New Investment for Theranostics in Europe

<p>The Japanese government has shown increasing expectations for the medical application of radioactive isotopes (RIs), as reflected in the 2024 Basic Policy on Economic and Fiscal Management and Reform. Additionally, the Fukushima Instutute for Research, Education and Innovation (F-REI) has launched RI-based diagnostic and therapeutic drug development projects, and the Ministry of Health, Labour and Welfare has proposed a draft guideline for clinical and non-clinical studies of radiopharmaceuticals for therapeutic use. Meanwhile, in Europe, three large-scale theranostics projects began in October 2024. These projects represent the first public-private research initiatives in RI drug discovery, with significant financial support of 60 million euros from the Horizon Europe project of the European Commission and the related industries. In terms of drug development, the Innovative Health Initiative (IHI) plays a key role in funding medical research projects as part of Horizon Europe. It designated the Thera4Care, Accelerate.EU, and ILLUMINATE projects, focusing on theranostics. Thera4Care aims to establish ecosystem for theranostics and expand its use across Europe. Accelerate.EU aims to develop targeted alpha therapy using astatine-211 (²¹¹At) for pancreatic, breast, and brain cancers, establishing a sustainable production network. The project plans to conduct phase1 clinical trials by 2028. ILLUMINATE focuses on optimizing lutetium-177 (¹⁷⁷Lu)-based therapies for prostate cancer while improving isotope production and supply chains. Japan has RI research initiatives sponsored by F-REI, but lacks strong industry participation and financial contribution mechanisms seen in Europe. It is desirable for researchers to inform companies and related organizations about commissioned projects, and for researchers themselves to improve the environment for joint research. The advancement of theranostics using RIs in Japan requires industry engagement, knowledge dissemination, and workforce training to facilitate clinical applications and foster international collaboration.</p>