The PET imaging agent for prostate cancer with low urinary excretion.
In continuation to our success with ¹⁷⁷Lu-PSMA-617 we focussed our efforts on the development of ¹⁸F-PSMA-1007 as a diagnostic agent for prostate cancer. ¹⁸F-PSMA-1007 was in-licensed from the German Cancer Research Centre (DKFZ) in 2016, as a new developed molecule, which never was in humans.
ABX made the entire clinical development (phase 0-3) and got a frist market approval in France.
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 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 ready to use in a one-step reaction. Our optimized precursor can be labelled directly with 18F-fluoride – without protecting groups.
The half-life of 110 min allows the production of ¹⁸F-PSMA-1007 according to the satellite concept. Central radiopharmacies are able to produce the radiopharmaceutical with kits and cassettes in automated synthesis modules just with pressing the start button - the process of reaction is always very similar. The formulated radiotracer can then be distributed to PET-centers and hospitals.
¹⁸F-PSMA-1007 is now used worldwide and is already a true success story. More than 50,000 people a year were imaged with it even before it was approved. This is possible because of compassionate use programs and similar programs according to local medicinal product regulations. With the approval, the number of patients is likely to multiply.
· Precursor development
· Formulation of the final product
· Establishment of a production process with corresponding audits
· Implementation of phase II and phase III studies
· Quality control
· Worldwide distribution under radiopharmaceutical regulations