KBRDG Is Spearheading the Future of Drug Development
KBRDG Is Spearheading the Future of Drug Development
  • Kim Sung-mi (info@koreaittimes.com)
  • 승인 2012.09.10 19:43
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Figure. Components of GX-188E

# On August 23, Seoul National University (SNU)’s research team announced that it had succeeded in porcine-to-monkey transplantation of islets of Langerhans by using its independently-developed antibody “MD-3.” The SNU research team also successfully treated a diabetic monkey by transplanting a healthy monkey’s islets into it. 

The SNU team minimized the use of immunosuppressants by using MD-3 antibodies and prevented rejections commonly accompanied by the transplantation of the islets of Langerhans, thereby curing diabetics. Once the islets of Langerhans are extracted, they are often damaged, so treating a diabetic patient requires the extraction of islets of Langerhans from 2 to 4 donor pancreases. The SNU team is expected to conduct human clinical trials at the end of next year.

In November 2011, the SNU team also reported that four diabetic monkeys with transplanted porcine islets of Langerhans were treated with MD-3 antibodies and immunosuppressants, surviving over six months without showing any side effects. One of the four monkeys survived up to eight months; while blood glucose levels of another two that were treated with immunosuppressants in a regulated manner went up after being controlled for a year. The fact that blood sugar levels were controlled for a year is very promising compared to previous records. The SNU team worked out what caused their blood sugar concentration to rise, so it is now working on follow-up measures.

Once the SNU team’s research is completed successfully, many diabetic patients can benefit from the transplantation of islets of Langerhans because such a procedure will make insulin injections a thing of the past.

 

Researchers who developed GX-188E

# On August 20, Genexine (a Korean biotechnology company) announced that on May 30 it obtained the Korea Food and Drug Administration’s go-ahead on carrying out the clinical trial (phase 1) of GX-188E (Papitrol-08) (a cure for cervical dysplasia (a precancerous condition)) and it will push for clinical trial in cooperation with a team led by Professor Sue-Young Heo of the Obstetrics & Gynecology Department of the Catholic University’s medical school.

Among Korea Biotech R&D Group (KBRDG)-supported drug development tasks, Gene-based vaccine GX-188E is the first that is entering into clinical trial. GX-188E is designed to encourage powerful immune responses to human papillomavirus (HPV) infection that triggers cervical dysplasia. Since three injections of GX-188E via needles are needed, it is simpler and cheaper than surgery. Besides, there is no need for a certain period of post-surgery hospital care and hysterectomies (the surgical removal of the uterus), thus significantly improving the quality of patients’ life.

Dr. Gio-bin Lim , General Director of the KBRDG and Professor of the University of Suwon

In the US and the EU, nearly 900,000 people are diagnosed with cervical dysplasia each year while the number of Korean women diagnosed with cervical dysplasia is about 80,000 every year. The only treatment that has been available to date is surgery that often accompanies serious side effects. 5-20% of early-stage cervical cancer patients relapsed after surgery. However, GX-188E is designed to destroy target cells infected by viruses, so it does not cause side effects. On top of that, immunological memory will help maintain the efficacy of the treatment for longer periods of time. 

GX-188E is forecast to be released in Korea starting in 2019. The estimated sales of GX-188E for 2021 stand at approximately KRW 300 billion. As more young females who want to have a baby develop cervical dysplasia, many expect that GX-188E will become a block buster cure in the future.

GX-188E is forecast to be released inKoreastarting in 2019. The estimated sales of GX-188E for 2021 stand at approximately KRW 300 billion. As more young females who want to have a baby develop cervical dysplasia, many expect that GX-188E will become a block buster cure in the future.

 

These cases are  the fruits of the KBRDG’s 8-year endeavor. In 2004, in tandem with global trends, the Korean government decided to develop the biotechnology sector as one of Korea’s new growth engines. The industry of course welcomed the government’s move with open arms. Technology-armed venture companies jumped on the bandwagon of developing genes and protein medicine that replace chemical drugs. Not to be outdone, large companies who had remained somewhat unenthusiastic about drug development also followed suit. 

