On October 9, 2024 Alpha Fusion, Inc. (CEO: Sunao Fujioka, headquartered in Kita-ku, Osaka), reported that it has raised a total of ¥1.02 billion through a Series B funding round (Press release, Alpha Fusion, OCT 9, 2024, View Source [SID1234647119]). The round was led by SBI Investment Co., Ltd. and OSAKA University Venture Capital, with participation from several new investors. This funding will enable Alpha Fusion to accelerate its research and development efforts, enhance its supply chain, and deliver Japan’s cutting-edge cancer therapies to the global market as quickly as possible.

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Alpha Fusion Leading the World in Astatine-based Drug Discovery

Alpha Fusion is a pioneering startup dedicated to bringing "Targeted Alpha Therapy (TAT) using Astatine (At-211)" to cancer patients worldwide. As a leader in the clinical development of Astatine-based therapeutics, Alpha Fusion is advancing its pipeline and building a highly efficient supply chain using cyclotrons in collaboration with partners across the globe. TAT is highly anticipated to become a foundational drug discovery platform in oncology, offering the potential to create numerous novel treatments.

In the past year, several major pharmaceutical companies in Europe and the U.S. have acquired startups developing Actinium (Ac-225) -based radiopharmaceuticals, signaling a surge of interest in this field. Astatine (At-211) is garnering attention for its short half-life, which anticipates clinical safety, its halogen properties that allow it to be directly labeled into low-mid sized-molecule ligands, its ease of sourcing raw material, and the simplicity of its production using cyclotrons.

Business Progress and the Impact of Series B Funding

Since our Series A funding round in May 2023, Alpha Fusion has made significant strides, as detailed below:

1.1st Pipeline (Thyroid Cancer, Phase 1 ongoing): Progress in high-dose administration, approaching the determination of recommended dosages.

2. 2nd Pipeline (Prostate Cancer, Phase 1 ongoing): Successful completion of the world’s first administration of [211At]PSMA-5 to a patient in June.

3. Additional Pipelines: Multiple pipeline developments underway through both in-house R&D and collaborations.

July 2023: Initiated joint research with QST Chiba for tumor-specific targeting.
August 2023: Began joint research with QST Takasaki/Niigata University on novel Astatine-labeling platform technologies.
4. Supply Chain: Progress in manufacturing preparations for clinical trial drugs both domestically and internationally, shaping the future of our supply chain.

First half of 2024: Completion of Osaka University’s TAT Cyclotron building to enable efficient Astatine production.
First half of 2024: Set up GMP facilities for clinical trial drug production in Japan and advanced collaboration with overseas CDMOs.
5. Intellectual Property: Received patent approvals covering manufacturing methods, materials, and applications related to our pipeline.

6. Research Centers: Expanded domestic research operations, including a new center in Tsukuba (SakuLab-Tsukuba), in addition to Osaka University’s research hub.

7. Team Expansion: Strengthened the advisory board and enhanced functional capabilities critical to pharmaceutical development (e.g., supply chain, CMC, quality assurance, clinical development, regulatory affairs).

With this funding, we will accelerate our R&D efforts and prepare for company-sponsored clinical trials, enhance our supply chain for GMP-grade clinical trial drug production domestically and internationally, and further expand our team. We are committed to demonstrating the unique advantages of Astatine-based drug discovery with tangible business results and clinical evidence.

Investors in Series B Round (in no particular order):

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