Telix Doses First Patient in Phase 3 LUTEON Trial of TLX250-Tx for Renal Cancer

About this update from Telix Pharmaceuticals Limited

MELBOURNE (Australia) and INDIANAPOLIS, July 21, 2026 (GLOBE NEWSWIRE) -- Telix Pharmaceuticals Limited (ASX: TLX, NASDAQ: TLX, "Telix") today announced that the first patient has been dosed with TLX250-Tx (lutetium-177 (177Lu) girentuximab tetraxetan) in the LUTEON study, the first radiopharmaceutical therapy to enter Phase 3 development for ccRCC. LUTEON is a randomized, prospective, open label, multi-center study evaluating a CAIX-targeting radionuclide therapy in patients with relapsed or recurrent ccRCC. The patient was dosed at GenesisCare Murdoch (Western Australia), under the supervision of Dr. Aviral Singh. Dr. Aviral Singh, Clinical Head of Theranostics and Nuclear Medicine at GenesisCare Murdoch and Principal Investigator on the LUTEON trial, commented, "Dosing the first patient in the LUTEON study marks an important milestone in the development of potential new treatment options for patients with relapsed or recurrent clear cell renal cell carcinoma. Despite advances in care, outcomes remain poor for many patients, underscoring the need for innovative therapeutic approaches. This study will play a critical role in evaluating the safety, tolerability and efficacy of this investigational CAIX-targeted radiopharmaceutical for patients globally, and we look forward to helping advance the clinical evidence for this promising therapeutic candidate." Dr. David N. Cade, Telix Group Chief Medical Officer, added, "LUTEON represents the next stage in Telix's global clinical development of TLX250-Tx and reflects our commitment to developing precision radiopharmaceuticals for patients with difficult-to-treat cancers. We aim to further evaluate the potential of TLX250-Tx that is designed to utilize the high prevalence of CAIX expression in ccRCC to deliver targeted radiation directly to tumor sites, while limiting exposure to healthy tissue." About TLX250-TxTLX250-Tx is a first-in-class CAIX-targeting rADC3 therapy candidate composed of a high-specificity monoclonal antibody chelated to the therapeutic radionuclide lutetium-177. CAIX is an attractive therapeutic target because it is expressed in more than 95% of ccRCC, while demonstrating limited expression in normal tissues, including kidney tissue4,5. LUTEON is being run under a Phase 3 protocol in Australia and forms part of Telix's global development program for TLX250-Tx, which includes the separa...

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