Rakuten Medical's ASP-1929 photoimmunotherapy for head and neck cancers to be designated under the Sakigake Designation System for its potential innovativeness and effectiveness

SAN MATEO, Calif, April 8, 2019 /PRNewswire/ -- Based on its exclusive license related to photoimmunotherapy, Rakuten Medical Inc., which is developing a cancer therapy to target cancer cells, announced that ASP-1929 received Sakigake designation under the Sakigake Designation System*, which is a Fast Track designation from the Japanese Ministry of Health, Labour, and Welfare as a treatment for head and neck cancer patients.

ASP-1929 qualified on all four criteria of the Sakigake Designation System: innovativeness of the product, the severity of the target condition, prominent effectiveness of the treatment, and with a plan to file the initial application first or simultaneously with others in Japan. This designation was referred for Sakigake Designation System based upon the results of analysis of a Phase I trial in Japan and a Phase I/IIa trial in the United States. The results of these studies in comparison to past data of the currently available standard treatments in a group of head and neck cancer patients suggest the potential for improved survival time.

Based on receipt of this designation, Mickey Mikitani, chairman and CEO of Rakuten Medical said, "Every day, we receive messages from many patients waiting for this treatment. To those people, I am delighted to be able to make an announcement today that brings them hope. This is a major step forward toward delivering a new treatment for head and neck cancer patients. We are aiming to get this therapy to as many patients as possible, and as soon as possible, by rigorously following the process established by the Sakigake Designation System."

ASP-1929 received Fast Track designation from the US Food and Drug Administration (FDA) for the treatment of head and neck squamous cell carcinomas (HNSCC) in the first quarter of 2018. Under the mission of Rakuten Medical, we will accelerate the development of photoimmunotherapy applying ASP-1929 to cancers of the head and neck.

*The Sakigake Designation System is the Japanese Fast Track designation which started as a national strategy and was announced by the Ministry of Health, Labour and Welfare on June 17, 2014. The measures included the creation of this designation system for groundbreaking drugs developed in Japan and identified in the early clinical trial phase as being likely to be remarkably effective. This would offer priority examination that would reduce the length of the approval examination period before commercialization.

About Rakuten Medical

Rakuten Medical is a private biotechnology firm that is developing cancer therapies with the ability to target cancer cells, based on an exclusive license photoimmunotherapy platform in the late development phase. In line with our mission of conquering cancer, we aim to take therapies from the R&D phase to the point of delivery to patients worldwide.

About photoimmunotherapy (PIT)

Since 2013, Rakuten Medical has been developing new cancer therapies based on its PIT platform. Photoimmunotherapy combines key advantages of antibody-mediated targeting of the cancer cells to achieve high tumor specificity, together with laser-activation of a biophysical mechanism that induces rapid cancer cell death with precision. Treatments with the Photoimmunotherapy platform lead to targeted and rapid tumor cell death by necrosis, with minimal effects on normal tissue.

Rakuten Medical aims to commercialize this therapy once it has conducted clinical trials of the therapy on its own and in combination with other medications.

About ASP-1929 photoimmunotherapy

ASP-1929, a conjugate of cetuximab and IRDye 700DX®, targets epidermal growth factor receptor (EGFR), a cancer antigen expressed in multiple types of solid tumors, including head and neck squamous cell carcinomas, esophagus, lung, colon, pancreas and other cancers. This first-in-class therapy targets cancer cells, after which the compound is locally activated with red light using a proprietary investigational laser and fiber optics. The local activation of the tumor-selective conjugate targets the tumor but not surrounding normal tissues and structures. ASP-1929 received Fast Track designation by the U. S. Food and Drug Administration for the treatment of Head and Neck Squamous Cell Carcinoma (HNSCC).

Currently, clinical trials are underway in Japan and overseas with HNSCCs and esophageal cancer patients.

Forward-looking statement

This press release contains forward-looking statements made pursuant to the safe harbor provisions of the (United States) Private Securities Litigation Reform Act of 1995 that involve risks, uncertainties, and assumptions that could cause Rakuten Medical's actual results and experience to differ materially from anticipated results and expectations expressed in these forward-looking statements. These forward-looking statements include information concerning the commercialization of services related to Rakuten Medical products such as ASP-1929 and other initiatives toward regulatory approval to be sold and marketed. These products may not successfully be granted regulatory approval to be sold and marketed, or may not be commercially successful. Forward-looking statements suggest potential profitability, efficacy and safety, and the status of the application for approval. Rakuten Medical has in some cases identified forward-looking statements by using words such as "anticipates," "believes," "hopes," "estimates," "looks," "expects," "intends," "potential," "may," "suggest," "plans," "strategizes," "likely", "will", and similar expressions. Such forward-looking statements are based upon Rakuten Medical's current beliefs. Moreover, this press release states an opinion related to clinical research data, hence the use of expressions such as "important," "notable" and "abnormal." Ongoing clinical studies involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements, including uncertainty of success in regulatory approval or commercialization of ASP-1929 which may be impacted by, among other things, problems with the manufacturing process for ASP-1929, the occurrence of adverse safety events, failure to demonstrate therapeutic benefit, and the other risks and uncertainties, both reasonable and unreasonable. Rakuten Medical undertakes no obligation to release publicly the results of any revisions to any such forward-looking statements that may be made to reflect new information obtained, events or circumstances after the date of this press release or to reflect the occurrence of unanticipated events, except as required by applicable law or regulation. In the event of one or more revisions to Rakuten Medical's forward-looking statement, it should not be inferred that such revisions or other forward-looking statements will be further revised.

Please refer Rakuten Medical communications-related inquiries to info@rakuten-med.com.

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SOURCE Rakuten Medical, Inc.