Telix Pharmaceuticals (ASX:TLX) has announced that it has received authorisation from the Belgian Agence Fédérale de Contrôle Nucléaire (AFCN) to decommission the first of two cyclotrons housed at the company’s licensed radiopharmaceutical production facility in Seneffe, Belgium.
Telix is focused on the development of diagnostic and therapeutic products using Molecularly Targeted Radiation.
The company said the authorisation means that the AFCN has accepted its decommissioning dossier, submitted with the support of SCK-CEN (the Belgian Nuclear Research Centre), and is satisfied that safety and operational requirements will be met.
Telix Seneffe general manager Sébastien Linard said, “This authorisation represents a significant milestone for Telix as it enables the build-out of a state-of-the-art radiopharmaceutical production facility that will ultimately serve as Telix’s primary EU manufacturing site.
"This outcome is also positive for the Wallonia region as Telix’s production footprint will create local employment and partnership opportunities, further contributing to Belgium’s impressive radiopharmaceutical ecosystem. We would like to thank our collaborator SCK-CEN and our radioprotection advisor Be.Sure ASBL for their support in developing the dossier for AFCN submission.”
Telix acquired the facility in 2020. It said the facility, which enables a vertically integrated approach to radioisotope and finished radiopharmaceutical production, will enable it to meet commercial production needs for its entire product portfolio in Europe.
The company has also announced that the first patient has been dosed in its ‘CUPID’ first-in-human Phase I study of its candidate TLX592 in patients with advanced prostate cancer.
The objective of the CUPID study is to evaluate the safety, tolerability, pharmacokinetics, biodistribution and radiation dosimetry of TLX592.
TLX592 targets prostate-specific membrane antigen (PSMA) like its existing TLX591 (177Lu-rosapatamab) prostate cancer therapy program. However, the company said TLX592 has been engineered with its proprietary RADmAb antibody technology to clear far more rapidly from a patient’s circulation than unmodified antibodies, while maintaining TLX591’s specificity for tumour-expressed PSMA and hepatic (liver) clearance. The company said this potentially makes it more suitable for use as a targeting agent for 225Ac, a potent therapeutic alpha-emitting radionuclide.