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National OncoVenture http://nov.ncc.re.kr

Designated by Ministry of Health & Welfare

Supported by National Cancer Center

Table of Contents

1. Mission & Objectives

2. Organization

3. Business summary

4. Operation Model & Procedure

5. Selection Process

2

6. Distinctive Features

7. Pipelines

8. Alliance Models

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Mission: Global Anti-Cancer Drug Development

Objective: Produce 4 Global Drug Candidates with PIIa completion per 5-year-period

1. Mission & Objective

National OncoVenture

Drug value↑

Drug Candidate

University Biotech

Nat'l Lab Domestic Pharma Global pharma

Global drug candidate Korean / Global

Pharmaceutical companies

License Out

Expert Network

Outsourcing CRO, CMOs

Global drug

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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

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President & CEO

In-Chull Kim

Ph.D. University of Illinois CEO at LG Life Science Head Researcher at Glaxo US Responsible Developer of Factiv”

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 Chemical drugs

Moon-hwan Kim Ph.D., Seoul National Univ. Director at Exelixis USA Research Advisor at New Drug dev. at Medical school of Stanford Univ.

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)

Business Development Drug Development

2. Organization

Management Team of OncoVenture

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Advisory Board

2. Organization

Jungshin Lee

President,

Institute of Innovative

Cancer Research

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.

Dept. of Internal Medicine

Yonsei Univ. College of

Medicine

Fellow (ex),

Medical Oncology, Vincent Lombardi Cancer

Research Center

Jinsoo Lee

President,

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

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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)

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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

2. Organization

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

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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

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Scientific Advisory Committee

2. Organization

Pre/Formulation

DMPK Regulatory Affairs

IP/Legal Affairs

Chemistry

Biology

Toxicology/Pathology Project Management

Manufacturing

Process Development

Clinical Design & Development

Marketing

Consists of >30 nationally & globally well-known cancer drug R&D experts

Provide expert opinions & recommendations throughout drug development

process

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3. Business Summary

Name : National OncoVenture

Business Period : 1st period: 2011~2016 / 2nd ~ period: 2017 + 5 yrs ~

Total Budget : ~$200MM (Private funds ~50%) for the first 5 years

Business Model:

Select early stage anti-cancer drug candidates from various sources

(Universities, National labs., Biotech & Pharmaceutical companies, etc.)

Develop through preclinical & 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.

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Joint Development Committee OncoVenture +

Candidate Provider

Global Anti-Cancer

Drug Candidate

Candidate Provider

National OncoVenture

Substance/ IP Knowhow

Fund

Fund Expertise

Knowhow Facility

Consulting

Ｌ/Ｏ Ｄｅｖ Global

Anti-Cancer Drug

Joint Development Agreement

Supporting Networks CMO/CRO

Nat’l Cancer Center/KFDA/ Academia/Nat’l Lab

Advisory board

4. Operation Model & Procedure

New Paradigm: A Gov-funded Virtual Drug Development Program

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Business Operation Procedure

Step 1. Candidate Selection Procedure

: Accepting application all year around, Evaluation 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

4. Operation Model & Procedure

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5. Selection Process

Drop

Drop

Go

No Go

Pre-Evaluation (Written document)

Development track

Application

Bridging track

Confidentiality is guaranteed for entire process.

Peer Review (Oral presentation)

CDA/ Due Diligence

MTA/ Substance Evaluation

Peer Review (Oral presentation)

Joint Development Agreement

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Term Negotiation

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Joint Development Committee Nat’l OncoVenture + Candidate Provider

Commercializing

Global Cancer Drug

Global Cancer Drug

Candidate

Non Clinical Evaluation

Clinical Evaluation

( I /IIa)

Joint Development Agreement

Originator

Drop

Licensing Out

Further Dev. & Licensing Out

Go

No Go

Conditional Go

5. Selection Process

Confidentiality is guaranteed for entire process.

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Supported by Ministry of Education, Science & Technology

Discovery

Development

Target, Hit, Lead, Lead optimization

P3, Approval & Commercialization

Bridging & Development

Preclinical, P1 & P2 Translational

Research

Develop selected drug candidates through human clinical PII stage

Support 100% government fund through preclinical stage

6. Distinctive features

National OncoVenture Supported by Ministry of

Health & Welfare Preclinical: 100% support

Clinical: 50% support

Pharmaceutical companies

(Domestic & Global)

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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

6. Distinctive features

Fast decision making throughout development

“Quick Win, Fast Fail” model Low cost / High efficiency paradigm

Continuous involvement of clinical oncologist Personalized medicine

Virtual oncology drug development w/ government support

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6. 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

Investor Candidate Provider

Investor

Candidate Provider

NOV

Return

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7. Pipeline (As of June 2014)

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Project ID Description MOA Indication Project non-GLP

GLP Ph 1 Ph 2

NOV1101 Anti-DLK1 Antibody DLK1 targeting

NOV1302 T-type Calcium Channel blocker

Blocking of Calcium Channel

NOV1105 Anti-HGF antibody Neutralizing HGF GBM, Sarcoma

NOV1204 Vascular Disrupting Agent

Tubulin polymerization inhibitor

Solid tumors

Oral

IV

NOV1301 ALK5 inhibitor Inhibition of EMT/metastasis

Metastatic tumors

NOV1201 Next Gen Pan-Her inhibitor

Inhibition of Her1,2&4

Gastric cancer

NSCLC 1st line

2nd line

Breast

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Collaboration between NOV & Global/Domestic Pharmaceutical Company

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 company’s in-house project ◈

Company can join the NOV’s oncology project as a co-development partner or matching fund provider, or can license in the project

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

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