First Patient Dosed in Phase II TLX250-CDx Trial for Recurrent Kidney Cancer Detection

MELBOURNE, Australia, Oct. 03, 2024 - Telix Pharmaceuticals Limited (ASX: TLX, Telix, the Company) announced the initiation of a Phase II clinical trial to investigate the efficacy of TLX250-CDx (89Zr-girentuximab) in detecting recurrent clear cell renal cell carcinoma (ccRCC) post-surgery. This PET agent aims to identify the recurrence of ccRCC, including metastatic cases, in a non-invasive manner. The trial, named 'CA-NINE,' is being led by Professor Brian Shuch at the University of California, Los Angeles (UCLA).

The CA-NINE trial is a prospective, single-centre study that will compare the diagnostic performance of TLX250-CDx using PET/CT to traditional imaging methods, such as contrast-enhanced CT alone. A total of 91 patients, who are at intermediate-to-high risk of ccRCC recurrence after surgery, will participate in the study. This trial is part of a series of planned and ongoing studies aimed at expanding the potential application of TLX250-CDx.

Professor Brian Shuch, MD, Director of the Kidney Cancer Program at UCLA, commented on the significance of the trial. According to him, Telix's previous ZIRCON trial showed the efficacy of TLX250-CDx in diagnosing localized ccRCC. However, the current focus is on metastatic ccRCC, a condition that claims many lives. The CA-NINE trial aims to extend the utility of TLX250-CDx beyond localized disease, given the presence of the CAIX biomarker in metastatic ccRCC. Professor Shuch expressed his enthusiasm for exploring this new frontier in kidney cancer management.

Associate Professor Jeremie Calais, MD, also a part of the CA-NINE trial, highlighted the potential benefits of TLX250-CDx. He emphasized that traditional imaging methods have limitations in staging ccRCC. He expressed optimism that the PET agent will improve patient outcomes by providing better insight into recurrent disease outside the kidney.

Dr. David N. Cade, Chief Medical Officer at Telix, expressed satisfaction over the dosing of the first patient in the CA-NINE trial. He acknowledged the efforts of Professor Shuch and Associate Professor Calais, and stressed the importance of this trial in addressing unmet medical needs in kidney cancer.

TLX250-CDx, known as Zircaix® (89Zr-girentuximab), is an investigational PET agent developed to non-invasively differentiate between ccRCC and non-ccRCC renal masses. Telix has already completed a pivotal Phase III ZIRCON trial, which involved 300 patients, of whom 284 were evaluable. The trial met all primary and secondary endpoints, demonstrating 86% sensitivity, 87% specificity, and a 93% positive-predictive value for ccRCC. These results highlighted the high accuracy and consistency of TLX250-CDx in detecting the clear cell phenotype.

In line with its commitment to enhancing medical access, Telix continues to operate an Expanded Access Program (EAP) in the U.S., named patient programs (NPPs) in Europe, and a special access scheme (SAS) in Australia. These programs provide TLX250-CDx to patients who have no comparable or satisfactory alternative treatment options outside clinical trials.

Telix Pharmaceuticals Limited, headquartered in Melbourne, Australia, specializes in the development and commercialization of radiopharmaceuticals and related medical devices for therapeutic and diagnostic purposes. The company operates internationally in the United States, Europe, and Japan. It is committed to addressing significant unmet medical needs in oncology and rare diseases. Telix's lead imaging product, gallium-68 (68Ga) gozetotide injection (marketed as Illuccix®), has received approval from the U.S. FDA, the Australian Therapeutic Goods Administration, and Health Canada.