ARTMS and Telix Pharmaceuticals Announce Successful Production of PSMA-11 with Cyclotron Produced 68Ga from a Solid Target

BURNABY, British Columbia & INDIANAPOLIS -- Businesswire -- ARTMS Inc. (‘ARTMS’) and Telix Pharmaceuticals Limited (ASX: TLX, ‘Telix’) are pleased to announce they have successfully produced Telix’s prostate cancer imaging product, TLX591-CDx (Kit for the preparation of 68Ga-PSMA-11)[1], using multi-Curie quantities of cyclotron-produced Gallium-68 (68Ga) via ARTMS’ proprietary Quantum Irradiation System (QIS®) solid target system.

The testing demonstrated an impressive six-hour stability of TLX591-CDx, a radiopharmaceutical targeting Prostate-Specific Membrane Antigen (PSMA) for the imaging of prostate cancer using Positron Emission Tomography (PET). Testing exceeded all relevant quality control standards for both low- (50 mCi and 100 mCi) and mid-level output (over 2,500 mCi) 68Ga production runs. The “cold kit” format of TLX591-CDx enables rapid radiolabelling at room temperature with high radiochemical purity and production consistency, ideally suited for the radiopharmacy setting.

ARTMS Chief Executive Officer, Charles S. Conroy, stated, “This collaboration and successful testing represents a significant step forward for the diagnosis of prostate cancer globally. The combination of Telix’s user friendly, high quality PSMA-11 kit along with robust production of 68Ga using our solid targetry approach moves us closer to having a PET diagnostic agent on demand for clinicians. Our goal at ARTMS is to ensure that the 68Ga supply is able to meet the substantial projected clinical demand for this isotope.”

Telix USA President, Dr Bernard Lambert, added, “When the Telix-ARTMS collaboration was announced in April 2020, we were confident that ARTMS’ proprietary technology to produce 68Ga from specialized solid 68Zn targets using low-energy cyclotrons would be valuable to the Molecular Imaging and Oncology community. ARTMS’ work represents a significant development in how 68Ga is able to be supplied to the market for large-scale production and, as a result, will contribute to the reliability of access to all men living with prostate cancer who require advanced prostate imaging. This outcome is a testament to both the ARTMS technology and Telix’s proprietary formulation of PSMA-11”

ARTMS will continue the development of cyclotron-produced 68Ga with a focus on optimizing production potential and satisfying regulatory requirements for use in radiopharmaceutical kits such as TLX591-CDx.

About Prostate Cancer

Prostate cancer is the second most common cancer in men following skin cancer and, in 2018, 1.3 million men were diagnosed with prostate cancer for the first time.[2] Despite advances in treatment, prostate cancer still accounts for a large number of deaths and in 2018 more than 365,000 men died from their disease. Rates of diagnosis are increasing, with the highest incidences of prostate cancer occurring in the United States, Europe, and Australia and New Zealand.

About ARTMS

Based in Vancouver, British Columbia, Canada, ARTMS Inc. is a global leader in the development of novel technologies and products which enable the high-quality and high-yield production of the world’s most-used diagnostic imaging isotopes. ARTMS’ flagship product, the QUANTM Irradiation SystemTM (QISTM), enables decentralized, cost-effective, large-scale production of important medical isotopes such as Gallium-68 (68Ga), zirconium-89 (89Zr), technetium‐99m (99mTc) and copper-64 (64Cu) using pharmaceutical distributor and hospital-based medical cyclotrons, empowering users to control their supply chain. ARTMS commercializes these award-winning and proprietary Canadian inventions on a global basis and has the prospect of revolutionizing the nuclear medicine industry. For more information on the QUANTM Irradiation System™ and ARTMS, please follow us on Twitter @Quantm99 and LinkedIn and visit http://www.artms.ca/.

About Telix Pharmaceuticals Limited

Telix is a clinical-stage biopharmaceutical company focused on the development of diagnostic and therapeutic products using Molecularly Targeted Radiation (MTR). Telix is headquartered in Melbourne, Australia with international operations in Belgium, Japan and the United States. Telix is developing a portfolio of clinical-stage oncology 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.

[1] TLX591-CDx is not currently approved in any jurisdiction including the United States, Canada and the European Union. [2] GLOBOCAN 2018.

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