JANESVILLE, Wis.--(BUSINESS WIRE)--SHINE Medical Technologies LLC today announced that its Therapeutics division has made its first commercial sales of lutetium-177 to multiple customers. Lutetium-177, or Lu-177, is a therapeutic isotope in demand by clinical trial sponsors because of its potential to revolutionize the treatment of cancer patients. There are dozens of clinical trials studying Lu-177’s potential to treat a range of cancers.
“SHINE’s recent sales of Lu-177 are a significant milestone for the company and important validation of our production and commercial processes,” said Katrina Pitas, vice president and general manager of SHINE Therapeutics. “We look forward to serving customers in both the clinical trial and cancer therapy markets. We expect demand for Lu-177 to grow rapidly as its efficacy and impact on the field of cancer therapy continue to be demonstrated.”
SHINE’s Lu-177 production process enables the company to produce the high specific activity, non-carrier-added Lu-177 that is required by today’s clinical trials. SHINE’s technology also has unique advantages that allow the company to scale production of the isotope quickly and more efficiently. The technology was developed with the help of SHINE’s scientific partners in the Czech Republic, the Institute of Organic Chemistry and Biochemistry (IOCB Prague) and the Nuclear Physics Institute (NPI) of the Czech Academy of Sciences.
Building One, the first building on SHINE’s isotope production campus, will serve as the company’s bridge production facility. SHINE will produce Lu-177 under GMP conditions at Building One in the short term, while the company builds a larger facility exclusively for the production of Lu-177. Groundbreaking for the larger facility is expected in November. SHINE’s new therapeutic isotope production facility will be able to scale to support the company’s anticipated Lu-177 demand for the next five years. It will be capable of producing more than 300,000 doses of Lu-177 per year.
“This milestone is really exciting, as Lu-177 is effectively a smart bomb for certain types of cancer,” said Greg Piefer, CEO of SHINE. “The ability to target metastatic cancer with very high precision can give hope of survival to patients who previously have had no real options. We’re enthusiastic about bringing our core competencies to this market, and believe we’ll play a major role in ensuring patients worldwide will have access to this very important isotope.”
Lu-177 is a low-energy beta-particle emitter that works by directly irradiating cancer cells after being delivered to the cancer site by a targeting molecule. Lu-177 is used to treat neuroendocrine cancers. It also shows promise for the treatment of metastatic prostate and other cancers.
About SHINE Medical Technologies
Founded in 2010, SHINE is a nuclear technology company working to become the world’s leading provider of radioisotopes for nuclear medicine. The SHINE system uses a patented, proprietary manufacturing process that offers major advantages over existing and proposed production technologies. It does not require a nuclear reactor, is better for the environment, generates less waste and is compatible with the nation’s existing supply chain for Mo-99. In 2014, SHINE announced the execution of Mo-99 supply agreements with GE Healthcare and Lantheus Medical Imaging. In 2015, with the help of Argonne National Laboratory, GE Healthcare demonstrated that SHINE Mo-99 can act as a drop-in replacement for reactor-based Mo-99. In 2016, SHINE received regulatory approval from the Nuclear Regulatory Commission to construct its production facility. The company began construction of the facility in the spring of 2019 and strong progress on it continues. SHINE created SHINE Therapeutics in 2019 to enhance the company’s ability to fill critical needs in the rapidly growing therapeutic isotope market. The division is commercializing Lu-177, a therapeutic isotope that is combined with a disease-specific target molecule to treat cancer.