お知らせ • Jun 09
Curasight Announces Preliminary Readout from Phase 1 Clinical Trial with uTREAT In Aggressive Brain Cancer Curasight A/S announced encouraging preliminary readout from its Phase 1 clinical trial with uTREAT in patients with aggressive brain cancer (glioblastoma). A preliminary readout of the Phase 1 clinical trial with uTREAT in glioblastoma, an aggressive brain cancer, has now been undertaken. The data support: The feasibility and safety of the mode of administration, super-selective intra-arterial cerebral injection (super-SIACI) with local, transient opening of the blood-brain barrier (BBB) using mannitol. High uptake and retention in tumor. Biodistribution and dosimetry compatible with the ability to deliver a therapeutically relevant radiation dose to the tumor without reaching dose limits for healthy organs. The data support continued development of Curasight's therapeutic program using uTREAT in aggressive brain cancer. The trial aims to investigate Curasight's uTREAT as a new targeted radioligand therapy for patients with glioblastoma. Participants in the trial are patients with newly diagnosed, verified or suspected GBM. uTREAT is administered via a catheter directly into the vessels that feed the tumor (super SIACI). To enhance tumor targeting, the blood-brain barrier is transiently opened with the osmotic compound mannitol. The mode of administration is designed to achieve high binding of uTREAT in tumors while minimizing radiation exposure to healthy organs. Curasight's uPAR theranostic platform combines two key technologies - uTRACE and uTREAT - both targeting uPAR. uTRACE is designed to deliver sensitive imaging for diagnosis, while uTREAT offers a targeted radiopharmaceutical therapy solution. Together, they form an integrated approach to improving the diagnosis and treatment of cancers that express uPAR. Curasight's ambition is to develop both uTRACE and uTREAT to improve diagnosis and treatment of uPAR-expressing cancers. Treatment of glioblastoma and other high-grade gliomas (WHO grades 3 or 4) presents a significant unmet medical need, necessitating innovative and effective treatments. A total of approx. 65,000 patients are diagnosed with primary brain tumors, and more than 30,000 patients are diagnosed annually with the most aggressive form, glioblastoma, in the US and EU. Approximately 10% of patients with primary brain tumors are children. The prognosis for individuals with glioblastoma is very poor, as approximately 50% of patients die within 14 months, and after five years from diagnosis, only 5% are still alive. External beam radiation is a cornerstone in the therapy of brain cancers. uTREAT could potentially complement current radiation strategies and reduce radiation exposure to healthy brain tissue due to more specific tumor tissue targeting. Board Change • May 20
No independent directors Following the recent departure of a director, there are no independent directors on the board. The company's board is composed of: No independent directors. 5 non-independent directors. Director Colin Hayward was the last director to join the board, commencing their role in 2026. The company's lack of independent directors is a risk according to the Simply Wall St Risk Model. お知らせ • Mar 25
Curasight A/S Announces Board Changes Curasight A/S announced that Marcel Reichen and Colin Hayward as new board members replacing Lars Trolle and Charlotte Vedel with consent of all votes represented at the general meeting. Andreas Kjær was elected as deputy chairman of the Board of Directors. お知らせ • Jan 28
Curasight A/S to Report Fiscal Year 2025 Results on Feb 26, 2026 Curasight A/S announced that they will report fiscal year 2025 results on Feb 26, 2026 お知らせ • Jan 13
Curasight A/S Announces Encouraging Preliminary Data from Phase 1 Trial Evaluating First-In-Class Radiopharmaceutical Utreat in High-Grade Gliomas Curasight A/S announced encouraging preliminary data from the first patient dosed in ongoing Phase 1 clinical trial in patients with high-grade gliomas. Position emission tomography (PET)- images from the first treated patient showed clear and sustained uptake of uTREAT in the tumor, confirming that the drug successfully targets cancer tissue. The signal remained visible for at least 24 hours, indicating prolonged tumor binding and supporting the potential for effective radiation delivery to the tumor. The patient's PET signal persisted until the last PET scan (24 hours), demonstrating that uTREAT has protracted binding kinetics, translating to a maximized tumor absorbed dose. These early results provide support for Curasight's uPAR-targeted approach in radiopharmaceuticals and the potential of uTREAT as a novel therapy for patients with high- grade gliomas and other uPAR expressing aggressive solid tumors (>85% of solid tumors). The preliminary dosimetry readout of uTREAT was in line with expectations and supports to continue with additional GBM patients. Currently more patients are enrolled, and top-line data is expected in second quarter of 2026. The phase 1 clinical trial is designed to evaluate the dosimetry and safety of Curasight's drug candidate uTREAT as a first-in-class uPAR targeted radiopharmaceutical therapy in patients with newly diagnosed, verified or suspected glioblastoma (GBM). Participants in the trial are patients with newly diagnosed verified or suspected GBM. The trial design is informed from research and earlier studies with uTRACE as well as protocol discussions with Key Opinion Leaders. Curasight's uPAR theranostic platform combines two key technologies - uTRACE (highly precise PET imaging diagnostic) and uTREAT (highly precise radiopharmaceutical therapy) both targeting uPAR (urokinase-type plasminogen activator receptor) with the same uPAR binding peptide AE105. Together, they form an integrated approach to next generation radiopharmaceuticals in aggressive solid tumors. uTRACE is fully developed, GMP manufactured and validated in 9 clinical trials (450 patients). uTRACE is partnered with Curium Inc. in the field of diagnostics for prostate cancer. Treatment of glioblastoma and other high-grade gliomas (WHO grades 3 or 4) presents a significant unmet medical need, necessitating innovative and effective treatments. A total of approx. 65,000 patients are diagnosed with primary brain tumors, and more than 30,000 patients are diagnosed annually with the most aggressive form, glioblastoma, in the US and EU. Approximately 10 % of the patients are children. お知らせ • Dec 19
Curasight A/S Announces Successful Dosing of First Patient in Phase 1 Trial with Utreat®? in Brain Cancer Curasight A/S announced the successful and safe dosing of the first patient in the Phase 1 trial using uTREAT in brain cancer (high grade gliomas). The news marks the initiation of the first clinical trial under the company's therapeutic platform uTREAT, investigating it as a potential treatment option for glioblastoma. The start of the phase 1 study with uTREAT means that Curasight is now in the clinical phase with both parts of its theranostic platform aimed at improving treatment and diagnosis of certain cancers. The company's diagnostic platform uTRACE is currently in a Phase 2 trial for prostate cancer under the strategic partnership with Curium Inc. The trial aims to investigate Curasight's uTREAT as a new type of targeted radiopharmaceutical therapy in glioblastoma patients. Participants in the trial are patients with newly diagnosed verified or suspected GBM. The trial design is informed from research and earlier studies with uTRACE® as well as protocol discussions with Key Opinion Leaders. お知らせ • Feb 27
Curasight A/S to Report Fiscal Year 2024 Final Results on Mar 26, 2025 Curasight A/S announced that they will report fiscal year 2024 final results on Mar 26, 2025 お知らせ • Jan 22
Curasight A/S to Report Fiscal Year 2024 Results on Feb 20, 2025 Curasight A/S announced that they will report fiscal year 2024 results on Feb 20, 2025