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
Quantum Immunologics (QI) is dedicated to the research, development and production of products and services that will promote immunologic cancer treatments and cancer detection technologies.
Vaccine is expected to be launched early next year against omicronDoriaFang
In the face of the menacing Omicron strain, companies such as Sinovac, Cansino, Pfizer, BioNTech, Moderna, Johnson & Johnson, and AstraZeneca have all expressed their active response.
In this SlideShare, we're covering an overview on RNA technologies and recent applications in the field of life sciences. RNA is the pivotal ‘molecule of life’, involved in almost all aspects of cell biology. Recent successes in mRNA-based vaccines indicate just one of the near-infinite possibilities that RNA technology can offer in life sciences.
VEGF-A modified mRNA in diabetic wound healing and future treatment opportuni...ModernaTherapeutics1
4th International mRNA Health Conference – November 1, 2016
Boston, MA
VEGF-A modified mRNA in diabetic wound healing and future treatment opportunities
Disease monitoring in wheat through remotely sensed dataCIMMYT
Remote sensing –Beyond images
Mexico 14-15 December 2013
The workshop was organized by CIMMYT Global Conservation Agriculture Program (GCAP) and funded by the Bill & Melinda Gates Foundation (BMGF), the Mexican Secretariat of Agriculture, Livestock, Rural Development, Fisheries and Food (SAGARPA), the International Maize and Wheat Improvement Center (CIMMYT), CGIAR Research Program on Maize, the Cereal System Initiative for South Asia (CSISA) and the Sustainable Modernization of the Traditional Agriculture (MasAgro)
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
Quantum Immunologics (QI) is dedicated to the research, development and production of products and services that will promote immunologic cancer treatments and cancer detection technologies.
Vaccine is expected to be launched early next year against omicronDoriaFang
In the face of the menacing Omicron strain, companies such as Sinovac, Cansino, Pfizer, BioNTech, Moderna, Johnson & Johnson, and AstraZeneca have all expressed their active response.
In this SlideShare, we're covering an overview on RNA technologies and recent applications in the field of life sciences. RNA is the pivotal ‘molecule of life’, involved in almost all aspects of cell biology. Recent successes in mRNA-based vaccines indicate just one of the near-infinite possibilities that RNA technology can offer in life sciences.
VEGF-A modified mRNA in diabetic wound healing and future treatment opportuni...ModernaTherapeutics1
4th International mRNA Health Conference – November 1, 2016
Boston, MA
VEGF-A modified mRNA in diabetic wound healing and future treatment opportunities
Disease monitoring in wheat through remotely sensed dataCIMMYT
Remote sensing –Beyond images
Mexico 14-15 December 2013
The workshop was organized by CIMMYT Global Conservation Agriculture Program (GCAP) and funded by the Bill & Melinda Gates Foundation (BMGF), the Mexican Secretariat of Agriculture, Livestock, Rural Development, Fisheries and Food (SAGARPA), the International Maize and Wheat Improvement Center (CIMMYT), CGIAR Research Program on Maize, the Cereal System Initiative for South Asia (CSISA) and the Sustainable Modernization of the Traditional Agriculture (MasAgro)
1. Revolutionizing the Fight
Against Cancers and
Infectious Diseases
Dr. J. Joseph Kim
PRESIDENT & CEO NASDAQ: INO
It’s All About the T-Cells
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, 2014, our Form 10-Q for the quarter
ended June 30, 2015, and other regulatory filings from time to
time.
2
3. 3
Licensing agreement and R&D collaboration
• MedImmune acquired the rights to INO-3112
• Inovio retains the rights to VGX-3100
• INO-3112 will be evaluated in combination with immune-oncology
molecules
• Joint research on two additional DNA-based cancer vaccine products not in
Inovio’s pipeline
Financial Terms:
• Upfront payment of $27.5 million
• Development and commercial milestone payments amounting to $700
million
• Up to double-digit tiered royalties on INO-3112 product sales
• MedImmune will pay all developments costs
Further validation of the potential of Inovio’s DNA immunotherapies to fight
cancer
Validating Partnership with MedImmune
4. Vital Weapon for Fighting Cancer and Infections: T Cells
Cytotoxic T lymphocyte
T cell
Target cell
4
• Targeted destroyer of
unhealthy cells
• Great strides in new
immuno-oncology therapy
technologies enabling T
cells to perform their
function
• Still unmet needs
• Just scratching the surface
5. 5
An “Ideal” T Cell-Generating Immunotherapy?
