This document provides an overview of Inovio Pharmaceuticals, a company developing DNA-based immunotherapies and vaccines. It summarizes that Inovio is a global leader in active immune therapy, with the best T cell responses shown in clinical studies. It notes that key upcoming value drivers in 2014 include Phase II efficacy data for their lead drug VGX-3100 for cervical dysplasia, and the initiation of multiple new clinical trials for various cancer and infectious disease indications. The document emphasizes Inovio's ability to generate best-in-class T cell responses for immunotherapy using their proprietary DNA delivery technology and development of synthetic vaccines.
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Global Cancer Immunotherapy Pipeline: 1834 Drugs
Marketed Cancer Immunotherapies: 113 Drugs
Cancer Monoclonal Antibodies Pipeline: 622 Cancer mAb
Cancer Vaccines Pipeline: 312 Vaccines
Marketed Cancer mAb: 36 mAb
Marketed Cancer Vaccines: 12 Vaccines
Targovax is developing two complementary and highly targeted approaches to cancer immunotherapy: a peptide-based targeted immunotherapy platform for patients with RAS-mutated cancers and a virus-based oncolytic immunotherapy platform based on engineered oncolytic viruses armed with potent immune-stimulating transgenes for patients with solid tumors.
Dr. Ignacio Melero - Simposio Internacional 'Terapias oncológicas avanzadas''Fundación Ramón Areces
Los días 15 y 16 de octubre de 2014, la Fundación Ramón Areces y la Real Academia Nacional de Farmacia, en colaboración con la Fundación de la Innovación Bankinter, reunieron en Madrid a algunos de los mayores expertos mundiales en nuevas terapias contra el cáncer. El Simposio Internacional, coordinado por la profesora y académica María José Alonso, analizó el momento actual de la lucha contra esta enfermedad. También fue un punto de encuentro para científicos de los más innovadores institutos de investigación en oncología, quienes debatieron sobre tres grandes temas: la Medicina Personalizada contra el cáncer, los nanomedicamentos en la terapia del cáncer y las terapias basadas en la inmunomodulación.
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Gene Therapy Pipeline: 246 Drugs
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Global cancer immunotherapy market outlook 2020KuicK Research
"Global Cancer Immunotherapy Market Outlook 2020" Report Highlight:
Introduction & Classification of Cancer Immunotherapy
Global Cancer Immunotherapy Pipeline by Company, Indication & Phase
Marketed Cancer Immunotherapies Clinical Insight & Patent Analysis by Company & Indication
Global Cancer Immunotherapy Pipeline: 1834 Drugs
Marketed Cancer Immunotherapies: 113 Drugs
Cancer Monoclonal Antibodies Pipeline: 622 Cancer mAb
Cancer Vaccines Pipeline: 312 Vaccines
Marketed Cancer mAb: 36 mAb
Marketed Cancer Vaccines: 12 Vaccines
Targovax is developing two complementary and highly targeted approaches to cancer immunotherapy: a peptide-based targeted immunotherapy platform for patients with RAS-mutated cancers and a virus-based oncolytic immunotherapy platform based on engineered oncolytic viruses armed with potent immune-stimulating transgenes for patients with solid tumors.
Dr. Ignacio Melero - Simposio Internacional 'Terapias oncológicas avanzadas''Fundación Ramón Areces
Los días 15 y 16 de octubre de 2014, la Fundación Ramón Areces y la Real Academia Nacional de Farmacia, en colaboración con la Fundación de la Innovación Bankinter, reunieron en Madrid a algunos de los mayores expertos mundiales en nuevas terapias contra el cáncer. El Simposio Internacional, coordinado por la profesora y académica María José Alonso, analizó el momento actual de la lucha contra esta enfermedad. También fue un punto de encuentro para científicos de los más innovadores institutos de investigación en oncología, quienes debatieron sobre tres grandes temas: la Medicina Personalizada contra el cáncer, los nanomedicamentos en la terapia del cáncer y las terapias basadas en la inmunomodulación.
Global gene therapy market & pipeline insightKuicK Research
“Global Gene Therapy Market & Pipeline Insight” Market Highlight:
Gene Therapy Market Overview
Significance of Gene Therapy in Cancer Therapeutics
Current Applications of Gene Therapy to Cancer Treatment
Gene Therapy Market Dynamics: Drivers, Challenges & Future Outlook
FDA & AMA Guidelines for Gene Therapy
Gene Therapy Pipeline by Phase, Indications, Country & Company
Gene Therapy Pipeline: 246 Drugs
Marketed Gene Therapy: 2 (Gendicine & Rexin-G)
Cancer Gene Therapy Pipeline: 69 Drugs
2. 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, 2012, our Form 10-Q for the quarter
ended September 30, 2013 and other regulatory filings from
time to time.
