First Patient Dosed in Study of Targeted Alpha Therapy Candidate for Bladder Cancer

Melbourne (Australia) and Nantes (France) – 21 December 2021. Telix announces that a first patient has been dosed in the ‘PERTINENCE’ Phase I study of TLX250-CDx in patients with non-muscle-invasive bladder cancer

Telix and Nantes-based ATONCO S.A.S. are pleased to announce that a first 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’ an investigator-led open-label, proof of concept study, is to evaluate safety, biodistribution and dosing properties of TLX250-CDx (⁸⁹Zr-DFO-girentuximab) in patients with NMIBC. The PERTINENCE study builds on the Telix and ATONCO licence and development agreement announced in December 2019, and will be led by Dr. Caroline Rousseau at ICO. It will recruit 6 patients over 12 months, with a successful outcome leading to therapeutic studies with astatine-211 (²¹¹At) for targeted alpha therapy (TAT). TLX250-CDx (girentuximab) targets carbonic anhydrase IX (CA9), a receptor that is overexpressed in many solid tumours, including urologic malignancies. 

The study is aligned with Telix’s focus on the development of alpha therapy in future pipeline expansion and its strategy to pursue additional indications for the CA9 target, a core pipeline asset, which is currently being evaluated in clear cell renal cell carcinoma (ccRCC) in the company’s Phase III imaging study (ZIRCON) and Phase II therapeutic studies (STARLITE 1 and 2). 

PERTINENCE is the third in a comprehensive series of studies investigating CA9 as a target for molecularly-targeted radiation (MTR) in other tumour types as well as providing a pathway to evaluate TLX250 with an alpha emitting isotope for the first time in humans.   

Alpha emitters 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.  

The two other studies evaluating CA9 (ZiP-UP and OPALESCENCE) have been initiated for urothelial carcinoma or bladder cancer, and triple negative breast cancer, respectively, with other collaborative studies in development for ovarian, colorectal, head and neck, lung, and pancreatic cancers. 

Principal Investigator for the PERTINENCE study, sponsored by ICO, Dr. Caroline Rousseau said, “CA9 is a very interesting target that is highly expressed in many hypoxic solid tumors. This study builds on the clinical work we are already doing with CA9 in the OPALESCENCE study and will help us generate a better understanding of the imaging properties of TLX250-CDx in NMIBC as a precursor to studying the role of girentuximab as a therapy with an alpha emitting radioisotope.”  

ATONCO CEO, Sylvain Fanier continued, “We are excited to extend our partnership with Telix, one of the most respected companies in nuclear medicine, and to develop an innovative MTR solution with our local academic and industry partners in Nantes, to improve therapeutic options for patients suffering from NMIBC.” 

Telix Chief Medical Officer, Dr. Colin Hayward added, “We are pleased to further our collaboration with ATONCO to explore girentuximab as a base for therapy with the alpha-emitting radioisotope astatine-211 (²¹¹At) as well as extending and accelerating development options to numerous cancer types where there is unmet medical need. We would like to express our gratitude to Dr. Caroline Rousseau and her clinical team at ICO, as well as the patients that will contribute to this ground breaking study.” 

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