Brain cancer will be the first indication for Curasight’s uTREAT therapy. The company’s decision to choose aggressive brain cancer for a fast single indications trial is backed by promising preclinical and clinical results demonstrating the potential of its uPAR-targeted technologies in neuro-oncology. Curasight aims to begin dosing the first patient in a clinical trial by the end of the second quarter of 2025. BioStock contacted CEO Ulrich Krasilnikoff to learn more. 

Precision oncology company Curasight has developed a proprietary platform targeting the urokinase plasminogen activator receptor (uPAR) to improve cancer diagnostics and treatment. Its diagnostic tool, uTRACE, is already being evaluated in several clinical trials, while uTREAT is designed to use the same targeting mechanism to deliver therapeutic radiation to tumors.  

Brain cancer, particularly glioblastoma, represents a critical unmet medical need, with current treatments often failing to provide durable outcomes. By leveraging uPAR, which is highly expressed in aggressive brain cancers, uTREAT aims to provide a more precise and effective treatment option, minimizing damage to surrounding healthy tissues. 

Targets a major medical challenge

The treatment of high-grade gliomas (WHO grades III and IV) is one of oncology’s greatest challenges. Each year, approximately 65,000 individuals in the US and EU are diagnosed with primary brain tumors, and over 30,000 of these cases are glioblastomas (WHO grad IV), the most aggressive form of brain cancer. Around 10 percent of those diagnosed are children. Despite current standard treatments, the prognosis for glioblastoma patients remains dire, with a median survival of just 14 months and a five-year survival rate of only 5 percent.  

Clinical study to start mid-2025

The next step for Curasight is to conduct a so-called Proof-of-Concept study with uTREAT in brain cancer designed to show the potential for treatment of this type of cancer. The announcement follows the recent publication of full phase II results in the leading scientific journal EJNMMI Research from a study with the company’s diagnostic technology uTRACE, which showcased the strong prognostic capabilities of uPAR-PET imaging in glioblastoma patients.  

These findings underline the potential of uPAR as both a diagnostic and therapeutic target in brain cancers. The data showed that approximately 94 percent of glioblastomas are uPAR-positive, making them viable candidates for uTREAT.  

Curasight plans to submit a clinical trial application in early Q1 and to dose the first patient by late Q2 2025. The trial will assess the safety and efficacy of uTREAT in patients with uPAR-positive glioblastomas, providing essential data to guide future development.  

Broadens patent protection

The company also recently submitted an international patent application regarding uTREAT. The new application aims to broaden patent protection for uTREAT.  Currently the platform is patent protected until 2033 in the US, Canada, Europe, Japan, China and Hong Kong. Upon approval, the new patent would extend the protection to 2043.  

Comments from the CEO

BioStock contacted Curasight CEO Ulrich Krasilnikoff to learn more. 

First and foremost, you have worked a while now with selecting primary indication for uTREAT. Why did you choose brain cancer? 

– The cancer has a poor prognosis, with essentially no improvement in outcome over the last decades. Accordingly, there is a large unmet medical need and we anticipate that uTREAT will prove to be a game-changer in this aggressive cancer. We have clinical and preclinical data showing that uPAR is highly expressed in brain cancer and preclinical data showing that uTREAT is effective in treating brain cancer.  

– We follow the concept of ”what you see is what you treat” – so brain cancer was an obvious choice to run a relatively small single indication clinical study to prove our hypothesis that uTREAT could offer an effective treatment option for brain cancer. As uPAR is expressed on a number of other cancers, once we have obtained clinical ’proof of concept’ that uTREAT is effective in brain cancer, we can proceed to broaden our clinical development into other relevant indications.   

Even with all available treatment options, the current prognosis for brain cancer patients is quite grim. Why is that? 

– The main reason is most likely the way these tumors grow with islets of cancer cells in a large area around the macroscopic (what you can see) tumor. Accordingly, there is diffuse growth into the brain tissue and there is no way to visualize these small cancer deposits.  

What does the competition look like within the radiation therapy field for brain cancer? 

– Today, external radiation therapy is standard of care. However, due to the diffuse growth of the tumor, it is impossible to delineate all tumor tissue for radiation planning. However, with uTREAT targeted radioligand therapy (injectable radiation therapy), the radiation automatically seeks out and binds to all cancer cells – also the ones we cannot see are there. This is the reason, why we believe our technology will be a game-changer for high-grade glioma patients. Also, radioligand therapy in general is gentler to healthy tissue than external radiation therapy. 

How much of an impact do you hope to make with uTRACE and uTREAT? 

– Brain cancer, as well as other cancer types, represent a clear unmet medical need. With our theranostic approach within targeted radiopharmaceutical, we aim to provide new options for both better diagnosis and more gentle treatments for patients with certain cancers. 

Dosing the first patient mid-2025, when do you hope to be able to present top-line results? 

– Once we dose the first patient, we will be able to give a more accurate timeline for when we expect data. However, rule of thumb and depending on recruitment, we could expect first data around Q4 2025. 

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