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Kafe 바로가기주관연구기관 | 한국파스퇴르연구소 |
---|---|
연구책임자 | 케빈 피트 |
보고서유형 | 3단계보고서 |
발행국가 | 대한민국 |
언어 | 한국어 |
발행년월 | 2014-07 |
과제시작연도 | 2013 |
주관부처 | 미래창조과학부 Ministry of Science, ICT and Future Planning |
등록번호 | TRKO201800009623 |
과제고유번호 | 1345197354 |
사업명 | 한국파스퇴르연구소운영(R&D/보조) |
DB 구축일자 | 2018-05-26 |
키워드 | 한국파스퇴르연구소.신약개발.중개연구.초고속/대용량 약효검색.감염성질환.결핵.C형간염.B형간염.선도물질.전임상 후보물질.Institut Pasteur Korea.Drug Discovery.translational research.High Throughput Screening (HTS).High Contents Screening (HCS).infectious diseases.Tuberculosis (TB).HCV.HBV.Lead.Preclinical candidate(PCC). |
DOI | https://doi.org/10.23000/TRKO201800009623 |
1) PhenomicScreenTM
- 자동화된 2개의 HTS 시스템을 포함하여 총 7기의 스크리닝 장비를 갖추고, 총 23만개의 화합물 라이브러리를 보유하여, 연간 100만개의 화합물을 스크리닝에 적용할 수 있음. 개발된 질명 모델을 시각적으로 판독할 수 있는 영상 분석 알고리즘 및 소프트웨어 개발. 이러한 기술을 생물안전 3등급 실험시설(BSL-3)에서 운영함으로써 전 세계적으로 인정받을 수 있는 첨단 감염성질환 연구 플랫폼 구축
2) PhenomicIDTM
- 시각
1) PhenomicScreenTM
- 자동화된 2개의 HTS 시스템을 포함하여 총 7기의 스크리닝 장비를 갖추고, 총 23만개의 화합물 라이브러리를 보유하여, 연간 100만개의 화합물을 스크리닝에 적용할 수 있음. 개발된 질명 모델을 시각적으로 판독할 수 있는 영상 분석 알고리즘 및 소프트웨어 개발. 이러한 기술을 생물안전 3등급 실험시설(BSL-3)에서 운영함으로써 전 세계적으로 인정받을 수 있는 첨단 감염성질환 연구 플랫폼 구축
2) PhenomicIDTM
- 시각화 탐색기술을 이용, 소규모 유전자 간섭 RNA(siRNA)의 원리를 활용하여 게놈 수준의 탐색방법을 선진화한 신기술로써, 신약개발의 원천기술인 질병발병의 조절 및 치료와 관련된 새로운 표적발굴이 가능함. 총 1.8만개의 siRNA 라이브러리를 보유하여 인간의 전체 유전자를 시각적으로 분석할 수 있는 플랫폼 구축
3) PhenomicTDTM
- 상기 구축한 기술들을 이용하여 신약후보물질의 작용점 규명을 가능하게 한 기술. 약효를 보이는 화합물과 siRNA를 함께 활용하여 저분자 화합물의 표적을 규명할 수 있는 플랫폼 구축
2. 신약 개발 연구
1) 결핵 (Tuberculrosis)
- 실제 결핵균의 감염 경로와 유사하도록 결핵균을 인간의 대식세포에 감염시킨 질병 모델 개발, 대식세포의 호흡을 담당하는 핵심 단백질에 특이적으로 결합하여 결핵균을 죽이는 새로운 작용기전 규명
- 연구소가 자체 보유한 약 20만개의 화합물 라이브러리를 독자 구축한 페노믹 스크리닝 기술을 적용하여 내성 결핵균을 사멸시키는 혁신신약 후보물질 Q203 개발
- 미래창조과학부와 한국과학기술기획평가원에서 선정한 ‘2014년도 국가연구개발 우수성과 100선’에 선정. 세계적 생명공학 권위지인 Nature Medicine에 게재. 스핀오프 회사인 ㈜큐리언트로 기술이전. 러시아 Infectex사에 성공적으로 라이센싱하였으며 2014년 후반 임상실험 진입 예정
2) C형 간염 (HCV)
