Telix Collaboration on Next Generation Urologic-Oncology Theranostic Published in Journal of Nuclear Medicine

MELBOURNE, Australia, Feb. 15, 2023 /PRNewswire/ -- Telix Pharmaceuticals Limited (ASX: TLX, Telix, the Company) today announces the successful completion of its joint research project conducted with Heidelberg University Hospital (UKHD) under the Research Cooperation Agreement announced in February 2021.^[1] The aim of this project was to create and validate a generator-based theranostic compound for urologic oncology targeting PSMA^[2] and utilising the beta-emitting isotope rhenium-188 (¹⁸⁸Re).

The outcomes from the research project – which included a pre-clinical and first-in-human evaluation – have been published in the latest issue of the Journal of Nuclear Medicine.^[3]

The project has resulted in new intellectual property and a translational data package that may be used to advance this compound into a Phase I clinical trial. Telix is now progressing discussions regarding the further development of the compound with the goal of spinning-out this program into an innovative new company, in partnership with leading academic researchers, to further advance the program into the clinic.

The technology platform consists of a targeting agent that can be conjugated with a true-theranostic pair of radioisotopes: ^99mTc (technetium-99m) for imaging and ¹⁸⁸Re for therapeutic use. ¹⁸⁸Re is a highly differentiated therapeutic beta-emitting isotope that is regarded as an attractive option for radiopharmaceutical therapy applications due to its high energy output over a 16.9 hour half-life and its ability to be reliably produced at the point of care via a generator.^[4]  

Radiopharmaceuticals based on more common therapeutic radioisotopes (on market or in development) such as lutetium-177 (¹⁷⁷Lu) and actinium-225 (²²⁵Ac), are typically centrally manufactured in facilities that require significant investment and infrastructure to operate, such as reactors or cyclotrons. The ¹⁸⁸Re-based approach decentralises drug manufacturing and may be suitable for a wide variety of markets and clinical applications where radiopharmaceutical manufacturing infrastructure or supply chain is limited.

Dr Christian Behrenbruch, Group CEO and Managing Director of Telix, said, "This collaboration has demonstrated the benefit of a purely generator-based theranostic deployment model. Generator-based therapeutic radiopharmaceuticals have the potential to be produced "on-demand" in any nuclear pharmacy, and therefore have the potential to greatly expand access to therapy."

The lead researcher on this project; Professor Dr Frederik Giesel of Universitätsklinikum Düsseldorf, Department of Nuclear Medicine and Telix Scientific Advisory Board member, said, "Rhenium-188 is a high potential generator-based therapeutic nuclide which can provide access to on-demand radiolabelling at reasonable costs. Our initial research has demonstrated that the product is stable after radiolabelling, with good tumour uptake and low uptake in non-target organs. These are all favourable characteristics for progressing the theranostic tandem of ^99mTc and ¹⁸⁸Re in imaging and therapy."

About Telix Pharmaceuticals Limited

Telix is a biopharmaceutical company focused on the development and commercialisation of diagnostic and therapeutic radiopharmaceuticals. Telix is headquartered in Melbourne, Australia with international operations in the United States, Europe (Belgium and Switzerland), and Japan. Telix is developing a portfolio of clinical-stage products that aims to address significant unmet medical need in oncology and rare diseases. Telix is listed on the Australian Securities Exchange (ASX: TLX). For more information visit www.telixpharma.com^[1] and follow Telix on Twitter^[2] (@TelixPharma) and LinkedIn^[3].

Telix's lead product, gallium-68 (⁶⁸Ga) gozetotide (also known as ⁶⁸Ga PSMA-11) injection, has been approved by the U.S. Food and Drug Administration (FDA),^[5] and by the Australian Therapeutic Goods Administration (TGA),^[6] and by Health Canada.^[7]

Telix Investor RelationsMs. Kyahn WilliamsonTelix Pharmaceuticals LimitedSVP Corporate Communications and Investor RelationsEmail: kyahn.williamson@telixpharma.com^[4]

Legal Notices

This announcement is not intended as promotion or advertising directed to any healthcare professional or other audience in any country worldwide (including Australia, United States and the United Kingdom). This announcement may include forward-looking statements 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", "outlook", "forecast" and "guidance", or other similar words.

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 the Company's good-faith assumptions as to the financial, market, regulatory and other risks and considerations that exist and affect the Company'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 studies, 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, manufacturing activities and product marketing activities; the commercialisation of Telix's product candidates, if or when they have been approved; estimates of Telix's expenses, future revenues and capital requirements; Telix's financial performance; developments relating to Telix's competitors and industry; 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.

Readers are cautioned not to place undue reliance on forward-looking statements. Except as required by applicable laws or regulations, Telix does not undertake to publicly update or review any forward-looking statements. Past performance cannot be relied on as a guide to future performance .Readers should read this announcement together with our material risks, as disclosed in our most recently filed reports with the ASX and on our website.

©2023 Telix Pharmaceuticals Limited. The Telix Pharmaceuticals and Illuccix name and logo are trademarks of Telix Pharmaceuticals Limited and its affiliates (all rights reserved).

References

1. ^{^} www.telixpharma.com (www.telixpharma.com)
2. ^{^} Twitter (twitter.com)
3. ^{^} LinkedIn (www.linkedin.com)
4. ^{^} kyahn.williamson@telixpharma.com (www.prnasia.com)