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) + 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

1. Program Summary

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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 DrugSmall 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

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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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

3. Operation Model & Procedure

8

Receipt of applicationDrop

Drop No go

No go

Due diligenceMTA/Option Agreement(Feasibility study for 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: Material Transfer Agreement

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

4. Project Selection Statistics

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Evaluation/Selection Development

9 programsOn going

7 programsStopped

Project Selection : 2011~2016

Due diligence

Document Evaluation

Oral Presentation

152 81 27 16

Co-development Agreement

Co-development Committee

5. Distinctive features

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•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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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

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InvestorCandidate Provider

Investor

Candidate Provider

NOVReturn

Bridge & Development

Representing Oncology Advisory Committee Members

5. Distinctive features

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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

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 March 2017)

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

NOV1601 TRK inhibitor Solid tumors

NOV1502KRAS/WNT inhibitor

Solid tumors

NOV1501Anti-VEGF/DLL4 bispecific mAb

Gastric cancer, Solid tumors

NOV1402PARP/Tankyrase

InhibitorSolid tumors

NOV1401 PARP 1 Inhibitor Breast, Ovarian

NOV1105 Anti-HGF mAbGBM, Ovarian,

Melanoma

NOV1204Oral Vascular

Disrupting Agent

Solid tumors Mono

CRCCombo w/ IRT

NOV1301 TGF-b R1 inhibitorSolid tumors

MDS

NOV1201Next Gen Pan-Her

inhibitor

Breast cancer Salvage

NSCLC1st line

2nd line

MFDS

MFDS

MFDS

FDA

MFDS

MFDS

MFDSLO

FDA

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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

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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