Rakuten Medical Secures $100 Million Series F to Advance ASP-1929 Toward U.S. Approval
核心洞察
Rakuten Medical (搜索) raised $100 million in an oversubscribed Series F financing round, doubling its initial target, to accelerate development of its investigational photoimmunotherapy ASP-1929.
The proceeds will primarily fund a global Phase 3 trial evaluating ASP-1929 combined with pembrolizumab as first-line therapy for recurrent head and neck cancer, targeting a U.S. FDA submission in 2028.
The financing was led by TaiAx Life Science Fund (搜索) with participation from the largest institutional investor group in company history, including major Japanese and Taiwanese financial institutions.
Rakuten Medical (搜索) has closed a $100 million Series F financing round to accelerate development of its investigational photoimmunotherapy ASP-1929 toward U.S. regulatory approval, the San Diego-based biotechnology company announced. The oversubscribed round includes $70 million in new capital and the conversion of $30 million in convertible promissory notes with accrued interest, doubling the company's initial fundraising target.
The financing underscores strong investor confidence in Rakuten Medical (搜索)'s proprietary Alluminox platform-based photoimmunotherapy, an innovative cancer treatment modality that combines pharmaceuticals with medical device technology. The company will use the proceeds primarily to advance its top priority: securing U.S. regulatory approval for ASP-1929, targeting a Biologics License Application (BLA) submission to the FDA in 2028.
Global Phase 3 Trial Acceleration
Rakuten Medical (搜索) is currently enrolling patients in its global Phase 3 trial (ASP-1929-381, NCT06699212), evaluating ASP-1929 photoimmunotherapy in combination with pembrolizumab as a first-line therapy for recurrent head and neck cancer. The Series F proceeds will strengthen operational capabilities to accelerate enrollment across multiple geographies, including the United States, Taiwan, Japan, Ukraine, and Poland.
The company is leveraging the regulatory dossier submitted in Japan for its approved drug Akalux (ASP-1929) and the BioBlade Laser System device, along with post-market real-world data, to supplement efforts seeking approvals in additional countries. Strategic partners with deep expertise in regional regulatory environments will support these accelerated efforts.
Expanding Beyond Head and Neck Cancer
Rakuten Medical (搜索) outlined plans to broaden clinical development beyond head and neck cancer through internal programs and investigator-initiated trials (IITs) supported by grants and external funding sources. The expansion includes:
Solid Tumors: A Phase 1 trial of RM-0256 photoimmunotherapy in Japan scheduled to initiate in Q2 2026, supported by Japan Agency for Medical Research and Development (AMED) grant funding, targeting malignant skin tumors among other solid tumors.
Esophageal and Gynecologic Cancers: Support for two ongoing IITs of ASP-1929 photoimmunotherapy in Japan, with the gynecologic cancer study backed by AMED funding.
Pancreatic and Lung Cancers: Support for two planned IITs of ASP-1929 photoimmunotherapy in the United States for pancreatic and non-small cell lung cancers, potentially supported by external grants.
International Investor Syndicate
The Series F round was led by TaiAx Life Science Fund (搜索) L.P., an international life science venture capital fund jointly established by Taiwania Capital Management (搜索) in Taipei, Taiwan, and Axil Capital Group (搜索) in Tokyo, Japan. The round included the largest institutional investor group in Rakuten Medical (搜索)'s history, featuring major Japanese financial institutions including Daiwa Securities (搜索), Mitsui Sumitomo Insurance (搜索), and Sumitomo Mitsui Banking (搜索), alongside Taiwanese venture firms ABIES Capital (搜索) and Nexus CVC (搜索).
Strategic partner OEP Group (搜索) also participated, along with existing investors including SBI Group (搜索), Rakuten Group (搜索), Inc., and Mickey Mikitani, who serves as both Rakuten Group Chairman and CEO and Rakuten Medical (搜索) CEO. This creates an exceptionally diverse investor base anchored in key global markets: the United States, Japan, and Taiwan.
Alluminox Platform Technology
The Alluminox platform represents Rakuten Medical (搜索)'s investigational technology combining pharmaceuticals, medical devices, and medical technology. The photoimmunotherapy involves two key steps: drug administration and targeted illumination using medical devices. The drug component consists of a cell-targeting moiety conjugated to a light-activatable dye, such as IRDye 700DX (IR700), that selectively binds to targeted cells like tumor cells.
ASP-1929, the company's first pipeline drug developed on the Alluminox platform, is an antibody-dye conjugate comprised of the anti-epidermal growth factor receptor (EGFR (搜索)) antibody cetuximab and IRDye 700DX. The therapy binds to EGFR, a cancer antigen expressed in multiple solid tumor types including head and neck, breast, lung, colorectal, prostate, and pancreatic cancers. After binding to cancer cells, ASP-1929 is locally activated by red light illumination (690 nm) to produce a photochemical reaction believed to cause selective necrosis of cancer cells.
Japanese Commercial Success
In Japan, ASP-1929 received marketing approval from the Japanese Ministry of Health, Labor, and Welfare for unresectable locally advanced or recurrent head and neck cancer in September 2020, under the Sakigake Designation System and the Conditional Early Approval System. Rakuten Medical (搜索) plans to continue driving commercial growth of ASP-1929 photoimmunotherapy for head and neck cancer in Japan to expand profitability and establish a reliable funding engine for global expansion.
"Securing significant investment from leading life science investors underscores the strength of our technology and the excellence of our team," said Mickey Mikitani, CEO of Rakuten Medical (搜索). "The Alluminox platform underlines a new treatment modality that requires advanced expertise in both drug development and medical device technology. Rakuten Medical is tightly focused and mission driven, having successfully developed, received approval for and commercialized an innovative therapy in 15 years."
Michael Huang, Managing Partner of Taiwania Capital Management (搜索), commented: "This oversubscribed Series F financing reflects our strong conviction in Rakuten Medical (搜索)'s differentiated technology and its ability to address profound unmet medical needs. We are thrilled to lead this round and to form a strong, like-minded global syndicate united by a shared vision to advance the future of cancer care."