Gio-bin Lim (General Director of the KBRDG and Professor of the Department of Chem. & Biochem. Engineering of The University of Suwon) explained, “Since the biotechnology industry is directly related to the health of humankind and human welfare, it will undoubtedly become one Korea’s growth engines. The Korean pharmaceutical industry that had been indifferent to the development of new drugs is now groping for appropriate responses to environmental changes such as the effectuation of Korea’s FTAs. He added, “The number of elderly people is highly likely to plateau in 2050, so responses to market changes should be drawn up as soon as possible. Expanding partnerships with multinational pharmaceuticals can be an option to facilitate the development of new, innovative drugs by Korean pharmaceuticals.”

 

The Process of Developing World-Class Medicine

The KBRDG was set in motion to create Korea’s new growth engine through the development of highly effective drugs in the biotech sector. In the first year of the KBRDG’s 8-year project in 2004, KRW 8.39 billion was invested and over KRW 10 billion has been invested annually since then. A total of KRW 115.2 billion was ploughed into the KBRDG’s project for eight years from August 2004 to July 2012. The KBRDG’s project was divided largely into four areas: bio organs, bio chips, drug delivery systems (DDS) and immune system control technology.

From the development of core technologies to the production and export of products, support provision systems were set up. The system of cooperation with ministries was built for each program to ensure the commercialization of technologies. A three-stage implementation plan was also carefully designed: the first stage (discovery of candidate substances through developing core technologies), the second stage (drawing participation from companies by presenting R&D results produced in the first stage), and the third state (commercialization after clinical trials led by companies’ R&D centers and filing investigational new drug applications (IND) with Korea Food and Drug Administration (KFDA)). Tasks that could not be finalized during the eight-year project are still being carried out via technology transfer or as part of other programs. The coverage of the KBRDG’s support was from the development of fundamental technology to animal experimentation.

The KBRDG made an all-out effort to fast-track the development of new drugs and raise the efficiency of R&D investment. For instance, the KBRDG adhered to the “selection and concentration” strategy: once 51 tasks entered the final stage (stage 3) in 2009, the KBRDG drastically narrowed them down to a select group of 28 tasks based on rigorous evaluations of corporate participation, entry to pre-clinical trial, and commercialization.  The KBRDG has also laid the groundwork for industry-academia exchanges and conducted in-depth analyses of patents from the early stage of each R&D task to check whether each task is headed in the right direction while also crafting responses to possible patent disputes. The KBRDG teamed up with industrial experts to match each task with eligible businesses and smooth out the process of technology transfer.

 

Commercialization of Core Technologies 

Developing a new drug normally takes an average of 10-15 years and costs, on average, KRW 800 billion to KRW 1 trillion. Yet, once a new drug is successfully developed, over KRW 10 trillion in annual sales is guaranteed. Thus, it is definitely a high-risk, high-return investment.

The eight-year project that was keen on the development of core technologies has indeed produced outstanding results: one IND application, 10 cases in the stage of pre-clinical trials, 36 technology transfer contracts worth KRW 11.2 billion,22 prototypes (including candidates for new drug development, new-found vectors, transgenic pigs and biochips), , 440 patent applications and 157 registered patents.

[Table-01] The KBRDG’s Tasks bound for Technology Transfer

 

Name of Technology

Researcher

Contact Number

1

Protein chip-based technology for milk quality control

Antibody-imitating technology for peptides searches

Chungbuk National University Jang, Sue-Ik

sichang@chungbuk.ac.kr

2

Biochip technology based on photonics and macromolecules

Korea University Ahn, Dong-June

ahn@korea.ac.kr

3

Nucleic acid vectors using biocompatible cationic lipids

KIST

Song, Soo- Chang

scsong@kist.re.kr

4

Docetaxel-loaded liquid suppository

Hanyang University Choi, Han-Gon

hangon@hanyang.ac.kr

5

Protein transduction technology-based biodrug for dry eye syndrome (DES)

