National OncoVenturehttp://nov.ncc.re.kr

Designated by Ministry of Health & Welfare

Supported by National Cancer Center

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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

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

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

AdvisoryCommittee

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/OncologyAdvisory 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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Head & SVP

Young-WhanPark

Ph.D. Rutgers UniversityProject Leader at Merck USA

ID research centerHead of Research Institute

at Daewoong Pharm. Co.ltd.

Head & VPDrug Dev.

Sung-SookLee

Ph.D., Ohio State University Committee of KDDFHead of Research Institute

at Chonkundang Pharm. Co.ltd.Senior Researcher at Cerep Inc.

Head & VPClinical Dev.

Jung-YongKim

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 ScienceHead Researcher at Glaxo USResponsible Developer of Factiv”

Business Development Drug Development

2. Organization

Management Team of OncoVenture

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Advisory Board

2. Organization

Jungshin Lee

Prof.Division of Medical OncologySeoul 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

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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 StemlineTherapeutics Boards of directors of Biogen Idec, Inc. Founder/CEO,PrimroseTherapeutics (ex)CMO & EVP ImCloneSystem Inc. (ex)Associate Professor Johns Hopkins University School of Medicine (ex)

New Paradigm: A Gov-funded Virtual Drug Development

Joint Development CommitteeOncoVenture +

Candidate Provider

Global Anti-Cancer

Drug Candidate

National OncoVenture

Candidate Provider

KnowhowFacility

Consulting

Ｌ/Ｏ Ｄｅｖ

GlobalAnti-

Cancer Drug

Joint Development Agreement

Supporting NetworksNat’l Cancer Center/KFDA/

Academia/Nat’l LabAdvisory board

CMO/CRO

3. Operation Model & Procedure

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Knowhow/Fund

Anti-Cancer Drug

Candidate

ExpertiseFund

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

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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

CommercializingNon Clinical Evaluation

Clinical Evaluation

( I /IIa)

Joint Development Agreement

Originator

LicensingOut

Further Dev. & Licensing Out

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Global Anti-Cancer

Drug Candidate

GlobalAnti-

Cancer Drug

4. Project Development Process

4. Project Selection Statistics

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Evaluation/Selection

Document Evaluation

Oral Presentation

& clinical evaluation

Due Diligence

Contract

137 68 21 13

Development

6 programsOn going

7 programsStopped

5. Distinctive features

12

•Target, Hit, Lead,

Lead optimizationDiscovery

•Preclinical, P1 & P2

•Translational

Research

Bridging &

Development

•P3, Approval &

•CommercializationDevelopment

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)

Dept. of Clinical

development

Candidate Provider

Advisory: NCC & Clinical

Oncology committee

CRO

Central LabGenetic Analysis

Lab

Tumor Assessment

PK Analysis Lab

Other Advisor group

Clinical Sites

Medical Writing

Statistics

DesignConcept

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

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Dong WookKim

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

JungsilRo

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-SooYoon

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 TaeKim

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

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SoonmyungPaik

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

Scientific Advisory Committee

5. Distinctive features

Pre/Formulation

DMPK

Regulatory AffairsIP/Legal Affairs

ChemistryBiologyProject

Management

ManufacturingProcess

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

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Toxicology /Pathology

6. Pipeline (As of Sept 2015)

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Project ID Description MOA Indication Project non-GLP GLP Ph 1 Ph 2

NOV1402PARP/Tankyrase

Inhibitor

ADP ribose polymerase & Tankyrase dual

inhibitor

Solid tumors

NOV1401 PARP 1 InhibitorADP ribose

polymerase 1 inhibitor

Metastatic tumors

NOV1105Anti-HGF antibody

Neutralizing HGF

GBM, Sarcoma,

HCC

NOV1204Vascular

Disrupting Agent

Tubulin polymerization

inhibitor

Solidtumors

Oral

IV

NOV1301 TGF-b inhibitor

Immune modulator,Inhibition of

EMT/metastasis

Metastatictumors

NOV1201Next 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

7. NOV performance

ROI (3.5 years): Estimated value based on data for Feb. 2015

InvestorCandidate Provider

Investor

Candidate Provider

NOVReturn

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Input:

~ 3 B won

Milestone payments & royalty:

~ 300 B won

Bridge & Development

~100x

Collaboration betweenNOV & 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

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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◈

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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