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LegoChem Bioscience, Inc.A Leading Chemistry-Based Venture Company
COMPANYOVERVIEW
Contents Company Overview
Business Approach
Project Overview
Summary
Mission Statement
LegoChem Biosciences ( “LCB”) is committed to the discovery and development of novel small-molecule drugs employing faster and more efficient ways by combining LegoChemistry and early ADME/T screening platform technologies.
ABOUT BUSINESS PROJECT SUMMARYABOUT
Corporate Overview Established in May 2006 (Daeduk Science Town, Daejeon, Korea )
Raised 10.3 billion Korean wons (≈ 10 million US$) since its inception
Has built sustainable pipelines in the therapeutic areas of antibiotics, anticoagulants, and oncology
The frontrunner, 2nd generation oxazolidinone antibiotics against MRSA is now in regulatory preclinical studies CRO: MPI in USA
Novel FXa Inhibitor (anticoagulants) is in regulatory preclinical studies jointly with Green Cross, and is licensed out at the candidate stage to Green Cross in June 2009
Experienced and seasoned executive and scientific management team
Preparing IPO to KOSDAQ
ABOUT BUSINESS PROJECT SUMMARYABOUT
Management Team
CEO & President
Director of New Drug R&D , 23 yrs at LGLS Co-Founder of LCB, Ph.D. /Chemistry, KAIST
CTO & Sr. VP
Project Leader, 10 yrs at LGLS Co-Founder of LCB, Ph.D. /Chemistry, MIT
Head of Biology /
VP
Project Leader, 5 yrs at LGLS Co-Founder of LCB, Ph.D. / Microbio, Ohio state
Chemistry Sr. Director
Project Leader at LGLS 18 journal, 5 patent publications Ph.D. / Chemistry, Yonsei U.
CFO / VP
GM, R&D Management, 20 yrs at LGLS Co-Founder of LCB, BS/Economy, Korea Univ
Chemistry Director
Principal Research at LGLS, Ph.D. / Seoul Nation U. 8 journal, 2 patent publications
Biology Director
Research Scientist, 11 yrs at LGLS, 4 journal, 10 patent pub. MS /Biochem, Yonsei U.
ABOUT BUSINESS PROJECT SUMMARYABOUT
Yong Zu Kim, Ph.D
Tae Kyo Park, Ph.D Sung Ho Woo, Ph.D Sejin Park Young Lag Cho, Ph.D Ho Young Song, Ph.D Hyang Suk Lee
Business Strategy and Model
Collaborative R&Dor
Research Services
Sponsored R&D
orCollaborative
R&D
Collaborative R&D
IndependentR&D
Model 1 : Independent R&D
Internal research & development up to phase 2a
License-out at early ~ mid stage (i.e. Oxazolidinone antibiotics, FXa Inhibitor)
Model 2 : Collaborative R&D
Joint research with strong biology platform up to phase IIa
License-out at early ~ mid stage (i.e. Anticancer : HSP90, Mitochondriotropic)
Model 3 : Sponsored R&D
Sponsored R&D cost from partner up to candidate stage
License-out to partner at candidate stage and developed & commercialized by partner (i.e. FVIIa Inhibitor)
RIS
K
CORE COMPETENCY
Biology BasedMed Chem
Based
ABOUT BUSINESS PROJECT SUMMARYBUSINESS
•Medicinal Chemistry• LegoChemistry
•Screening• Early ADMET
◆ Proprietary drug discovery candidates
◆ Early stage L/O
Proprietary Drug Development(chemistry –driven challenge)
◆ Drug discovery and development of candidate
◆ Early~mid stage L/O
Drug development through collaborative research
(Biology-driven challenge)
◆ Customized compound synthesis
◆ Early ADME/T service
Business Research Service
Strategic Alliances
Gate Decision System
Core Technology
Business ModelABOUT BUSINESS PROJECT SUMMARYBUSINESS
Efficacy Focus
In vitro/in vivo efficacy
Selectivity
Metabolic stability
