NUCLIDIUM Receives Notice Of Allowance For Composition-Of-Matter Patent Covering FAP Inhibitor-Based Radiodiagnostics And Therapeutics In The United States

(MENAFN- GlobeNewsWire - Nasdaq) Basel, Switzerland / Munich, Germany, October 01, 2025 – NUCLIDIUM AG , a clinical-stage radiopharmaceutical company developing a proprietary copper-based theranostic platform, today announced that it has received a Notice of Allowance from the U.S. Patent and Trademark Office (USPTO) for a patent covering the company's Kalios^TM-program. Once issued, the composition-of-matter patent will protect a variety of small molecule inhibitors of the fibroblast activation protein (FAP) that can be used in combination with a range of radionuclides bound with a variety of chelating moieties for the diagnosis and treatment of diseases, including solid tumors. The Kalios^TM-program consists of a tumor-targeting FAP inhibitor labelled with a pre-selected copper radioisotope: Copper-61 for diagnostics and Copper-67 for therapeutics. The program is currently in development for the diagnosis and treatment of certain breast and lung cancer indications.

“The Notice of Allowance from the U.S. Patent and Trademark Office is an important milestone for NUCLIDIUM as we continue to advance our best-in-class copper-based radiotheranostics. This initial action from the U.S. Patent office strengthens our intellectual property position in a highly competitive field. It also recognizes the innovation inherent in our approach and supports our long-term goal of addressing unmet needs in oncology, especially in women's health, through innovative copper-based radiopharmaceuticals. We are committed to building a robust patent portfolio that protects our discoveries and to advancing our copper-based theranostics into clinical evaluation,” said Leila Jaafar, PhD, CEO and Co-Founder of NUCLIDIUM .

The expected patent covers a diverse range of inhibitors that target FAP, representing broad protection for Nuclidium's current and future radiopharmaceuticals and theranostics in its Kalios^TM-program. FAP is a membrane-bound serine protease (dipeptidyl peptidase) present in epithelial tumors that make up 80-90% of all cancer cases. It is highly expressed on cancer-associated fibroblasts in the tumor stroma as well as in degenerative tissues or inflamed tissues such as bursitis and fibrosis. These characteristics render FAP an attractive target for cancer diagnosis and treatment. Currently approved FAP-targeted radioligands, labelled with either ⁶⁸Ga or ¹⁸F, have a short half-life, which restricts their ability for delayed imaging to identify and treat smaller metastases and, in addition, limits their possible distribution range after production.

Nuclidium and its collaborators recently published a preclinical study in the European Journal of Nuclear Medicine and Molecular Imaging - Radiopharmacy and Chemistry , highlighting the unique potential of copper-based FAP-targeting PET radiotracers. In the study, [⁶¹Cu]Cu-Kalios PET radioligands showed favorable pharmacokinetics, high tumor uptake, and strong tumor-to-background ratios with delayed 4h imaging when compared to established FAP-targeting radiotracers. These findings underscore the clinical potential of 61-copper-based radiopharmaceuticals to improve the temporal imaging range for precise detection of FAP-expressing tumors.¹

About NUCLIDIUM
NUCLIDIUM AG is a clinical-stage biotechnology company pioneering the development of next-generation copper-based radiopharmaceuticals for the diagnosis and treatment of cancer. Leveraging copper isotopes – Copper-61 for diagnostics and Copper-67 for therapeutics – NUCLIDIUM is creating a differentiated platform with the potential to overcome existing limitations in radiotheranostics. The company's operations in Switzerland and Germany combine innovative chemistry, deep clinical expertise, and strategic manufacturing capabilities to deliver scalable, accessible, and clinically superior theranostic solutions to patients worldwide. NUCLIDIUM is committed to expanding the reach and efficacy of radiotheranostics, including addressing critical unmet medical needs in oncology and women's health.

For more information, please contact:
NUCLIDIUM
Leila Jaafar, PhD, CEO
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Investor/Media Contact NUCLIDIUM
Trophic Communications
Stephanie May
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Phone: +49 171 1855682

¹ Millul, J., Basaco Bernabeu, T., Gaonkar, R.H. et al. Enhanced contrast in FAP-targeting PET imaging with ⁶¹Cu-labeled FAP inhibitors: development and preclinical evaluation of novel [⁶¹Cu]Cu-Kalios PET radioligands. EJNMMI radiopharm. chem. 10 , 55 (2025).

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