Sundia would like to congratulate its partner, the National Health Research Institutes (NHRI) in Taiwan, for successfully receiving both US and Taiwan IND approvals for DBPR114 on July 20th and Nov 7th 2017, respectively. This is NHRI’s second successful IND application to be approved by both the United States and Taiwan Food and Drug Administration (FDA).
DBPR114 is a novel, multi-target kinase inhibitor (MTKI) aiming to provide innovative treatment to cancer patients. These MTKIs havebeen demonstrated to exert potent antitumor effects through several different pathways. DBPR114 has shown excellent tumor growth inhibition and good results overcoming drug resistance.
The treatment of advanced cancer is becoming more and more complex compared to other illnesses. Tumor growth and survival are not just dependent on a single receptor or signal transduction pathway, resulting in less focus on mono-targeted anti-cancer drugs in cancer research and therapeutic development. Furthermore, multi-targeted anticancer drugs have enhanced therapeutic effects and have demonstrated potent anti-tumor effects through several different pathways. NHRI’s approved compound DBPR114 is a multi-kinase inhibitor that has shown excellent tumor cell growth inhibition and significant tumor shrinkage in tumor xenograft mouse models of several cancer types. Patients of pancreatic, liver, stomach, and colorectal cancers are target populations for further clinical studies.
‘This study was approved based on the excellent work with Sundia’s seasoned CMC team who helped us navigate our program towards success in an efficient and economical way.’ stated NHRI, ‘ We were very glad to work with Sundia this time, and we are expecting more collaborations in the near future.’ ‘We are happy to see this drug has potential to be developed into a best-in-class drug with demonstrated better clinical efficacies,’ said Sundia.
As a leading, fully-integrated ‘one-stop shop’ service provider, Sundia provides a range of CRO services in drug discovery and development ranging from Library design, Parallel Synthesis, Custom Synthesis, Materials Chemistry, Discovery Biology and DMPK to Process Development and Analytical Chemistry, Formulation Development and Preclinical testing to meet clients’ specific project needs. Leveraging our rich project management and IND submission expertise, Sundia can efficiently integrate all the studies that are required for CFDA/FDA IND submissions and are compliant with global GMP standards.
About IBPR of the NHRI
IBPR of the NHRI has established a mission-driven drug discovery and development engine (as a project initiator, accelerator, and developer) with vertical and horizontal coordination and integration. The paradigm has been shifted from an early me-too/me-better approach to a first-in-class/best-in-class approach to elevate the Institute’s research capability with a goal of being recognized as the “Center of Excellence for Innovative Drug Discovery in Asia, CEIDDA”. For more information, visit http://ibpr.nhri.org.tw/en/ .