Rakuten Medical and MD Anderson Announce Strategic Alliance to Advance Illuminox Platform for Cancer Treatments

SAN MATEO, Calif. and HOUSTON, June 4, 2020 /PRNewswire/ -- Rakuten Medical, Inc. (Rakuten Medical) and The University of Texas MD Anderson Cancer Center (MD Anderson) today announced a strategic alliance collaboration agreement to advance the development of new cancer therapies based on Rakuten Medical's proprietary Illuminox™ technology platform.
 
Under the terms of the agreement, Rakuten Medical and MD Anderson will collaborate to conduct studies based on the Illuminox technology platform and to determine study designs, combination therapies, and target patient populations for future clinical trials. The alliance is designed to expand development of the technology and bring a novel therapeutic approach to patients with cancer, with an initial focus on those with head and neck cancers. This agreement expands upon an existing sponsored research agreement between Rakuten Medical and MD Anderson.

"We are honored that MD Anderson has recognized the exciting potential of our Illuminox technology by entering into this strategic alliance agreement," said Hiroshi Mikitani, Chairman and CEO of Rakuten Medical. "We believe our collaboration will allow us to develop novel treatments for different cancer types.  We are energized by MD Anderson's shared optimism and conviction to bring treatments to patients in need."

The Illuminox technology platform is based on a cancer therapy called photoimmunotherapy, developed by Dr. Hisataka Kobayashi and colleagues from the National Cancer Institute. Illuminox is a technology combining drugs and laser device systems being evaluated for the treatment of different cancers.

"The Illuminox technology represents a new form of therapy with the potential to selectively target cancer cells while sparing surrounding normal tissues through light-activatable antibody-dye conjugates," said Jeffrey Myers, M.D., Ph.D., chair of Head and Neck Surgery at MD Anderson. "We are pleased to build upon our collaborative relationship with Rakuten Medical to work toward bringing investigational treatment options forward with the goal of providing the best options for our patients."

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. 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 MD Anderson

The University of Texas MD Anderson Cancer Center in Houston ranks as one of the world's most respected centers focused on cancer patient care, research, education and prevention. The institution's sole mission is to end cancer for patients and their families around the world. MD Anderson is one of only 51 comprehensive cancer centers designated by the National Cancer Institute (NCI). MD Anderson is ranked No.1 for cancer care in U.S. News & World Report's "Best Hospitals" survey. It has ranked as one of the nation's top two hospitals for cancer care since the survey began in 1990 and has ranked first 15 times in the last 18 years. MD Anderson receives a cancer center support grant from the NCI of the National Institutes of Health (P30 CA016672). 

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 achieved Fast Track designation from the FDA and Sakigake Designation from the Japanese Ministry of Health, Labour, and Welfare 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. 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. 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

MD Anderson:
Clayton R. Boldt, Ph.D.
713-792-9518, Crboldt@mdanderson.org

SOURCE Rakuten Medical, Inc.

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