presentaiton inovio 314

29
Revolutionizing Vaccines Dr. J. Joseph Kim President & CEO NYSE MKT: INO

Upload: company-spotlight

Post on 03-Dec-2014

2.033 views

Category:

Documents


3 download

DESCRIPTION

 

TRANSCRIPT

Page 1: Presentaiton inovio 314

Revolutionizing Vaccines

Dr. J. Joseph Kim President & CEO NYSE MKT: INO

Page 2: Presentaiton inovio 314

Forward Looking Statement

Our commentary and responses to your questions may contain forward-looking statements, including comments concerning clinical trials and product development programs, evaluation of potential opportunities, the level of corporate expenditures, the assessment of Inovio’s technology by potential corporate partners, capital market conditions, timing of events, cash consumption and other subjects. Information concerning factors that could cause actual results to differ materially from those set forth in our Annual Report on Form 10-K for the year ended December 31, 2013, and other regulatory filings from time to time.

2

Page 3: Presentaiton inovio 314

3

2013: Dynamic Year • Best T cell responses in published clinical studies • Validating license deal with Roche in 2013

2014: Transformative Year

• Phase II efficacy and immunogenicity data from lead drug mid-year

• More cancer trials starting (cervical, head & neck, prostate, breast, lung, pancreatic cancers)

• Additional pharma discussions on-going

Inovio: Global Leader in Active Immune Therapy

Page 4: Presentaiton inovio 314

• Collaborating with a global leader in innovative cancer drugs • Develop and commercialize Inovio’s prostate cancer (INO-5150)

and hepatitis B (INO-1800) immunotherapies • $10 million up-front payment • Roche funding all ongoing development costs as well as funded

research for new prostate cancer antigens • $412.5 million milestone payments for certain development and

commercial events • Roche may pay other development milestone payments if it

pursues other indications with INO-5150 or INO-1800 • Up to double-digit royalties on sales of a marketed product

Validating Partnership with Roche (September 2013)

4

Page 5: Presentaiton inovio 314

Broad Medical and Market Opportunities

Product Name

INTERNALLY FUNDED

Indication Preclinical Phase I Phase II

Vgx-3100

Ino-5150

Ino-1400

EXTERNALLY FUNDED

pennvax®

Ino-3510

Ino-8000

ino-1800

malaria MaV-12

Phase III

Preventive

5

INO-3112

INO-3112

Preventive

Hepatitis C Therapeutic

Hepatitis B Therapeutic

influenza

Preventive

hiv

Preventive/Therapeutic

Breast/lung / Pancreatic cancers

Therapeutic

Prostate cancer Therapeutic

Head & Neck Cancer Therapeutic

Cervical Cancer Therapeutic

Cervical dysplasia

Therapeutic

Page 6: Presentaiton inovio 314

• Are safe and tolerable

• Requires a directive to attack

T cells: Inovio Commands the Body’s SWAT Team

T cell Cytotoxic T lymphocyte

Target cell

Provided by Dr. Philip Greenberg Hutchinson Cancer Research Center

6

Page 7: Presentaiton inovio 314

• T cells are vital to clearing cancerous or infected cells

• Active immuno-therapies: harnessing the power of T cells

• Inovio’s DNA immunotherapies displaying best-in-class T cells

• Functional killing effect • Safe and well tolerated • >400 patents globally

T cells: Inovio Commands the Body’s SWAT Team

Antigen- specific T cell Cytotoxic T lymphocyte CD8+ T cells

Target cell and antigen(s)

7

Page 8: Presentaiton inovio 314

8

Checkpoint Inhibitors Alone are Good but Not Good Enough

• Inovio cancer vaccines greatly

increase T cells

• Overwhelm cancer cells as monotherapy

• Potential to combine with checkpoint inhibitors to increase efficacy

• Potential to improve safety and tolerability

• Unprecedented efficacy • Melanoma • Lung cancer

• Validate potential of T cell active

immunotherapies

• Evidence suggests that non-responders do not have sufficient pre-existing T cell levels

• Concerns re: safety/tolerability

• Projected $24 billion market Source: Citi

Page 9: Presentaiton inovio 314

Strain 1

Strain X

Strain 2

Antigen Y

Antigen Y Antigen Y

T Cells by Design: Antigen-Specific, Optimized, Best-in-Class

9

Identify gene sequence of selected antigen(s) from chosen strains/variants of the virus/cancer

Synthetically create optimal consensus gene sequence for the selected antigen – PATENTABLE

Page 10: Presentaiton inovio 314

Insert SynCon® gene sequence for selected antigen into DNA plasmid.

