Urothelial carcinomas are among the most common tumors of the urinary tract and represent a significant unmet medical need, particularly in advanced stages. The Uroec project focuses on developing radioligands based on peptides for the targeted diagnosis and treatment of urothelial carcinoma.

Suitable ligands are developed, optimized, and investigated with different radioisotopes for diagnostic and therapeutic applications. During the course of the project, promising candidates have been identified and further developed that specifically bind to the selected tumor target. Structural optimization has further improved the properties of the radioligands for molecular imaging.

The results obtained provide a foundation for the further development of theranostic approaches for the targeted diagnosis and treatment of urothelial carcinoma.

Partners:

• ROTOP Pharmaka GmbH
• Helmholtz-Zentrum Dresden-Rossendorf
• CUP Laboratorien Dr. Freitag GmbH

Funding: Development of radiopeptide conjugates for the theranostics of urothelial carcinoma based on a radiocopper platform (European Regional Development Fund (ERDF) and Sächsische Aufbaubank (SAB)), 12/2023–11/2026.

Gliomas are among the most common and aggressive brain tumors and currently remain incurable. They account for a large proportion of malignant brain tumors and, due to their biological heterogeneity, pose a particular challenge for diagnosis and treatment. However, advances in molecular characterization are opening up new approaches for more precise treatment.

The IDH-PET2 project focuses on developing an innovative PET radiotracer for the non-invasive detection of the IDH1 mutation as a glioma-specific biomarker. The aim is to significantly improve molecular imaging, thereby enabling more precise diagnostics, optimized treatment planning, and targeted patient stratification.

Partners:

• ROTOP Pharmaka GmbH
• Helmholtz-Zentrum Dresden-Rossendorf

Publications:

Lai, T.H.; Dukić-Stefanović, S.; Deuther-Conrad, W.; Maisonial-Besset, A.; Teodoro, R.; Toussaint, M.; Wenzel, B. Fluorinated Derivatives of AG-881 for Positron Emission Tomography Detection of Mutated Isocitrate Dehydrogenase 1. Pharmaceuticals 2026, 19, 660. https://doi.org/10.3390/ph19050660

Lai, T.H.; Wenzel, B.; Dukić-Stefanović, S.; Teodoro, R.; Arnaud, L.; Maisonial-Besset, A.; Weber, V.; Moldovan, R.-P.; Meister, S.; Pietzsch, J.; Kopka, K.; Juratli, T.A.; Deuther-Conrad, W.; Toussaint, M. Radiosynthesis and biological evaluation of [18F]AG-120 for PET imaging of the mutant isocitrate dehydrogenase 1 in glioma. Eur J Nucl Med Mol Imaging 2024, 51, 1085–1096. https://doi.org/10.1007/s00259-023-06515-7

Funding: Non-invasive imaging of brain tumors – development of a radiopharmaceutical for the detection of isocitrate dehydrogenase mutations in gliomas (European Regional Development Fund (ERDF) and Sächsische Aufbaubank (SAB)), 07/2023–06/2026.

The preclinical development and quality assurance of pharmaceuticals still rely heavily on animal testing, despite its limited transferability to humans. At the same time, regulatory requirements are increasing, along with the need for more efficient and ethically responsible testing methods.

RadioSecure addresses these challenges by developing microphysiological systems (MPS) that realistically replicate human organs and tissues in vitro. Combined with standardized testing protocols, these systems are intended to fundamentally improve the preclinical development and batch testing of radiopharmaceuticals.

The aim is to establish scalable, animal-free, and economically viable testing methods, setting new standards in pharmaceutical development.

Partners:

• ROTOP Pharmaka GmbH
• Helmholtz-Zentrum Dresden-Rossendorf
• Fraunhofer IWS
• Michael Sander Kunststofftechnik GmbH

Funding: Innovative microphysiological systems for radiopharmaceutical preclinical testing and quality assurance (European Regional Development Fund (ERDF) and Sächsische Aufbaubank (SAB)), 06/2025–12/2027.