- C형 간염 바이러스 감염시스템 및 레플리콘(replicon)을 이용한 약효검색법 개발, HCV 감염시스템을 이용한 초고속/대용량 약효 검색 후 다수의 유효화합물 도출
- replicon시스템, 바이러스진입 억제 분석, 모든 HCV 유전자형에 대한 활성 분석, 약물병용 투여 효과 분석, 내성 바이러스 제작, 바이러스 방출 분석법 개발 및 의약화학 연구를 통해 선도후보물질 (DABA) 및 선도물질(TU) 도출. 새로운 작용기전 규명
3) B형 간염 (HBV)
- HBV 패키징 분석법을 개발하여 11만개의 화합물 라이브러리를 스크리닝하여 B형 간염 바이러스의 유전체 포장 과정을 억제하는 유효화합물 9종 도출, 이중 1종이 선도물질 도출과정에 진입. 추가로 B형 간염 면역조절물질 분석법 개발하여 10,000개의 화합물 스크리닝
- 사노피사의 화합물 라이브러리 31만개 스크리닝 완료하여 공동연구 착수예정
4) 병원내세균감염질환 (HABI)
- 녹농균 및 폐렴간균에 대한 약효검색 실험법 개발하여 초고속/대용량 스크리닝 완료. 유효물질로 도출된 Oxythiamine의 약리작용을 규명하고 다른 화합물과의 상승약효 실험
- Sanofi-Aventis의 1백만개 화합물 라이브러리를 분석 예정
5) 인플루엔자 (Influenza)
- 인플루엔자 A형 H1N1에 대한 이미지기반 분석법을 구축하여 11만개 화합물 약효검색 완료. 6개의 선별된 유효물질 발굴. 바이러스 생활주기에 따른 다양한 이차 분석법 구축
- 인플루엔자 바이러스의 NS1 단백질에 대한 가상 스크리닝을 통해 유효 화합물 1종 도출. 인플루엔자 A 및 조류 독감에 대한 광범위 항바이러스 효능 확인
6) 간암 (HCC)
- 선별된 간암종 세포의 특징을 규명하고 간암 및 간암 줄기세포의 특이적인 마커를 이용한 화합물 약효검색법 개발. 간암세포 혼합 배양 시스템을 이용한 초고속/대용량 약효검색 진행
7) 흑색종 (Melanoma)
- Kinase 저해제 라이브러리로부터 선별된 화합물로부터 암세포의 노화를 촉진하는 신개념의 선도화합물 1종 도출. 이종 및 동종 종양모델동물 실험에서 우수한 항종양 작용을 보임.
- 선도물질의 타겟 규명을 위해 삼성메디컬센터 및 연세대학교와 작용기전 연구 진행중.
8) 소외질환 (Kinetoplastid)
- 소외질환 연구 비영리국제기구인 DNDi로부터 2010년과 2011년‘올해의 파트너’로 선정
- 리슈마니아, 샤가스 및 수면병 등 여러 소외질환에 대한 각각의 표현형 초고속 대용량 스크리닝 진행 완료, 리슈마니아에 대한 6종의 유효물질로부터 2종의 선도후보물질 도출
9) 항염증 (Inflammation)
- 5-LO 저해제 개발에 있어 기존의 질루톤 작용기전을 공유하며 독성 및 약물동력학을 개선시킨 2종의 선도물질 도출하여 2013년 (주)큐리언트에 기술 이전
(출처 : 요약서 3p)
Research Goal and its Necessity
Institut Pasteur Korea (IP-K) was established in 2004 as a nonprofit research institute. IP Korea was initially hosted on the KIST campus and moved to its definitive location in Pangyo in April 2009.
The purpose of IP Korea is to conduct research and technol
Research Goal and its Necessity
Institut Pasteur Korea (IP-K) was established in 2004 as a nonprofit research institute. IP Korea was initially hosted on the KIST campus and moved to its definitive location in Pangyo in April 2009.