SYNCON® DNA

Antigen consensus

sequence

DNA Plasmid

Designed to Break Tolerance or Provide Universal Protection

10

SynCon DNA plasmid ready to manufacture.

Page 11: Presentaiton inovio 314

Electroporation Delivery Plays a Vital Role

11

Page 12: Presentaiton inovio 314

Optimized DNA Plasmid + EP: Better Antigen Expression

Ref: Sardesai & Weiner Curr. Opin. Immunol. 2011

1000x enhancement in cellular uptake and antigen expression

Intramuscular Intradermal

12 EP = electroporation

Page 13: Presentaiton inovio 314

Inovio DNA/EP Beats Previous Gold Standard (Merck Ad5 Viral Vector) for T Cell Generation (Non-Human Primates)

SIV Model: UPenn/Merck/Inovio Assay: Data Co-Published T Cell ELISpot Assay T Cell Proliferation Assay

DNA + EP Ad5 DNA + EP Ad5

Ref: Hirao et al. Molecular Therapy, August 2010

Flow Cytometry Assay

13

Page 14: Presentaiton inovio 314

PENNVAX®: Highest CD8+ T Cell Responses for HIV Vaccine

Ref: Kalams et al JID 2013 14

A: 3X vaccination without EP B: 4X vaccination without EP C: 2x vaccination with EP (month 2) D: 3x vaccination with EP (month 4) E: Memory response (month 9)

A B C D E

• Best CD8+ T cell response in HIV clinical studies

• Durable T cell memory responses

• Safe and well tolerated

Page 15: Presentaiton inovio 314

Inovio’s Lead Program

VGX-3100: • Capitalizes on Inovio’s ability to generate T cells • Immunotherapy for pre-cancers and cancers caused by

human papillomavirus (HPV) • Targeting E6/E7 oncogenes

• Phase II on-going: high grade cervical pre-cancers (CIN 2/3 dysplasia)

• Efficacy and immunogenicity data: mid-2014

15

Page 16: Presentaiton inovio 314

Inovio’s Lead Product Targets All HPV-caused Diseases

16 Source: CDC

Incidence rates in the U.S.

Page 17: Presentaiton inovio 314

Combined Cohorts Individual Dose Cohorts

VGX-3100 Induces Robust and Durable T Cell Responses

Bagarazzi, Yan, Morrow et al. Sci Transl Med 4, 155ra138 (2012)

• 14/18 (78%) subjects responded to at least one antigen • 13/18 (72%) responded to at least two antigens • 9/18 (50%) responded to all four antigens

17

ELISpot Assay

Page 18: Presentaiton inovio 314

Bagarazzi, Yan, Morrow et al, Science Trans. Med. (2012)

HPV16-, HPV18-Specific IFN-γ Production

Multi-parameter flow cytometry: CD4, CD8 activation phenotype

Page 19: Presentaiton inovio 314

HPV16-, HPV18-Specific CD107a, Granzyme B, Perforin

Bagarazzi, Yan, Morrow et al, Science Trans. Med. (2012)

CD8 cytolytic phenotype

19

Page 20: Presentaiton inovio 314

VGX-3100 Flow Cytometry – Functional Killing Assays

Inovio Confidential Bagarazzi, Yan, Morrow et al. Sci Transl Med 4, 155ra138 (2012)

Quantitative Assay

Qualitative Assay

• Patient pre-VGX3100 PBMC are targets, post-VGX3100 PBMC are effectors • Quantitative - PBMC added irrespective of Ag-specific CD8 frequency • Qualitative - PBMC normalized to account for Ag-specific CD8 frequency • Measure granzyme B delivery to targets

20

Page 21: Presentaiton inovio 314

21

VGX-3100 Phase II Study Design

Page 22: Presentaiton inovio 314

Phase II Data Impact on Medical and Market Opportunities

• Efficacy data • Path forward to phase III for CIN 2/3 • Expansion of product use to other HPV-related indications

(cervical cancer, head/neck cancer, and anogenital cancer) • Seek orphan designation potential