CYP inhibition (DDI)
Protein Binding
Solubility
Stability(plasma, solution)
Safety Focus
Ames
hERG (Patch Clamp)
Single dose Tox
Repeated dose Tox (1W)
3rd GatePre-CandidateConfirmation
Phase I CandidateConfirmation
Lead Preclinical CandidateConfirmation2nd Gate1st Gate
PK/PD Focus In vitro/in vivo efficacy Selectivity Metabolic stability CYP inhibition (DDI) Protein Binding Solubility Stability (plasma, solution) PK (t1/2, Vd, CL, AUC) Cytotoxicity BA(rat) > 20%
Establish 3 level gate systems for preclinical candidates, and define the evaluation criteria based on experience and know-how, to pre-validate and apply failing factors during the post
preclinical development phase
Gate Decision System
ABOUT BUSINESS PROJECT SUMMARYBUSINESS
Platform Technology: LegoChemistry
“New Lego block” molded into existing best chemical structures
New Pieces of Lego Block
Way of Implementation
1. Previously unknown2. Known but not well-exploredLCB has more than 20 drug-like unique scaffolds
AREA1. Disease area with experience2. Validated (existing) target
METHOD3. Fragment-based approach4. Multi-component reactions5. Replacement of existing subgroup
A
B
C
Time to candidate : 12 ~ 18 months
Successful cases1. FXa inhibitor (LCB02-0133)2. Antibiotics (LCB01-0371)
Derived from same Lego Block
ABOUT BUSINESS PROJECT SUMMARYBUSINESS
LegoChemistry / Affi. assayCombi-Chem/HTS
기존 Approach 레고켐 Approach
1990 Present
(one by one) (multi by semi-multi) (once and all)
Traditional approach
Manual single synthesis
Singleton Assay
Combi-Chem - Simultaneous synthesis of
various substances / Individual
Separation - druglike lack of verification
HTS - Fixed unit multi-well Assay
LegoChemistry
- Synthesis of various materials
simultaneously without separation - Starts from Druglike scaffold
Affinity Assay
- One conclusive assay for
complete mixture of synthetic
material
Candidate
Discovery Method
3,800 : 1
Over 5 years
5,800 : 1
Average 5 years
R&DProductivity
(Candidate for discovery) ☞ Merck Standard
The synthesis of core competencies
Shortening candidate discovery time from 5 to 3 years by utilizing tools like LegoChemistry
500 : 1 (or less)
Less than 3 years
ABOUT BUSINESS PROJECT SUMMARYBUSINESS
More than 5 clinical pipelines for new drug by 2012(Benchmarking: Gilead Science)
Initiate pipeline(’06 ~’08)
Grow pipeline(’09 ~’11)
Sustain pipeline (’12 ~ )
2 Preclinical candidates,
1 License-out1 Co-Research
contract
3 Clinical pipeline 2 License-out
1 preclinical study/year
5 Clinical pipeline3 License-out
1 clinical study / year
Collaboration network Global network Global licensing-out
Independent research and development company
Manage the process from discovery to development
Output
CoreCompetencies
Mid-term Business Plan
ABOUT BUSINESS PROJECT SUMMARYBUSINESS
Research Projects
Project Selection Guideline
Management’s Previous Experience
antibiotics, anticoagulants, anticancer
Attractiveness to big pharm
unmet medical needs
Portfolio Balance (risk management)
best-in-class vs. first-in-class
Projects
Antibiotics
Oxazolidinone antibiotics , MDR-TB
Gram(-) antibiotics
Anticoagulants
FXa inhibitor (Partnered with Green Cross)
FVIIa inhibitor (Partnered with Hanmi)
FXIa inhibitor
Anti-cancer
HSP 90 (Partnered with Boram Pharma) Mitochondriotropic
Others
DDR2 / HIF-1(Wondonin) / CD-99
ABOUT BUSINESS PROJECT SUMMARYPROJECT