The purpose of IP Korea is to conduct research and technology in the field of life science, thereby developing industrialization techniques for biotechnology and contributing to the advancement of the biotechnology industry. As a translational research institute, IP-K aims at facilitating the application of basic research towards the development of novel therapeutic interventions exploiting innovative, proprietary technology based on the visualization of physiologically relevant cellular disease models. The technology enables on one hand an efficient and unprejudiced, target-free drug discovery approach and on the other hand the identification of relevant drug targets exploiting the identified active chemical entities. This bidirectional approach thus not only promotes an accelerated development of novel therapeutic options, it also provides important tools for the elucidation of highly relevant, fundamental cellular disease mechanisms.
By anticipating a new model of research institutes, IP-K evolved into a world class institute that balances cutting edge fundamental research with state-of-the art translational research in the quest for ground-breaking scientific and therapeutic advances. By developing unique technologies to accelerate the discovery of new drug candidates, IP-K became a strong link in the value chain of Korean biomedical R&D and beyond.
The goal of the institute is to accelerate the translation of basic research toward new therapies. In a nutshell, the major objectives of IP-K have been:
1. To advance the completion of initiated Drug Discovery Programs towards the development of competitive preclinical drug candidates in the areas of infectious diseases and chronic diseases
2. To provide a professional translational research infrastructure for productive public-private partnerships with both Korean Academic and Pharma partners, as well as with global pharmaceutical companies.
3. To combine imaging-based technologies and chemical genomics approaches to discover fundamental disease mechanisms and novel target pathways for improved treatment options.
4. To secure IP-K’s future competiveness through consolidating its technological lead.
Research Contents and Scope
IP Korea is conceptualized around the virtual genome to drugs pipeline. The goal of IP Korea is to actively implement post-genomic approaches to accelerate drug discovery. Accordingly, the institute is situated at the very fault line between basic research and biomedical applications. The positioning of IP Korea is in accordance with the Pasteurian tradition and mission. During its long history, Institut Pasteur in Paris have been able to combine scientific achievements with their application in public health. This has improved the lives of millions of patients over the last 130 years, and has earned Institut Pasteur 10 Nobel prizes. To extend and build on these achievements, IP Korea was one of the first research institutes to develop a technology-based approach for the development of novel therapeutics.
Strategically, the institute combines its strength in biotechnology with Korean expertise in information and chemical technologies.
IP-K has pioneered the successful implementation of visual High Content/throughput Screening (HC/TS) as the initial step in target & drug discovery. The core technology of the institute revolve around visualization of living cells, both healthy and diseased, and the algorithm driven identification and quantification of cellular phenotypes. The Technology Resource Center of the institute provides an ideal HC/TS capacity with no less than 7 high content readers, 4 platforms for robotized fluorescence microscopy, a large compound library, a full human genome siRNA library and a dedicated image analysis group for image mining and software development. Disease experts have exploited this unique resource to build unique complex High Content disease models that were adapted to the requirement of High-Throughput Screening, and exploited them to discover new drug candidates and new drug targets.
The expertise of IP-K for the development of High-content assays applied to infectious diseases is being recognized worldwide through publication or highlights in the most prestigious scientific journals. Beyond the technologies that was developed at IP-K, it is the multi-disciplinary nature of the institute that makes it truly unique: the capacity to attract and retain global talents from various cultures and scientific backgrounds (including computer science, mathematics, biology, medicinal chemistry and biotechnology) has allowed IP-K to pave a new way to rationalize the discovery of innovative drug candidates and novel drug targets.
Research Outcomes
Building on its expertise in HC/TS technologies, IP-K has developed one of the most productive screening platform in research institutes worldwide. IP-K has assembled one of the largest collection of small molecules in research institutes worldwide, and more productive HCS/HTS platform, which is a fantastic potential source of novel drug candidates or tool compounds.
TECHNOLOGY
Three strategic HC/TS technologies at the heart of our activities were developed at IP-K:
1. PhenomicScreenTM is a visual high content screening platform that allows the identification of small-molecules that exert an effect of interest in a live disease model. It represents a robust platform to identify chemicals that revert a disease phenotype at the cellular level. Being target-free by nature, PhenomicScreenTM has the power to interrogate all possible drug target in a complex disease model in an unprejudiced manner.
2. PhenomicIDTM is a visual high content screening platform that allows the discovery of new drug targets in a live disease model. It relies on a library of siRNA that can knock-down the expression of any gene from the human genome.
