Therapeutics division focused on fundamental change to cancer treatment
The company created SHINE Therapeutics last October. The division is focusing initially on the development and commercialization of Lu-177. The isotope has the potential to fundamentally change the way cancer patients are treated. Studies have shown improved patient survival with Lu-177 treatment of neuroendocrine tumors and prostate cancer in patients who do not respond to other treatments. Lu-177 directly irradiates cancer cells after being delivered to the cancer site by a targeting molecule.
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Last May, SHINE entered an agreement with IOCB Prague that provides the company with an exclusive global license to a novel technology that enables SHINE to produce therapeutically desirable non-carrier-added Lu‑177.
SHINE also achieved a number of other key milestones, including the following:
In September, SHINE established a direct presence in Europe with the appointment of industry expert Harrie Buurlage as SHINE's vice president of European operations. Mr. Buurlage is leading the company's effort to site, construct and run an isotope production facility in Europe. When the European facility begins production, SHINE will be capable of producing more than two-thirds of the global patient demand for Mo-99.
Paul Ryan, the former Speaker of the U.S. House of Representatives, joined the company's board of directors in August. Mr. Ryan brings decades of national and international experience with complex health care, business, energy and other issues to SHINE's board.
During 2019, the company performed demonstrations of the neutron generator that will be at the heart of the production facility. Last June, SHINE and its sister company Phoenix LLC tested the first production-ready neutron generator over 5½ days, achieving greater than 99 percent uptime. The two companies last October announced that they had achieved a new world record for a nuclear fusion reaction in a steady-state system. The company's production facility will house eight of these neutron generators when it is completed.
The U.S. Nuclear Regulatory Commission began its official review of SHINE's operating license application after accepting the application last October. SHINE submitted its operating license application to the commission last July. The submission of the application signaled the start of the company's transition from the design and engineering phase to the construction and delivery phase.