The highly selective CSF-1R kinase inhibitor drug (EI-1071) developed by the Institute of Pharmaceutics, Development Center for Biotechnology can inhibit CSF-1R kinase activity and target the tumor microenvironment. The IND enabling study has been completed. The portfolio of EI-1071 has been exclusively licensed out to Elixiron Immunotherapeutics, Inc. (Elixiron). The goal is to conduct the phase 1 clinical trial. As the research results shows international competitiveness, the Development Center for Biotechnology wins the Technology Transfer Award - Silver Medal Award in the 2020 Taipei Biotech Awards.

According to recent medical studies, CSF-1R inhibitor drug can reshape the tumor microenvironment and is regarded as a new generation drug for cancer immunotherapy. At present, CSF-1R inhibitor drug is used to reshape the tumor microenvironment in conjunction with cancer immunotherapy. It is still on clinical trial with potential for further development and market value.

As an investigational new drug (IND), EI-1071 is the first highly selective CSF-1R kinase inhibitor drug independently developed by the Development Center for Biotechnology in Taiwan. It is novel and its chemical structure is different from CSF-1R inhibitors already on the market. EI-1071 can effectively and selectively inhibit the activity of CSF-1R kinase and kill CSF-1R mutant cancer cells. EI-1071 can be administered orally. EI-1071 exhibits superior in vitro potency, in vivo anticancer activity, and safe profile to TURALIO™ (Pexidartinib), a launched CSF-1R inhibitor. Therefore, EI-1071 shows international competitiveness and potential for further clinical development. Patent applications for relevant lab results have been made in many countries. At present, Taiwan’s patent has been granted, creating an opportunity to compete with international pharmaceutical companies in the global market. EI-1071 manifests Taiwan’s ability to develop small-molecule drugs at an international level.

The Development Center for Biotechnology has completed the IND enabling study of EI-1071. The portfolio of EI-1071 has been exclusively licensed out to Elixiron. The goal is to conduct the phase 1 clinical trial. Through the experienced research team and international partners, Elixiron expects to speed up the integration of the supply chain in Taiwan’s biotechnology and pharmaceutical industry using a rally-based specialization model.

EI-1071 is currently on phase 1 clinical trial in the U.S. At the same time, clinical trials are underway in Taiwan. To accelerate clinical development, an application for IND has been made to the Taiwan Food and Drugs Administration, Ministry of Health and Welfare. In addition to Elixiron, the Development Center for Biotechnology will work with or relicense pharmaceutical companies or new drug developers in Europe, the .U.S, Asia, and Australia for effectively promoting EI-1071 worldwide in a most niche way.

In line with an idea that pharmaceutical technology roots in Taiwan, the entire drug development process, from research and development to clinical trials and to commercialization, is completed in Taiwan. By reshaping the tumor microenvironment, EI-1071 increases the clinical response rate of immune checkpoint inhibitors, providing more effective and safe treatment for patients.

The Institute of Pharmaceutics, Development Center for Biotechnology strives to become the best partner for small-molecule drug development. Currently, the areas of research and development cover cancer, autoimmunity, metabolism (diabetes) and nerves, all of which are under clinical development. In particular, ON101, a new drug for diabetic foot ulcer (DCB-WH1) transferred to Microbio Co., Ltd./Oneness Biotech Co., Ltd., has passed the third phase of clinical trials in Taiwan, with a new drug application (NDA) made to TFDA for approval. ON101 is on phase 3 clinical trial in China and the U.S. The Institute of Pharmaceutics is one of the few new drug development and research institutes in Taiwan with successful experience in pre-clinical development and marketing.