Company Announcements

MELBOURNE, Australia, Sept. 10, 2024 /PRNewswire/ -- Telix Pharmaceuticals Limited (ASX: TLX, Telix, the Company) today announces that primary results from its Phase III ZIRCON^[1] trial have been published in The Lancet Oncology, reporting that Telix's first-in-class investigational PET^[2] agent, TLX250-CDx (Zircaix®^[3], ⁸⁹Zr-girentuximab), is highly accurate in detecting and characterising clear cell renal cell carcinoma (ccRCC) in patients with indeterminate renal masses (IRMs).

In this peer-reviewed manuscript, Professor Brian Shuch (University of California, Los Angeles, UCLA) and colleagues report results from this prospective, open-label, multicentre, Phase III trial in which 300 patients with an IRM ≤7cm (cT1) received TLX250-CDx. Authors conclude that TLX250-CDx "has a favourable safety profile and is a highly accurate, non-invasive imaging modality for the detection and characterisation of ccRCC, which has the potential to be practice changing."

Authors explain that small masses in the kidney are increasingly being detected incidentally when patients undergo abdominal imaging, often for other health conditions, contributing to "an era of gross overtreatment". Diagnosis and treatment are limited by current imaging techniques, and renal mass biopsy is invasive, which can often lead to complications. Up to 30% of patients undergo unnecessary surgery, removing masses that are later determined to be benign^[4]. If confirmed, however, ccRCC is the most common and aggressive form of kidney cancer, and delays in diagnosis can significantly reduce survival rates.

Professor Brian Shuch, MD, Director of the Kidney Cancer Program and the Alvin & Carrie Meinhardt Endowed Chair in Kidney Cancer Research at UCLA Institute of Urologic Oncology, and a ZIRCON principal investigator, said, "Until now, assessing whether renal masses are cancerous has been difficult and often involves invasive surgery or percutaneous biopsy. This is because standard imaging technology – either a CT or MRI scan – cannot reliably differentiate between benign or malignant renal lesions or provide information about disease biology.

"The challenges and uncertainty in diagnosing ccRCC underscore a critical unmet need for a new, non-invasive technique that accurately detects and differentiates ccRCC from other renal masses in patients, to inform clinical decision making. The ZIRCON trial has shown that TLX250-CDx is a breakthrough technology that can address this need."

TLX250-CDx is a zirconium-89 (⁸⁹Zr) radiolabelled monoclonal antibody that targets carbonic anhydrase IX (CAIX), a tumour-associated antigen highly expressed in ccRCC. Following successful Phase I and II trials to establish safety and preliminary efficacy, the ZIRCON trial was designed to assess sensitivity and specificity of TLX250-CDx PET/CT imaging to non-invasively detect ccRCC in patients with cT1 IRMs (≤7 cm in diameter) who underwent nephrectomy, using central histological confirmation as standard of truth.

Key findings of the ZIRCON trial, outlined in the paper, include:

• ⁸⁹Zr-girentuximab PET/CT imaging accurately detected ccRCC in patients with cT1 IRM (≤7cm), demonstrating a mean sensitivity of 86%, specificity of 87% and positive predictive value of 93%
• ⁸⁹Zr-girentuximab PET/CT imaging has high diagnostic performance for detection and characterisation of small and very small renal masses
• The primary and secondary endpoints were met by all three radiology readers and exceeded pre-specified thresholds. Inter-reader variability indicated robust agreement among the readers and intra-reader variability was 100%, indicating perfect agreement
• No safety concerns associated with the administration of ⁸⁹Zr-girentuximab were revealed
• Imaging performed 5±2 days after administration is sufficient to visualise and assess ccRCC lesions, with the flexible imaging window offering several advantages for patient management
• The non-invasive nature of this technique may be especially beneficial to those at risk of complications from a surgical renal mass biopsy.

Dr David N. Cade, Chief Medical Officer at Telix said, "The results of the ZIRCON trial make a compelling case for TLX250-CDx as a breakthrough product for kidney cancer imaging, and validate CAIX as a novel target to accurately identify renal cell carcinoma.

"Professor Shuch and his co-investigators, at 36 sites worldwide, found that its high diagnostic performance, including for very small lesions, may support early and accurate diagnosis, inform patient risk stratification and clinical decision making, and reduce over- and under-treatment. We believe this result will lead to improved patient outcomes".

If approved by the United States (U.S.) Food and Drug Administration (FDA), TLX250-CDx will be the first and only targeted PET agent specifically for kidney cancer to be commercially available in the U.S.

The full paper can be found at: https://www.thelancet.com/journals/lanonc/article/PIIS1470-2045(24)00402-9/fulltext

About TLX250-CDx (Zircaix®³)

TLX250-CDx (Zircaix®³) is an investigational radiodiagnostic PET agent that is under development to characterise IRMs as ccRCC or non-ccRCC in a non-invasive manner. Telix's pivotal Phase III ZIRCON trial evaluating TLX250-CDx in 300 patients, of which 284 were evaluable, was completed in 2022 and met all primary and secondary endpoints^[5].

About Telix Pharmaceuticals Limited

Telix is a biopharmaceutical company focused on the development and commercialisation of therapeutic and diagnostic radiopharmaceuticals and associated medical devices. 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 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).

Telix's lead imaging product, gallium-68 (⁶⁸Ga) gozetotide injection (also known as ⁶⁸Ga PSMA-11 and marketed under the brand name Illuccix®), has been approved by the FDA^[6], by the Australian Therapeutic Goods Administration (TGA)^[7], and by Health Canada^[8]. No other Telix product has received a marketing authorisation in any jurisdiction.

Visit www.telixpharma.com for further information about Telix, including details of the latest share price, announcements made to the ASX, investor and analyst presentations, news releases, event details and other publications that may be of interest. You can also follow Telix on X and LinkedIn.

Telix Investor Relations

Ms. Kyahn Williamson
Telix Pharmaceuticals Limited
SVP Investor Relations and Corporate Communications
Email: kyahn.williamson@telixpharma.com

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) 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 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 commercialisation 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; 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.

©2024 Telix Pharmaceuticals Limited. The Telix Pharmaceuticals®, Illuccix® and Zircaix®³ names and logos are trademarks of Telix Pharmaceuticals Limited and its affiliates – all rights reserved.

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