Attributes
• Activate targeted, antigen-specific T cells
• Functional, with “killing tools” granzyme and perforin
• Robust in magnitude
• Persistent and durable over time
• In vivo (in the body) rather than ex vivo production
• No unwanted immune response against a vector
• No toxic inflammatory response
• Capable of breaking immune system tolerance to a
cancer
6. Inovio DNA Immunotherapies: T Cells by Design
IT’S ALL
ABOUT THE
T CELLS
Identify pertinent
disease-specific antigen(s)
Encode one or more DNA
plasmids with genetic code
for individual antigens
Deliver plasmids
into cells, enabling them
to produce antigen(s)
T cells eliminate cells
displaying disease-
specific antigen
Immune system responds
to antigens; activates
antigen-specific T cells
Effective, efficient, safe in vivo T cell activation
Cellular machinery uses
DNA code to produce
encoded disease antigens
ANTIGENIC
PROTEINS
5
7. 7
• Activate disease-specific CD8+ killer T cells and
antibodies
Antigen targeting
immunotherapies &
vaccines
• Enhance immune response activation
• Impact durability of immune responses
• Drive immune responses to sites of infection
Immune activators
• Simplified design, product stability, better
manufacturing, dosing, and cost effectiveness
• Rapidly activates robust antibody responses
• Target infections or cancers (checkpoint inhibitors)
DNA-Based
Monoclonal Antibodies
(dMAbs)
DNA Immunotherapy Platform: Multiple Applications
8. 8
Immuno-Oncology Development Strategy
1
2
3
Monotherapy
• Single agent T cell activating immunotherapies: potential in
specific scenarios (e.g. early stage or slowly progressing
cancers)
Combination Therapies With Partners
• Checkpoint inhibitors achieving 20-40% response rates; missing link
is robust T cell presence
• Inovio immunotherapy: best-in-class T cells
• MedImmune partners with Inovio; pursue combos
Combination Therapies In-House Using dMAbs
• Inovio’s dMAb application encodes for checkpoint inhibitors to
overcome cancer detection avoidance
• Brings all IP under one roof; strategic power/flexibility
9. Inovio Immuno-Oncology Pipeline
Product Name Indication Preclinical Phase I Phase II
Vgx-3100
Ino-5150
Ino-1400
Phase III
9
INO-3112
INO-3112
Breast/lung/Pancreatic
cancers
Prostatecancer
Head&NeckCancer
CervicalCancer
Cervicaldysplasia
AerodigestiveCancerINO-3106
10. 10
Cervical Dysplasia: Schiffman et al. Arch Pathol Lab Med (2003), Public Health England Cervical Cancer Screening Programme,
Stoler et al. Anatomic Path (2011), Castle et al. JNCI (2005), Mayrand et al. NEJM (2007)
Cancers: CDC, www.hpvcentre.net, WHO IARC
HIGHGRADE
CERVICAL
DYSPLASIA
(CIN2/3)
US:
220,000 –
270,000
EU5:
260,000
HighGrade
Vulvar
Neoplasia
(VIN)
US:
4,400 -
27,000
EU5:
6,500
Highgrade
Anal
Neoplasia
(AIN)
US:
13,400
EU5:
13,400
ORO-
PHARYNGEAL
CANCER
