ATONCO announces that the first patient has been dosed in the Phase I ‘PERTINENCE’ study of TLX250-CDx in patients with non-muscle-invasive bladder cancer.

Telix Pharmaceuticals and ATONCO are pleased to announce that the first patient has been treated in the PERTINENCE feasibility study 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 the PERTINENCE study, an investigator-led, open-label proof-of-concept study, is to evaluate the safety, biodistribution and dosing properties of 89Zr-DFO-girentuximab in patients with bladder cancer. The PERTINENCE study builds on the license and development agreement between Telix and ATONCO announced in December 2019, and will be led by Dr. Caroline Rousseau at the ICO. It will enroll 6 patients over 12 months, with a positive outcome leading to therapeutic studies with astatin-211 (²¹¹At) for targeted alpha therapy (TAT). TLX250-CDx (girentuximab) targets carbonic anhydrase IX (CA9), a receptor that is overexpressed in many solid tumors, including urologic malignancies.

The study is consistent with Telix’s focus on developing an alpha therapy as part of its future pipeline expansion and its strategy to seek additional indications for the CA9 target, a key pipeline asset 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 therapeutic molecular target (MTR) in other tumor types, and provides a pathway to evaluate TLX250 with an alpha emitter isotope for the first time in humans.

Alpha emitters have the potential to deliver very large amounts of energy to cancerous tissue, while the short path length may reduce the risk of damage to surrounding healthy cells, thereby increasing the selectivity and power of radiation therapy. Alpha emitters may be complementary to beta emitters at different stages of the disease.

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

Dr. Caroline Rousseau, principal investigator of the ICO-promoted PERTINENCE study, 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 investigating the role of girentuximab as an alpha emitting radioisotope therapy.”

ATONCO President Sylvain Fanier continued: “We are delighted 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 industrial partners in Nantes, to improve treatment options for patients with non-invasive bladder muscle cancer (NIBMC).”

Dr. Colin Hayward, Chief Medical Officer of Telix, added, “We are pleased to continue our collaboration with ATONCO to explore girentuximab as a basis for therapy with the alpha-emitting radioisotope astatin-211 (²¹¹At), as well as to expand and accelerate development options to many types of cancer for which there is an unmet medical need. We would like to express our gratitude to Dr. Caroline Rousseau and her clinical team at the ICO, as well as to the patients who will contribute to this groundbreaking study.”

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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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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