Clinical evidence

Human uPAR Validation

uPAR has moved from tissue biology to non-invasive imaging in patients.

Human evidence before therapeutic expansion

Curasight has built a broad human uPAR imaging dataset. This section focuses on what has actually been observed in patients, including study-level imaging, prognostic, diagnostic and dosimetry evidence.

More than 500 patients have been imaged in the uPAR PET clinical program across eight cancer settings. PET imaging has been used to investigate tumor uptake, target accessibility, prognostic associations and potential diagnostic applications. This human evidence informs target selection and therapeutic development, but does not establish therapeutic efficacy.

First-in-human studies established that AE105-based uPAR PET ligands could be administered to patients and visualize primary tumors and metastases.

Subsequent prospective studies expanded the human evidence across several cancer settings and clinical questions. The study-level evidence is summarized below and in the publication library.

>500

patients imaged in the uPAR PET clinical program

cancer settings

investigator-initiated uPAR PET clinical trials

What the human program shows

Target engagement

uPAR-targeted PET ligands accumulate in malignant lesions and uptake has been linked to tissue uPAR expression in multiple studies.

Aggressiveness signal

Higher uPAR PET uptake has been associated with higher-grade or poorer-prognosis disease in settings including prostate cancer, glioma, head-and-neck cancer and non small cell lung cancer.

Cross-tumor relevance

uPAR PET has generated human data across multiple tumor settings rather than a single tumor lineage (pan solid tumor target).

Therapeutic selection logic

Imaging may help identify and quantify uPAR-positive disease before therapeutic radionuclide dosing and can provide biodistribution and dosimetry information relevant to development.

The therapeutic hypothesis remains under clinical evaluation.

Imaging evidence validates target accessibility and informs patient selection and dosimetry, but therapeutic benefit must be demonstrated in dedicated uTREAT® trials.