ITM Enters Global Supply Agreements with Telix Pharmaceuticals for Clinical and Commercial Use of ITM’s n.c.a. Lutetium-177

GARCHING, Germany–(BUSINESS WIRE)–ITM AG, a privately held radiopharmaceutical biotech company, announced today that is has signed two strategic agreements with Telix Pharmaceuticals Limited for the global supply of ITM’s highly pure therapeutic radioisotope no-carrier-added Lutetium-177 (n.c.a. ¹⁷⁷Lu). ITM’s n.c.a. ¹⁷⁷Lu, known under the brand name EndolucinBeta®, is a high-purity version of the beta-emitting radioisotope Lutetium-177 that can be linked to a variety of tumor-specific targeting molecules for Targeted Radionuclide Therapy and has demonstrated significant anti-tumor effects in clinical and commercial use.

Under the terms of the agreements, ITM will supply n.c.a. ¹⁷⁷Lu for Telix’s clinical development programs, including clinical supply for prostate cancer therapy candidate TLX591 (¹⁷⁷Lu-rosapatamab) currently entering Phase III development. Following successful completion of the clinical development and upon potential regulatory approval, ITM will also provide n.c.a. ¹⁷⁷Lu for the commercial phase. The agreement was executed through ITM’s fully owned subsidiary ITM Medical Isotopes GmbH.

“Through these global supply agreements with Telix, we have further expanded our international leadership position as a premier developer and supplier of radioisotopes. Parallel to building our own proprietary pipeline, this enables us to advance future Targeted Radionuclide Therapy treatments that address a variety of cancers, which positions us as the partner of choice for precision oncology solutions,” said Steffen Schuster, CEO of ITM. “Telix shares our vision of leveraging the full potential of nuclear medicine for the benefit of patients and we look forward to continue our strong global collaboration with them.”

Telix CEO Christian Behrenbruch stated, “ITM is a leading global supplier of high quality medical radioisotopes, and has established significant production capacity for n.c.a. lutetium, a radioisotope that has potentially broad applications in the treatment of human cancers. These agreements with ITM will support both near-term clinical trial activity and commercial-scale activity in the future.”

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About n.c.a. Lutetium-177 / EndolucinBeta®

No carrier-added Lutetium-177 (n.c.a. ¹⁷⁷Lu) chloride, is a radiopharmaceutical precursor used in Targeted Radionuclide Therapy for the treatment of various diseases, like cancer. When labeled with a tumor-specific targeting molecule (e. g. peptide or antibody), the targeted radiopharmaceutical binds to a tumor-specific receptor, according to the lock and key principle. N.c.a. ¹⁷⁷Lu has a half-life of 6.647 days and provides the highest specific activity of more than 3,000 GBq/mg at Activity Reference Time (ART). Optimal preconditions for efficient radiolabeling of biomolecules over its entire shelf-life of 9 days after production are ensured. N.c.a. ¹⁷⁷Lu exhibits an extraordinary level of radionuclidic purity and does not contain metastable Lutetium-177m circumventing cost intensive clinical disposal management.

About ITM Isotopen Technologien München

ITM, a privately held radiopharmaceutical biotech company founded in 2004, is dedicated to providing the most precise cancer radiotherapeutics and diagnostics to meet the needs of patients, clinicians and our partners through excellence in development, production and global supply. With patient benefit as the driving principle for all we do, ITM is advancing a broad pipeline combining its superior radioisotopes with targeting molecules to create Precision Oncology treatments. ITM is leveraging its leadership and nearly two decades of radioisotope expertise combined with its worldwide network to enable nuclear medicine to reach its full potential for helping patients live longer and better. For more information, please visit www.itm.ag.

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 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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