First Patient Dosed in Phase II 'CA-NINE' Trial of TLX250-CDx for Detection of Recurrent Kidney Cancer After Surgery

MELBOURNE, Australia, Oct. 4, 2024 /PRNewswire/ -- Telix Pharmaceuticals Limited (ASX: TLX, Telix, the Company) today announces that the first patient has been dosed in a Phase II trial exploring the clinical utility of Telix's first-in-class investigational PET^[1] agent, TLX250-CDx (⁸⁹Zr-girentuximab) in recurrent clear cell renal cell carcinoma (ccRCC) after surgery.

'CA-NINE'^[2] – led by Professor Brian Shuch at University of California, Los Angeles (UCLA) – is a Phase II prospective, single-centre trial comparing the diagnostic performance of TLX250-CDx PET/CT^[3] to conventional imaging (contrast-enhanced CT alone) in 91 patients with intermediate-to-high risk ccRCC post-surgery. The investigator-initiated trial is designed to identify ccRCC where it has recurred, including metastatic disease, and is one of multiple trials either underway or planned, which may inform future label expansion for TLX250-CDx.

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 Principal Investigator on the CA-NINE trial, said, "Telix's ZIRCON trial demonstrated the accuracy of TLX250-CDx at diagnosing localised ccRCC. However, we know that many patients die of metastatic disease, where the cancer has spread. There are plenty of data showing that metastatic ccRCC also expresses the carbonic anhydrase IX (CAIX) biomarker, which demonstrates potential use beyond localised ccRCC. We are on the cusp of a revolution in how we detect and manage advanced kidney cancer before and after surgery, and I'm excited to work with Telix to hopefully bring this technology to patients should it receive regulatory approval."

Associate Professor Jeremie Calais, MD, Director of the Theranostics Program of the Ahmanson Translational Theranostics Division of the Department of Molecular and Medical Pharmacology at UCLA School of Medicine, and an investigator on the CA-NINE trial, added, "With TLX250-CDx it is exciting that we can now characterise indeterminate renal masses with greater confidence. However, this only scratches the surface of the clinical potential of this investigational agent. With conventional imaging, we are very limited in our ability to stage patients, and we are hopeful that this investigational agent will improve patient outcomes by shedding light on sites of recurrent ccRCC outside of the kidney."

Dr David N. Cade, Chief Medical Officer at Telix continued, "We are pleased that a first patient has been imaged in the CA-NINE trial, which supports potential label expansion for TLX250-CDx into recurrent, metastatic disease. We would like to thank Professor Shuch and Associate Professor Calais at UCLA for their commitment to addressing unmet medical need in kidney cancer, as well as the patients who will contribute to this important trial."

About TLX250-CDx

TLX250-CDx (Zircaix®^{[4] 89}Zr-girentuximab) is an investigational PET agent that is under development to characterise indeterminate renal masses as ccRCC or non-ccRCC in a non-invasive manner. Telix's pivotal Phase III ZIRCON trial (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^[5]. 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.^[6], 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 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 U.S. Food and Drug Administration (FDA)^[7], by the Australian Therapeutic Goods Administration (TGA) ^[8], and by Health Canada^[9]. No other Telix product has received a marketing authorisation in any jurisdiction.

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Telix Investor Relations

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

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