National OncoVenture (NOV) was launched as a now government R&D program for cancer drug development in 2011 to bridge the gap between discovery and development in drug development in Korea. NOV is carrying out high standard preclinical and early stage clinical trials of novel anti-cancer drug candidates from industry, academia and research institutes in Korea.

1. National OncoVenture
http://nov.ncc.re.kr
Designated by Ministry of Health & Welfare
Supported by National Cancer Center

2. 2
Table of Contents
1. Program summary
2. Organization
3. Operation Model & Procedure
4. Selection Process
5. Distinctive Features
6. Pipelines
7. NOV Performance
8. Alliance Models

3. 1. Program Summary
 Mission: Support Korean global anti-cancer drug development & Korean
pharmaceutical industry
 Program Period : 2011~2016 (1st stage) + 5 yrs (2nd stage)
 Budget : Ministry of Health & Welfare + Matching fund from originator
 Model:
 Select pre-clinical anti-cancer drug candidates from various sources
(Universities, National labs., Biotech & Pharmaceutical companies, etc.)
 Develop through clinical stages (PIIa)
 Project managed by joint development committee between National
OncoVenture and drug candidate provider
 Eventually, license out to domestic/global pharmaceutical companies
 Share profit with candidate provider and collaborators
 Operation methods:
 Directed by new (anti-cancer) drug development experts
 Virtual drug development operation utilized by CROs, CMOs, consulting
network, etc.
3

4. 2. Organization
President
General management
Business Development
- R&D&B trend analysis
- Identify drug candidates
- L/I, L/O, contract
- Patent/Legal management
Steering Committee
- Overall strategic decision
- Decision sub-committee
recommendations
Advisory
Committee
Advisory
recommendation
Drug Development
- Project management for
drug candidates through
preclinical & clinical stages
- Manage outsourcing studies
- Study result analysis
NCC Research Institute
- Pilot preclinical studies
- Clinical study plan
Administrative Office
- Business planning
- Personnel, Budget
- Public Relation
Network Group
- Collaborative studies: University, Nat’l Lab, Biotech/Pharma
- Outsourcing studies: CRO, CMOs
- Advisory consulting: KFDA, Global network
Scientific/Oncology
Advisory Committee
- Provide expert opinions &
recommendations throughout
drug development stages
NOV-KFDA Committee
-Provide expert opinion on regulatory strategy
-Guide requirements for efficient approval
process
4

5. Head & SVP
Young-
Whan
Park
Ph.D. Rutgers University
Project Leader at Merck USA
ID research center
Head of Research Institute
at Daewoong Pharm. Co.ltd.
Head & VP
Drug Dev.
Sung-
Sook
Lee
Ph.D., Ohio State University
Committee of KDDF
Head of Research Institute
at Chonkundang Pharm. Co.ltd.
Senior Researcher at Cerep Inc.
Head & VP
Clinical Dev.
Jung-
Yong
Kim
MD. Seoul National Univ.
Roswell Park Cancer Inst./ SUNY
at Buffalo
Practicing at Prostate Cancer
center (National Cancer Center)
President & CEO
In-Chull Kim
Ph.D. University of Illinois
CEO at LG Life Science
Head Researcher at Glaxo US
Responsible Developer of Factiv”
Business Development Drug Development
2. Organization
Management Team of OncoVenture
5

6. Advisory Board
2. Organization
Jungshin Lee
Prof.
Division of Medical Oncology
Seoul ASAN Medical Center
President(ex),
Seoul ASAN Medical Center
Prof.(ex), Fox Chase Cancer Center
YungJue Bang
Prof.
Dept. of Internal Medicine
Seoul Nat’l Univ.
College of Medicine
Scientific Council Member ,
WHO /IARC
Jaekyung Rho
Prof. (ex)
Dept. of Internal Medicine
Yonsei Univ. College of
Medicine
Fellow (ex),
Medical Oncology, Vincent Lombardi Cancer
Research Center
Jinsoo Lee
President (ex)
National Cancer
Center of Korea
Prof, (ex),
MD Anderson Cancer Center
Hoogeun Chun
Director,
Catholic Comprehensive
Cancer Inst. at Seoul St.
Mary's Hospital,
Catholic Univ. of Korea
President,
Korean Assoc. for Clinical Oncology
6
Paul A. Bunn
Prof & Head, Division of
Medical Oncology , State
Univ. of Colorado
President of ASCO, IASLC,
and AACI (ex)
Chairman of the FDA
Oncology Drug Advisory
Committee (ex)
Eric K. Rowinsky
CMO & EVP Stemline
Therapeutics
Boards of directors of
Biogen Idec, Inc.
Founder/CEO,Primrose
Therapeutics (ex)
CMO & EVP ImClone
System Inc. (ex)
Associate Professor Johns
Hopkins University School
of Medicine (ex)

