In June, he left Curasight submitted its clinical trial application to the European Medicines Agency (EMA) for a Phase I study of uTREAT in patients with glioblastoma. With approval secured, the company is now preparing for the next step towards initiating clinical testing. The first patient is expected to be dosed in the fourth quarter of 2025.
A major step forward in Curasight's therapeutic development
The approval is a major milestone for Curasight. While the company's diagnostic platform uTRACE has already been clinically evaluated, the therapeutic platform uTREAT is now also entering the clinic. This means that both technologies are being developed in parallel as part of Curasight's uPAR theranostics platform – an integrated approach designed to improve both the diagnosis and treatment of cancers that express the uPAR receptor, in line with the strategy announced by the company late last year.
The uTRACE platform is designed to provide sensitive imaging of cancer cells, while uTREAT delivers targeted radiation to destroy tumor tissue. By combining these tools, Curasight aims to improve treatment precision and reduce side effects that often occur with conventional radiation therapy.
Why glioblastoma?
Glioblastoma is one of the most aggressive forms of brain cancer and represents a significant medical need. Each year, more than 30 people in the US and EU are diagnosed, of whom about 000 percent are children. The prognosis remains extremely poor: half of patients die within 10 months and only 14 percent survive beyond five years.
Traditional treatment, which includes external beam radiation, is effective in slowing the disease but often damages healthy brain tissue. By targeting the uPAR receptor – which is found in the majority of glioblastomas – uTREAT has the potential to deliver radiation more precisely to tumors while sparing healthy areas of the brain. This could significantly improve both treatment outcomes and quality of life.
The upcoming clinical trial
The Phase I study will enroll patients with newly diagnosed glioblastoma and will primarily focus on safety and tolerability at different dose levels. The design builds on previous research with uTRACE and has been developed in consultation with leading clinical experts.
If the study is successful, it could lay the foundation for larger studies investigating uTREAT's efficacy and ultimately enable a treatment that reduces, or even replaces, the need for traditional radiation therapy for brain cancer.
CEO comment
We contacted Curasight's CEO, Ulrich Krasilnikoff, for a comment on the approval of the application and the outlook for uTREAT in glioblastoma.
What does the EMA's approval mean for Curasight?
– This is a very important step forward – Curasight is now in clinical development for both our diagnostic (uTRACE) and treatment (uTREAT) platforms. Today's news where EMA gives the green light for the Phase 1 study testing uTREAT in patients with aggressive brain cancer means we can soon start enrolling patients and be on track to deliver first data by the end of the year. The recent capital injection means we are now well equipped to deliver on this plus other key milestones in our clinical development pipeline.
How do you see uTREAT's potential to change the way glioblastoma is treated?
- We believe uTREAT has the potential to provide more targeted and more gentle treatment to glioblastoma. This is a very aggressive cancer where there has been little progress in the treatment regime for the last decade so we believe uTREAT could represent an important new treatment option for patients with glioblastoma.
What are the most important goals of this phase I trial?
– The phase I trial will enroll patients with newly diagnosed glioblastoma and will focus primarily on safety and tolerability at different dose levels. This will inform us of optimal dose levels for future clinical development.
What role does the uTRACE diagnostic platform play alongside uTREAT in your theranostic strategy?
– We pursue a theranostic platform development for better diagnosis and more gentle treatment options for certain cancers, With our diagnostic platform uTRACE we believe we can provide more precise and improved diagnosis and categorization of certain types of cancer, and then we can use our uTREAT platform for more targeted treatment of the cancer. In other words – if we can visualize the cancer on a scan image with uTRACE, then there is also a high probability that we can kill the cancer cells with uTREAT, since we use the same link to the cancer cells (the biomarker uPAR) in both uTRACE and uTREAT. This means we use uTRACE to qualify those patients who will also benefit from uTREAT based on "what you see is what you treat" - and that is what the theranostic principle is based on. This is of great value to the patient and our healthcare system – just as we will hit cancers with spread right down to the cellular level, which you cannot see with the naked eye.
How significant is the finding that 94 percent of high-grade gliomas are uPAR-positive?
– The fact that 94% of high-grade gliomas are uPAR-positive is highly significant because it shows that Curasight's uTREAT has the potential to be relevant for almost all glioblastoma patients, validating the target and broadening both clinical impact and market opportunity.”
Finally, what key milestones do you expect in the project?
- We expect to enroll patients in the coming time and pending recruitment, as this is a relatively small and nimble trial in terms of numbers of patients and design, we aim to have data before the end of the year. This will be a very big milestone – both for Curasight but even more importantly for a patient group where the prognosis for recovery is still very poor – and that is what we hope we can do better.
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