Telix Pharmaceuticals Enters into Collaboration Letters of Intent with EDAP and Profound Medical
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.
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- Strategic Collaboration Agreement: Telix Pharmaceuticals and United Imaging Healthcare have signed a Memorandum of Understanding in the U.S. to evaluate a strategic research collaboration aimed at advancing integrated theranostics solutions, fostering innovation in medical technology.
- Focus on Molecular Imaging: The partnership will initially assess Telix's molecular imaging portfolio and validated clinical protocols in conjunction with United Imaging's advanced scanner platforms, enhancing the efficiency of imaging diagnostics and treatment.
- Product Development Outlook: The collaboration will initially focus on TLX101-Px (Pixclara), a PET imaging candidate that has received FDA Fast Track and Orphan Drug designations, with a New Drug Application decision expected on September 11, 2026.
- Market Expansion Potential: This collaboration not only aids in product development within the U.S. market but also has the potential to expand into additional markets, further driving Telix's market share in the biopharmaceutical sector.
- Safety and Tolerability: Among 36 patients treated with TLX591-Tx, all received both doses per protocol with no new safety signals identified, where the most common adverse events were fatigue (53%) and nausea (28%), indicating good tolerability alongside standard treatments.
- Dosimetry and Pharmacokinetics: Radiation exposure to key organs was well below safety limits, with the highest absorbed dose in the liver ranging from 1.62 to 5.08 mGy/MBq, ensuring patient safety during treatment.
- Clinical Trial Progress: Part 2 of the randomized treatment expansion has commenced in jurisdictions with regulatory approval, targeting approximately 490 patients to further validate the efficacy of TLX591-Tx in combination with standard care.
- Market Potential: Telix's Chief Medical Officer noted that despite significant advances in clinical practice, mCRPC patients urgently need new treatment options, and the positive results from TLX591-Tx may introduce a new therapeutic avenue in this field.
- Patient Enrollment Completed: Telix Pharmaceuticals announced the completion of patient enrollment for the IPAX-2 study of TLX101-Tx (¹³¹I-iodofalan) in newly diagnosed glioblastoma patients, marking a significant milestone in the drug's development.
- Safety of Maximum Dose Confirmed: The study reached a maximum administered dose of 10GBq without any dose-limiting toxicities (DLTs) observed, providing strong support for the continued development of TLX101-Tx as a potential treatment for glioblastoma.
- Multicenter Study Design: The IPAX-2 study is an international, multicenter, open-label Phase 1 dose-finding study involving four sites across Australia, Austria, and the Netherlands, enrolling 12 patients to assess the safety and tolerability of TLX101-Tx in combination with standard treatment.
- Follow-up Clinical Trial Plans: TLX101-Tx is also under evaluation in the IPAX BrIGHT trial, assessing its combination with chemotherapy (lomustine), which is expected to be the first radiopharmaceutical therapy to enter Phase 3 development for glioblastoma, further advancing its clinical application.
- Partnership Formation: Telix has signed letters of intent with EDAP TMS and Profound Medical to develop advanced minimally invasive and image-guided technologies for prostate cancer treatment, marking a strategic expansion in the prostate cancer treatment landscape.
- Technology Integration: The collaboration will explore the integration of Telix's PSMA-PET imaging agents with high-intensity focused ultrasound (HIFU) and other treatment modalities, aiming to optimize treatment efficacy while minimizing side effects, thereby enhancing patient experience.
- Clinical Evidence Generation: The partnership will focus on generating clinical evidence to support the establishment of best practices, which is expected to accelerate the adoption of PSMA-PET imaging technology in prostate cancer treatment and promote the development of personalized medicine.
- Market Leadership: Telix's CEO emphasized that as minimally invasive technologies continue to evolve, the importance of PSMA-PET imaging in clinical decision-making is increasingly significant, and this collaboration will further solidify Telix's leadership position in the prostate cancer treatment market.

- Significant Predictive Value: The independent analysis reveals that TLX250-Px PET/CT imaging demonstrates high predictive capability across all renal cancer subtypes, particularly in non-clear cell renal cell carcinoma (nccRCC), with a reported positive predictive value (PPV) of 98%, providing crucial insights for early diagnosis of renal malignancies.
- Impact on Clinical Management: Results from the ZIRCON trial indicate that nearly 48.6% of patients imaged with TLX250-Px could experience changes in clinical management, showcasing the technology's potential in optimizing treatment decisions, especially in differentiating tumor types.
- Scientific Recognition: The findings published in European Urology reflect the scientific rigor of the ZIRCON trial, supporting the broader application of TLX250-Px in renal cancer management and potentially reducing unnecessary overtreatment.
- Expansive Market Potential: As TLX250-Px's applications in renal imaging continue to expand, Telix is poised to secure a significant position in the global market, particularly in the non-invasive diagnosis and management of renal cancer patients.
- Clinical Trial Progress: Telix Pharmaceuticals presented dosimetry data for TLX597-Tx from the Phase 2 OPTIMAL-PSMA trial involving 120 men with metastatic castration-resistant prostate cancer, utilizing a novel dose-intensification regimen to enhance treatment efficacy.
- Reduced Side Effects: Initial dosimetry data indicates low uptake in salivary glands and kidneys, supporting dose intensification, which helps minimize adverse effects such as xerostomia and renal toxicity for patients.
- Enhanced Tumor Uptake: TLX597-Tx demonstrates higher tumor uptake levels compared to existing PSMA radioligand therapies, suggesting potential advantages in treatment effectiveness and improved patient outcomes.
- Future Research Plans: The company is initiating the OPTIMAL-E Phase 2 study for androgen pathway-sensitive prostate cancer while advancing TLX591-Tx in the Phase 3 ProstACT global trial, showcasing its ongoing innovation in prostate cancer treatment.







