NUCLIDIUM and NorthStar Enter Long-Term Strategic Partnership for Radiotheranostic Oncology Pipeline

NUCLIDIUM AG and NorthStar Medical Technologies, LLC have entered into a long-term strategic partnership to advance NUCLIDIUM’s radiotheranostic oncology pipeline, focusing on the supply and manufacturing of Copper-67 (Cu-67) from clinical development through commercialization. The collaboration leverages NorthStar’s vertically integrated radiopharmaceutical campus, which includes proprietary Copper-67 production technology, cGMP manufacturing, and commercial-scale infrastructure.

Based in Basel, Switzerland, and Munich, Germany, NUCLIDIUM AG is a clinical-stage radiopharmaceutical company with a pipeline that includes lead programs NU101 for metastatic castration-resistant prostate cancer (mCRPC) and NU201 for metastatic breast cancer (mBC). The company’s pipeline also encompasses earlier-stage programs targeting solid tumor indications, with a particular focus on women’s oncology. NUCLIDIUM AG is pioneering next-generation copper-based radiotheranostics that enable the direct conversion from cancer diagnosis to treatment. Leveraging copper isotopes, Copper-61 for diagnostics and Copper-67 for therapeutics, NUCLIDIUM has built a pipeline of differentiated candidates combining superior clinical performance, easy-to-scale production, and seamless integration into hospital workflows. The company’s lead programs NU101 in metastatic castration-resistant prostate cancer (mCRPC) and NU201 in metastatic breast cancer (mBC) have demonstrated compelling efficacy and safety in Phase 1/2 diagnostics trials and are advancing into Phase 1/2 theranostics trials.

NorthStar Medical Technologies, LLC, based in Beloit, Wis., is a global radiopharmaceutical supply-chain partner. The partnership will utilize NorthStar’s advanced isotope production technologies, significant investments in cGMP manufacturing, and commercial-scale infrastructure to support NUCLIDIUM’s therapeutic programs. NorthStar’s comprehensive approach is designed to facilitate a seamless transition from clinical development to commercialization, thereby reducing supply-chain complexity and accelerating program execution. NorthStar is building the supply chain that powers the future of radiopharmaceutical medicine. Through its vertically integrated campus in Beloit, Wisconsin, NorthStar produces Copper-67 (Cu-67) and is the industry’s first commercial-scale producer of no-carrier-added actinium-225 (n.c.a. Ac-225) using electron accelerator technology. The company combines isotope production, cGMP radiopharmaceutical manufacturing, and CDMO services in a single infrastructure platform designed to accelerate the development, commercialization, and delivery of life-changing cancer therapies to cancer patients worldwide.

As demand for copper-based radiotheranostics continues to grow, reliable isotope supply and scalable manufacturing infrastructure will be essential for successful commercialization. NorthStar’s integrated platform is designed to provide both, allowing NUCLIDIUM to advance its programs efficiently from clinical development through future commercial launch.

Copper-67 is a short-range radioisotope that emits beta radiation to induce cell death in targeted tumor cells. The isotope’s short half-life and lower radiation burden limit the impact on surrounding healthy tissue. NUCLIDIUM’s radiopharmaceutical programs link Copper-67 to tumor-specific ligands to enable precision delivery and have the potential to achieve a best- or first-in-class clinical profile. The use of copper isotopes offers several distinct advantages over competing radioligands, including streamlined manufacturing, seamless integration into hospital workflows, reduced waste burden, and the potential for a wider therapeutic window.