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.

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.