TEADES on ClinicalTrials.gov.
What combination work is already underway?
Orion also points to a broader program exploring monotherapy and combinations with standard-of-care agents. TEADCO (NCT07563738) is a Phase 1/2 open-label combination trial of ODM-212 with anti-cancer therapy in advanced solid tumours.
TEADCO’s ClinicalTrials.gov record shows recruiting status, estimated enrollment of 229, start date March 27, 2026, and primary completion estimated September 2029.
Registry: NCT07563738 — TEADCO on ClinicalTrials.gov.
Why BD teams care about Hippo/TEAD readouts in 2026
TEAD inhibitors are being tested where Hippo pathway dysregulation is a biologic hook—mesothelioma and EHE are the clearest early signals in Orion’s release. For BD and competitive intelligence, the question is whether monotherapy ORR can deepen in expansion cohorts and whether combinations (TEADCO) improve durability.
ASCO first-in-human data should be read as hypothesis-generating. Cross-trial comparisons to other TEAD programs require matched lines of therapy, biomarker definitions, and follow-up—not headline ORR alone.
What remains unproven after ASCO 2026
The release does not establish confirmatory efficacy, a recommended Phase 2 dose narrative in peer-reviewed full text, or overall survival benefit. Proteinuria management and long-term renal monitoring details will matter for real-world combinability.
Do not treat “best-in-class” marketing language as a clinical conclusion. Stick to the disclosed ORR/DCR and TRAE percentages until peer-reviewed manuscripts or later cutoffs update NCT06725758.
For APAC BD teams, also track site activation and biomarker screening criteria on ClinicalTrials.gov as TEADES expansion cohorts open. Hippo-pathway assay definitions can differ across sponsors, so align companion-diagnostic plans before assuming a mesothelioma ORR will translate into a regional filing strategy in 2026–2027.
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Frequently Asked Questions
What is the NCT number for the TEADES trial?
TEADES is registered as NCT06725758 on ClinicalTrials.gov. It is a Phase 1/2 first-in-human study of ODM-212 in selected advanced solid tumours, sponsored by Orion Pharma.
What efficacy did Orion report for ODM-212 at ASCO 2026?
Orion reported an overall response rate of 15.6% by RECIST 1.1 across multiple doses, with higher signals in mesothelioma (ORR 27.8%, DCR 77.8%) and epithelioid hemangioendothelioma (ORR 22.2%, DCR 100%).
What safety findings were highlighted?
No dose-limiting toxicities were reported and the maximum tolerated dose was not reached. The most frequent treatment-related adverse event was proteinuria (19.7%), with increased lipase (15.8%) and nausea (10.5%) also common.
Primary Sources
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