Wisconsin-based SHINE Medical Technologies announced on November 4 that its Therapeutics division has made its first commercial sales of lutetium-177 to multiple customers. Lu-177 is a therapeutic isotope in demand by clinical trial sponsors because of its potential to treat a range of cancers.
SHINE said that its production process enables the company to produce the high specific activity, non-carrier-added Lu-177 that is required by today’s clinical trials. In the short term, SHINE will produce Lu-177 at Building One of the company’s Janesville campus while a larger facility is being constructed exclusively for the production of the radioisotope. Building One, which was completed in 2018, houses SHINE’s first integrated, full-size production system and is used to train staff and develop operating history with the equipment.
Groundbreaking for the larger facility is expected in November. According to SHINE, the new 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, the company said.
Quote: “We expect demand for Lu-177 to grow rapidly as its efficacy and impact on the field of cancer therapy continue to be demonstrated,” said Katrina Pitas, vice president and general manager of SHINE Therapeutics.
The technology: SHINE’s Lu-177 production technology was developed in collaboration with the company’s scientific partners in the Czech Republic—the Institute of Organic Chemistry and Biochemistry (IOCB Prague) and the Nuclear Physics Institute of the Czech Academy of Sciences. In May 2019, SHINE entered into 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.
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.