3. PhenomicTDTM is a unique platform that was developed to identify the cellular target of any small molecule on a unique spot-array format that enable us to perform high density screening of ~4,000 individual siRNAs in an area less than 2cm2.
These technologies, recognized through publication in the most prestigious scientific journals and patent issuance, were applied to the field of infectious & chronic diseases and lead to the identification of dozens of tool compounds and potential drug candidates.
As an example, the development of the first cellular model to visualize the infection process of Mycobacterium tuberculosis inside human macrophages culminated in the development of Q203 as a drug candidate for drug-resistant tuberculosis. This project was recently recognized as one of the 100 greatest national R&D performance of 2014 from MSIP & KISTEP (among 50,000 national R&D projects) and published in the scientific journal Nature Medicine. Importantly, Q203 has the potential to become the first first-in-class drug candidate developed in Korea to reach clinical development.
Likewise, a unique cellular assay for hepatitis C permitted the identification of new compound series that interfere with the infection process through a novel mode of action. A grant of more than USD 1.2 million was recently awarded by the prestigious Korean Drug Development Fund to support the development of the most advanced lead series.
It is important to note at this point that, given the attrition in drug development across industry, it is quite remarkable that a medium-size institute like IP-K to have several drug candidates in late preclinical development stage.
DRUG DISCOVERY PROGRAMS
[Ongoing programs]
1. The Tuberculosis program has delivered Q203 as one of the most potent drug candidate ever discovered. The development of the compound is advancing well ahead on track since Qurient is planning to initiate clinical development late 2014. In addition, Qurient has successfully licensed out Q203 to Infectex to development and commercialization in the Russian market. Q203 could be become the first first-in-class drug candidate discovered in Korea to reach clinical development. Two backup series with a novel mechanism of action are being explored
2. The HCV program developed extremely well and has delivered highly active lead series that have a novel mechanism of action. The most advanced TU series has excellent overall properties, including accumulation to target organ, pico- to nano-molar activity against all genotypes tested and good safety profile. Lead optimization is currently ongoing with support from the Korean Drug Discovery Fund.
3. The lead project on HBV in collaboration with Yonsei University has been successfully leveraged to Sanofi. Two interesting projects supported by Sanofi are currently under way. The most ambitious projects aiming at finding a radical cure for HBV infections delivered multiple hits.
4. The leading NGO (DNDi) has again awarded IP-K the prestigious "Partner of the Year" Award (2011) for its excellence in neglected diseases and extended further the term of our collaboration by heavily supporting our activities in the field of drug discovery for Leishmaniasis and Chagas disease.
5. An Influenza group has been established in collaboration with Institut Pasteur Paris, with the goal will be to develop novel antiviral therapies. The program is set to be developed in collaboration with the Asian IP network. The team has been successful in attracting external funding and discovering interesting small-molecules active against pandemic and/or seasonal influenza strains.
6. A program on Hospital-acquired bacterial infections has been established. The team developed innovative screening methodologies that has delivered interesting tool compounds active against drug-resistant bacteria and has attracted interest from Sanofi-Aventis to carry out a full screen of 1 million compounds from the Sanofi-Aventis compound collection deck.
7. A program on Hepatocellular carcinoma (HCC) was developed in collaboration with Asan hospital. Clinicians provides expertise from the field to develop predictive screening assays aiming at finding the next generation of drugs for the treatment of HCC.
8. In cancer, a Melanoma screen has been designed targeting senescence as an entirely novel strategy in combinatorial treatment with kinase inhibitors. The project has seen a successful pilot screen and has been retained after international review. The program delivered an innovative compound series with activity in the low nanomolar range, and demonstrated activity in vivo in a xenograft and allograft mice models. Chemical optimization was put on hold internally. Nevertheless, mode of action studies are currently ongoing in collaboration with experts from Samsung Medical Center and Yonsei University.
[Discontinued programs]
1. The Inflammation program generated several lead series with optimized cellular activity against 5-LO and satisfactory early-ADME properties opening up the chance for IP-K to make a major contribution in this disease area. The series was licensed out to Qurient who is pursuing preclinical studies.