7. New Paradigm: A Gov-funded Virtual Drug Development
Joint
Development
Committee
OncoVenture +
Candidate Provider
Global
Anti-Cancer
Drug
Candidate
National
OncoVenture
Candidate
Provider
Knowhow
Facility
Consulting
Ｌ/Ｏ Ｄｅｖ
Global
Anti-
Cancer
Drug
Joint
Development
Agreement
Supporting Networks
Nat’l Cancer Center/KFDA/
Academia/Nat’l Lab
Advisory board
CMO/CRO
3. Operation Model & Procedure
7
Knowhow/Fund
Anti-Cancer
Drug
Candidate
Expertise
Fund

8. Business Operation Procedure
 Step 1. Candidate Selection Procedure
: Accepting application all year around, Evaluation 2-3 times/year
 Step 2. Development of Candidate
: Drug development by Joint Development Committee
Pre-evaluation procedure required for premature candidates
 Step 3. License Out & Further Development
: License out for global development during or upon completion of human
clinical phase2a
2 page simple
application
Evaluation by new
drug R&D experts
Document
Evaluation
Oral Presentation
Evaluation by
clinical oncologist
Clinical
Evaluation
Confirm integrity
of data &
development
capability
Due Diligence
Rapid agreement
contract within 2
months
Joint
Development
Agreement
3. Operation Model & Procedure
8

9. 4. Project Selection Process
Pre-Evaluation
(Written document)
Development track
Application
Bridging track
Peer Review
(Oral presentation)
CDA/
Due Diligence
MTA/
Substance Evaluation
Peer Review
(Oral presentation)
Joint
Development
Agreement
9
Term
Negotiation

10. Commercializing
Non Clinical
Evaluation
Clinical
Evaluation
( I /IIa)
Joint Development
Agreement
Originator
Licensing
Out
Further Dev. &
Licensing Out
10
Global
Anti-Cancer
Drug
Candidate
Global
Anti-
Cancer
Drug
4. Project Development Process

11. 4. Project Selection Statistics
11
Evaluation/Selection
Document
Evaluation
Oral
Presentation
& clinical
evaluation
Due
Diligence
Contract
137 68 21 13
Development
6 programs
On going
7 programs
Stopped

12. 5. Distinctive features
12
•Target, Hit, Lead,
Lead optimization
Discovery
•Preclinical, P1 & P2
•Translational
Research
Bridging &
Development
•P3, Approval &
•Commercialization
Development
 Develop selected pre-clinical anti-cancer drug candidates through P2 stage
 Academic candidates: 100% government fund through preclinical stage
 Commercial candidates: 50-75% financial support through clinical stage
Supported by
Ministry of Education, Science &
Technology
National OncoVenture
Supported by
Ministry of Health &
Welfare
Preclinical: 100% support
Clinical: 50-75% support
Pharmaceutical companies
(Domestic & Global)

13. Dept. of
Clinical
development
Candidate
Provider
Advisory:
NCC & Clinical
Oncology
committee
CRO
Central Lab
Genetic Analysis
Lab
Tumor
Assessment
PK
Analysis Lab
Other
Advisor group
Clinical
Sites
Medical
Writing
Statistics
Design
Concept
Genotyping
plan
DMPK plan Production &
Packaging
Vendor selection,
Delivery & Insurance
eCRF
Safety/
DSMB
Site due
diligence
Site contract
IRB
Clinical
Study!
KFDA
IND
An Example of Virtual Development: Clinical Development Division Interface
5. Distinctive features
 Virtual oncology drug development w/ government support
 Go/No-go milestone evaluation by global drug development experts
 Early involvement of clinical oncologist  Optimized clinical trial
 “Quick Win, Fast Fail” model  Low cost / High efficiency paradigm
13

