#Japan #Kobe #Alpha Fusion #Kobe City Medical Center #At-211

Alpha Fusion and Kobe City Medical Center Innovate with At-211

On October 8, 2025, Alpha Fusion Inc. announced a groundbreaking collaboration with Kobe City Medical Center General Hospital (KCGH) to establish a comprehensive supply system for investigational drugs involving Astatine-211 (At-211). This initiative represents a significant leap forward in cancer treatment accessibility, marking a pivotal moment in the establishment of company-led clinical trials featuring At-211.

The partnership has successfully navigated regulatory approval from Japan's Nuclear Regulation Authority, enabling KCGH to begin the transfer of technology and commence manufacturing trials for Alpha Fusion's primary drug candidate, af-001, aimed at treating differentiated thyroid cancer. This innovative collaboration is not just about creating drugs; it’s about redefining how drug discovery transitions from concept to clinical practice.

The Significance of At-211 in Cancer Treatment

At-211 is seen as a revolutionary radionuclide for targeted alpha therapy. Its short half-life of approximately 7.2 hours and straightforward decay process make it an ideal candidate for precise cancer treatment. Historically, the establishment of a reliable supply system for At-211 has been a significant challenge, hindering the progress of clinical trials which have predominantly been led by academic institutions.

With the partnership between Alpha Fusion and KCGH, a new supply chain system aimed specifically at harnessing the potential of At-211 has emerged. KCGH's experience in producing investigational drugs using short-lived radionuclides for PET (Positron Emission Tomography) will be instrumental in adapting the existing methodologies for At-211 formulations. This effort marks a significant milestone in the global pursuit of therapeutic solutions utilizing At-211.

Collaborating for Clinical Success

Alpha Fusion has previously developed a robust network with Japanese academic cyclotron facilities capable of producing At-211, and by incorporating KCGH’s GMP manufacturing capabilities, a multi-site supply chain is being created. This new chain interlinks radionuclide production, drug manufacturing, and clinical testing, ultimately speeding up the process of getting innovative treatments into the hands of patients in need.

The first candidate in this pipeline, af-001, exploits At-211’s unique property of being taken up by the Sodium-Iodide Symporter (NIS), which facilitates its preferential accumulation in cancerous thyroid cells. Such a precise mechanism of action is unique to At-211 among alpha-emitting radionuclides. Given At-211’s low surrounding radiation risk, treatment can most likely be managed on an outpatient basis, thus providing a novel and convenient therapeutic option for thyroid cancer patients.

Insights from the Leaders

CEO of Alpha Fusion, Sunao Fujioka, expressed his enthusiasm for the partnership, emphasizing that targeted alpha therapy with At-211 could become a cornerstone in cancer treatment. The newly established supply system resolves a key challenge, accelerating their efforts to develop and deliver novel therapeutic options swiftly.

Tomohiko Yamane, Director of the Department of Molecular Imaging Research at KCGH, echoes this sentiment, highlighting the hospital's decade-long journey in producing PET diagnostic radiopharmaceuticals and now moving into the realm of cancer therapies. This partnership signifies KCGH’s commitment to leverage its manufacturing expertise in translating it into therapeutic applications for the benefit of patients globally.

Looking Ahead

The establishment of a domestic supply chain for At-211 not only serves current clinical needs but sets the groundwork for future international clinical trials and supply chain strategies. Alpha Fusion plans to expand its clinical trials focusing on multiple At-211 pipelines worldwide, initiated by af-001. The ongoing development in Japan offers a model that could be replicated in other markets, including the U.S., as discussions with potential partners begin.

Alpha Fusion is devoted to accelerating the creation of therapeutic solutions for patients who currently lack effective treatment options. Through this collaboration with KCGH, the journey toward effective and innovative cancer care continues to unfold, promising hope for many patients and setting a new standard in pharmaceutical development for cancer therapy.