Advanced diagnostics of prostate cancer

In continuation of our success with ¹⁷⁷Lu-PSMA-617, we focused our efforts on the development of ¹⁸F-PSMA-1007 as a diagnostic agent for prostate cancer. ¹⁸F-PSMA-1007 was licensed from the German Cancer Research Centre (DKFZ) in 2016.

Building on the experience we had gathered with ¹⁷⁷Lu-PSMA-617, we decided to conduct all clinical studies, including phase III, ourselves for ¹⁸F-PSMA-1007. With success: The diagnostic agent was approved in France at the end of 2021.

¹⁸F-PSMA-1007 works in a similar way to ¹⁷⁷Lu-PSMA-617. The compound is injected into the patient and binds to the prostate-specific membrane antigen (PSMA) – a cell surface protein which is highly overexpressed in prostate cancer cells. The radioactive fluorine-18 subsequently makes the cancer visible for positron emission tomography (PET) and at the same time decays quickly in the body.

For a reliable and robust production of the PET radiopharmaceutical, ABX developed a novel precursor molecule, which is suitable for a one-step radiolabeling reaction. Our optimized precursor can be labelled directly with 18F-fluoride – without protecting groups. The radiosynthesis delivers high radiochemical yields – an important factor for an efficient production. 

The half-life of 110 min allows the production of ¹⁸F-PSMA-1007 according to the satellite concept. Central radiopharmacies can produce the radiopharmaceutical with kits and cassettes in automated synthesis modules. Just by pressing the ‘start’ button the reaction runs similar everywhere and yields consistent a high quality of the final drug product. The formulated radiotracer can then be distributed to PET centres and hospitals.

¹⁸F-PSMA-1007 is now used worldwide and is already a true success story. About 20,000 people per year were imaged with it even before it was approved. This was possible by compassionate use programs or similar national regulations. With the approval in other European countries, the number of patients is likely to multiply.

Our expertise

• Precursor development
• Development of labelling strategy with 18F-fluoride
• Formulation of the final product
• Development of quality control methods
• Implementation of phase II and phase III studies
• Establishment of a production process in radiopharmacies within Europe with corresponding audits

·-          Precursor development

-          Development of labelling strategy with 18F-fluoride

-          Formulation of the final product

-          Development of quality control methods

-          Implementation of phase II and phase III studies

-          Establishment of a production process in radiopharmacies within Europe with                       corresponding audits