US FDA approves Taiwan-developed anti-cancer drug-delivery system for phase I clinical study

DBPR115, a small molecule drug conjugate developed in Taiwan by the National Health Research Institutes’ Institute of Biotechnology and Pharmaceutical Research (IBPR) and by Taivex Therapeutics, had its investigational new drug application approved on January 15, 2021, by the U.S. Food and Drug Administration for initiation of a phase I clinical study. This will be an open-label, dose-finding clinical study to assess the safety, pharmacokinetics, and efficacy of DBPR115 in patients. The primary objectives are twofold: (1) to determine the maximum tolerated dose and the recommended phase 2 dose and (2) to characterize the pharmacokinetic and safety profiles of DBPR115 in patients. In addition, the tolerability and preliminary antitumor activity of DBPR115 will also be assessed.

IBPR’s initial research for a novel anti-cancer drug-delivery system was funded by the Ministry of Economic Affairs. DBPR115 was selected as a developmental candidate and its technology transferred to Taivex Therapeutics in August 2016. The technical highlight of DBPR115 is the conjugation of Zn(II)-dipicolylamine (Zn-DPA) to the anti-cancer drug through a proprietary linker design. This patented platform provides a substantial increase of drug concentration at targeted tumor sites, increases the therapeutic index of anti-cancer drugs, reduces drug dosage, and subsequently lessens the adverse effects induced by the drug. Patent protections have been filed in several territories; the US patent was issued in July 2016.