Collaboration spans Copper-67 supply and radiopharmaceutical manufacturing from clinical development through commercialization
NUCLIDIUM AG, a clinical-stage radiopharmaceutical company, and NorthStar Medical Technologies, LLC (NorthStar), a global radiopharmaceutical supply-chain partner, 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.
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“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.
Source: Businesswire