2. The HIV program was terminated in 2012 despite the discovery of two compound series with favorable SARs in the nano-molar range. Unfortunately, it
was found that those compound did not fulfill the clinical target product profile.
3. In Malaria, four hit series from a previous screening effort targeting the asexual stage of the parasite have emerged that meet the desired characteristics after validation and characterization. The program was terminated due to the global competition in the field and a strategic decision to focus our activities to the most promising programs
4. Likewise, assay development efforts to target two new disease areas, namely Dengue Virus (DV) and Chikungunya Virus (CHIKV) were terminated due to a lack of innovation and global competition.
5. For Alzheimer’s disease all essential assays to conduct a comprehensive drug discovery strategy have been successfully implemented and a full scale screening campaign has been launched. Further a compound series from a previous pilot screen is in an advanced hit validation stage demonstrating satisfactory properties in terms of activity, toxicity and secondary biological assessments. In addition establishment of an in vivo efficacy mouse model is currently finalized.
However, after careful internal review and advices from our Scientific Advisory Committee, the current program was terminated. This is mainly due to the lack of clarity in clinical development and issues with predictivity of current cellular assays. Instead, effort are being pursued to develop robust cell assay using patient-derived neurons.
6. The program on Diabetes has not succeeded in developing appropriate cellular screening systems that comply with IP-Ks stringent standards. The diabetes and metabolic disease programs was discontinued end of 2011.
IP KOREA: A GLOBAL HUB FOR BIOMEDICAL TRANSLATIONAL RESEARCH
With a demonstrated track-record of translating basic understanding of disease mechanisms into innovative drug discovery, IP-K became a global translational hub and built and unmatched network of global collaborators. IP-K is a highly collaborative institute that is working, or has worked, with the most prestigious universities, research centers or pharmaceutical companies. Since the institute was founded, we entered a total of 80 Research agreements, 161 MTAs, 36 service agreements, 20 MOUs, 147 CDAs and 9 licensing agreements. This portfolio of global collaborators is a unique contribution to the Korean R&D arena that can efficiently to link Korean institutes with global pharmaceutical players.
The most significant agreements signed in the last 10 years are:
1. Sanofi: Proprietary compounds representative of the entire Sanofi compound library is being shared for the first time outside of a consortium arrangement.
Research collaboration on HBV that was initiated in 2011 is successfully moving forward with a variety of hit compounds. A Master Collaboration Agreement (MRA) and signing ceremony was held at the end of a joint forum on Open Innovation with Sanofi on April 5th 2013. Chris Viehbacher, CEO of the Sanofi Group gave the keynote address at the forum. The MRA allows for the expedient transfer of Sanofi Compounds to IP-K for mutually agreed upon projects. IP-K is also continuing its collaboration with Sanofi on two HBV projects, one in hit to lead phase and the other is currently in the screening phase. A project on bacterial lung infection due to Pseudomonas aeruginosa was also initiated.
2. GSK: is financing the further development IP-K’s new anti-tuberculosis compound (oxodiazol) which has an interesting mechanism of action specific for intracellular mycobacteria. We are also continuing out collaboration under a EUFP7 consortium grant where we are now moving past screening into hit to lead studies with GSK on a GSK molecule identified as active in our propriety macrophage assay (KRW400 Mio to date). IP-K was rewarded an Open Lab grant from the Tres Cantos division of GSK and the corresponding research collaboration agreement was finalized on March 20 2013. This partnership allows IP-K to jointly further develop one of its anti-TB compounds with GSK at its site in Tres Cantos and allows for IP-K scientists to work alongside and learn from GSK drug development specialists.
3. DNDi: A term sheet is currently being drafted for a master agreement covering an in-depth collaboration with IP-K beyond the scope of a fee for service arrangement (funding undergoing negotiation). DNDi key personnel are coming to visit IP-K the end of March to further discussions. On August 13 2013 IP-K and DNDi signed a Master Research Agreement allowing both parties to continue their historical screening relationship as well as provide the opportunity for additional collaborations on compounds being worked on by IP-K and/or DNDi.
4. Servier: Servier and IP-K are now embarking on their first collaborative research project on IP-K’s PhenomicTD technology. Future projects will be discussed if the first interaction proves mutually beneficial.
