Nuclear fusion technology company SHINE Technologies LLC announced Friday that the company had submitted a drug master file (DMF) with the U.S. Food and Drug Administration (FDA) for a radioisotope used in cancer treatment.
The cancer-killing radioisotope, lutetium-177 (Lu-177), is paired with a cancer-seeking molecule used in cancer therapy to help target and attack cancer cells, according to a press release.
The FDA submission allows SHINE’s customers for Lu-177 – which are mainly pharmaceutical companies – to reference the file in order to use the radioisotope in clinical trials, said Todd Asmuth, president and chief strategy officer of Janesville-based SHINE Technologies.
“By filing the drug master file, it means that SHINE is moving into the stage where we can ship product that is going to be used in patients with commercial drugs and in late-stage trials,” Asmuth told the Milwaukee Business Journal.
Prior to the filing, SHINE was shipping product to customers for them to test and validate or use in pre-clinical and early-stage trials, Asmuth said.
The DMF submission includes information about the facilities, procedures or articles used in the manufacturing, processing and storing of drugs, according to the release.
“This ends our R&D stage in this product,” Asmuth said. “Our goal now is to service more clients with it and to continue to add scale. This is a great step towards meeting customer demands.”
Formerly known as SHINE Medical Technologies, SHINE Technologies has a long-term goal to produce clean fusion energy and in 2021 had raised at least $650 million from private investors and government sources when it announced its $150 million Series C-5 funding round.
The company’s CEO Greg Piefer delivered a keynote speech at the Wisconsin Entrepreneurs’ Conference in Milwaukee in June.
