First patient treated in alpha-targeted therapy study

MELBOURNE, Australia and NANTES, France, December 20, 2021 (GLOBE NEWSWIRE) – Telix Pharmaceuticals Limited (ASX: TLX, Telix, the Company) and ATONCO SAS (‘ATONCO’), based in Nantes, today announce that a first patient was administered in a phase I study of TLX250-CDx in patients with non-muscle invasive bladder cancer (NMIBC) at the Western Cancer Institute (ICO) at St Herblain, France.

The objective of ‘RELEVANCE¹” an open-label, investigator-led proof-of-concept study evaluating the safety, biodistribution and assay properties of TLX250-CDx (⁸⁹Zr-DFO-gissentuximab) in patients with NMIBC. The RELEVANCE study is based on the Telix and ATONCO license and development agreement announced in December 2019,² and will be led by Dr Caroline Rousseau at ICO. It will recruit 6 patients over 12 months, with a positive result leading to therapeutic studies with astatine-211 (²¹¹At) for alpha targeted therapy (TAT). TLX250-CDx (girentuximab) targets carbonic anhydrase IX (CA9), a receptor overexpressed in many solid tumors, including urologic malignancies.

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

RELEVANCE is the third in a comprehensive series of studies investigating CA9 as a target for molecularly targeted radiation (MTR) in other tumor types and providing a way to assess TLX250 with an alpha emitting isotope for the first times in humans.

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

The other two studies evaluating CA9 (ZiP-UP³ and OPALESCENCE⁴) were initiated for urothelial carcinoma or bladder cancer and triple negative breast cancer, respectively, with further collaborative studies in development for ovarian, colorectal, head and neck, breast cancer. lung and pancreas.

The principal investigator of the ICO-sponsored PERTINENCE study, Dr Caroline Rousseau, said: “CA9 is a very interesting target which 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 better understand the imaging properties of TLX250-CDx in NMIBC as a precursor to studying the role of gissentuximab as therapy with a radioisotope emitting alpha.

ATONCO CEO 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 suffering from NMIBC.

Telix Medical Director Dr Colin Hayward added: “We are delighted to continue our collaboration with ATONCO to explore girentuximab as a basis of treatment with the alpha emitting radioisotope astatine-211 (²¹¹At) as well as to expand and accelerate development options for 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 ICO, as well as to the patients who will contribute to this groundbreaking study.

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¹ Clinicaltrials.gov ID: NCT04897763
² ASX Disclosure 12/16/19.
³ ASX Disclosure 06/23/21.
⁴ Press release 05/10/21.

About bladder cancer

Bladder cancer is the sixth most common cancer in men and the tenth most common cancer in the world.⁵ In 2020, 573,278 people worldwide were diagnosed with bladder cancer and 212,536 people died from their disease.⁶ Muscular non-invasive bladder cancer (NMIBC) is found in the tissue that lines the inner surface of the bladder and is responsible for about 75-85% of newly diagnosed bladder cancers.^seven

About ATONCO

ATONCO is a clinical-stage radiopharmaceutical company developing innovative radiopharmaceuticals using astatine-211 (²¹¹At), an alpha emitting radionuclide for the treatment of cancer. ATONCO, founded in 2019, built with an experienced and passionate team, holds an exclusive worldwide license to use Telix’s girentuximab (TLX250) for radiolabelling with ²¹¹To for the treatment of NMIBC. ATONCO, based on disruptive and innovative alpha-immunotherapy, meets two objectives: clinical indications with a real unmet need and rapidly accessible tumor targets, adapted to the short half-life of astatine-211 (7, 2h) and with a small size adapted to the very short path of the alpha particles emitted. ATONCO is a private company registered in Nantes-Saint Herblain, France. For more information, contact: [email protected]

About the TLX250-CDx

TLX250-CDx (⁸⁹Zr-DFO-girentuximab) is being developed by Telix for the purpose of determining whether ‘indeterminate kidney masses’, typically identified on the basis of CT or MRI imaging, are either clear cell kidney cancer (ccRCC) or not. -ccRCC, using positron emission computed tomography (PET) imaging. Gireuximab is a monoclonal antibody that targets carbonic anhydrase IX (CA9), a cell surface target highly expressed in several human cancers, including kidney, lung and esophageal cancers. In July 2020, the United States Food and Drug Administration (FDA) granted Breakthrough Therapy (BT) designation⁸ for TLX250-CDx, reflecting the significant unmet clinical need to improve the diagnosis and staging of ccRCC, the most common and aggressive form of kidney cancer.

On Telix Pharmaceuticals Limited

Telix is ​​a biopharmaceutical company specializing in the development of diagnostic and therapeutic products using Targeted Molecular Radiation (MTR). Telix is ​​headquartered in Melbourne, Australia, with international operations in Belgium, Japan, Switzerland and the United States. Telix is ​​developing a portfolio of clinical stage products that address significant unmet medical needs in oncology and rare diseases. Telix is ​​listed on the Australian Securities Exchange (ASX: TLX). For more information, visit www.telixpharma.com and follow Telix on Twitter (@TelixPharma) and LinkedIn.

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⁵ World Cancer Research Fund (WCRF).
⁶ Globocan 2021.
^seven Somoncu et al. Nature. 2020.
⁸ ASX Disclosure 07/01/20.

Telix Media Contact

Dr Stewart Holmstrom
Telix Pharmaceuticals Limited
Director of Corporate Communications
Email: [email protected]

Important information

This announcement does not constitute an offer to sell or the solicitation of an offer to buy any securities in the United States or any other jurisdiction in which such an offer would be illegal. The securities referred to herein have not been and will be not to be registered below the United States Securities Act of 1933 (the “WE Securities Act”), Where below the titles laws of any state Where other jurisdiction of the United States and can not to be Free Where sold in the United States, unless the securities have summer registered below the we Securities Act Where a exemption from the the registration requirements of the US Securities Act is available. None of the technologies or products described in this document have received marketing authorization in any jurisdiction. The publication of this announcement has been authorized by Dr Christian Behrenbruch, Managing Director and Chief Executive Officer. The Telix Pharmaceuticals name and logo are registered trademarks of Telix Pharmaceuticals Limited and its affiliates (all rights reserved)