NUCLIDIUM and NorthStar Enter Long-term Strategic Partnership to Advance NUCLIDIUM’s Copper-67 Radiotheranostic Oncology Pipeline

• Collaboration spans Copper-67 supply and radiopharmaceutical manufacturing from clinical development through commercialization.
• Partnership leverages NorthStar's vertically integrated campus, combining proprietary Copper-67 production technology, cGMP manufacturing, and commercial-scale infrastructure.

BASEL, Switzerland & MUNICH & BELOIT, Wis.--(BUSINESS WIRE)--NUCLIDIUM AG, a clinical-stage radiopharmaceutical company, and NorthStar Medical Technologies, LLC (NorthStar), a global radiopharmaceutical supply-chain partner, today announced a long-term strategic partnership through which NorthStar will produce Copper-67 (Cu-67) and provide comprehensive radiopharmaceutical manufacturing services to support NUCLIDIUM's therapeutic programs from clinical development through commercialization. Copper-67 is the therapeutic isotope component of NUCLIDIUM’s radiotheranostic programs to treat cancers with high unmet medical need.

The partnership underscores NUCLIDIUM and NorthStar’s mutual commitment to expanding global patient access to precision radiopharmaceutical therapies. NUCLIDIUM’s pipeline includes lead programs NU101 addressing metastatic castration resistant prostate cancer (mCRPC) and NU201 for metastatic breast cancer (mBC) as well as earlier stage programs in other solid tumor indications with a focus on women’s oncology.

The work will be led through NorthStar's vertically integrated U.S.-based radiopharmaceutical campus, where the company has pioneered advanced isotope production technologies, made significant investments in cGMP manufacturing, and maintains commercial-scale infrastructure to support growing global demand for targeted radiopharmaceutical therapies. NorthStar’s comprehensive approach enables a seamless transition from clinical development to commercialization, while reducing supply-chain complexity and accelerating program execution.

“Our collaboration with NorthStar strengthens our copper isotope supply chain at a critical moment, ensuring we are well prepared to execute on our near-term clinical development objectives and meet the long-term demand for our radiotheranostics,” said Leila Jaafar, PhD, CEO and Co-Founder of NUCLIDIUM. “NUCLIDIUM remains on track to initiate multiple therapeutic studies utilizing Copper-67 for mCRPC and mBC in the coming months, while expanding our radiotheranostic portfolio into the clinic, including specifically women´s oncology indications.”

“As demand for copper-based radiotheranostics continues to grow, reliable isotope supply and scalable manufacturing infrastructure will be essential for successful commercialization,” said Dr. Frank Scholz, President & CEO of NorthStar. “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 short half-life and lower radiation burden of Copper-67 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.

About NUCLIDIUM
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. Our goal is to expand the reach and clinical profile of radiotheranostics to deliver the full value of the modality and address critical unmet medical needs in oncology and women’s health.

About NorthStar
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.