Rakuten Medical announced the acquisition of phthalocyanine dyes, including IRDye 700DX, from LI-COR Biosciences in a strategic move to secure its supply chain for photoimmunotherapy development. IRDye 700DX serves as a key component in the mechanism of action for products being developed on Rakuten Medical's Illuminox platform and is currently being studied in ASP-1929 clinical trials across multiple oncology indications.
"This important business transaction reaffirms our commitment at Rakuten Medical to advance our core, Illuminox, platform for treatment of cancer – and will ensure the consistent reliable supply of IRDye 700DX," said Hiroshi Mikitani, Chairman and CEO of Rakuten Medical. "This acquisition reinforces our confidence, adds additional flexibility to our supply chain, and will enable us to further improve our product development on the Illuminox platform."
Strategic Timing Aligns with Clinical Progress
The acquisition comes as Rakuten Medical accelerates development of ASP-1929, its first-in-class photoimmunotherapy agent. On December 23, 2020, the company announced that its Phase 1b/2 clinical trial enrolled and treated its first patient in the United States at The University of Texas MD Anderson Cancer Center. This open-label study is investigating ASP-1929 photoimmunotherapy in combination with anti-PD1 therapy in EGFR expressing advanced solid tumors, with approximately 74 patients planned for enrollment.
Greg Biggs, CEO of LI-COR Biosciences, noted that "this agreement with Rakuten Medical supports our current long-standing supply agreement and is a forward-looking strategic and operational win for both companies. We are pleased that the innovative technology we developed will potentially produce meaningful benefit to the medical community, patients, and families battling cancer."
ASP-1929 Mechanism and Clinical Status
ASP-1929 represents an antibody-drug conjugate comprised of the antibody cetuximab and IRDye 700DX, a light activatable dye. The therapy binds to epidermal growth factor receptors (EGFR), a cancer antigen expressed in multiple types of solid tumors, including head and neck cancer, esophageal cancer, lung cancer, colon cancer, and pancreatic cancer.
After binding to cancer cells, ASP-1929 is locally activated by non-thermal red light (690 nm) illumination emitted by an investigational laser device system. Pre-clinical data indicate that Illuminox technology induces a biophysical process that compromises cell membrane integrity, leading to cancer cell death and tumor necrosis.
The therapy achieved a significant regulatory milestone when Rakuten Medical Japan K.K. received conditional marketing approval from Japan's Ministry of Health, Labour and Welfare in September 2020 for treating unresectable locally advanced or recurrent head and neck cancer. ASP-1929 is currently under investigation in a global Phase 3 clinical trial for recurrent head and neck cancer.
Illuminox Platform Technology
The Illuminox platform represents an investigational approach based on photoimmunotherapy, originally developed by Dr. Hisataka Kobayashi and his team from the National Cancer Institute. The platform consists of both drug and device components working in concert to achieve targeted cancer cell destruction.
The drug component features a targeting moiety conjugated with one or more dyes leading to selective cell surface binding, while the device component consists of a light source that locally illuminates targeted cells with non-thermal light to transiently activate the drug. Pre-clinical data have shown that this activation elicits rapid and selective necrosis of targeted cells through a biophysical process that compromises membrane integrity.
Therapies developed on Illuminox may also result in local and systemic innate and adaptive immune activation due to immunogenic cell death of the targeted cells and removal of immunosuppressive elements within the microenvironment. Outside of Japan, Illuminox therapies have not yet been approved as safe or effective by any regulatory authority.
Company Positioning and Future Development
Rakuten Medical operates as a global biotechnology company with six locations across five countries, including Japan, the Netherlands, Germany, and Taiwan. The company has been developing cancer therapies based on its Illuminox technology platform since 2013, using an exclusively licensed antibody complex.
The acquisition ensures strategic control over a critical component of the company's core technology platform while supporting ongoing clinical development programs. Rakuten Medical continues to advance product development through clinical trials of both monotherapy and combination therapy approaches with other drugs across multiple cancer indications.
