Telix Precision Medicine Announces AlFluor Radiochemistry Platform
- Strategic agreement with University Hospital Ghent provides exclusive access to Phase 3 trial data and CMC package
- Phase 3 trial demonstrated comparable diagnostic performance to commercial agents with ~90% specificity
- Platform offers flexibility in manufacturing methods and isotope choice
- Technology has potential applications beyond PSMA imaging, including NETs and FAP targeting
- Regulatory approval pathway for [18F]AlF-PSMA-11 still pending
- Market adoption may require changes to existing clinical workflows
Insights
Telix's new AlFluor platform enables flexible radioisotope labeling for cancer imaging, expanding market potential with versatile production options.
Telix's introduction of the AlFluor™ platform represents a meaningful advancement in PET radiochemistry. The technology's dual-isotope capability (18F-aluminium fluoride or gallium-68) addresses a significant operational challenge in nuclear medicine by offering both centralized manufacturing and point-of-care preparation options.
The strategic agreement with University Hospital Ghent delivers substantial value through immediate access to a complete CMC package and Phase 3 clinical data for [18F]AlF-PSMA-11. This acquisition strategy accelerates Telix's regulatory timeline while avoiding significant R&D investment and clinical trial costs.
The platform's versatility extends beyond prostate cancer to potentially include neuroendocrine tumors (NETs) and fibroblast activation protein (FAP) targets, significantly expanding the technology's market potential. The Phase 3 data showing comparable diagnostic performance to established products like Illuccix® with high specificity (~90%) for metastatic detection provides technical validation.
AlFluor™ addresses a critical supply chain vulnerability in nuclear medicine. Fluorine-18 offers longer half-life (110 minutes vs. 68 minutes for gallium-68), enabling wider distribution networks. This flexibility allows hospitals to maintain consistent imaging capabilities regardless of isotope availability fluctuations, potentially increasing procedural reliability and adoption rates.
The platform aligns with healthcare's movement toward precision medicine by enabling the same targeting molecule to be deployed with different isotopes based on clinical requirements and resource availability, ultimately improving patient access to advanced diagnostic tools.
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 (~
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: kyahn.williamson@telixpharma.com
Telix Investor Relations (U.S.)
Annie Kasparian
Telix Pharmaceuticals Limited
Director Investor Relations and Corporate Communications
Email: annie.kasparian@telixpharma.com
Telix Media Relations (U.S.)
Eliza Schleifstein
ES Media Relations
Email: eliza@schleifsteinpr.com
Phone: 917-763-8106
Legal Notices
You should read this announcement together with our risk factors, as disclosed in our most recently filed reports with the Australian Securities Exchange (ASX), U.S. Securities and Exchange Commission (SEC), including our Annual Report on Form 20-F filed with the SEC, or on our website.
The information contained in this announcement is not intended to be an offer for subscription, invitation or recommendation with respect to securities of Telix Pharmaceuticals Limited (Telix) in any jurisdiction, including the United States. The information and opinions contained in this announcement are subject to change without notification. To the maximum extent permitted by law, Telix disclaims any obligation or undertaking to update or revise any information or opinions contained in this announcement, including any forward-looking statements (as referred to below), whether as a result of new information, future developments, a change in expectations or assumptions, or otherwise. No representation or warranty, express or implied, is made in relation to the accuracy or completeness of the information contained or opinions expressed in the course of this announcement.
This announcement may contain forward-looking statements, including within the meaning of the U.S. Private Securities Litigation Reform Act of 1995, that relate to anticipated future events, financial performance, plans, strategies or business developments. Forward-looking statements can generally be identified by the use of words such as “may”, “expect”, “intend”, “plan”, “estimate”, “anticipate”, “believe”, “outlook”, “forecast” and “guidance”, or the negative of these words or other similar terms or expressions. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance or achievements to differ materially from any future results, levels of activity, performance or achievements expressed or implied by these forward-looking statements. Forward-looking statements are based on Telix’s good-faith assumptions as to the financial, market, regulatory and other risks and considerations that exist and affect Telix’s business and operations in the future and there can be no assurance that any of the assumptions will prove to be correct. In the context of Telix’s business, forward-looking statements may include, but are not limited to, statements about: the initiation, timing, progress and results of Telix’s preclinical and clinical trials, and Telix’s research and development programs; Telix’s ability to advance product candidates into, enrol and successfully complete, clinical studies, including multi-national clinical trials; the timing or likelihood of regulatory filings and approvals for Telix’s product candidates, manufacturing activities and product marketing activities; Telix’s sales, marketing and distribution and manufacturing capabilities and strategies; the commercialization of Telix’s product candidates, if or when they have been approved; Telix’s ability to obtain an adequate supply of raw materials at reasonable costs for its products and product candidates; estimates of Telix’s expenses, future revenues and capital requirements; Telix’s financial performance; developments relating to Telix’s competitors and industry; the anticipated impact of U.S. and foreign tariffs and other macroeconomic conditions on Telix’s business; and the pricing and reimbursement of Telix’s product candidates, if and after they have been approved. Telix’s actual results, performance or achievements may be materially different from those which may be expressed or implied by such statements, and the differences may be adverse. Accordingly, you should not place undue reliance on these forward-looking statements.
©2025 Telix Pharmaceuticals Limited. Telix Pharmaceuticals®, Telix Group company, and Telix product names and logos are trademarks of Telix Pharmaceuticals Limited and its affiliates – all rights reserved. Trademark registration status may vary from country to country.
______________________________________________
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.
FAQ
What is Telix's new AlFluor radiochemistry platform?
What were the results of the Phase 3 trial for TLX's [18F]AlF-PSMA-11?
What is the manufacturing flexibility of Telix's AlFluor platform?
What additional applications does TLX's AlFluor platform have?
What is the current regulatory status of Telix's [18F]AlF-PSMA-11?
