Curasight Announces Encouraging Preliminary Data from Phase 1 Trial Evaluating First-in-Class Radiopharmaceutical uTREAT in High-Grade Gliomas®

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Curasight Announces Encouraging Preliminary Data from Phase 1 Trial Evaluating First-in-Class Radiopharmaceutical uTREAT in High-Grade Gliomas®

PR Newswire

  • Clear uptake of uTREAT® in aggressive brain cancer (glioblastoma)
  • Early data support the potential of first-in-class uPAR-targeted theranostic approach to enable more specific diagnosis and more targeted treatment of high-grade gliomas and other uPAR expressing aggressive solid tumors

COPENHAGEN, Denmark, Jan. 12, 2026 /PRNewswire/ -- Curasight A/S ("Curasight" or "the Company" – TICKER: CURAS), a clinical-stage radiopharmaceutical company developing first-in-class drug candidate uTREAT® targeting uPAR (urokinase-type plasminogen activator receptor), the functional driver of invasion, angiogenesis, and metastasis across most solid tumors, today 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 Q2 2026.

"This first-patient data represents an important early milestone for Curasight and uTREAT®," says Ulrich Krasilnikoff, CEO of Curasight. "The clear tumor uptake and high retention observed in aggressive glioblastoma provide early clinical validation of our uPAR-targeted radiopharmaceutical approach. The results further support the potential of uTREAT® as a next generation radiopharmaceutical targeting uPAR for multiple solid aggressive tumors using one drug and one target. It further supports our theranostic uPAR platform designed to provide highly specific and personalized treatment for certain types of cancer".

About the uTREAT® Phase 1 trial in glioblastoma

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. 

About the uPAR theranostic platform

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.

About high grade glioma

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. Approx. 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. External beam radiation is a cornerstone in the therapy of brain cancers. uTREAT® could potentially replace or reduce the use of external beam radiation and thereby lower side effects to the healthy brain due to more specific tumor tissue targeting.

CONTACT:

For more information regarding Curasight A/S, please contact:

Ulrich Krasilnikoff, CEO

E-mail: uk@curasight.com

www.curasight.com

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https://mb.cision.com/Main/19744/4291355/3872417.pdf

Curasight Press release - Initial Ph1 data (Final)-12.01.2025

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SOURCE Curasight