5. GreenCross: A strategic alliance has been finalized on formation of a joint compound library and the term sheet is under final negotiation for an additional research collaboration (KRW600 Mio to date).
6. Jeil Pharmaceutical: IP-K and Jeil entered into a partnership agreement where Jeil will test IP-K’s advanced lead compound from its melanoma program in a number of different xenograft models. Jeil will have first right to enter into a research collaboration and option to license agreement with IP-K depending on the results of the study.
7. Dong-A: Proprietary compounds from Dong-A were tested in IP-K’s in house HABI assays. Although no Dong-A compounds were identified for further progression, the positive interaction between the two organizations stimulated further advanced discussions on HCV and neurodegenerative diseases.
8. Yonsei University: Research collaboration on HBV has been extended due to its positive results and continues to be funded by the downstream partner, Sanofi.
9. Asan Hospital: IP-K is setting up a research station at Asan for closer access to clinicians and patient samples and to find ways to form a research alliance in the field of oncology.
10. SNU: Cooperation agreement for joint research program was signed in November of 2012 and several thousand proprietary pure compounds of SNU will be tested in IP-K’s novel malaria assay to identify particular compounds warranting further joint investigation by IP-K and SNU.
In conclusion, since IP-K started to be fully operational, the institute has been highly productive in various field of research as witnessed by : the developed of breakthrough technologies to accelerate drug discovery, the identification of 3 compounds series (two for tuberculosis, one for inflammation) that were licensed out as preclinical candidates to downstream partners, the identification of 10 lead candidates were identified, the completion of 18 High-content screens, the identification of disease-relevant targets through chemical genomics or siRNA screens, the publication of 110 scientific articles in peer-reviewed journals. In addition, 98 patents covering 13 inventions were filed. Among them, 15 US Provisional applications were converted to PCT and 68 patent applications went into the national phase and 20 countries.
Plan for Research Application
IP-K is well on its way to developing drugs for a variety of diseases. Our endpoint for success is chemical small molecule therapeutics and identification of novel drug targets. Utilization of IP-K research is centered on this task.
Partnerships with institutions with complementary expertise and resources will help with this mission, as advancement to lead optimization, late preclinical development and clinical trials require substantial monetary investment.
To this end, on the path to drug discovery, projects are in different stages, as the initiation and difficulty of various disease models vary. The expected utilization of the research performances is as follow:
1. The most advanced programs on tuberculosis and hepatitis C are well on track to enter late preclinical and clinical development and have great potential to generate novel medicines for those diseases, thereby contributing to the control of major public health issues.
Drug candidates have for vocation to be licensed-out to biotech or pharma companies for clinical development. The clinical candidate Q203 (TB program) was licensed-out to Qurient and subsequently licensed-out to infectex for development and commercialization to the Korean market. This is a good excellent of creative economy fuelled by technological and scientific advances. IP-K is entitled to receive milestones payments that we will be invested back to R&D.
The project on Hepatitis C which is currently supported by KDDF as attracted the interest of several local pharmaceutical companies such as Dong-A
2. A number of new large-scale screens based on innovative assay technology delivered promising tool compounds or novel drug targets that are currently studied.
For instance, the cutting-edge HC/TS assays employed for Influenza A virus, hospital-acquired bacterial infections or melanoma have a high potential to generate reliable and novel level of interventions for those diseases that could be licensed out to downstream partners. Industrial partners were already identified for the program on hospital-acquired bacterial infections.
3. Phenomic IDTM/Target DeconvolutionTM, as the last aspect of IP-K’s first generation technology development, has been successfully implemented as a standard platform in 2011. It now constitutes a robust and reproducible process, and is fully automated. This achievement firmly underpins IP-Ks international technology leadership and will significantly contribute to further advance IP-K’s drug discovery efforts and constitutes a strong link in the value chain of Korean biomedical R&D and for global open innovation.
4. Technology development programs are streamlined within a newly generated center and focus on highly innovative disease models and screening technology (e.g. patient-derived iPS cell models, 3D cultures and screening in heterogeneous cell populations). These programs are anticipated not only to advance to publication stage but will be incorporated as standard platform technologies to maintain IP-K’s leading position as a translational research institute in the future.
(출처 : Research Summary 15p)
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