Achievements
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.
Scientific Innovation:
- 23 new drug candidates have been identified to date in the areas of cancer, infectious diseases, chemotherapy-induced peripheral neuropathy, pain control and metabolic diseases
- 173 patents have been approved and maintained, with 103 patents transferred to industries, resulting in a patent utilization rate of 59%
- More than 696 peer-reviewed papers have been published in field-leading international journals
Overview of IBPR new drug development candidates:
Industrial Impacts:
A total of 10 cases (11 developmental drug candidates) of technology transfer to industry have been successfully accomplished up to 2024. 8 drug candidates have obtained IND (investigational new drug) approval in the United States, Taiwan and China. Among these, 7 drug candidates are at different stages of clinical trials, one of which has completed human Phase III clinical trials and submitted an NDA (new drug application) for a marketing drug license.
The 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 the establishment of a start-up biotech company, SynCore Biotechnology Co. Ltd. Pharmaceutical developments of DBPR104 and DBPR204 were conducted by SynCore under the names SB01 and SB02, respectively. The IND applications for SB01 were submitted to the FDA and TFDA by SynCore in 2010 and approved for the conduction of Phase I clinical trials, followed by the completion of Phase II clinical trials in 2019. This is the first case of a new chemical entity invented domestically in Taiwan and followed by development by an industry partner. The overall process has paved the way for government, academic, research, and industry cooperation.
The anti-diabetes drug candidate, DBPR108, was co-developed by IBPR and an industrial alliance that included six domestic pharmaceutical companies, 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 advance the drug candidate DBPR108 into preclinical and clinical stages. The first-in-human single ascending dose and multiple ascending dose phase I clinical trials were successfully completed in Taiwan in 2015. In 2013, Genovate Biotech sub-licensed to China Shijiazhuang Pharmaceutical Group Co., Ltd. (CSPC), one of the major pharmaceutical companies in China. After CSPC conducted Phase I, Phase II, and Phase III clinical trials in China from 2013 to 2022, it finally submitted the new drug application for approval in April 2023.
The anti-cancer drug delivery system, DBPR115, a drug-conjugate candidate discovered and identified by IBPR in December 2015, was developed as a novel and specific delivery system for cancer therapeutics through collaboration with the US biotech company Molecular Targeting Technologies Inc. (MTTI).In 2016, DBPR115 was licensed to Taivex Therapeutics Corporation and renamed as T-1201. Following the completion of CMC and preclinical studies, IND applications of DBPR115 were successively approved by the US and the Taiwan FDA in 2021. A Phase I clinical trial commenced in mid-2021.
The 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. DBPR216 was licensed to Taivex Therapeutics Corporation in2019 and renamed as T-1301. IND applications of DBPR216 were successively approved by the US and the Taiwan FDA in 2021. A Phase I clinical trial commenced in early 2022.
The anti-cancer drug candidate, DBPR112, is a novel EGFR-TKI designed for NSCLC, exhibiting promising inhibitory effects in the treatment of specific EGFR-mutated lung cancers, such as exon20 insertion (exon20INS). DBPR112’s IND applications were successively approved by the US and the Taiwan FDA in 2016. The Phase I clinical study was conducted in collaboration with the NTUH (National Taiwan University Hospital) and TMUH (Taipei Medical University Hospital) from 2017 to 2018. In 2020, DBPR112 was licensed to a local pharmaceutical company, Anbogen Therapeutics, and renamed ABT-101. A Phase Ib clinical trial commenced in 2022.
The anti-diabetic drug candidate, DBPR211, is a peripheral cannabinoid receptor 1 (CB1) antagonist, which controls CB1 in peripheral organs such as adipose tissue, liver, and muscles, and has shown efficacy in improving obesity, type 2 diabetes, and non-alcoholic fatty liver disease. DBPR211’s IND applications were successively approved by the US and the Taiwan FDA in 2016 and 2017, respectively. In 2021, it was licensed to Applied Biopharma LLC (a subsidiary of Agentix Corp.) and renamed as AGTX-2004. A Phase I human clinical trial will be commenced in Australia in 2024.
The stem cell mobilizer drug candidate, DBPR215, is a selective antagonist with high affinity for the CXCR4 receptor. It has demonstrated significant efficacy and an ideal therapeutic index in animal models of peripheral blood stem cell transplantation, making it a promising Best-in-Class stem cell mobilizer. In 2021, it was successfully licensed to Jiayi Life Sciences Co., Ltd., which will drive the development of DBPR215.
The anti-cancer drug candidate, DBPR114, a multi-target kinase inhibitor, effectively inhibits the growth of various human tumors in nude mouse xenograft models. These tumors include leukemia, pancreatic cancer, gastric cancer, colorectal cancer, liver cancer, and bladder cancer. DBPR114’s IND were successively approvaed by the US and the Taiwan FDA in 2017. In 2021, it was licensed to Launxp Biomedical and renamed as LXP1788. A Phase I clinical trial will be commenced in Taiwan in 2024.
The anti-cancer drug delivery system drug candidate, DBPR186, is a novel next-generation anti-cancer drug known as a positive feedback encoded drug conjugate (PFEDC). It replaces the role of antibodies with small molecule amines and combines with anti-tumor drugs to deliver and concentrate them in tumor tissues. This approach increases drug concentration in tumors, enhances anti-tumor efficacy, and reduces side effects. In 2021, it was successfully licensed to Taivex Therapeutics Corporation, renamed T-1501, and is currently undergoing preclinical trials.
Social aspect:
- To respond to national emergency needs swiftly, we mobilized for drug development to stabilize public sentiment and to resolve the healthcare issues in Taiwan:
– During the COVID-19 outbreak in early 2020, we completed process simulations and synthesized grams scale amount for the therapeutic drug, Remdesivir.
– During the H5N1 influenza pandemic in 2005, we completed process simulations and synthesized a sizable amount for the anti-flu drug, Tamiflu (oseltamivir). Subsequently, this initiative led to Roche agreeing to provide an adequate stockpile of Tamiflu to the Taiwan CDC.
– During the SARS outbreak in 2003, we identified two existing drugs capable of inhibiting the SARS virus.” - To collaborate closely with domestic and international academics, research institutes, and industrial partners and foster a robust spirit of cooperation, significantly accelerating the R&D progress of novel drugs in Taiwan.
- To cultivate undergraduate, graduate students, and postdoctoral fellows as interdisciplinary professionals in new drug research and development. These individuals, trained at IBPR, have pursued careers in industries, government agencies, and universities, demonstrating significant impact and influence on the public.