Telix (Melbourne, Australia) and Nantes-based company ATONCO S.A.S. (‘ATONCO’) today announced that the last patient has been treated 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 open-label, investigator-led proof-of-concept study that has reached its recruitment target of six patients, is to evaluate the safety, biodistribution, and dosimetric properties of TLX250-CDx (⁸⁹Zr-DFO-girentuximab) administered directly into the bladder in NMIBC patients, and to establish CAIX as a potential therapeutic target in this disease. If the trial proves conclusive, the next step will be to initiate therapeutic studies with astatine-211 (²¹¹At) for targeted alpha therapy (TAT). This aligns with Telix’s strategy to both develop alpha therapies and expand the potential indications of radiolabelled girentuximab (TLX250), which targets Carbonic Anhydrase IX (CAIX), a cell surface protein highly expressed in several human cancers, including renal, bladder, lung, and oesophageal cancers.
Alpha emitters such as ²¹¹At have the ability to deliver very large amounts of energy to cancerous tissues, while their short path length can reduce the risk of damaging surrounding healthy cells, thereby increasing the selectivity and potency of radiotherapy. Alpha emitters may be complementary to beta emitters at different stages of the 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 Phase III imaging pivotal study (ZIRCON) of TLX250-CDx (⁸⁹Zr-DFO-girentuximab), also in ccRCC, has recently completed enrolment.
Dr Caroline Rousseau, Principal Investigator of the ICO-sponsored PERTINENCE study: “We are pleased to have successfully completed recruitment 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-211-labelled girentuximab as a targeted alpha therapy.”
Dr Colin Hayward, Chief Medical Officer of Telix: “We would like to congratulate Dr Caroline Rousseau and her clinical team at ICO for recruiting this trial ahead of schedule, and express our gratitude to all study participants for their commitment to exploring innovative treatment options for patients living with NMIBC. Subject to positive results, we look forward to Atonco progressing to therapeutic studies with astatine-211 and exploring targeted alpha therapy in bladder cancer, as part of Telix and Atonco’s ambition to establish leadership in urological oncology.”
About Telix Pharmaceuticals Limited
Telix Pharmaceuticals Limited is an Australian clinical-stage biopharmaceutical company focused on the development of diagnostic and therapeutic products using targeted molecular radiotherapy (TMR). The company is headquartered in Melbourne with international offices in Brussels (EU), Kyoto (JP), and Indianapolis (US). Telix is developing a portfolio of clinical-stage oncology products addressing significant unmet medical needs in prostate, kidney, and brain (glioblastoma) cancers. Telix is listed on the Australian Securities Exchange (ASX: TLX).
For more information, visit www.telixpharma.com
About the Institut de Cancérologie de l’Ouest (ICO)
The ICO is a non-profit cancer centre with 1,400 professionals dedicated to fighting cancer. It welcomes nearly 48,000 patients per year and fulfils the mission and service of a public hospital. With its four missions – Prevention, Care, Research, and Education – the ICO offers broad and specialized expertise exclusively dedicated to oncology.
The integration of care, research, and innovation is an integral part of the ICO. Research activities, which constitute a specific mission of the ICO, are undertaken from concept through to clinical trials. Research is conducted across all disciplines of oncology: medical oncology, radiotherapy, surgery, anaesthesia, 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 Centre, opened in 2021, is dedicated to supporting innovation in oncology, backing both internal and external projects from concept through to operational deployment.
For more information, visit www.institut-cancerologie-ouest.com
About ATONCO
ATONCO is a French private company developing molecularly targeted radiopharmaceutical products for oncological applications. Originating from the world-class nuclear medicine centre in Nantes, ATONCO and its partners are committed to the clinical use of alpha-emitting radionuclides, particularly astatine-211 (²¹¹At).
For more information, visit www.atonco-pharma.com