Curasight has selected aggressive brain cancer as the first indication for uTREAT therapy and plans to conduct a short-term study next year. The decision is based on promising preclinical and clinical results that demonstrate the potential of uPAR-targeted technologies in neuro-oncology. Curasight aims to start dosing the first patient in a clinical trial by the end of the second quarter of 2025. BioStock reached out to CEO Ulrich Krasilnikoff to learn more.
Curasight are active in precision oncology and have developed a platform that targets uthe rokinase receptor uPAR to improve cancer diagnostics and treatment. Their diagnostic tool, uTRACE, is already being evaluated in several clinical trials, while uTREAT uses the same targeted mechanism to deliver therapeutic radiation to tumors.
Brain cancer, particularly glioblastoma, has a large unmet medical need, where current treatments often fail to provide long-term results. By targeting uPAR, which is highly expressed in aggressive brain tumors, uTREAT aims to offer a more precise and effective treatment option, minimizing damage to surrounding healthy tissue.
Facing a major medical challenge
The treatment of high-grade gliomas (WHO grade III and IV) is one of the greatest challenges in oncology. Each year, approximately 65 people in the US and EU are diagnosed with primary brain tumors, of which over 000 cases are glioblastoma (WHO grade IV), the most aggressive form of brain cancer. Approximately 30 percent of those diagnosed are children. Despite existing standard treatments, the prognosis for glioblastoma patients is dismal, with a median survival of only 000 months and a five-year survival of just 10 percent.
Clinical trial planned to start in 2025
The next step for Curasight is to conduct a Proof-of-Concept study with uTREAT in patients with brain cancer to demonstrate the potential for treating this type of cancer. The company's recent publication of phase II results in the leading scientific journal EJNMMI Research with the diagnostic technology uTRACE demonstrates strong prognostic potential with uPAR-PET imaging in patients with glioblastoma.
These results underscore the potential of uPAR as both a diagnostic and therapeutic target in brain cancer. The results showed that approximately 94 percent of glioblastomas are uPAR positive, making them potential candidates for uTREAT.
Curasight plans to submit a clinical trial application early in Q1 and to dose the first patient by the end of Q2 2025. The study will evaluate the safety and efficacy of uTREAT in patients with uPAR-positive glioblastomas and provide important data to guide future development.
Broadens patent protection
The company also recently filed a new international patent application for uTREAT, which aims to broaden the patent protection for uTREAT. The platform is currently patented until 2033 in the US, Canada, Europe, Japan, China and Hong Kong. If approved, the new patent would extend the protection until 2043.
CEO comments
BioStock contacted Curasight's CEO Ulrich Krasilnikoff to find out more.
First and foremost, you have worked a while now with selecting the 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.