WS5-3 - Development of an HDAC/PI3K dual inhibitor in academia

Abstract

We have developed an HDAC/PI3K dual inhibitor as a novel molecular target agent for cancer therapy. With supports of Ministry of Education, Culture, Sports, Science and Technology (MEXT) and Japan Agency for Medical Research and Development (AMED), the seed research has been developed for a non-clinical proof of concept (POC) study, non-GLP toxicity test and in vivo pharmacokinetics test towards clinical trials. We have applied to the United States and Europe for the basic patent as well as a novel method of the industrial manufacturing process of the drug via PCT. We have negotiated with drug industries for collaborative investigation or a license out now. During the process of a drug development, we have realized that, unlike pure scientific research, know-hows are required for inexperienced university researchers. In addition to research and development expenses, the know-how including strategies for both an intellectual property and a pharmaceutical affair, strategic technical assistance of the drug development and assistance of progress management are desired earnestly. Also, we have realized that the consciousness change of the university side including the action to a study being aware of an exit strategy was necessary, targeting not only academic value but also market value. To accelerate the drug development from university and from Japan, further enhancement of cooperation with industry, government and university is necessary.