Rakuten Medical, Inc. announced on Jan 7 the completion of a US$100 million Series F financing. The round was led by TaiAx, a joint venture venture capital fund between Taiwan’s Taiwania Capital and Japan’s Axil Capital, and attracted prominent investors including Daiwa Securities, Mitsui Sumitomo, SBI Group, and Taiwan’s ABIES Capital and Nexus CVC.

Clinical Roadmap: The funding is primarily designated to secure US FDA approval for the ASP-1929 photoimmunotherapy. Rakuten Medical is currently conducting a global Phase 3 trial combining ASP-1929 with immune checkpoint inhibitors for first-line treatment of recurrent head and neck squamous cell carcinoma (HNSCC).

• Clinical Sites: Key enrollment is occurring in the US, Taiwan (10 major hospitals), Japan, Ukraine, and Poland.
• Regulatory Goal: The company aims to submit a Biologics License Application (BLA) to the FDA by 2028.
• Pipeline Expansion: Beyond head and neck cancer, research is expanding into malignant skin tumors, esophageal, non-small cell lung (NSCLC), and pancreatic cancers.

CEO Mickey Mikitani emphasized that the Alluminox™ platform is an innovative drug-device combination requiring expertise in both molecular biology and medical hardware. This round prepares the company for its next phase of global commercialization.

Resource: 樂天醫藥超額完成1億美元F輪融資 加速推動Alluminox平台光免疫療法