TLX News & Events

Telix Pharmaceuticals announces that the IPAX-2 study1 of TLX101-Tx in patients with newly diagnosed glioblastoma has completed patient enrolment. No dose-limiting toxicities have been observed to date, including with two doses of 5GBq, the maximum administered dose in the study.

Telix Pharmaceuticals (TLX) announces that it has entered into letters of intent, or LoI, to pursue collaborations with EDAP TMS (EDAP) and Profound Medical (PROF), companies developing advanced minimally invasive and image-guided treatment ablative technologies for prostate cancer, including focal, subtotal, and whole-gland treatment approaches. These initiatives reflect Telix's commitment to advancing the integration of molecular imaging into the evolving prostate cancer treatment landscape to help inform clinical decision-making. The collaborations will explore the investigational use of Telix's PSMA-PET1 imaging agents Gozellix and Illuccix with robotic high-intensity focused ultrasound, or HIFU, and other image-guided therapies designed to treat localized prostate cancer, such as transurethral ultrasound ablation, or TULSA. Telix's intention is to work with select partners to explore how PSMA-PET imaging may support emerging therapy workflows, which aim to preserve healthy tissue and minimize the risk of side effects such as incontinence and impotence. Collaborative activities will focus on non-promotional scientific, educational, and research engagement.

Telix Pharmaceuticals announced the publication of a new independent analysis of Phase 3 ZIRCON trial data in European Urology, demonstrating that TLX250-Px PET/CT3 imaging may be highly predictive of renal malignancy across all subtypes, not limited to clear cell renal cell carcinoma. Recognizing that carbonic anhydrase IX expression is also observed in other renal cancer subtypes, this subsequent analysis conducted by international investigators who participated in ZIRCON Phase 3 trial, evaluated centrally reviewed imaging and pathology data to explore whether tracer uptake in renal masses correlated with malignancy beyond ccRCC. The analysis demonstrated that positive PET findings were highly predictive of malignancy overall, including in non-clear cell renal cell carcinoma, with a reported positive predictive value of 98%, sensitivity of 82%, and specificity of 87%. These exploratory scientific findings suggest TLX250-Px has applications beyond the detection of ccRCC in primary renal masses and may have implications to management of nccRCC. David Cade, group CMO at Telix, added: "Publication of these data in European Urology reflects the scientific strength of the ZIRCON trial and the robustness of its central imaging and pathology review. While ZIRCON was designed to address ccRCC, this analysis supports continued evaluation of TLX250-Px PET imaging across a broader spectrum of renal malignancies, with potential application in the management of patients with non-clear cell RCC. Furthermore, essentially all false-positives for ccRCC in the ZIRCON study have now been shown to be other malignant kidney cancer subtypes, reducing the risk of overtreatment and further supporting clinical adoption."

Telix Pharmaceuticals announces that the marketing authorization application, or MAA, filed in Europe for TLX101-Px, its glioma imaging candidate, has been validated and accepted for review. The application, covering commercially significant European markets, has now moved into a 210-day active assessment phase. Telix is seeking to expand patient access to advanced brain imaging through a broad clinical label, reflective of current clinical practice guidelines. Assuming a positive outcome from the application at Day 210, national marketing authorizations are expected to follow shortly after. In Europe, there is currently no generally available commercial product for PET5 imaging of glioma with 18F-FET, resulting in an acute and immediate need for a consistent, high-quality product. Through this MAA, Telix aims to expand patient access to advanced imaging that can distinguish progressive or recurrent glioma from treatment-related changes in both adults and children, with potential for additional future indications.