Positive results in uPAR-PET/MR Phase II study in brain cancer
- uPAR-PET with 68Ga-NOTA-AE105 (now known as uTRACE®) was highly prognostic both regarding progression-free survival and overall survival.
- 94% of glioblastomas (WHO grade 4 gliomas) in the study were uPAR-PET positive underlines validity of using this target for improved diagnosis and categorisation.
- Together with our recently reported positive preclinical data on therapy with uTREAT® in glioblastoma, this strongly supports our ambition to pursue a theranostic approach using uTRACE® and uTREAT® in glioblastoma patients.
Copenhagen, Denmark, June 29, 2023 - Curasight A/S ("Curasight" or the “Company" - TICKER: CURAS) announces today positive results from the investigator-initiated phase II study using uPAR-PET (uTRACE®) in primary brain cancer. The study found that uPAR-PET/MR was a suitable target for the detection and prognosis of primary glioblastomas, the most common type of primary brain cancer.
The investigator-initiated trial tested 68Ga-NOTA-AE105 uPAR-PET/MR in a total of 24 glioma patients of which 16 (67%) were WHO grade 4 (glioblastomas), 6 (25%) were WHO grade 3 and 2 (8%) were WHO grade 2. Among glioblastoma patients, 94% had uPAR-PET positive tumors. uPAR-PET positivity indicates that a patient may be eligible for future uPAR-targeted radionuclide therapy, e.g. uTREAT®.
Results from the study, carried out at Rigshospitalet in Copenhagen, will be presented at the World Molecular Imaging Congress (WMIC) in Prague, September 2023.
“We are extremely pleased that the brain cancer study using the uTRACE® technology has now reported positive results. Not only does the study demonstrate how uTRACE® can be used for tumor characterization and risk stratification that may be used for therapy planning and monitoring. However, most important the study strongly supports our strategy of pursuing the use of uTREAT® as therapy in glioblastomas as almost all patients showed clear and substantial uptake of uTRACE® that predicts that a similarly uptake of uTREAT® will happen”, said Ulrich Krasilnikoff, CEO of Curasight. “The prognosis for patients with (glioblastoma) is currently poor, and today’s data, combined with our recently announced positive preclinical data of uTREAT® therapy in brain cancer support our ambition to pursue a theranostics approach – using uTRACE® and uTREAT® to improve diagnosis and treatment of this type of aggressive brain cancer.”
About high grade glioma and glioblastoma
Treatment of glioblastoma presents a significant unmet medical need, necessitating innovative and effective treatments. Curasight's research and development efforts aim to address this challenge and improve the lives of patients facing aggressive brain cancer. Glioblastoma is the first indication for uTREAT®, but uTREAT® has also potential in several other cancer types expressing the biomarker uPAR. A total of approx. 65,000 patients are diagnosed with primary brain tumors and more than 30,000 patients are diagnosed with the aggressive form, glioblastoma, annually in the US and EU. Approximately 10% of the patients are children. The prognosis for individuals with glioblastoma is very poor as approximately 50% of the patients die within 14 months and after five years from diagnosis only 5% are still alive.
