New ZIRCON Phase III Data Presented at SNMMI: Potential Utility of TLX250-CDx in Staging and Monitoring ccRCC

MELBOURNE, Australia, June 27, 2023 /PRNewswire/ -- Telix Pharmaceuticals Limited (ASX: TLX, Telix, the Company) today announces further details of the positive results from its completed pivotal Phase III ZIRCON study of TLX250-CDx (⁸⁹Zr-DFO-girentuximab) in clear cell renal cell carcinoma (ccRCC) (ClinicalTrials.gov Identifier: NCT03849118).

New data demonstrates the ability of TLX250-CDx to detect extrarenal lesions, supporting potential clinical utility in the metastatic or recurrent setting, and for staging and informing treatment decisions.

TLX250-CDx PET/CT detected more lesions in liver and bone than diagnostic CT imaging alone. This reinforces the performance of this investigational diagnostic imaging agent across all analyses, with previously presented data showing an excellent overall sensitivity and specificity of 86% and 87%, respectively, together with high intra-reader agreement.^{[1], [2]}

The results were featured in an oral presentation delivered on Monday, 26 June 2023 (CDT) by Jeremie Calais, MD, Director of the Clinical Research Program of the Ahmanson Translational Theranostics Division of the Department of Molecular and Medical Pharmacology at University of California, Los Angeles (UCLA), and a principal investigator in the Phase III ZIRCON study, at the Society of Nuclear Medicine and Molecular Imaging (SNMMI) 2023 Annual Meeting in Chicago.

New data presented:

• 25 patients had ≥1 extrarenal lesions detected by whole body PET/CT (n=10), abdominal PET/CT (n=17), or both modalities (n=2)
• Extrarenal lesions were mostly localised in bone, liver, lung, adrenal glands and lymph nodes

Jeremie Calais, MD commented, "It is a pleasure to be showcasing further results from Telix's highly successful Phase III ZIRCON study at SNMMI, the premier educational, scientific, research, and networking event in nuclear medicine and molecular imaging worldwide. Data presented here in Chicago on extrarenal lesions demonstrates potential utility of TLX250-CDx for staging and monitoring high risk patients where there is a great deal of interest from the clinician community."

Telix is in the process of implementing an expanded access program in the United States and establishing named patient programs for TLX250-CDx in Europe.

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).

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 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),^[3] and by the Australian Therapeutic Goods Administration (TGA),^[4] and by Health Canada.^[5] Telix is also progressing marketing authorisation applications for this investigational candidate in the United Kingdom and the European Union.^[6]

Telix Investor Relations

Ms. Kyahn WilliamsonTelix Pharmaceuticals LimitedSVP Corporate Communications and Investor RelationsEmail: kyahn.williamson@telixpharma.com

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