Nucleus RadioPharma, the world’s first fully integrated development, manufacturing, and supply chain organization for radiopharmaceuticals, has appointed SHINE Technologies as its lutetium-177 supplier.

As the largest producer of the radioisotope in North America, SHINE will provide Nucleus with a sufficient supply for use in radioligand therapy (RLT), an approach that uses a ligand to locate cancer cells and a radioisotope to destroy the tumors without damaging surrounding healthy cells. It can target cancer cells anywhere in the body.

Nucleus will use the supply in its current RLT treatment regimens for neuroendocrine and prostate cancers and in clinical trials to investigate the efficacy of RLT in treating additional solid tumors.
"Nucleus launched with the goal of addressing the scarcity of radionuclides and theranostics in production, which poses major challenges for patient care and clinical trials of new radiopharmaceuticals. We are pleased to partner with SHINE, allowing us to utilize its dependable supply of lutetium-177 to develop highly effective treatments for cancer patients,” said Charles Conroy, chief executive officer of Nucleus, in a statement.

Two Lu-177 based radiotherapies, lutetium Lu-177 dotatate (Lutathera) and 177Lu-PSMA-617 (Pluvicto), are FDA approved for treating endocrine tumors and prostate cancer, respectively, and more are expected to become commercially available for clinical use in the coming years.

In June, SHINE announced that it would open Cassiopeia this year, the largest production facility for non-carrier-added lutetium-177, which it produces with a proprietary process that is more efficient, cost-effective, and environmentally friendly than existing production methods. It also produces Lu-177 at the University of Missouri Research Reactor.

Cassiopeia, which opened in August, is located in Janesville, Wisconsin, the same place as SHINE’s headquarters, and is expected to produce up to 200,000 doses annually, helping to curb shortages and meet increasing global demands.

SHINE plans to become the world’s first vertically integrated supplier of Lu-177 and is producing its own ytterbium-176, the raw material for making Lu-177, which has historically been supplied solely by Russia.

At the same time as SHINE’s announcement, ITM Isotope Technologies Munich SE opened the largest production facility in the world for Lu-177 in Neufahrn near Munich, in Bavaria, Germany. It will increase ITM’s capacity tenfold to supply clinics, pharmaceutical partners, and its own drug pipeline. Test runs are currently taking place at the site, with final official approvals expected by next year.

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