Rakuten Medical, Inc. Acquires Key Assets and Manufacturing Technology from LI-COR Biosciences
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Rakuten Medical, Inc. Acquires Key Assets and Manufacturing Technology from LI-COR Biosciences

Acquisition Underpins and Further Enhances Rakuten Medical’s Innovative Illuminox™ Cancer Therapy Platform

SAN MATEO, Calif. – January 11, 2021 – Rakuten Medical, Inc. (Rakuten Medical) today announced the acquisition of phthalocyanine dyes, including IRDye® 700DX, from LI-COR Biosciences. IRDye 700DX is a key component of the mechanism of action for products being developed by Rakuten Medical, and is currently being studied in ASP-1929 clinical trials across multiple oncology indications. This strategic acquisition ensures a consistent and flexible supply chain to further advance development and commercialization of therapies on the Illuminox™ platform, such as ASP-1929 and other photoimmunotherapy products.

“This important business transaction reaffirms our commitment at Rakuten Medical to advance our core, Illuminox, platform for treaent 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.”

Greg Biggs, CEO, LI-COR Biosciences noted, “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.”

This strategic acquisition follows other recent news from Rakuten Medical regarding global actions to accelerate the development of its first-in-class agent, ASP-1929, for Head and Neck and other cancer applications.

  • On December 23, 2020, Rakuten Medical announced that its Phase 1b/2 clinical trial, an Open-label Study Using ASP-1929 Photoimmunotherapy in Combination With Anti-PD1 Therapy in EGFR Expressing Advanced Solid Tumors (ClinicalTrials.gov Identifier: NCT04305795) enrolled and treated its first patient in the United States, at The University of Texas MD Anderson Cancer Center, Houston, Texas. This is the first of approximately 74 patients planned for this trial.
  • On September 25, 2020, Rakuten Medical, Inc. announced that its wholly owned subsidiary Rakuten Medical Japan K.K. received conditional marketing approval in Japan from the Ministry of Health, Labour and Welfare for ASP-1929 Photoimmunotherapy to treat unresectable locally advanced or recurrent head and neck cancer.

About Rakuten Medical, Inc.

Rakuten Medical, Inc. is a global biotechnology company developing precision, cell-targeting investigational therapies on its Illuminox™ platform, which, in pre-clinical studies have shown to lead to rapid and selective cell killing and tumor necrosis. Outside of Japan, Illuminox therapies have not yet been approved as safe or effective by any regulatory authority. Rakuten Medical is committed to its mission to conquer cancer and aims to realize a society where cancer patients can lead fulfilling lives. Headquartered in the United States, Rakuten Medical has 6 locations in 5 countries, including Japan, the Netherlands, Germany and Taiwan. For more information, visit www.rakuten-med.com.

About LI-COR Biosciences

LI-COR Biosciences offers research solutions for therapeutics development and robust Western Blotting. The company is an industry leader in imaging systems, analysis software, and IRDye® Infrared Dye and other reagents for clinical research, optical image-guided surgery research, quantitative protein analysis, and small animal imaging. From academic discovery through clinical studies, for characterizing a pathway to validating a therapeutic or contrast agent candidates, LI-COR technology helps move research through the development process. LI-COR Biosciences is also a leading innovator in systems for measuring global climate change, plant research, and gas analysis. For more than 50 years LI-COR has worked to improve the human condition through the design and development of innovative research tools that help scientists solve the challenges that face humanity. More information at www.licor.com.

About ASP-1929

Since 2013, Rakuten Medical, Inc. has been using an exclusively licensed antibody complex to develop new cancer therapies based on its Illuminox™ technology platform. Rakuten Medical’s first pipeline drug developed on Illuminox is ASP-1929, an antibody-drug conjugate comprised of the antibody cetuximab and IRDye® 700DX, a light activatable dye. ASP-1929 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. ASP-1929, has received conditional early approval from the Japanese Ministry of Health, Labor, and Welfare in September 2020, and is currently under investigation in a global phase 3 clinical trial for recurrent head and neck cancer. Rakuten Medical, Inc. is moving forward with product development by conducting clinical trials of monotherapy and combination therapy with other drugs. Outside of Japan, ASP-1929 has not yet been approved by any regulatory authority.

About Illuminox™

The Illuminox platform is an investigational platform based on a cancer therapy called photoimmunotherapy, which was developed by Dr. Hisataka Kobayashi and team from the National Cancer Institute in the United States. Rakuten Medical is developing the Illuminox platform as a technology consisting of a drug, device and other related components. The drug component of the platform consists of a targeting moiety conjugated with one or more dyes leading to selective cell surface binding. The device component consists of a light source that locally illuminates the 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 the membrane integrity of the targeted cells. 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/or the 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.

Forward Looking Statements

This press release contains forward looking statements that correspond to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These statements include various risks, uncertainties, and assumptions that may cause Rakuten Medical's business plans and results to differ from the anticipated results and expectations expressed in these statements. These “forward looking statements” contain information about the status and development of our products, including ASP- 1929, Illuminox technology and other regulatory and marketing authorization efforts. The approval and commercial success of the product may not be achieved. Forward looking statements relate to the potential benefits, efficacy, and safety of ASP-1929, and the status of regulatory filings. Such statements may include words such as "expect," "believe," "hope," "estimate," "looks as though," "anticipate," "intend," "may," "suggest," "plan," "strategy," "will," and "do”, and are based on our current beliefs. In addition, this press release uses terms such as "important," "notable," and "abnormal" to express opinions about clinical trial data. Ongoing clinical trial studies include various risks and uncertainties, in particular, problems that arise during the manufacturing stage of ASP-1929, the occurrence of adverse safety events, situations in failure to demonstrate therapeutic benefits, and other various risks and uncertainties, both reasonable and unreasonable. For this reason, actual results, including regulatory approvals and uncertainties in the commercialization process of ASP-1929, may differ from published information. Except to the extent required by applicable law, we undertake no obligation to publicly update this or any other forward- looking statement, whether because of new information, future developments or events, changes in assumptions, changes in the factors affecting forward-looking statements. If one or more forward-looking statement(s) is updated, no inference should be drawn that additional updates will be made to those or other forward-looking statements.

Corporate Communications Contact:

Email: PR@rakuten-med.com
For Corporate Partnering, please contact: partnerships@rakuten-med.com
LI-COR PR: doc.chaves@licor.com