National OncoVenture (NOV) is a Korean government funded oncology drug development program. We are focusing on non-clinical and early stage clinical development of promising oncology drug candidates. These candidates are provided by researchers in academics, research institutes, biotech and pharmaceutical companies. We are co-developing the compounds with the originators through a virtual development model. The majority of the development activities are outsourced to domestic and global CRO/CMOs as well as specialized laboratories throughout the world. During the pre-clinical and clinical development, we aim to improve the value of our candidates by out-licensing our development programs to global pharmaceutical companies who can develop them further for the global market.
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) + 2017~2021 (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 (PII)
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. 1. Program Summary
4
Expanding the area of interest in 2nd Stage
1st Stage (2011~2016) 2nd stage (2017~2021)
Development area New Anticancer drug
New Anticancer drug
Biomarker
Companion Diagnostics
Originators
Universities, National labs.,
Biotech & Pharmaceutical
companies, etc
Universities, National labs.,
Biotech & Pharmaceutical
companies, etc
Operation
Project managed by JDC,
led by NOV
Project managed by JDC,
led by NOV
Type of Drug
Small Molecule,
Monoclonal Antibodies
Small Molecule,
Monoclonal Antibodies
Cell therapeutics
Gene therapeutics
Level of Innovation Mainly Best-in-class Mainly First-in-class
Development stage Validation ↔ Phase 2a Validation ↔ Phase 2
5. 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
5
6. 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
6
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. 3. Operation Model & Procedure
8
Receipt of application
Drop
Drop Nogo
Nogo
Due diligence
MTA/Option Agreement
(Feasibilitystudyfor development)
Co-development
Agreement
Non Clinical
development
Clinical
development
Strategic
Alliance or LO
Commercialization
Process for Project selection and Agreement↑
Process for Co-development ↓Co-development
Committee
Document
Evaluation
Oral Presentation
MTA:MaterialTransferAgreement
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
Step 1. Candidate Selection Procedure :
Accepting application all year around,
Evaluation 2~3 times/year
Project Selection and Development
9. 4. Project Selection Statistics
9
Evaluation/Selection Development
9 programs
On going
7 programs
Stopped
Project Selection : 2011~2016
Due
diligence
Document
Evaluation
Oral
Presentation
152 81 27 16
Co-
development
Agreement
Co-development
Committee
10. 5. Distinctive features
10
•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)
11. 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
11
12. 5. Distinctive features
Maximize candidate value by drug development experts
Support to patent strategy and improvement
Contract with high return to candidate provider
Provide Korean oncology drugs & contribute to drug cost down
12
Investor
Candidate
Provider
Investor
Candidate
Provider
NOV
Return
Bridge &
Development
13. Representing Oncology Advisory Committee Members
5. Distinctive features
13
Yoon-Koo Kang
·Dept. of Oncology, ASAN medical
center, Univ. of Ulsan College of
Medicine
·Specialized Area :Stomach
Cancer, Hepatoma, GIST
Dong Wook Kim
·Division of Hematology, Seoul St. Mary’s
Hospital, The Catholic Univ. of Korea
·Specialized Area : Leukemia
Do-Hyun Nam
·Dept. of Neurosurgery,
Samsung Seoul Medical
Center, Sungkyunkwan
Univ. School of Medicine
·Specialized Area : Glioma,
Cancer/Neuro stem cell
Sun Young Rha
·Dept. of Medical Oncology,
Severance Hospital, Yonsei
Univ. College of Medicine
·Specialized Area : Stomach
cancer, Renal cancer,
Sarcoma
Sung-Soo Yoon
·Dept. of Internal Medicine,
Hematology/Oncology, Seoul
Nat’l Univ. Hospital
·Specialized Area : Blood
Cancer, Multiple myeloma
Soonmyung Paik
·Severance Biomedical Science Institute,
Yonsei Univ. College of Medicine
·Division of Pathology, NSABP (The National
Surgical Adjuvant Breast and Bowel Project)
·Specialized Area : Pathology, Clinical trial
design, adjuvant chemotherapy treatment /
response prediction
Yeul-Hong Kim
·Dept of Internal Medicine,
Hematology/Oncology, Korea Univ.
Anam Hospital Cancer Center
·Specialized Area : Stomach cancer,
Gastrointestinal cancer
·Unit of Biomolecular Function
Research, Center for Gastric
cancer, National Cancer Center,
·Specialized Area : Stomach
Cancer, Diagnostic Markers
and Anticancer Drug
Susceptibility Predictors
Kim Hark Kyun
·Dept. of Clinical Pharmacology
and Therapeutics, ASAN
medical center, Univ. of Ulsan
College of Medicine
·Specialized Area : Clinical
Pharmacology and
Therapeutics
Lim Hyeong-Seok
14. 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
14
Toxicology
/Pathology
15. 6. Pipeline (As of March 2017)
15
Project ID Description Indication Project non-GLP GLP Ph 1 Ph 2
NOV1601 TRK inhibitor Solid tumors
NOV1502
KRAS/WNT
inhibitor
Solid tumors
NOV1501
Anti-VEGF/DLL4
bispecific mAb
Gastric cancer,
Solid tumors
NOV1402
PARP/Tankyrase
Inhibitor
Solid tumors
NOV1401 PARP 1 Inhibitor Breast, Ovarian
NOV1105 Anti-HGF mAb
GBM, Ovarian,
Melanoma
NOV1204
Oral Vascular
Disrupting Agent
Solid tumors Mono
CRC
Combo
w/ IRT
NOV1301 TGF-b R1 inhibitor
Solid tumors
MDS
NOV1201
Next Gen Pan-Her
inhibitor
Breast cancer Salvage
NSCLC
1st line
2nd line
MFDS
MFDS
MFDS
FDA
MFDS
MFDS
MFDSLO
FDA
16. 16
7. Area of Interest
□ Common Requirements
1. Anticancer drug candidates being developed between nonclinical and clinical phases
2. Substances that have no problems in securing IP for global anti-cancer drug development or
global technology transfer
3. Materials with innovative molecular targets or medical unmet needs
□ Areas of Primary Interest
1. First-In Class chemicals and Biologics including antibodies, antibody-drug conjugate
2. Targeting cancer signaling pathway, metabolism, epigenetics, etc.
3. Novel immunotherapeutic agents (Immune checkpoint, Immune cell modulator, etc.)
4. Gene therapy or cell therapeutics that is feasible due to a new mechanism for action or
differentiation.
5. Targeted therapy that can be developed simultaneously with accompanying companion diagnostics
□ Areas of Secondary Interest
1. A cancer metastasis inhibitor with a clear mechanism of action that can produce synergistic effects
when used in combination with a NOV pipeline
2. Anticancer drug using targeted drug delivery system
17. 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
17
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◈
18. 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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