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Lisa Chamoff, Contributing Reporter | June 06, 2024
Radioisotope producer SHINE Technologies announced a partnership with radiopharmaceutical developer Blue Earth Therapeutics to use SHINE’s first supply of non-carrier-added lutetium-177 chloride, normally in short supply, for a prostate cancer trial.
SHINE recently submitted to the FDA for a Drug Master File for the radioisotope under the brand name Ilumira.
The radioisotope, also known as n.c.a. Lu-177, will be used in Blue Earth’s Phase 2 study, which should open later this year and enroll roughly 70 patients in the U.S. and Europe, according to SHINE. Results are expected in 2026.
“SHINE partnered with Blue Earth Therapeutics due to their leadership in innovative radiopharmaceuticals for treating prostate cancer,” Greg Piefer, SHINE's founder and chief executive officer, told HCB News.
Using radiopharmaceuticals allows for targeted treatment that minimizes damage to surrounding healthy tissue.
“This partnership represents a significant advance in the evolution of delivering cancer treatment,” said David Gauden, the chief executive officer of Blue Earth Therapeutics, in a statement announcing the partnership. “Our partnership with SHINE aids us in our mission to develop next generation radioligand therapies for cancer patients, and we look forward to sharing results from our 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.”
There have been supply chain challenges for n.c.a. Lu-177, with a limited number of reactors producing it.
SHINE, headquartered in Janesville, Wisconsin, has the greatest production capacity for n.c.a. Lu-177 in the U.S. According to the company, it uses a proprietary production process that’s more efficient and environmentally friendly, and is one of the only producers of ytterbium-176 at scale outside of Russia.
“SHINE has developed a cleaner, safer, and more cost-effective source of non-carrier-added lutetium-177 chloride (n.c.a. Lu-177) to help improve patient outcomes,” Piefer said. “Blue Earth Therapeutics is committed to developing top-tier therapies for prostate cancer patients. … With SHINE’s Ilumira (its n.c.a. Lu-177), Blue Earth can conduct clinical trials to develop prostate cancer treatments, helping both companies achieve their mission-driven goals.”
SHINE branded the radioisotope as Ilumira to symbolize “the idea of illuminating and treating cancer” with “lu” an abbreviation for lutetium and “mira” related to the Latin word for “wonder.”
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