Gallium-68 NOTA AE105(Curasight A/S)

Oral presentation gives more details from the Phase II data where topline results were released on June 29, 2023. Investigators for the Phase II trial concluded that: The majority of the glioma patients displayed uPAR-positive tumors High uPAR expression is significantly correlated with a worse outcome The study demonstrates the potential of uPAR-targeted radionuclide therapy (uTREAT®) for patients with high-grade gliomas COPENHAGEN, Denmark, Sept. 14, 2023 /PRNewswire/ -- Curasight A/S ("Curasight" or the "Company" - TICKER: CURAS) announces today that the previously announced results from the investigator-initiated phase II study using uPAR-PET (uTRACE®) in primary brain cancer have been presented in an oral presentation at the World Molecular Imaging Congress (WMIC) 2023 in Prague. The oral presentation expanded on the topline results released earlier this year on June 29th and were presented in the session "Prospective Phase II Trial of [68Ga-NOTA-AE105] uPAR-PET/MRI in Patients with Primary Gliomas: Prognostic Value and Implications for uPAR-Targeted Radionuclide Therapy" by Dr. Aleena Azam from Rigshospitalet and University of Copenhagen. The abstract of the presentation will, together with the other abstracts presented at the WMIC, be published in an upcoming issue of the medical journal Molecular Imaging and Biology (Springer Publisher). The Phase II study was carried out in 24 glioma patients, 22 with high-grade gliomas and 2 with low-grade gliomas. Of the high-grade gliomas, 16 were grade IV (Glioblastomas). All 24 patients underwent a uPAR-PET scan with 68Ga-NOTA-AE105 (uTRACE®), and tumor uptake was evaluated as SUV values. The patients were followed over time to assess progression-free survival (PFS) and overall survival (OS). Patients were divided into high and low uPAR groups. Of the Glioblastomas 94% (15 of 16) were uPAR-PET positive. uPAR-PET was highly prognostic, and the high uptake group compared to the low uptake group had a more than 10-fold poorer prognosis (hazard ratio). "We are proud that the investigator-initiated phase II trial in brain cancer was selected for an oral presentation at the World Molecular Imaging Congress in Prague. We believe this Phase II clinical data supports our focus on brain cancer and we will make every effort to move our theranostic strategy with uTRACE® and uTREAT® in these patients forward. The current poor prognosis in these patients and the need for better therapies make us committed to bring our technology fast forward to we hopefully will be able to help the patients to a better outlook and life.", said Ulrich Krasilnikoff, CEO of Curasight. 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. For more information regarding Curasight, please contact: Ulrich Krasilnikoff, CEO Phone: +45 22 83 01 60 E-mail: [email protected] Curasight is a clinical development company based in Copenhagen, Denmark. The company is a pioneer in the field of exploiting a novel theranostic platform with Positron Emissions Tomography (PET) imaging and Radionuclide Therapy targeting the urokinase-type plasminogen activator receptor ("uPAR"). The technology is expected to improve diagnosis, risk stratification and therapy in multiple cancer types. The following files are available for download: SOURCE Curasight

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 /PRNewswire/ -- 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. For more information regarding Curasight, please contact: Ulrich Krasilnikoff, CEO Phone: +45 22 83 01 60 E-mail: [email protected] The following files are available for download: SOURCE Curasight