Alpha Fusion Boosts Astatine Drug Discovery with Series B Funding

Alpha Fusion Secures ¥1.02 Billion in Series B Funding

OSAKA, Japan, Oct. 9, 2024 /PRNewswire/ -- Alpha Fusion, Inc., led by CEO Sunao Fujioka and headquartered in Kita-ku, Osaka, has successfully raised ¥1.02 billion in a Series B funding round. This round was spearheaded by SBI Investment Co., Ltd. and Osaka University Venture Capital, with contributions from several new investors. The funding will allow Alpha Fusion to boost its research and development activities, enhance its supply chain, and expedite the delivery of advanced cancer therapies from Japan to the global market.

Pioneering Astatine-based Treatments

Alpha Fusion is at the forefront of developing "Targeted Alpha Therapy (TAT)" using Astatine (At-211) to treat cancer patients globally. As a leader in the clinical development of Astatine-based drugs, the company is advancing its therapeutic pipeline and creating an efficient supply chain through partnerships worldwide. TAT is expected to become a fundamental platform in oncology drug discovery, offering the potential for numerous new treatments.

Recently, major pharmaceutical companies in Europe and the U.S. have shown increased interest in radiopharmaceuticals, particularly those based on Actinium (Ac-225). Astatine (At-211) is attracting attention due to its short half-life, which suggests clinical safety. Its halogen properties allow it to be directly labeled into small to mid-sized molecule ligands, it is easy to source, and it can be produced simply using cyclotrons.

Advancements and Impact of Series B Funding

Since the Series A funding in May 2023, Alpha Fusion has achieved significant progress:

1. Thyroid Cancer Pipeline: The first pipeline, currently in Phase 1, is progressing with high-dose administration, moving towards determining the recommended dosages.
2. Prostate Cancer Pipeline: The second pipeline, also in Phase 1, saw the world's first administration of [211At]PSMA-5 to a patient in June.
3. Additional Pipelines: Multiple developments are in progress through in-house R&D and collaborations.
- In July 2023, joint research with QST Chiba focused on tumor-specific targeting.
- In August 2023, joint research with QST Takasaki/Niigata University began on new Astatine-labeling platform technologies.

On the supply chain front, Alpha Fusion is making strides in preparing for the manufacturing of clinical trial drugs, both domestically and internationally. By the first half of 2024, Osaka University's TAT Cyclotron building will be completed, enabling efficient Astatine production. Additionally, GMP facilities for clinical trial drug production will be set up in Japan, with advanced collaboration with overseas CDMOs.

The company has also received patent approvals covering manufacturing methods, materials, and applications related to its pipeline. Research operations have been expanded with a new center in Tsukuba (SakuLab-Tsukuba) alongside Osaka University's research hub. The team has been strengthened with an enhanced advisory board and improved functional capabilities essential for pharmaceutical development, including supply chain, CMC, quality assurance, clinical development, and regulatory affairs.

Alpha Fusion is committed to demonstrating the unique advantages of Astatine-based drug discovery with concrete business results and clinical evidence. This funding round is crucial for accelerating R&D efforts, preparing for company-sponsored clinical trials, and ensuring the production of GMP-grade clinical trial drugs domestically and internationally.

Series B Investors:

New Investors:
- SBI Investment Co., Ltd.
- Mitsui Mining & Smelting Co., Ltd.
- Kobe University Capital
- Joyo Capital Partners

Existing Investors (Follow-on Investment):
- Osaka University Venture Capital
- D3 LLC
- JGC Corporation

Alpha Fusion CEO, Sunao Fujioka, stated, "In the past year, Alpha Fusion has made significant progress. We are advancing pipeline R&D and supply chain construction by leveraging the unique characteristics of Astatine: its short half-life, potential for pipeline expansion due to its halogen properties, and stable supply enabled by cyclotron production. The market is rapidly evolving with ongoing M&A and large-scale funding in the TAT sector globally. As we continue developing TAT pipelines, this funding round is a critical step toward company-sponsored clinical trials and GMP-grade Astatine drug production. We will push forward, engaging more stakeholders to realize our mission of advancing cancer treatment."

Alpha Fusion was established to commercialize Astatine (At-211) drug discovery, based on research outcomes from Osaka University and the Japan Science and Technology Agency (JST) OPERA QiSS program. The company is dedicated to harnessing the therapeutic potential of Alpha (Astatine) therapy in the emerging field of Targeted Alpha Therapy. Through top-tier R&D and business development, Alpha Fusion aims to lead the way in innovative cancer treatment.