Rakuten Medical Closes $100 Million Series F to Push Lead Cancer Therapy Toward FDA Review

Rakuten Medical, Inc., a global biotechnology organization headquartered in the United States with operations spanning Japan, Taiwan, Switzerland, and India, has closed an oversubscribed $100 million Series F financing round. The capital injection marks a pivotal expansion for the company’s proprietary Alluminox® platform, a precision oncology technology that is already approved in Japan as Akalux® for the treatment of unresectable locally advanced or recurrent head and neck cancer.

The financing was led by the TaiAx Life Science Fund, a cross-border venture jointly established by Taiwan’s Taiwania Capital and Japan-based Axil Capital. The syndicate includes a record number of institutional investors from the United States, Japan, and Taiwan, signaling strong international confidence in the company’s clinical trajectory as it moves its lead therapy, ASP-1929, from an investigational status toward broader global approval.

Strategic Capital in a Shifting Market

The Series F round, which includes $70 million in new equity and $30 million in converted debt, surpassed initial fundraising targets by more than twofold. New participants include major Japanese financial institutions Daiwa Securities Group, Sumitomo Life Insurance, and Sumitomo Mitsui Banking Corporation (SMBC), alongside Taiwanese venture firms ABIES Capital and Nexus CVC.

“We were able to more than double the amount of financing from our initial target,” said Minami Maeda, President of Rakuten Medical, during a briefing in Taipei. “With this diverse institutional investor base, we will further accelerate the development of our platform in the world.”

The Road to FDA Approval: The 2028 Target

The primary focus of this capital is the advancement of the company’s global Phase 3 study evaluating ASP-1929 in combination with immune checkpoint inhibitors as a first-line therapy for recurrent head and neck squamous cell carcinoma.

Rakuten Medical is currently overperforming on enrollment projections across its key hubs. While the company is already active in the U.S., Japan, and Taiwan—where 10 major hospitals serve as critical clinical sites—it recently expanded operations into Ukraine, with Poland expected to follow in early 2026.

“The most important priority for us is the global Phase 3,” Maeda noted. “We are overachieving our initially projected enrollment numbers, and we expect an interim analysis in the middle of this year, followed by another in 2027.” The company has set a firm target to submit a Biologics License Application (BLA) to the U.S. FDA by 2028.

Precision Oncology and Indication Expansion

The Alluminox® platform utilizes photoimmunotherapy to induce rapid and selective cell killing. When the drug binds to cancer cells and is activated by a specific wavelength of light from the BioBlade® medical device, it triggers immediate tumor necrosis while sparing surrounding healthy tissue.

While currently only commercially available in Japan, the company is leveraging government grants—including funding from Japan’s Agency for Medical Research and Development (AMED)—to diversify its pipeline:

• New Molecules: Clinical trials for RN-0256, a PD-L1 conjugate targeting skin cancer, are slated to begin this year.
• Broadening Scope: Investigator-initiated trials are evaluating applications in esophageal, lung, pancreatic, and gynecological cancers.
• Geographical Strategy: Rakuten is in active discussions with regulators in Saudi Arabia for 2026 approval and Taiwan for 2027. The company is also exploring “Reliance” pathways in the UK and Commonwealth countries like Australia and Canada to fast-track approvals based on existing Japanese clinical data.

Global Collaboration and Future Growth

The involvement of the TaiAx Fund underscores a deepening collaboration between the Taiwanese and Japanese biotech ecosystems. By maintaining a multi-national footprint, Rakuten Medical aims to bridge the gap between regional innovation and global commercialization.

“With this diverse institutional investor base, we would like to further accelerate the development of our platform in the world,” Maeda explained. “We now have more than 10 institutional investors and more than three strategic partners that are supporting our company.”

Maeda highlighted that the company’s momentum is built on an increasingly global clinical footprint. “We are also discussing with U.S. investigators about investigating trials for lung cancers and pancreatic cancers,” he said. “The biotech ecosystem in Taiwan has been supporting this initiative very much, and I am very happy to be back in Taiwan to speak with you today as we research this very significant new stage in both company growth and clinical development.”

Global Phase 3 enrollment is exceeding projections as Rakuten Medical activates sites in Ukraine and prepares to launch trials in Poland, supporting an accelerated path toward its targeted 2028 BLA submission. Image: GeneOnline

Author

Bernice Lottering