14. Dong Wook
Kim
Division of Hematology
Seoul St. Mary’s Hospital
The Catholic University of Korea
Specialized in :Leukemia
2005- Tasigna P1/2, Sprycel P2
2007- Bosutinib P2, Tasigna P3
2008- Sprycel P3, Bosutinib P3
2008- Supect P1/2
Sun Young
Rha
Dept. of Medical Oncology
Severance Hospital
Yonsei Univ. College of Medicine
Specialized in : Stomach cancer ,
Renal cancer, Sarcoma
2004~ RPR109881 P2
Epothilone P3
2008~ Sutent GIST P3
2010~ Votrient vs. Sutent
Do-Hyun
Nam
Dept. of Neurosurgery
Samsung Seoul Medical Center
Sungkyunkwan Univ. School of
Medicine
Specialized in : Glioma, Cancer
/Neuro stem cell
2006~Temodal P2
2009~Cilengitide P3
2009~INNOCELL Immuncell-LC P3
2010~GBM-BO21990 P3
Oncology Advisory Committee
Center for Lung Cancer;
National Cancer Center, Korea
Specialized in: Lung cancer,
Esophagus cancer
2006~ Alimta P3
2007~ Aflibercept P3
2008~ TS-1 (TSIP) P1/2
2010~ Avastin P3 ,Belotecan P2b
Jungsil
Ro
Center for Clinical Trials
Center for Breast Cancer
National Cancer Center, Korea
Specialized in: Breast cancer
2002~ Herceptin P3
2006~ Tykerb P3
2008~ Tykerb P1b
2009~ Afnitor P3
Sung-Soo
Yoon
Dept of Internal Medicine,
Hematology/Oncology
Seoul Nat’l University Hospital
Specialized in : Blood Cancer ,
Multiple myeloma
2008~Velcade P3
2008~Vorinostat P2
2010~ GSK 220183 P1
2010- Panobinostat P3
Yoon-Koo
Kang
Dept of Oncology
ASAN medical Center
Univ.of Ulsan College of
Medicine
Specialized in: Stomach cancer,
hepatoma, GIST
2007~ Avastin P3
2008~ Sutent P3
2009~Tasigna P3
2010~ Regorafenib P3
Heung Tae
Kim
5. Distinctive features
Yeul-Hong
Kim
Dept of Internal Medicine,
Hematology/Oncology
Korea University Anam Hospital
Cancer Center
Specialized in : Stomach cancer ,
Gastrointestinal cancer
2008~ KT&G-MB40 P1
2008~ Nimotuzumab P2
2009~ RAD001 P3
14
Soonmyung
Paik
Director, Division of Pathology,
NSABP
1995 ~ : NSABP breast B27-51:
tratuzumab, lapatinib, pertuzumab,
bevacizumab, TDM1, etc. : P3
1995 ~: NSABP colon C06-11: UFT,
oxaliplatin, bevacizumab: P3
1995~ : NSABP rectal R04:
capecitabine, bevacizumab: P3
2004: OncotypeDx breast cancer
2010: OncotypeDx colon cancer

15. Scientific Advisory Committee
5. Distinctive features
Pre/Formulation
DMPK
Regulatory AffairsIP/Legal Affairs
ChemistryBiology
Project
Management
Manufacturing
Process
Development
Clinical Design &
Development
Marketing
 Consists of ~100 nationally & globally well-known cancer drug R&D experts
 Provide expert opinions & recommendations throughout drug development
process
15
Toxicology
/Pathology

16. 6. Pipeline (As of Sept 2015)
16
Project ID Description MOA Indication Project non-GLP GLP Ph 1 Ph 2
NOV1402
PARP/Tankyrase
Inhibitor
ADP ribose
polymerase &
Tankyrase dual
inhibitor
Solid
tumors
NOV1401 PARP 1 Inhibitor
ADP ribose
polymerase 1
inhibitor
Metastatic
tumors
NOV1105
Anti-HGF
antibody
Neutralizing
HGF
GBM,
Sarcoma,
HCC
NOV1204
Vascular
Disrupting Agent
Tubulin
polymerization
inhibitor
Solid
tumors
Oral
IV
NOV1301 TGF-b inhibitor
Immune
modulator,
Inhibition of
EMT/metastasis
Metastatic
tumors
NOV1201
Next Gen Pan-
Her inhibitor
Inhibition of
Her1,2&4
Breast
cancer
Salvage
NSCLC
1st line
2nd line
KFDA (IND)
KFDA
KFDA
US-FDA
KFDA
KFDA
KFDA
LO

17. 7. NOV performance
 ROI (3.5 years): Estimated value based on data for Feb. 2015
Investor
Candidate
Provider
Investor
Candidate
Provider
NOV
Return
17
Input:
~ 3 B won
Milestone payments & royalty:
~ 300 B won
Bridge &
Development
~100x

18. Collaboration between
NOV & Global/Domestic Pharmaceutical Company
Company can join the NOV’s oncology project as a co-development partner or
matching fund provider, or can license in the project
Domestic company can join the NOV’s project◈
NOV can join domestic company to develop in-licensing oncology project from global
bio/pharmaceutical companies as a co-development partner.
NOV can join domestic company to develop in-licensing oversea project◈
8. Flexible Alliance Model
18
NOV develops/co-develops the company’s in-house project (pre-clinical or clinical) with
the research infra (NCC), extensive networks, expert’s know-how as well as development
fund
NOV co-develops the domestic company’s in-house project◈

19. Thank You!
National OncoVenture contact:
Business Development at
BD.NOV@ncc.re.kr
Lee, Mina
Sr.Director, minalee@ncc.re.kr
82-31-920-2772 (O)
Park, Young-Whan
SVP, parkyo@ncc.re.kr
82-31-920-2780 (O)
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