MELBOURNE, Australia and INDIANAPOLIS, June 20, 2025 (GLOBE NEWSWIRE) — Telix Pharmaceuticals Limited (ASX: TLX, NASDAQ: TLX, “Telix”, “the Company”) today announces it has launched a novel PET1 radiochemistry solution based on 18F-aluminium fluoride (AlF), named AlFluor™.
The AlFluor™ platform technology enables flexible radiolabeling of PSMA2 with either AlF or gallium-68 (68Ga). It also has the potential to be used with ligands targeting NETs3 and FAP4, as well as other novel imaging agents under development by Telix and its strategic partners. Developed to combine the imaging benefits of 18F with the convenience of 68Ga kit-based workflows, the AlFluor™ platform supports both centralized cyclotron manufacturing and distributed “shake-and-inject” kit production. This flexibility allows a complementary product with the same targeting agent to be labeled with either isotope, catering to clinical setting or physician preference.
As part of AlFluor’s development, Telix has signed a strategic agreement with University Hospital Ghent and Ghent University for a novel [18F]AlF-PSMA-11 targeting agent. The agreement includes a comprehensive chemistry, manufacturing and controls (CMC) package suitable for the preparation of a Drug Master File (DMF), and provides exclusive access to [18F]AlF-PSMA-11 clinical safety and efficacy data, including a Phase 3 trial in 96 prostate cancer patients, where PSMA-11 (gozetotide) was labeled interchangeably with 18F and 68Ga.
The trial demonstrated diagnostic performance comparable to commercial 68Ga-labeled PSMA-11 agents such as Illuccix® and Gozellix®, both known to deliver high specificity (~90%) for metastatic detection at initial staging5. [18F]AlF-PSMA-11 has also demonstrated favorable biodistribution, high tumor-to-background ratios, and low off-target uptake in multiple studies6. Telix has commenced engagement with regulators to determine the pathway to approval for [18F]AlF-PSMA-11.
Kevin Richardson, Chief Executive Officer, Telix Precision Medicine, said, “Telix’s goal is to expand the utilization 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.”
About
Telix Pharmaceuticals Limited
Telix is a biopharmaceutical company focused on the development and commercialization of therapeutic and diagnostic radiopharmaceuticals and associated medical technologies. Telix is headquartered in Melbourne, Australia, with international operations in the United States, Brazil, Canada, Europe (Belgium and Switzerland), and Japan. Telix is developing a portfolio of clinical and commercial stage products that aims to address significant unmet medical needs in oncology and rare diseases. Telix is listed on the Australian Securities Exchange (ASX: TLX) and the Nasdaq Global Select Market (NASDAQ: TLX).
Illuccix® (kit for the preparation of gallium-68 (68Ga) gozetotide injection), Telix’s first generation PSMA-PET imaging agent, has been approved in multiple countries globally. Gozellix® (kit for the preparation of gallium-68 (68Ga) gozetotide injection) has been approved by the U.S. FDA7.
Visit www.telixpharma.com for further information about Telix, including details of the latest share price, ASX and SEC filings, investor and analyst presentations, news releases, event details and other publications that may be of interest. You can also follow Telix on LinkedIn, X and Facebook.
Telix Investor Relations
Ms. Kyahn Williamson
Telix Pharmaceuticals Limited
SVP Investor Relations and Corporate Communications
Email: [email protected]
Telix Investor Relations (U.S.)
Annie Kasparian
Telix Pharmaceuticals Limited
Director Investor Relations and Corporate Communications
Email: [email protected]
Telix Media Relations (U.S.)
Eliza Schleifstein
ES Media Relations
Email: [email protected]
Phone: 917-763-8106
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1 Positron emission tomography.
2 Prostate-specific membrane antigen.
3 Neuroendocrine tumors.
4 Fibroblast activation protein.
5 PSMA-PreRP clinical study. ClinicalTrials.gov ID: NCT02919111.
6 Piron et al. Sci Rep. 2021; Malik et al. EJNMMI Res. 2020; Boschi et al. EJNMMI Res. 2020.
7 Telix ASX disclosure 21 March 2025.
