SHINE Medical Technologies LLC, the Institute of Organic Chemistry and Biochemistry (IOCB Prague) and GE Healthcare today announced the production of patient doses of the therapeutic isotope lutetium-177 (Lu-177). The lot passed GE Healthcare’s quality control testing, including internationally recognized radionuclide purity (RNP) standards. The delivery of Lu-177 in this quantity and purity demonstrates the suitability of the IOCB technology for Lu-177 production. It is a major step toward commercial production of the therapeutic isotope by SHINE.
Last May, SHINE entered an agreement with IOCB Prague that granted the company exclusive access to IOCB Prague’s novel technology, which is used to separate lutetium from enriched ytterbium targets. The technology enabled the production of the non-carrier-added (nca) Lu 177 supplied to GE Healthcare. The isotope was produced in collaboration with the Nuclear Physics Institute in Czechia. The Nuclear Physics Institute and IOCB Prague are members of the Czech Academy of Sciences.
“Non-carrier-added Lu-177 at the dosage and purity delivered to us bodes well for the potential to provide physicians and patients with a vital, highly effective therapeutic isotope,” said Charles Shanks, GE Healthcare’s principal engineer, Life Sciences. “Lu-177 is one of the key drivers of growth in the medical isotope market. It represents a major opportunity to better serve the market.”
“The delivery of patient doses of Lu-177 to GE Healthcare is a significant step forward for SHINE Therapeutics,” said Katrina Pitas, the vice president and general manager of SHINE Therapeutics. “Together with our collaborators from the Czech Academy of Sciences, we have demonstrated the capability to produce Lu-177 at a very high standard of purity. We look forward to continuing to work with GE Healthcare to move Lu-177 closer to commercialization and the patients who will benefit from it most.”
“Producing clinically relevant doses of any therapeutic radionuclide is not easy and we have demonstrated that our technology can meet the challenge for nca Lu-177,” said Dr. Miloslav Polasek of IOCB Prague. “I am very grateful to the SHINE, IOCB and NPI teams for the progress we are making together.”
Lu-177 is used to treat neuroendocrine cancers. It also shows promise for the treatment of metastatic prostate and other cancers. The isotope 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.
About GE Healthcare Life Sciences
GE Healthcare Life Sciences
helps therapy innovators, researchers and healthcare providers accelerate how precision diagnostics and therapies are invented, made and used. Our products enable biological analysis, research, development and the manufacture of advanced therapies and vaccines. Life Sciences is part of the $19.8 billion healthcare business of GE. With over 100 years of experience in the healthcare industry and more than 50,000 employees globally, GE Healthcare helps efficiently improve outcomes for patients, healthcare providers, researchers, and life sciences companies around the world.
About SHINE Medical Technologies LLC
Founded in 2010, SHINE
is a development-stage company working to become a manufacturer 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, uses less electricity, 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.
About IOCB Prague
The Institute of Organic Chemistry and Biochemistry of the Czech Academy of Sciences / IOCB Prague is a leading internationally recognized scientific institution whose primary mission is the pursuit of basic research in chemical biology and medicinal chemistry, organic and materials chemistry, chemistry of natural substances, biochemistry and molecular biology, physical chemistry, theoretical chemistry, and analytical chemistry. An integral part of the IOCB Prague’s mission is the implementation of the results of basic research in practice. Emphasis on interdisciplinary research gives rise to a wide range of applications in medicine, pharmacy, and other fields.