Alpha Fusion Establishes World's First Commercial At-211 Drug Supply Chain for Thyroid Cancer Trial
核心洞察
Alpha Fusion (搜索) and Kobe City Medical Center General Hospital have established the world's first company-sponsored supply system for Astatine-211 (搜索) investigational drugs, overcoming a major global bottleneck in targeted alpha therapy development.
The partnership enables clinical testing of af-001 (搜索), targeting differentiated thyroid cancer (搜索) by exploiting At-211's unique property of being taken up by the Sodium-Iodide Symporter (搜索) for selective cancer cell accumulation.
This multi-site supply chain connects radionuclide production, GMP drug manufacturing, and clinical trial sites, representing a landmark achievement that could transform At-211 from academic research to clinical practice.
Alpha Fusion (搜索) Inc. has announced a groundbreaking partnership with Kobe City Medical Center General Hospital (KCGH) to establish the world's first commercial supply system for investigational drugs utilizing Astatine-211 (搜索) (At-211), positioning the company to launch what is expected to be the first company-sponsored clinical trial using this promising radionuclide.
The collaboration addresses a critical global challenge that has limited At-211 therapeutic development to academic-led trials. KCGH has secured usage approval for At-211 from Japan's Nuclear Regulation Authority and is proceeding with technology transfer and test manufacturing of Alpha Fusion (搜索)'s lead pipeline candidate, af-001 (搜索), which targets differentiated thyroid cancer (搜索).
Overcoming the At-211 Supply Chain Bottleneck
At-211 is recognized as an exceptionally promising radionuclide for targeted alpha therapy due to its short half-life of approximately 7.2 hours and simple decay properties. However, establishing a stable supply system for investigational drugs has been a major global hurdle, preventing commercial development and limiting all clinical trials to date to academia-led initiatives.
The partnership with KCGH represents a breakthrough in solving this supply chain challenge. The hospital operates a radioactive investigational drug GMP manufacturing facility and brings extensive experience in manufacturing investigational drugs using short-lived radionuclides for PET (Positron Emission Tomography), which will be adapted for At-211 formulations.
Alpha Fusion (搜索) has already established a network with Japanese academic cyclotron facilities capable of At-211 production. By incorporating KCGH's GMP manufacturing facility into this system, the company is building the world's first multi-site supply chain for an At-211 radiopharmaceutical, seamlessly connecting radionuclide production, drug manufacturing, and clinical trial sites.
af-001: Targeting Thyroid Cancer with Unique At-211 Properties
The established supply system will enable Alpha Fusion (搜索) to launch its first company-led trial with af-001 (搜索), targeting differentiated thyroid cancer (搜索). The program exploits At-211's unique property—shared with iodine—of being taken up by the Sodium-Iodide Symporter (搜索) (NIS (搜索)), allowing the drug to selectively accumulate in cancer cells. This specific targeting approach is only feasible with At-211 among alpha-emitting radionuclides.
The low surrounding radiation risk associated with At-211 is expected to allow for outpatient treatment, offering what the company describes as a powerful and highly convenient new therapeutic option for thyroid cancer (搜索) patients.
Industry Leadership and Future Expansion
"Targeted alpha therapy with At-211 could become a new cornerstone of cancer treatment, yet supply has been the global bottleneck," said Sunao Fujioka, CEO of Alpha Fusion (搜索). "By partnering with KCGH to launch this investigational drug supply system, we have solved this key challenge ahead of the world, marking a giant leap toward clinical implementation."
Tomohiko Yamane, Director of Department of Molecular Imaging Research at KCGH, noted the hospital's decade-long experience manufacturing in-house investigational PET diagnostic radiopharmaceuticals and supporting numerous clinical trials, including those for Alzheimer's disease treatments. "We regard our participation in Alpha Fusion (搜索)'s company-led trial as a significant step forward in applying our manufacturing and quality-control expertise in radiopharmaceuticals to therapeutic applications," Yamane said.
The expertise gained through this Japanese system will serve as a foundation for future overseas clinical trials and commercial supply chain design. Alpha Fusion (搜索) plans to use the successful Japanese model as a template for replication and expansion in international markets, beginning with the United States. The company is already in active discussions with domestic and international partners to manage future supply chains and plans to launch clinical development of multiple At-211 pipelines both domestically and internationally, starting with af-001 (搜索).