Curasight application
| Published June 19, 2025

Curasight applies for clinical trial for uTREAT in brain cancer

Danish biotech company Curasight has submitted an application to the EMA for clinical trial authorisation to the EMA for a phase I study of uTREAT in patients with glioblastoma. The first patient is expected to receive treatment in the second half of 2025.

Glioblastoma is the most common cause of brain cancer death in adults, with a significant unmet medical need due to the lack of innovative and effective treatments. Approximately 30 000 patients are diagnosed annually in the USA and EU alone, with this aggressive cancer presenting a poor prognosis – about half of patients pass away within 14 months, and only 5 per cent survive for five years.

Targeted radiation therapy with precision

Curasight’s uPAR theranostic platform combines two key technologies – uTRACE and uTREAT – both targeting the uPAR receptor. uTRACE is designed to deliver sensitive imaging for diagnosis, while uTREAT provides a targeted treatment solution. Together, they form an integrated approach to improving the diagnosis and treatment of cancers that express uPAR, such as glioblastoma, where uTREAT delivers targeted radiation directly to cancer cells while sparing healthy brain tissue.

- This is important as the cancer has a poor prognosis, with essentially no improvement in outcome over the last decades. Accordingly, there is a significant unmet medical need, and we hope that uTREAT will prove to be a game-changer for patients with this aggressive cancer, says CEO Ulrich Krasilnikoff.

Phase I application submitted

The planned phase I study aims to investigate uTREAT as a novel targeted radiation therapy for glioblastoma patients. The study is designed to provide data on uTREAT’s safety and tolerability in glioblastoma patients, with results critical for the candidate’s further development.

– Today’s news marks important progress in our efforts to develop uTREAT for treatment of patients with aggressive brain cancer. The recently published investigator-initiated Phase II uPAR-PET data highlights the potential of uTRACE and uTREAT in diagnosing and treating brain cancer, in particularly glioblastoma. The study revealed that 94 per cent of Grade 4 gliomas – including glioblastomas – were uPAR-positive, strongly supporting the potential of uTREAT as a therapy for this cancer type, says Krasilnikoff in connection with the submitted application.

Potential to replace traditional radiotherapy

External beam radiation is a cornerstone of brain cancer treatment today. uTREAT could potentially replace or reduce the need for this, avoiding side effects on healthy brain tissue through more specific tumour targeting. If successful, it could significantly improve patients’ quality of life.

With the CTA application, Curasight has taken the next step toward initiating human clinical trials. The company plans to recruit patients for the phase I study in 2025, aiming to dose the first patient in the second half of the year.