Telix (Melbourne, Australia) and Nantes-based ATONCO S.A.S. (‘ATONCO’) today announced that the final patient has been dosed in a Phase I study of TLX250-CDx in patients with non-muscle invasive bladder cancer (NMIBC) at the Institut de Cancérologie de l’Ouest (ICO) in St Herblain, France.

The objective of ‘PERTINENCE’ (NCT04897763), an investigator-led, open-label, proof of concept study, which has reached target enrolment of six patients, is to evaluate safety, biodistribution and dosing properties of TLX250-CDx (89Zr-DFO-girentuximab) given directly into the bladder in patients with NMIBC and establish CAIX as a potential therapeutic target in this condition. Should the trial prove successful, the next stage will be to commence therapeutic studies with astatine-211 (211At) for targeted alpha therapy (TAT). This is aligned with Telix’s strategy to both develop alpha therapeutics and expand potential indications for radiolabelled girentuximab (TLX250), targeting carbonic anhydrase IX (CAIX), a cell surface protein that is highly expressed in several human cancers including renal, bladder, lung and oesophageal cancers.

Alpha emitters such as 211At have the potential to deliver very high amounts of energy to cancer tissue whilst the short path length can decrease the risk of damage to surrounding healthy cells, increasing the selectivity and potency of the radiation treatment. Alpha emitters have the potential to be complementary to beta-emitters in different stages of disease.

Lutetium-labelled TLX250 (177Lu-DOTA-girentuximab) is currently being evaluated in clear cell renal cell carcinoma (ccRCC) in Phase II therapeutic studies in combination with checkpoint inhibitors (STARLITE 1 and 2), and the Company’s pivotal Phase III imaging study (ZIRCON) of TLX250-CDx (89Zr-DFO-girentuximab) also in ccRCC, has recently completed enrolment.

Principal Investigator for the PERTINENCE study, sponsored by ICO, Dr. Caroline Rousseau said, “We are pleased to have successfully completed enrolment in this proof-of-concept study, which we hope will improve our understanding of the imaging properties of TLX250-CDx in NMIBC and pave the way for studying astatine-labelled girentuximab as a targeted alpha therapy.”

Telix Chief Medical Officer, Dr Colin Hayward added, “We would like to congratulate Dr. Caroline Rousseau and her clinical team at ICO for recruiting this trial ahead of time, and extend our gratitude to all study participants for their commitment to exploring innovative treatment options for patients living with NMIBC. Subject to positive outcomes, we look forward to Atonco proceeding to therapeutic studies with astatine-211 and exploring targeted alpha therapy in bladder cancer, as part of Telix’s and Atonco’s drive to establish category leadership in urologic oncology.”

About Telix Pharmaceuticals Limited

Telix Pharmaceuticals Limited is a clinical-stage biopharmaceutical company focused on the development of diagnostic and therapeutic products using molecularly targeted radiation (MTR). The company is headquartered in Melbourne and has international offices in Brussels (EU), Kyoto (JP) and Indianapolis (US). Telix is developing a portfolio of clinical-stage oncology products that address significant unmet medical needs in prostate, kidney and brain (glioblastoma) cancer. Telix is listed on the Australian Securities Exchange (ASX: TLX).

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About ICO (Institut de Cancérologie de l’Ouest)

The ICO is a non-profit center of 1,400 professionals that fights cancer. It welcomes nearly 48,000 patients per year and provides the mission and service of a public hospital. With its four missions – Prevention, Care, Research and Education – the ICO offers a wide range of specialized expertise exclusively dedicated to cancer.

The integration of care, research and innovation is an integral part of the ICO. Research activities, which are a specific mission of the ICO, are undertaken from concept to clinical trials. Research is conducted in all cancer disciplines: medical oncology, radiotherapy, surgery, anesthesia, nuclear medicine, medical imaging, supportive care and human sciences. Patients treated at the ICO benefit from privileged access to cutting-edge clinical trials in oncology. The Innovation Center, which will open in 2021, is dedicated to supporting innovation in oncology, and thus supports internal and external projects, from concept to operational deployment.

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ATONCO is a privately held French company developing molecularly targeted radiopharmaceuticals for oncology applications. Originating from the world-class nuclear medicine cluster in Nantes, France, ATONCO and its partners are committed to the clinical use of alpha-emitting radionuclides, in particular astatine-211 (²¹¹At).

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