SHINE Technologies is supplying UK-based Blue Earth Therapeutics with a key material for a prostate cancer clinical trial, the Janesville company says.
In a recent release, SHINE announced its partnership with the business, which develops radiopharmaceutical medicines. SHINE has provided the first supply of its lutetium-177 chloride — or Ilumira — product to Blue Earth Therapeutics, for use in clinical trials evaluating a possible treatment for prostate cancer patients.
Greg Piefer, founder and CEO of SHINE, says this product is meant to “give the world access to a cleaner, safer and more cost-effective and robust source” of Lu-177 to improve care for cancer patients.
Radiopharmaceuticals, typically made up of a radioactive molecule and a targeting component, can be used to diagnose or treat diseases. They can be used to “localize therapy” to tumors, while limiting damage to nearby healthy tissues.
The announcement notes non-carrier added Lu-177 has faced significant challenges in its supply chain, as only a limited number of reactors produce the material. SHINE has the most production capacity for the material in the country, according to a release, and is one of the only producers or precursor material ytterbium-176 outside of Russia.
It’s more difficult to create non-carrier added Lu-177 than carrier-added Lu-177, which includes inactive materials meant to ensure radioactivity stability, SHINE notes. But producing the non-carrier added version “leads to a much more useful end result” with fewer drawbacks, the company’s website shows.
To produce it, SHINE bombards pure ytterbium-176 with neutrons, creating a less stable form called Yb-177, which then decays into Lu-177. This form of the element “can be more readily used, has a stronger therapeutic concentration, and reduces post-procedure radioactive waste,” the company says.
Still, the rarity of the precursor material is one drawback to this approach. SHINE currently sources the pure form of ytterbium-176 from fission reactors, but plans to phase out this supply chain over the next few years in favor of its own in-house production method.
Earlier this year, SHINE submitted its Drug Master File to the FDA for non-carrier added Lu-177, which it produces at its Cassiopeia facility in Janesville.
“We’re rapidly scaling production to meet the demand created by exciting new therapies,” Piefer said in the announcement. “Treating cancer, especially for people who historically have had no hope, is a wonderful way to advance our long-term ambitions to create a better world using nuclear technology.”
David Gauden, CEO of Blue Earth Therapeutics, says the partnership with SHINE will help the company develop “next generation” nuclear medicines for cancer patients through clinical trials.
“Critically, this also helps to further de-risk and improve the efficiency of our supply chain in the United States, an important element in the delivery of radiopharmaceuticals,” Gauden said.
