TLX News & Events

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.

Telix Pharmaceuticals announced that the first patient has been dosed with TLX101-Tx in Telix's pivotal IPAX BrIGHT trial, marking the first radiopharmaceutical therapy to enter Phase 3 development for glioblastoma, an aggressive form of brain cancer. The patient was dosed at Austin Health in Melbourne, Australia, under the supervision of Professor Hui Gan. IPAX BrIGHT is assessing the safety and efficacy of TLX101-Tx in combination with chemotherapy, compared to chemotherapy alone. The global, multicenter, open-label study will enroll patients with radiographically confirmed recurrent glioblastoma at first recurrence. Professor Gan, Director of Cancer Clinical Trials at Austin Health, said, "Based on the prior safety profile and early efficacy data for TLX101-Tx in the IPAX-1 and IPAX-Linz studies, I am pleased to continue to explore this therapeutic modality in the first radiopharmaceutical pivotal trial in recurrent glioblastoma, where there are currently few effective treatment options."

Telix Pharmaceuticals (TLX) and Regeneron Pharmaceuticals (REGN) announce a collaboration to jointly develop and commercialize next generation radiopharmaceutical therapies. The collaboration combines Telix's radiopharmaceutical development platform, global manufacturing capabilities and supply chain infrastructure with Regeneron's extensive biologics expertise, including bispecific antibody discovery. The collaboration will include multiple solid tumor targets from Regeneron's portfolio of antibodies, generated from VelocImmune mice. With a shared commitment to precision oncology, the parties also plan to develop radio-diagnostics to support patient selection and treatment response assessment. Under the terms of the agreement, Telix will receive an upfront cash payment of $40M from Regeneron for access to its radiopharmaceutical manufacturing platform for four initial therapeutic programs, with Regeneron having the option to expand to include four additional programs with additional upfront payments. Telix and Regeneron will share equally in the global commercialization costs and potential profits, with Telix retaining the option to co-promote certain potential products. Should Telix opt-out of the co-funding model for a particular program, it is instead eligible to receive up to $535M in development and commercial milestones, plus low double-digit royalites on future net sales, for that program. Telix and Regeneron will also jointly develop diagnostic assets, with Telix leading commercialization and Regeneron receiving a set percentage of profits.