• First patient dosed in Part 2 of ProstACT Global Phase 3 trial
• Trial evaluates Telix's lead prostate cancer therapy TLX591 with Standard of Care
• Part 2 to enroll approximately 490 patients across multiple countries

Telix Pharmaceuticals Limited has announced that the first patient has been dosed in Part 2 (randomized treatment expansion) of its ProstACT Global Phase 3 study evaluating its lead prostate cancer therapy candidate TLX591 (lutetium (177Lu) rosopatamab tetraxetan) in patients with metastatic castration resistant prostate cancer (mCRPC). The patient was dosed at the Australian Prostate Centre (APC) in Melbourne, Australia. ProstACT Global is the first Phase 3 trial to combine a PSMA-targeted radio antibody drug conjugate (rADC) therapy administered together with Standard of Care (SOC; abiraterone, enzalutamide or docetaxel) versus SOC alone. Part 2 of ProstACT Global will enroll approximately 490 patients and is currently recruiting patients in Australia, New Zealand and Canada. Telix will submit Part 1 data to the FDA to enable clearance to expand Part 2 of the trial to U.S. sites, and will also file a clinical trial application with the EMA to enable expansion into EU sites. The antibody approach of TLX591 demonstrates different targeting and pharmacology compared to other PSMA-targeted small peptide radioligand therapies, with collective long-term follow-up not observing significant acute or delayed kidney toxicity.