Telix to Showcase Additional ZIRCON Phase III Data in Kidney Cancer Imaging and Theranostic Pipeline Developments at EAU

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Mar 08, 2023, 15:53 ET

MELBOURNE, Australia, March 8, 2023 /PRNewswire/ -- Telix Pharmaceuticals Limited (ASX: TLX, Telix, the Company) today announces presentations from the Company's carbonic anhydrase IX (CAIX) targeting kidney and bladder cancer programs at the 38^th Annual European Association of Urology (EAU) Congress to be held in Milan from 10 – 13 March 2023.

Further data from Telix's completed pivotal Phase III ZIRCON study of TLX250-CDx (⁸⁹Zr-DFO-girentuximab) in clear cell renal cell carcinoma (ccRCC) (ClinicalTrials.gov Identifier: NCT03849118) will be presented in a "Game Changing" oral session.

Game Changing sessions are reserved for Phase III trials or other developments that the EAU's Scientific Congress Office believes will have a large impact on daily practice.

In addition, presentations will report on the potential utility of TLX250-CDx in urothelial carcinoma or bladder cancer (ZiPUP study, ClinicalTrials.gov Identifier: NCT05046665); and a preclinical evaluation of a Telix targeted radionuclide therapy candidate in combination with an immune checkpoint inhibitor.

Dr Colin Hayward, Telix Chief Medical Officer, said, "In support of Telix's vision to drive innovation in urologic oncology, we are pleased that our programs in renal and bladder cancer will be presented at EAU 2023, the largest urological event in Europe. Notably, Professor Peter Mulders from Radboud UMC will be presenting further data from the Phase III ZIRCON study of TLX250-CDx, our investigational renal cancer imaging agent, which is generating significant interest in the medical community, following a highly positive result. We are also excited to announce two additional presentations on Telix's CAIX-targeting candidates further exploring potential theranostic applications beyond ccRCC."

EAU presentation details are as follows:

Session: Game Changing Session
Title: ⁸⁹Zr-DFO-girentuximab for PET/CT imaging of clear cell renal cell carcinoma – results from phase 3 ZIRCON study
Date and Time: 11-Mar-2023, 10:00 AM-10:15 AM
Presenter: Prof. P.F.A. Mulders, Radboud UMC, Nijmegen, The Netherlands

Session: Clinical Trials in Progress
Title: 89Zirconium-labelled girentuximab (⁸⁹Zr-TLX250) PET in Urothelial Cancer Patients (ZiPUP) – A phase I trial of a novel staging modality for urothelial carcinoma
Date and Time: 12-Mar-2023, 10:45 AM-12:15 PM
Presenter: Dr. D. Hayne, University of Western Australia, Australia
Abstract ID: A0520

Session: Cell biology and novel biomarkers in kidney cancer
Title: Preclinical evaluation of targeted radionuclide therapy combined with immune checkpoint inhibition
Date and Time: 13-Mar-2023, 10:45 AM-12:15 PM
Presenter: Ass. Prof. E. Oosterwijk, Radboud UMC, Nijmegen, The Netherlands
Abstract ID: A1032

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 and follow Telix on Twitter (@TelixPharma) and LinkedIn.

TLX250-CDx has not received a marketing authorisation in any jurisdiction. 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),^[1] and by the Australian Therapeutic Goods Administration (TGA),^[2] and by Health Canada.^{^[3]}

Telix Investor Relations

Ms. Kyahn Williamson
Telix Pharmaceuticals Limited
SVP Corporate Communications and Investor Relations
Email: [email protected]

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.

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.

[1] ASX disclosure 20 December 2021.

[2] ASX disclosure 2 November 2021.

[3] ASX disclosure 14 October 2022.

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