The Institute of Biotechnology and Pharmaceutical Research (IBPR) emphasizes mission-oriented discovery and development of novel therapeutics in the treatment of cancers, metabolic diseases, infectious diseases, chemotherapy-induced peripheral neuropathy, aging, rare diseases and prevalent local diseases. IBPR aims to engage in cutting-edge biomedical research for the improvement of health and quality of life for humanity. The representative accomplishments by IBPR are highlighted in several aspects below.
- Twenty new drug development candidates were identified to-date in the area of cancer, infectious diseases, chemotherapy-induced peripheral neuropathy, pain control and metabolic diseases
- More than 218 patents were granted since establishment of IBPR
- More than 624 peer-reviewed papers were published in field-leading international journals
Overview of IBPR new drug development candidates:
A total of 10 cases (11 developmental drug candidates) of technology transfer to industry have been successfully accomplished up to the end of 2021, including 8 IND approvals by US and Taiwan’s Food and Drug Administration (FDA). Moreover, 1 drug candidate, DBPR108, has completed Phase III clinical trials.
- Anti-cancer drug candidates, DBPR104 and DBPR204 with all the IND-enabling studies completed, were transferred to a local pharmaceutical company (Sinphar Group) in 2008 and led to a start-up biotech company, SynCore Biotechnology Co. Ltd.. Pharmaceutical developments of DBPR104 and DBPR204 were conducted by SynCore with the names of SB01 and SB02, respectively. The IND (Investigational New Drug) applications for SB01 was submitted to FDA and TFDA by SynCore in 2010 and approved for conduction of Phase I clinical trial, and then followed completion of phase II clinical trial in 2019. This is the first case of new chemical entity invented domestically in Taiwan and followed with development by the industry partner. The overall process has paved the way for government, academic, research and industry cooperation.
- Anti-diabetes drug candidate, DBPR108, was co-developed by IBPR and an industrial alliance which included six domestic pharmaceutical companies and led by Genovate Biotechnology Co., Ltd.. IBPR and the industrial alliance applied for a governmental grant as a “Case of Success” of biotechnology investment in Taiwan to move forward the drug candidate DBPR108 into preclinical and clinical stage. The single ascending dose and multiple ascending dose phase I clinical trials in humans were completed successfully in Taiwan in 2015. Genovate Biotech sub-licensed to China Shijiazhuang Pharmaceutical Group Co., Ltd. (CSPC), one of the major pharmaceutical companies in China, in 2013. CSPC’s IND application for Phase I clinical trial to CFDA (now called NMPA) has been approved in March 2015.
- Anti-HCV drug candidate, DBPR110, was licensed to a local pharmaceutical company, Microbio, in 2013. Preclinical and pharmaceutical development of DBPR110 was conducted by IBPR and afterwards completed by Microbio with the name of MB-110. The IND application to FDA has been approved in Dec. 2015. DBPR110 was sub-licensed to Microbio (Shanghai) in 2017 for further development in China.
- Anti-cancer drug delivery system, DBPR115, was a drug-conjugate candidate discovered and identified by IBPR in Dec. 2015. Through the collaboration with an US biotech company, Molecular Targeting Technologies Inc. (MTTI), a novel and specific delivery system for cancer therapeutics was developed as DBPR115. DBPR115 was licensed to a local pharmaceutical company, Taivex, in Aug. 2016 and IND applications were approved by US and Taiwan Food and Drug Administration (FDA) in Jan. and Apr. 2021, respectively. Phase I clinical trial was initiated in Jul. 2021.
- Anti-cancer drug candidate, DBPR216, is a multi-targeted tyrosine kinase inhibitor that shows very good inhibitory effects on mutant c-KIT, FLT3, PDGFR kinases. It exhibits excellent growth inhibition against GIST and AML cell lines. DBPR216 was licensed to a local pharmaceutical company, Taivex, in Apr. 2019 and IND applications were approved by US and Taiwan Food and Drug Administration (FDA) in Apr. and Aug. 2021, respectively.
- Anti-cancer drug candidate, DBPR112, is a novel EGFR-TKI for NSCLC, which shows good inhibitory potential in the treatment of specific EGFR mutated lung cancers such as exon20 insertion (exon20INS). DBPR112’s IND applications were approved by US and Taiwan Food and Drug Administration (FDA) in 2016, respectively. The Phase I clinical study was completed in cooperation with National Taiwan University Hospital (NTUH) and Taipei Medical University Hospital (TMUH) during 2017-2018. DBPR112 was licensed to a local pharmaceutical company, Anbogen Therapeutics, in 2020 for further clinical trial development.
- Clinical drug candidate, DBPR211, is a peripheral cannabinoid receptor 1 (CB1) antagonist. Its unique characteristics in drug distribution in vivo allows it to target peripheral CB1 receptors only, not central CB1 receptors. Its activities in various metabolic organs (e.g. adipose tissue, liver and muscle) has led to beneficial effects in treatment of obesity, type 2 diabetes, and non-alcoholic fatty liver disease. DBPR211 had received IND approvals from US and Taiwan Food and Drug Administration in 2016 and 2017, respectively. It has been licensed to a US-based pharmaceutical company, Applied Biopharma, in 2021 for subsequent clinical development.
- Stem cell mobilizer drug candidate, DBPR215, is a CXCR4 antagonist with good affinity and selectivity to CXCR4 receptor. DBPR215 exhibits good efficacy in the CFU-GM model in vivo with high therapeutic index. DBPR215 might become a “Best-in-Class” drug for peripheral blood stem cell transplantation (PBSCT) and was licensed to a local pharmaceutical company, Jiayi Biomedical, in 2021 for subsequent development.
- Anti-cancer drug candidate, DBPR114, is a multi-kinases inhibitor which significantly shrank tumor growth of many different human cancer cells, including AML, pancreatic, liver and gastric cancers in xenograft studies. These results indicate DBPR114 is potential development candidate. DBPR114 had received IND approvals from US and Taiwan Food and Drug Administration in 2017, respectively. DBPR114 was licensed to a local pharmaceutical company, Launxp Biomedical, in 2021 for subsequent clinical development.
- Anti-cancer small molecule drug conjugate (SMDC), DBPR186, is a new generation of positive feedback encoded drug conjugate (PFEDC) which provides substantial increase of drug concentration at targeted tumor sites, increases therapeutic index of the anti-cancer drugs, reduces drug dosage and subsequently lessens adverse effects induced by the drug. DBPR186 was licensed to a local pharmaceutical company, Taivex, in 2021 for subsequent development.
- Emergent actions to resolve the healthcare issues in Taiwan:
– Synthesized gram-scaled amount of Remdesivir, an approved drug to treat COVID-19 after the SARS-CoV-2 outbreak in early 2020.
– Synthesized a sizable amount of Oseltamivir (Tamiflu) during an influenza outbreak in 2005.
– Identified two generic drugs which showed the inhibition of the SARS-CoV virus in 2003.
- Working closely with domestic/international academics, research institutes, and industrial partners and fostering good collaborative spirits led to acceleration of the R&D progress of novel drugs in Taiwan.
- Cultivation of undergraduate/graduate students and postdoctoral fellows.
- Students and fellows trained at IBPR, pursuing careers in industries, and government agencies, universities, have shown great impacts.