Project RoadmapProgram Lead Optimiza-
tion Preclinical Phase 1 Phase 2a
Antibiotics
- Oxazolidinone(LCB01-371)
- Gram(-) antibioticss
- TB
Anticoagulants
- FXa Inhibitor
- FVIIa Inhibitor
- FXIa Inhibitor
Anticancer
- HSP90(Small molo)
- Mitichondriotropic
Others
- DDR2
- HIF1(Wondonin)
(by Green Cross)
ABOUT BUSINESS PROJECT SUMMARYPROJECT
Discovery Projects: Summary
Res. Area
Project Current Stage and Future Plan
Anti-biotics
Gram(-) Expecting preclinical candidate at the end of 2010 National Research Fund
TB Several lead compounds selected Expecting preclinical candidate at the end 2010
Anti-coagu-lant
FVIIa Lead optimization stage with 1 PCT filed: Joint research with Hanmi Pharm Pre-candidate expected by the end of 2010
FXIa Lead Optimization Stage Mainly operated by Fragment-based Drug Discovery approach Three novel fragments (~uM) under extensive optimization
Anti-cancer
HSP90 (1)
Joint research with Boram Pharm, Asan Medical Center, Seoul Small molecular approach; candidate soon-to-be selected
HSP90 (2)
Mitochondriotropic agent in Joint Research with Hanmi Pharm Selected as one of LEADER Program: Currently at pre-candidate stage
Others
HIF-1(Won-donin)
Extensive derivatization of natural product known to be a HIF-1 inhibitor Evaluating for ophthalmic therapy with the Catholic Univ. of Ko-rea, School of Medicine
CD-99 Pre-candidate inhibitors in hand: RA, Anticancer, Diabetic Retinopathy Joint Research with Kangwon Univ.
DDR-2 Pre-candidate inhibitors in hand: atopic application planned Joint Research with Korea Institute of Science & Technology
ABOUT BUSINESS PROJECT SUMMARYPROJECT
Scope of IP landscape
Antibiotics
FXa inhibitors
FVIIa inhibitors
Anticancer Patent to be published
2006 2007 2008 2009 2010
0
1
2
3
4
Patent Filings
Year
# P
ate
nt
file
d
+
ABOUT BUSINESS PROJECT SUMMARYSUMMARY
Summary of LCB Experienced and skilled researchers
Hands on experience on driving project from early lead discovery to FDA approval
Established experience and network for licensing-out, collaboration, and negotiation with multi-national pharmaceutical companies
Excellence of Core Technology Unique distinction of LegoChemistry scaffold approach
Ability to generate consistent project pipeline ( >20 novel Scaffold, 25,000 compounds focused library)
Systematic research plan via Gate Decision System Established guidelines for key stage decision to distinguish between ‘good’ and ‘bad’
drugs
Implementing ‘fast track’ new drug discovery
Passion for new drug development New drug discovery is the only way to survive!
“Establishing a new drug pipeline is dependent on securing drug-like leads, and LCB has the necessary technology, system and passion to
deliver it.”
Candidate discovery
Preclinical Phase I Phase II Phase III FDA approval
Cases 4 1 4 2 - 1
Project Antiboitics, Dementia, Hyperlipidemia, Hepatitis C
Chemotherapy
HIV, Diabetes, Anticoagulation, Obesity
Hepatitis B, Caspase inhibitor
Quinolone antibiotics (Factive)
ABOUT BUSINESS PROJECT SUMMARYSUMMARY
Contact LegoChem Biosciences, Inc.
Daejeon Bio Venture Town, 461-8 Jeonmin-dong, Yuseong-gu, Daejeon, 305-811, South Korea
http://www.legochembio.com/
CONTACT: Sung-Ho Woo, Ph.D. Biology Director & Senior VP [Tel] +82-42-861-0688
[Fax] +82-42-861-0689
E-mail: [email protected]
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