Pipeline Overview
A therapy-led portfolio with a clear sequence from human target characterization to delivery and dosimetry, therapeutic dosing and next-generation systemic development.
From human target validation to therapeutic development
Curasight’s pipeline is organized around one biological target, uPAR, but separates each product and development path according to its actual stage of maturity.
Curasight organizes development around two uPAR platform brands. uTRACE® is the imaging and diagnostic platform and provides the human imaging evidence base. uTREAT® is the therapeutic development platform. The current glioblastoma clinical program sits within uTREAT® and uses 64Cu-DOTA-AE105 at imaging and dosimetry activity to establish delivery, biodistribution and dosimetry before a separate 177Lu AE105 therapeutic product candidate. In parallel, a next-generation systemic uPAR ligand is being advanced within uTREAT® with an alpha-emitting lead product path and modular capability (alpha and beta payload) for additional distinct therapeutic products.
Pipeline
Three therapeutic product paths and a diagnostic franchise on one target
uTREAT® glioblastoma program
64Cu now, 177Lu-AE105 next
Next gate
64Cu delivery and dosimetry top-line H1 2027
Then 177Lu therapeutic dosing
Next-generation ligand, α
Homogeneous small volume uPAR-positive tumors
Next gate
Next-generation ligand candidate selection
Then basket dosimetry trial
Next-generation ligand, β
Heterogeneous uPAR-positive tumors
Next gate
Next-generation ligand candidate selection
Then basket dosimetry trial
uTRACE® Prostate
Partnered with Curium
Next gate
Phase 2 decision threshold
Top-line H1 2027
uTRACE® imaging evidence base
Nine prospective imaging trials
PCa
n=137
NET
n=99
H&N
n=57
Breast
n=55
OPSCC
n=50
Glioma
n=48
NSCLC
n=25
Bladder
n=24
mCRPC
n=18
>500 patients across 8 tumor types · multiple prospective Phase 2 · 68Ga-NOTA-AE105*
Next gate
Indication selection for Ph2 with 64Cu-DOTA-AE105
* Primarily run with 68Ga-NOTA-AE105
Diagnostic evidence · uPAR-PET imaging trials
Nine prospective Phase 2 uPAR-PET imaging trials across eight tumor types
Prostate, localized
n = 137
Key result
Feasibility and patient selection
Neuroendocrine, NET / NEC
n = 99
Key result
Prognostic PFS / OS (Carlsen 2022)
Head and neck, HNSCC
n = 57
Key result
Prognostic for relapse-free survival (Risør 2022)
Breast
n = 55
Key result
Primary-tumor detection (Fosbøl 2024)
Oropharyngeal, OPSCC
n = 50
Key result
Nodal / occult-metastasis detection (Diagnostics 2023)
Glioma and glioblastoma
n = 48
Key result
Prognostic OS / PFS (Azam 2024)
Lung, NSCLC
n = 25
Key result
Predicts recurrence, HR 2.16 (Soldath 2026)
Urinary bladder
n = 24
Key result
Feasibility in metastatic disease
Prostate, mCRPC
n = 18
Key result
Feasibility in metastatic disease (Fosbøl 2021)
9 trials · >500 patients · 8 tumor types
All trials registered as Phase 2. Phase 1 is the first-in-human study (safety, biodistribution, dosimetry), performed once per tracer: 64Cu-DOTA-AE105 (Persson 2015) and 68Ga-NOTA-AE105 (Skovgaard 2017). Every subsequent study with the same tracer is Phase 2, regardless of tumor type or endpoint. 64Cu-DOTA-AE105 is the lead Phase 2 diagnostic now (prostate, Curium); 68Ga-NOTA-AE105 across the cohorts shown. n = patients imaged; investigator-initiated; prognostic / feasibility imaging, not therapeutic efficacy.
Glioblastoma program
uTREAT®
Glioblastoma program: current imaging and dosimetry step
- 64Cu-DOTA-AE105 at imaging and dosimetry activity
- Delivery, biodistribution and dosimetry
uTREAT®
Glioblastoma program: 177Lu uTREAT® therapeutic path
- Subsequent dose-finding and phase 2 study in glioblastoma
- Subject to successful development, regulatory approval and the supporting human dosimetry data
Explore the pipeline
Pipeline
Building the uTREAT® therapeutic platform through distinct product paths.
Pipeline
uTRACE® is Curasight’s uPAR-targeted imaging and diagnostic platform.
Clinical evidence
A clinical program spanning imaging, prognosis, diagnosis and the first human delivery and dosimetry study supporting therapeutic development.