2
3. Inovio: Global Leader in Active Immune Therapy
2013: Dynamic Year
• Best T cell responses in published clinical studies
• Validating license deal with Roche in 2013
• $10 mm up-front, all development costs, $412.5 mm in
milestones, plus royalties
2014: Transformative Year
• Phase II efficacy data from lead drug mid-year
• More cancer trials starting (cervical, head & neck, prostate,
breast, lung)
• Additional pharma deals in the works
3
5. T cells: Inovio Commands the Body’s SWAT Team
Target cell
• Key player in effective
immune therapy
• Kills tumors and
infected cells
• Are safe and tolerable
• Requires a directive
to attack
T cell
Cytotoxic T lymphocyte
5
6. T cells: Inovio Commands the Body’s SWAT Team
Target cell
T cell
Cytotoxic T lymphocyte
6
Provided by Dr. Philip Greenberg
Hutchinson Cancer Research Center
9. Passive Immune Therapy: Checkpoint Inhibitors
T cell
Validation of Inovio’s
aggressive T cell
therapy
PD-1
Checkpoint
inhibitor
9
PD-1 Therapy
PD-L1
10. Active Immune Therapy: Inovio Therapeutic Vaccines
Active
10
Best-in-class T cells with powerful
killing effect
11. Active Immune Therapy: Inovio Therapeutic Vaccines
11
T cells are the key to
clinical outcome
12. Inovio: Leader in Active Cancer Immunotherapies
• Efficacy can be improved by
combining with active cancer
vaccines
• Inovio cancer vaccines:
Potential to increase efficacy
• Cervical/head & neck cancers
• Breast cancer
• Lung cancer
• Pancreatic cancer
• Melanoma
• Prostate cancer
• Concerns about safety and
tolerability signals
• Potential to improve safety
and tolerability
• Projected to be a $24 billion
12
market
• Major products in
multi-billion market
• Unprecedented efficacy
• Melanoma
• Lung cancer
• Others
16. VGX-3100:Demonstrated Data In Class T cell Responses
VGX-3100 Phase I Study Best
• Strong T-cell response in 14 of
18 (78%) vaccinated subjects at
month 4
• 83% response rate in highest
dose group
16
*Immunotherapy against HPV16/18 generates potent TH1 and cytotoxic cellular immune responses.
Sci Transl Med. 2012 Oct; 4:155ra13. dOI:10.1126/scitranslmed.3004414
17. Durable T cell Responses and T Cell Killing Effects
•
•
17
9 month durability of
robust T cell response
in 12/14 responders
• 10/11 responders
showed killing effect against
target cells
Safe & well tolerated
Source: Science Translational Medicine Oct. 2012
18. PENNVAX® HIV Vaccine: Highest CD8+ T cell Responses
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
Ref: Kalams et al JID 2013
18
C
D
E
19. Broad Medical and Market Opportunities
Product Name
Indication
Preclinical
Vgx-3100
Therapeutic
INO-3112
Cervical Cancer
Therapeutic
INO-3112
Head & Neck Cancer
Therapeutic
Ino-5150
Prostate cancer
Therapeutic
Ino-1400
Breast/lung cancers
Therapeutic
pennvax®
hiv
Preventive/Th
erapeutic
Ino-3510
influenza
Preventive
Ino-8000
Hepatitis C
Therapeutic
ino-1800
Hepatitis B
Therapeutic
Preventive
MaV-12
19
Cervical dysplasia
malaria
Preventive
INTERNALLY FUNDED
EXTERNALLY FUNDED
Phase I
Phase II
Phase III
20. 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)
• Phase II on-going: high grade cervical pre-cancers (CIN
2/3 dysplasia)
• Projected efficacy data: mid-2014
20
23. Broad Medical and Market Opportunities
HPV product
franchise planning
• CIN 2/3 phase III
• Other HPV-related indications (cervical cancer and head/neck
cancer): initiate phase II studies
• Orphan designation potential
23
27. Management
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
27
Peter Kies
CFO
• Ernst & Young
• Experience with growth companies
Louis Pasteur
Mark L. Bagarazzi, MD
CMO
• Clinical research experience incl. Merck
• Led clinical/regulatory for shingles and
rotavirus vaccines; DNA vaccine expert
28. Board of Directors
Morton Collins, PhD
Avtar Dhillon, MD
• General Partner, Battelle Ventures and
Innovations Valley Partners
Chairman, BOD
• Former President & CEO,
Inovio Biomedical
J.Joseph Kim, PhD
Simon X. Benito
• Former Senior Vice President,
Merck Vaccine Division
Angel Cabrera, PhD
• President, George Mason University
• Former President, Thunderbird School of
Global Management
28
Louis Pasteur
• President & CEO, Inovio
Adel Mahmoud, PhD
• Professor, Princeton University
• Former President, Merck Vaccines
• Responsible for Gardasil®, Zostavax®,
Proquad® and Rotateq®
29. Scientific Advisory Board
Philip Greenberg, MD
David B. Weiner, PhD
• Expert in T-cell immunology
• Head, Immunology Program, Fred
Hutchinson Cancer Research Center
Chairman
•“Father of DNA vaccines”
• Dept. of Pathology & Laboratory Medicine,
University of Pennsylvania
Stanley A. Plotkin, MD
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®
29
Louis Pasteur
• Developed rubella and rabies vaccines
• Oversaw Sanofi flu vaccine
• Emeritus Professor, Wistar Institute &
University of Pennsylvania
35. The Opportunity
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
35