• T cell and safety data

• Broader platform validation for all Inovio immunotherapy products in the pipeline

22

Page 23: Presentaiton inovio 314

INO-1400: Potential Universal Cancer Therapy

Yan J et al., Cancer Immunol Res. (2013) 23

Dharmapuri et al., Mol Ther. (2009)

Page 24: Presentaiton inovio 314

anthrax Louis Pasteur

Peter Kies CFO • Ernst & Young • Experience with growth companies

Mark L. Bagarazzi, MD CMO • Clinical research experience incl. Merck • Led clinical/regulatory for shingles and rotavirus vaccines; DNA vaccine expert

24

J.Joseph Kim, PhD President & CEO

• Decades of biotechnology/pharma management

• Merck: hepatitis A and B vaccines manufacturing; HIV vaccine (Ad5) R&D

Niranjan Y. Sardesai, PhD COO

• Extensive biotech management and product development experience

• Led development of diagnostics for mesothelioma, bladder cancer, and ovarian

cancer for Fujirebio Diagnostics

Management

Page 25: Presentaiton inovio 314

anthrax Louis Pasteur

J.Joseph Kim, PhD • President & CEO, Inovio

Adel Mahmoud, PhD • Professor, Princeton University • Former President, Merck Vaccines • Responsible for Gardasil®, Zostavax®, Proquad® and Rotateq®

Morton Collins, PhD • General Partner, Battelle Ventures and Innovations Valley Partners

25

Simon X. Benito • Former Senior Vice President,

Merck Vaccine Division

Angel Cabrera, PhD • President, George Mason University

• Former President, Thunderbird School of Global Management

Avtar Dhillon, MD Chairman, BOD

• Former President & CEO, Inovio Biomedical

Board of Directors

Page 26: Presentaiton inovio 314

anthrax Louis Pasteur

Stanley A. Plotkin, MD • Developed rubella and rabies vaccines • Oversaw Sanofi flu vaccine • Emeritus Professor, Wistar Institute & University of Pennsylvania

Philip Greenberg, MD • Expert in T cell immunology • Head, Immunology Program, Fred Hutchinson Cancer Research Center

26

Thomas S. Edgington, MD • Founded multiple biotech companies;

extensively published • Emeritus Professor, Scripps

Research Institute

Anthony W. Ford-Hutchinson, PhD • Former SVP, Vaccines R&D, Merck

• Oversaw development: Singulair®, Januvia®, Gardasil®, Zostavax®, Proquad® and Rotateq®

David B. Weiner, PhD Chairman

•“Father of DNA vaccines” • Dept. of Pathology & Laboratory Medicine,

University of Pennsylvania

Scientific Advisory Board

Page 27: Presentaiton inovio 314

Financial Information

Cash, cash equivalents & short-term investments3 $ 52.6 M

Debt3 0 M

Cash runway 4Q 2017

Shares outstanding2 239.6 M

Recent price1 $3.42

Market cap1 $ 819.4 M

NYSE MKT: INO

1Mar 17, 2014 3 Dec 31, 2013 27

Additional cash after year end4

$ 69.3 M

2Mar 7, 2014 4 Mar 14, 2014

Page 28: Presentaiton inovio 314

INTERNALLY FUNDED EXTERNALLY FUNDED

Ino-5150 1H 2014 Initiate phase I Prostate cancer

Vgx-3100 Mid-2014 Phase II study data Cervical dysplasia

INO-3112 1H 2014 Initiate phase I/IIa

Head & Neck Cancer

28

Upcoming Value Drivers

INO-3112 1H 2014 Initiate phase I/IIa

Cervical Cancer

Ino-1400 2H 2014 Initiate phase I/IIa

Breast/lung/ Pancreatic Cancer

PennVAX® 2H 2014 Initiate PENNVAX -GP phase I HIV

Ino-8000 2015 Report phase I data

Hepatitis C

Ino-1800 Early 2015 Initiate phase I/IIa Hepatitis B

c

Page 29: Presentaiton inovio 314

Investor Highlights • Break-through active immune therapy with the

power to save lives and maximize shareholder value

• Targeting broad range of diseases and billion dollar markets • Best-in-class T cells to prevent, treat & cure cancers and infectious diseases

• Phase II efficacy data coming

• Validating partnership with Roche with more deals in the works

The Opportunity

29