US:
14,410
EU5:
33,330
CERVICAL
CANCER
Annual incidences: US and EU5
HPV-Caused Pre-Cancers & Cancers
US:
12,900
EU5:
43,670
HPV driven cancers
11. Phase II: Study Design
• 148 subjects: 18-55 year old females with
high-grade cervical dysplasia (CIN2/3)
• HPV 16 and/or 18 positive
• 6 mg VGX-3100 or placebo(IM followed by EP)
at weeks 0, 4, and 12
Placebo-Controlled,
Randomized, Double
Blind
• Regression of CIN2/3 to CIN1 or normal at six
months post third dose (Week 36)Primary Endpoint
• Regression of CIN2/3 to CIN1 or normal and
• Clearance of HPV 16 and/or 18 genotype
detected during screen
Secondary Endpoint
11
12. 0
10
20
30
40
50
60
Phase II: Regression of Cervical Lesions to CIN 1 or Normal
Pre-Specified 1° Endpoint: Histopathologic
Regression of CIN2/3 to CIN1 or Normal
30.6%
(11/36)
Statistically significant difference
(p=0.017; strata-adjusted)
Post-Hoc Analysis: Regression of CIN2/3
to Normal
0
10
20
30
40
50
60
40.2%
(43/107)
16.7%
(6/36)
Percent
VGX-3100 Placebo VGX-3100 Placebo
Statistically significant difference
(p=0.006; strata-adjusted)
Overall Histopathologic Regression Incidence
Per-Protocol Population (N=143)
12
49.5%
(53/107)
Percent
13. Phase II: Clinically Significant Efficacy; Achieves Endpoints
49.5%
(53/107)
30.6%
(11/36)
Histopathologic Regression to CIN1 or Normal
AND Virological Clearance (HPV16 or 18) (n=143)
0
10
20
30
40
50
60
40.2%
(43/107)
14.3%
(5/35)
Percent
VGX-3100 Placebo
Statistically significant difference
(p=0.001; strata-adjusted)
13
15. Regression of CIN3 to Normal and HPV Clearance Observed in
VGX-3100 Treated Patient (via IHC)Week0:CIN3pathology
IHC Staining: HPV
Week36:Nosignificant
pathology
IHC Staining: CD815
16. Powerful Impact of VGX-3100 Phase II T Cell & Efficacy Data
• Simple 3 monthly injections generated antigen-specific
CD8 killer T cells
• Measured in blood
• Observed in cervical tissue (tissue infiltrating T cells)
• Direct correlation found between CD8 T cells and efficacy
• Demonstrated phase II efficacy and safety
• Regressed disease to normal
• Cleared virus which caused the disease
• Non-surgical option for the treatment of CIN2/3
• Proof of principle regarding all HPV-related antigens and diseases
• Advance other anti-cancer therapies (lung, breast, pancreas, prostate)
• Virus (HPV) clearance supports other anti-viral therapies (HBV, HCV, HIV)
16
Phase II results facilitate strategic cancer vaccine collaboration and license
with MedImmune and support advancement into phase III HPV precancer trial
17. VGX-3100: Next Steps
EXPANSION OF HPV PROGRAM TO RELATED
CANCERS AND PRE-CANCERS
• HPV cancers licensed to MedImmune for use in combination therapies
• Inovio to pursue HPV pre-cancers
SCIENTIFIC PAPER IN PEER REVIEWED JOURNAL
• Completed immunological analysis to characterize T cell subsets.
