Lu-177 is a radioactive agent that, when paired with a cancer-seeking molecule, delivers highly targeted radiation to cancer metastases, killing cancer cells while minimizing damage to surrounding healthy cells. There are currently two Lu-177-based radiotherapies that have been commercially approved, and the market is expected to continue its rapid growth with advancements across new therapies and indications in clinical trials.
"At SHINE we innovate to serve markets where there is a nexus of unmet demand, challenges where our unique capabilities will drive value, and positive impact on the world. We're at that intersection with our therapeutics business, currently focused on delivering lutetium-177 at the largest scale in the U.S.," said Greg Piefer, founder and CEO of SHINE. "Advancements in radiopharmaceutical therapies have shown great results in extending the lives of patients who might otherwise be out of options, and earlier therapy appears even more promising. We're excited to play an important role in making sure these groundbreaking therapies reach patients faster, potentially saving or extending the lives of many tens of thousands of people each year."
SHINE continues to demonstrate its advantaged processes and production abilities and is positioned to meet the rapidly growing market. SHINE is currently producing its own ytterbium-176 – the raw material needed to produce Lu-177 that has historically been sole-sourced from Russia. SHINE made its first commercial sales of Lu-177 in 2020 and submitted its first Drug Master File with the U.S. Food and Drug Administration in 2022.
"We're working diligently with our partners to ensure this revolutionary cancer treatment is readily available to the patients that need it," said Jess Giffey, SHINE's COO of Systems and Therapeutics. "Cancer does not have a hold period. Scaling up our production capabilities will help our partners secure their supply and fill the urgent market demand."
Installation of equipment in the new facility is ongoing and slated to be finished in July. Following the completion of licensing and validation runs, SHINE expects to have product available for commercial use from its new facility in late 2023.
Additionally, SHINE has initiated design and licensing processes for a dedicated therapeutic medical isotope production facility in Europe. SHINE expects its European facility to have a similar production capacity to its U.S. facility, further bolstering its ability to meet customer needs and service the growing Lu-177 market.
Moving forward, SHINE plans to become the first vertically integrated supplier of Lu-177 in the world. Along with producing its own ytterbium-176, the company plans to be able to utilize its fusion-driven medical isotope production facility, The Chrysalis, as its irradiation source for the production of Lu-177. The Nuclear Regulatory Commission issued its Final Safety Evaluation Report related to the Operating License Application for that facility earlier this year.
SHINE will showcase the commercial scale-up of its lutetium-177 production while exhibiting at the Society of Nuclear Medicine and Medical Imaging's Annual Meeting, Booth 1039, from June 24-27 in Chicago.
About SHINE Technologies
Based in Janesville, Wisconsin, SHINE deploys its safe, cost-effective and environmentally friendly fusion technology in a stepwise approach. Its systems are used to inspect industrial components in aerospace, defense, energy and other sectors. SHINE's proprietary medical isotope production processes create non-carrier-added lutetium-177 and are expected to create molybdenum-99. In the future, SHINE plans to scale its fusion technology to help solve one of energy's toughest hurdles by recycling nuclear waste. Through a purpose-driven and phased approach, SHINE aims to generate fusion power to deliver clean, abundant energy that could transform life on Earth. Want to learn more about SHINE? Visit www.shinefusion.com and follow us @shinefusion.
SOURCE SHINE Technologies, LLC
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