Hallym University Choi, Soo-Yeoung

sychoi@hallym.ac.kr

6

CD9-specific human antibody for cancer treatment

Korea Research Institute of Bioscience and Biotechnology Park, Yong-Woo

ywpark@kribb.re.kr

The thirty-eight tasks selected in 2004 were participated in by three industries. Noteworthy was that only KRW 300 million of the project’s funding was required from the private sector. In 2011, 28 tasks were partaken in by 21 Korean pharmaceuticals including LG Life Sciences, Green Cross, Daewoong Co., Chong Kun Dang, CJ, Macro Gen, Genexine, ViroMed, S&G Biotech, etc. Accordingly, the private sector made an investment of KRW 4.1 billion, a 13-fold increase from KRW 300 million This means that pure research aimed to advance scientific knowledge has actually led to industry-academia joint researches and is moving towards commercialization.

Cases in point are the aforementioned transplantation of porcine islets of Langerhans in a diabetic monkey (by Seoul National University),  the KFDA’s approval of the GX-188E IND application and entry to clinical trial (Genexine), the production of transgenic miniature pigs for organ replacement (Dankook University), ultra-small protein-coated SPR (Surface Plasmon Resonance) chip analysis system (Korea Research Institute of Bioscience and Biotechnology(KRIBB)), Multi-prong needle (S&G Biotech), etc.

 

Future Visions

Now, the KBRDG’s 8-year journey nears its end, but the Korean biotechnology industry still has a long way to go. Between 2013 and 2014, the KBRDG will have to file numerous INDs with KFDA and have the submitted INDs approved. In 2013 - A sepsis cure using cholate derivatives (Seoul National University (SNU), localized protein drug delivery system using nano-scale hydrogels (Korea University), anti-EGFR (epidermal growth factor receptor) monoclonal antibodies to cure colorectal cancer (Green Cros)) while in 2014 – Aid pro-angiogenesis protein treatment for ischaemic cardiovascular diseases (Theragen Etex) and adenovirus-mediated double suicide genes (CD-TK) for selective killing of brain tumors (Hanyang University) must be approved.

These remedies have proven thatKoreacan develop world-class drugs solely with domestic technologies. If these therapies are left uncommercialized, the 8-year investment will go down the drain. To prevent such a tragedy, the KBRDG has pressed ahead with drug development in close collaboration with other ministries from the onset. Furthermore, the KBRDG has sought ways to transfer some technologies deemed ineligible for domestic commercialization to foreign companies or continuously developed them in partnership with foreign pharmaceuticals. As a result, many of the KBRDG’s unfinished tasks  are now being pursued under the Ministry of Knowledge Economy’s program for the optimization of candidate substances and the clinical trial program led by the Ministry of Health and Welfare.

Unfortunately however, a number of tasks that produced promising results are on the verge of abrupt termination.

Gio-bin Lim, General Director of the KBRDG,  strongly emphasized, “The most important thing is to continue researches to prevent excellent R&D results sitting idle on lab shelves. As a tremendous amount of time, money and R&D personnel is required, the Korean government’s support for drug development is a must in a situation where the domestic pharmaceutical industry is dwarfed by multinational pharmaceuticals in terms of technology and capital.”

 

General Director Lim received his bachelor’s degree and master’s degree in chemical engineering from Yonsei University and a PhD in chemical engineering from the University of Pittsburgh. After receiving a PhD, he worked as a researcher at Cornell University and Princeton University in the US. As of now, he serves as General Director of the KBRDG and Professor of the Department of Chem. & Biochem. Engineering of The University of Suwon. Also, he is currently on the boards of directors and steering committees of Asian Federation of Biotechnology (AFOB) and the Korean Federation of Science and Technology Societies (KOFST) and is in charge of PR on the organizing committee of the 9th World Congress of Chem. Eng. (WCCE9).


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