Phase II data adds to phase I data, which was extensively
characterized (Bagarazzi, et al. Sci Transl Med 2012)
• Manuscript accepted in top-tier journal
PHASE III PLANNING FOR EARLY 2016 LAUNCH
• Clinical and regulatory
• Scale up immunotherapy production
• Market research
• Supply chain strategy
• EP device production
• Pricing & reimbursement
17
18. • 20 men/women
• Safety, tolerability, immunogenicity
• Anti-tumor effects & progression free survival
• Arm #1: treat before/after tumor resection
• Arm #2: treat after chemoradiation
HPV-Associated Head & Neck Cancer Studies: INO-3112
Phase I/IIa clinical trial
INO-3112 (VGX-3100 + IL-12 DNA immune activator)
HPV 16/ 18 related disease
18
Head & Neck Squamous Cell Carcinoma
Being advanced as part of MedImmune’s license and combination
strategy development plan with Inovio
19. • 126 women with cervical carcinoma
• Safety & progression free survival at 18
months
• INO-3112 administered during standard
chemo-radiotherapy (CRT) or during
and after standard CRT as an adjuvant
• Funded by the EORTC
• 20 women with cervical carcinoma
• Safety, tolerability, immunogenicity
• Cervical histology
• Treat after chemoradiation
HPV-Associated Cervical Cancer Studies: INO-3112
Two clinical trials for cervical cancer:
INO-3112 (VGX-3100 + IL-12 DNA immune activator)
HPV 16/ 18 related disease
19
Phase I/II Cervical Cancer Phase II Cervical Cancer
Being advanced as part of MedImmune’s license and combination
strategy development plan with Inovio
20. Phase I:
INO-1400 +/- IL-12 DNA immune activator
Human telomerase reverse transcriptase (hTERT), associated with cancer cell
survival
hTERT-Associated Cancers Study: INO-1400
• hTERT overexpressed in 85% of cancers - potential “universal” cancer therapy
• 54 patients
• Safety, tolerability, immunogenicity
• Anti-tumor effects and progression free survival
• Trial launched: 4Q 2014
20
Breast, Lung, or Pancreatic Cancers
21. • Men with biochemically relapsed prostate cancer
• Safety, tolerability, and immunogenicity of INO-5150 alone or in combination with
DNA-based IL-12 immune activator
• Evaluating changes in PSA levels
• Study initiated 3Q 2015
Prostate Cancer Study: INO-5150
Phase I clinical trial
INO-5150 or INO-5150 + IL-12
Targeting PSA & PSMA
Prostate cancer
21
Prostate Cancer
23. • 126 patients
• Safety, tolerability, immunogenicity
• Trial started: 2Q 2015
• Roche paying all development costs plus milestones
• 240M+ global market opportunity
23
Hepatitis B Study: INO-1800
Phase I:
INO-1800 +/- IL-12 DNA immune activator
Multi-antigen: HBV pan-clade surface antigens & core antigens
Chronic Hepatitis B Virus
24. 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
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 diagnostics development
for mesothelioma, bladder
cancer, and ovarian cancer for
Fujirebio Diagnostics
Management
24
25. 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
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
25
Nancy Wysenski , MBA
• Former COO of Endo
Pharmaceuticals and Vertex
Pharmaceuticals
26. 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
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
27. Financial Information
Cash & short-term investments2
$ 154.6 M
Debt2 0 M
Cash runway 4Q 2018
Shares outstanding2 71.8 M
Recent share price1
$8.19
Market cap1 $ 588.0 M
NASDAQ: INO
27
1Aug 10, 2015 2June 30, 2015 3 Payable in Q3, 2015
Upfront payment: MedImmune 3 $ 27.5 M
28. INTERNALLYFUNDED EXTERNALLYFUNDED
Ino-1400 2016
Report interim data
Breast,Lung,And
PancreaticCancer
Vgx-3100
2015 Publish data in med journal
Early 2016 Initiate phase IIICervicaldysplasia
28
Value Drivers
INO-3112 Phase I/II studies progressingHead&Neck and
Cervical Cancer
Ino-8000
2015
Report interim phase I data
Hepatitis C
Ino-1800 2Q 2015
Initiated phase I
Hepatitis B
Ebola
2Q 2015
Initiated phase I
INO-4212
Ino-5150 3Q 2015
Initiated phase I
Prostatecancer
PennVAX® 3Q 2015
Initiate PENNVAX-GP phase I
HIV
INO-3112
2016
Initiate phase II with EORTCCervical Cancer
29. Best-in-class
immune
responses to
fight cancers
and infectious
diseases
Targeting broad
range of billion
dollar disease
markets
Breakthrough
in vivo T cell
generating
technology Validating
partnerships
with
MedImmune
& Roche
Lead product
achieved phase
II efficacy
endpoints
Investor Highlights
29