NUCLIDIUM Secures US Patent Protection for Copper-Based FAP-Targeting Radiotheranostics Platform
核心洞察
NUCLIDIUM AG (搜索) received Notice of Allowance from the USPTO for a composition-of-matter patent covering FAP (搜索) inhibitor-based radiodiagnostics and therapeutics.
The patent protects the company's Kalios (搜索) program, which uses Copper-61 (搜索) for diagnostics and Copper-67 (搜索) for therapeutics targeting breast and lung cancers.
Preclinical studies demonstrate superior performance of copper-based FAP (搜索)-targeting radiotracers with enhanced tumor uptake and delayed imaging capabilities.
NUCLIDIUM AG (搜索), a clinical-stage radiopharmaceutical company, has received a Notice of Allowance from the U.S. Patent and Trademark Office (USPTO) for a composition-of-matter patent covering its innovative copper-based theranostic platform. The patent protects a variety of small molecule inhibitors of the fibroblast activation protein (搜索) (FAP (搜索)) that can be combined with radionuclides and chelating moieties for diagnosing and treating diseases, including solid tumors (搜索).
Kalios Program Advances Copper-Based Radiotheranostics
The patent covers NUCLIDIUM's Kalios (搜索) program, which consists of tumor-targeting FAP inhibitors (搜索) labeled with copper radioisotopes: Copper-61 (搜索) for diagnostics and Copper-67 (搜索) for therapeutics. The program is currently in development for the diagnosis and treatment of certain breast and lung cancer (搜索) 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," said Leila Jaafar, PhD, CEO and Co-Founder of NUCLIDIUM. "This initial action from the U.S. Patent office strengthens our intellectual property position in a highly competitive field."
Targeting FAP for Enhanced Cancer Detection
FAP (搜索) is a membrane-bound serine protease present in epithelial tumors (搜索) that comprise 80-90% of all cancer cases. The protein is highly expressed on cancer-associated fibroblasts in the tumor stroma as well as in degenerative and inflamed tissues such as bursitis and fibrosis, making it an attractive target for cancer diagnosis and treatment.
Currently approved FAP (搜索)-targeted radioligands, labeled with either 68Ga or 18F, have significant limitations due to their short half-life, which restricts their ability for delayed imaging to identify and treat smaller metastases and limits their distribution range after production.
Preclinical Data Demonstrates Superior Performance
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 (搜索)-targeting PET radiotracers. In the study, [61Cu]Cu-Kalios (搜索) PET radioligands showed favorable pharmacokinetics, high tumor uptake, and strong tumor-to-background ratios with delayed 4-hour imaging when compared to established FAP-targeting radiotracers.
These findings underscore the clinical potential of copper-61 (搜索)-based radiopharmaceuticals to improve the temporal imaging range for precise detection of FAP (搜索)-expressing tumors, addressing key limitations of current radiotheranostic approaches.
Broad Patent Protection for Future Development
The expected patent covers a diverse range of inhibitors that target FAP (搜索), representing broad protection for NUCLIDIUM's current and future radiopharmaceuticals and theranostics in its Kalios (搜索) program. This intellectual property protection supports the company's long-term goal of addressing unmet needs in oncology, particularly in women's health, through innovative copper-based radiopharmaceuticals.
NUCLIDIUM'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. The company is committed to expanding the reach and efficacy of radiotheranostics while building a robust patent portfolio to protect its discoveries as it advances copper-based theranostics into clinical evaluation.