Curasight A/S has announced that brain cancer, specifically high-grade glioma (HGG), will be the first indication targeted by its uTREAT® radioligand therapy. The company anticipates dosing the first patient in late Q2 2025, marking a crucial step in its clinical development program. This decision is based on the significant unmet medical need in treating HGG and promising clinical evidence of uPAR expression in these tumors.
The selection of high-grade glioma as the initial focus for uTREAT® is supported by data from a recently published Phase II trial with uTRACE®, Curasight's diagnostic imaging agent. The trial revealed that 94% of glioblastomas, a particularly aggressive form of brain cancer, exhibited positive uPAR expression. This high prevalence of uPAR suggests that uTREAT®, which targets uPAR, has the potential to be an effective therapeutic intervention.
Clinical Development Plan
Curasight has established a comprehensive clinical development plan (CDP) for uTREAT® in high-grade gliomas. The company expects to submit a clinical trial application (CTA) in early Q1 2025, paving the way for the initiation of the first-in-human study. The accelerated timeline reflects Curasight's commitment to addressing the urgent need for improved treatments for brain cancer.
"The recently published Phase II uTRACE® data in EJNMMI Research highlights the importance of both uTRACE® and uTREAT® in treating brain cancer, particularly glioblastoma," said CEO Ulrich Krasilnikoff. "The study revealed that 94% of glioblastomas were uPAR-positive, strongly supporting the need for further exploration of uTREAT® for this cancer type."
Unmet Medical Need in High-Grade Glioma
High-grade gliomas represent a significant challenge in oncology. Approximately 65,000 patients are diagnosed with primary brain tumors annually in the US and EU, with over 30,000 cases being glioblastoma. The prognosis for glioblastoma patients remains poor, with approximately 50% succumbing to the disease within 14 months of diagnosis, and only 5% surviving beyond five years. The lack of significant improvement in outcomes over the past decades underscores the urgent need for innovative therapeutic approaches.
Curasight's Theranostic Approach
Curasight is leveraging its theranostic uPAR-platform to combine diagnosis and treatment of cancer. By developing both diagnostic (uTRACE®) and therapeutic (uTREAT®) agents that target uPAR, the company aims to personalize cancer management and improve patient outcomes. The "what you see - is what you treat" approach allows for targeted delivery of therapy to tumors expressing uPAR, potentially minimizing off-target effects and maximizing efficacy.
"We are extremely proud of announcing high-grade glioma as the first indication for testing uTREAT®," Krasilnikoff added. "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 hope that uTREAT® will prove to be a game-changer in this aggressive cancer."
