Telix Pharmaceuticals has introduced a new positron emission tomography (PET) radiochemistry solution, AlFluor, based on ¹â¸F-aluminium fluoride (AlF).

This platform technology is designed to improve the radiolabelling process of prostate-specific membrane antigen (PSMA) imaging agents with gallium-68 (â¶â¸Ga) or AlF.

It may also be applicable for use with ligands that target neuroendocrine tumours (NETs) and fibroblast activation protein (FAP), as well as additional new imaging agents being explored by the company and its collaborative partners.

AlFluor brings together the imaging advantages of ¹â¸F with the ease of the workflows based on the â¶â¸Ga kit.

The platform also claims to support centralised cyclotron manufacturing and distributed production of the “shake-and-inject” kit, allowing for a tailored approach to radiolabelling that meets the needs of various clinical settings and preferences of the physician.

Telix’s agreement with Belgium’s University Hospital Ghent and Ghent University for [¹â¸F]AlF-PSMA-11 targeting agent has been a cornerstone in the development of AlFluor.

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This agreement encompasses a chemistry, manufacturing, and controls (CMC) package, which will support the creation of a Drug Master File (DMF).

It also grants exclusive access to clinical safety and efficacy data of [¹â¸F]AlF-PSMA-11, which includes a Phase III trial involving 96 prostate cancer subjects.

In this study, PSMA-11 (gozetotide) was interchangeably labelled with ¹â¸F and â¶â¸Ga.

The Phase III trial showed diagnostic capabilities, which are on par with commercial â¶â¸Ga-labelled PSMA-11 agents like Gozellix and Illuccix.

[¹â¸F]AlF-PSMA-11 also claims to have exhibited high tumour-to-background ratios, biodistribution, and minimal off-target uptake in various studies.

The company is currently in discussions with regulatory bodies to determine the approval pathway for [¹â¸F]AlF-PSMA-11.

Telix Precision Medicine CEO Kevin Richardson said: “Telix’s goal is to expand the utilisation of PSMA-PET imaging through clinical leadership and novel, flexible product deployment that enables physician choice. AlFluor is an example of innovation that meets the evolving needs of physicians and their patients.

“The addition of this advanced-stage technology and product candidate aligns with our strategy to offer the broadest choice of PSMA-PET imaging agents, with the service, flexibility and reliability that define the Telix customer experience.â€

With headquarters in Australia and operations across Brazil, Canada, the US, Japan, and Europe, the company is focused on addressing unmet medical needs in oncology and rare diseases through its portfolio, which includes both clinical and commercial stage products.

In March 2025, the Brazilian Health Regulatory Agency (ANVISA) approved Telix’s Illuccix.

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