First Patient Dosed in Phase III ZIRCON-CP Trial of TLX250-CDx for Kidney Cancer Imaging in Chinese Patients

MELBOURNE, Australia, Nov. 28, 2024 /PRNewswire/ -- Telix Pharmaceuticals Limited (ASX: TLX; Nasdaq: TLX, Telix, the Company) and Grand Pharmaceutical Group Limited (00512.HK, Grand Pharma) today announce that a first patient has been dosed in the Phase III ZIRCON-CP trial of TLX250-CDx positron emission tomography (PET) imaging of clear cell renal cell carcinoma (ccRCC). The patient was successfully dosed and imaged at Beijing Cancer Hospital in Beijing, China.

ZIRCON-CP is a multi-centre Phase III registration trial in China intended to bridge to Telix's global Phase III ZIRCON trial, which met all co-primary and secondary endpoints, including showing 86% sensitivity and 87% specificity, and a mean positive-predictive value (PPV) of 93% for ccRCC^[1]. The trial, which will enrol up to 82 patients, is being conducted in collaboration with the Company's strategic partner for the Greater China region, Grand Pharma, to demonstrate that the diagnostic utility of TLX250-CDx is equivalent in Chinese and Western populations. The clinical data from ZIRCON-CP is intended to support future marketing authorisation applications for this breakthrough technology.

Greater China represents a major market opportunity for radiopharmaceuticals, including TLX250-CDx, driven by increasing cancer incidence rates and an investment in installation of PET/CT cameras. In China alone – 73,000 people are newly diagnosed with kidney cancer each year^[2].

Dr David N. Cade, Chief Medical Officer at Telix said, "Dosing and imaging a first patient in the ZIRCON-CP trial is a significant milestone for Telix and our partner Grand Pharma. We would like to thank Professor Peng Du and his team, as well as the patients who will contribute to this important trial, helping to advance TLX250-CDx towards regulatory filings in Greater China, where there is currently critical unmet medical need."

About TLX250-CDx

TLX250-CDx (Zircaix®^[3]) is an investigational PET agent that is under development to characterise indeterminate renal masses (IRMs) as ccRCC or non-ccRCC in a non-invasive manner. Telix's pivotal Phase III ZIRCON trial (Zirconium in Renal Cancer Oncology, ClinicalTrials.gov ID: NCT03849118) evaluating TLX250-CDx in 300 patients, of which 284 were evaluable, met all primary and secondary endpoints including showing 86% sensitivity and 87% specificity and a 93% positive-predictive value for ccRCC across three independent readers. We believe this demonstrated the ability of TLX250-CDx to reliably detect the clear cell phenotype and provide an accurate, non-invasive method for diagnosing ccRCC. Confidence intervals exceeded expectations in all three readers, showing evidence of high accuracy and consistency of interpretation.

As part of Telix's commitment to access to medicine, the Company continues to run an expanded access program (EAP) in the U.S.^[4], named patient programs (NPPs) in Europe, and a special access scheme (SAS) in Australia to allow continued access to TLX250-CDx outside of a clinical trial to patients for whom there are no comparable or satisfactory alternate options.

Telix's Policy on Offering Compassionate Use to Investigational Medicines can be downloaded at the following link.

About Telix Pharmaceuticals Limited

Telix is a biopharmaceutical company focused on the development and commercialisation of therapeutic and diagnostic radiopharmaceuticals and associated medical technologies. 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) and the Nasdaq Global Select Market (Nasdaq: 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 U.S. Food and Drug Administration (FDA)^[5], by the Australian Therapeutic Goods Administration (TGA)^[6], and by Health Canada^[7]. 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, 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 X and LinkedIn.

Telix Investor Relations

Ms. Kyahn WilliamsonTelix Pharmaceuticals LimitedSVP Investor Relations and Corporate CommunicationsEmail: kyahn.williamson@telixpharma.com

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©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.