US-based Shine Medical Technologies announced on 4 Novemberthat its Therapeutics division has made its first commercial sales of lutetium-177 (Lu-177) to multiple customers. 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, Shine Therapeutics vice president and general manager. “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 allows 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. The new therapeutic isotope production will be capable of producing more than 300,000 doses of Lu-177 a year.
“This milestone is really exciting, as Lu-177 is effectively a smart bomb for certain types of cancer,” said Shine CEO Greg Piefer. “The ability to target metastatic cancer with very high precision can give hope of survival to patients who previously have had no real options.”
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.