DBPR112, a novel small-molecule anticancer drug candidate, was approved for Phase I clinical study by the US Food and Drug Administration (FDA)

The Investigational New Drug (IND) application of DBPR112 was approved on April 8, 2016 for initiation of phase I clinical study. This will be an open-label, dose-finding and expansion clinical study to assess the safety, pharmacokinetics, and efficacy of DBPR112 in patients with head and neck cancer and EGFR mutated non-small cell lung cancer. The primary objectives are twofold: 1) to determine the maximum tolerated dose (MTD) and the recommended phase 2 dose 2) to characterize the pharmacokinetics (PK) and safety profiles of DBPR112 in East Asian patients. In the mean time, the tolerability and preliminary antitumor activity of DBPR112 will also be assessed.

With supports from the National Research Program for Biopharmaceuticals (NRPB), Ministry of Science and Technology (MOST), and National Health Research Institutes (NHRI), the project was aimed at accomplishing a comprehensive program of pre-clinical development and phase I clinical study for DBPR112. Many patents (composition of matters, uses and pharmaceutical formulations) of DBPR112 series (>150 compounds) covering the territories of USA, ROC, Japan and China have already been granted to NHRI.  DBPR112 was also recognized by the Tenth National Innovation Award in 2013. The success in the development of DBPR112 thus far also witnesses the importance of integrating essential disciplines including cancer biology, chemistry, pharmacology, pharmacokinetics/metabolism, formulation development, toxicological studies, clinical trial planning, and project management within the Institute of Biotechnology and Pharmaceutical Research (IBPR) as an effective team effort for the new drug discovery and development.

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