(CMV) Vaccine

Nasdaq: VBIV
Corporate Presentation
December 2014
Forward-Looking Statement Disclaimer
This presentation contains forward-looking statements within the meaning of the provisions of Section 27A
of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as
amended. Forward-looking statements are generally identifiable by the use of words like "may," "will,"
"should," "could," "expect," "anticipate," "estimate," "believe," "intend," or "project" or the negative of
these words or other variations on these words or comparable terminology. The reader is cautioned not to
put undue reliance on these forward-looking statements, as these statements are subject to numerous
factors and uncertainties outside of our control that can make such statements untrue, including, but not
limited to, inadequate capital, adverse economic conditions, intense competition, lack of meaningful
research results, entry of new competitors and products, adverse federal, state and local government
regulation, termination of contracts or agreements, technological obsolescence of our products, technical
problems with our research and products, price increases for supplies and components, inability to carry out
research, development and commercialization plans, loss or retirement of key executives and research
scientists and other specific risks. We currently have no commercial products intended to diagnose, treat,
prevent, or cure any disease. The statements contained in this presentation regarding our ongoing research
and development and the results attained by us to-date have not been evaluated by the Food and Drug
Administration. There can be no assurance that further research and development, and/or whether clinical
trial results, if any, will validate and support the results of our preliminary research and studies. Further,
there can be no assurance that the necessary regulatory approvals will be obtained or that we will be able
to develop new products on the basis of our technologies. In addition, other factors that could cause actual
results to differ materially are discussed in a Proxy Statement filed with the SEC on June 30th, 2014.
Investors and security holders are urged to read these documents free of charge on the SEC's web site at
www.sec.gov. We undertake no obligation to publicly update or revise our forward-looking statements as a
result of new information, future events, or otherwise.
2
VBI – A Novel Vaccine Biotech Co.
VBI is developing novel technologies that seek to expand vaccine
protection in significant markets of unmet medical need.
VBI IN BRIEF
 Public market debut in late July 2014 with a $16.25M private placement and a $6M
secured debt facility. NasdaqCM: VBIV
 Share Price: $2.68 (12/8/14 – market close)
 Common Stock Currently Outstanding: 20M, 50-Day Avg Vol: 39,000 (12/8/14)
 Market Cap: $54M (12/8/14); Cash $14.8M (9/30/14)
 Headquartered in Cambridge, MA with main research site in Ottawa, Canada.
 U.S. incorporation in 2006.
3
Opportunity Highlights
T W O C O M P L E M E N TA R Y T E C H N O L O G Y P L AT F O R M S
 Enveloped Virus-Like Particle (eVLP) Technology Platform for the development of thirdgeneration synthetic vaccines that closely resemble the structure of the virus they mimic.
 Thermostable LPV™ Platform enables the development of vaccines that can withstand
storage or shipment at elevated or constantly fluctuating temperatures.
 Prophylactic cytomegalovirus (CMV) vaccine candidate with strong proof of concept in
preclinical studies.1
 Large and well-defined market opportunities:
 CMV market could exceed $1B annually; CMV vaccine doses could exceed 7.6M by
20302 with pricing similar to HPV at $140 per dose.3
 Thermostable LPV™ Platform – currently, more than 90% of all vaccines require “cold
chain” shipment at 4°C.4
 IP strategy protects core platforms; CMV IP extends to 2032 and LPV™ IP extends to 2030.
 World-class leadership team includes Steve Gillis and Jeff Baxter.
4
Experienced Leadership
VBI’s management and board brings vaccine discovery, development,
financing, and commercialization expertise.
DR. STEVE GILLIS, CHAIRMAN OF THE BOARD
Dr. Gillis is a Ph.D. immunologist by training with expertise in molecular
and tumor immunology. Previously, he served as the Founder and CEO of
Corixa, which was acquired in 2005 by GSK for $300M. Prior to Corixa, Dr.
Gillis was Founder and Director of Immunex, acquired in 2002 by Amgen
for $16B. Dr. Gillis is a managing Director of ARCH Venture Partners.
JEFF BAXTER, PRESIDENT & CEO
Mr. Baxter joined VBI in September of 2009. Previously, he was a managing
partner of The Column Group, a venture capital firm. Until July 2006, Mr.
Baxter was SVP, R&D Finance and Operations, of GlaxoSmithKline (GSK). His
19 year pharma career has spanned finance, commercial operations,
manufacturing, R&D operations, and SROne, GSK’s in-house venture fund.
5
Experienced Leadership Cont.
Dr. Michel De Wilde, Ph.D, Director was Senior Vice President, R&D, at Sanofi Pasteur, the human
vaccines division of Sanofi from 2001 until June 2013. In this position, he was responsible for
managing approximately 1,500 employees and a broad portfolio of development projects.
Dr. Michael Steinmetz, Ph.D., Director, has been Managing Director of Clarus Ventures since the
firm’s inception in 2005. Prior to Clarus, Dr. Steinmetz was a General Partner at MPM Capital, a
healthcare venture capital firm. He has over 25 years of healthcare industry investment experience.
Sam Chawla, Director, is a Portfolio Manager of Perceptive Advisors LLC, an investment fund focused
on the healthcare sector. Prior to joining Perceptive Advisors in 2013, Mr. Chawla was a Managing
Director at UBS Investment Bank in the Global Healthcare Group.
Dr. David E. Anderson, Ph.D., Senior VP Research, is a dynamic and well-published immunologist
with broad expertise in the areas of vaccine development, autoimmunity, and tumor immunology. Dr.
Anderson joined VBI full time in 2009 from Harvard Medical School.
Egidio Nascimento, CA , Chief Financial Officer, joined VBI in 2005, bringing his experience in finance
and accounting at early-stage ventures. Mr. Nascimento previously served as VP of Finance at
Genome Canada and as the CFO of two start-up companies.
6
Platform Technologies
Two complementary vaccine platform technologies in development.
e V L P P L AT F O R M
T H E R M O S TA B L E P L AT F O R M
 Enveloped (e) virus-like particle (VLP)
vaccines resemble viruses, but are noninfectious and do not contain viral genetic
material.
 Lipid Particle Vaccines (LPV™) platform
enables the development of vaccines that
can withstand months of storage or
shipment at constantly fluctuating or
elevated temperatures.
 eVLPs are capable of generating strong
immune response due to similarity to viruses
found in nature.
 eVLP platform is applicable to diseases;
established proof of concept in Flu, HCV,
West Nile and CMV.1
 Lead candidate is a prophylactic CMV vaccine
that, if approved for marketing, is expected
to addresses a large unmet market need.2
 Completed proof of concept studies on
vaccine and biologic targets including
Influenza, Rabies, MMR, and Herceptin®like monoclonal antibody.3
 LPV™ allows for rapid reformulation of
existing vaccines; pursuing self-funding
collaborations with undisclosed prospects.
7
eVLP Platform
Virus-like Particle Vaccine Evolution
Virus-like particle vaccines have evolved considerably since their
introduction in early 1990s.
1 S T G E N E R AT I O N
 Design: Antigens are produced
and self-assemble.
 Key Advantage: Simple structures
and repetitive pattern of antigenic
epitopes.
 Key Limitation: Only a very limited
number of antigens
spontaneously form orderly VLP
structures; cannot be applied to
all enveloped viruses.
 Examples: Gardasil®, Cervarix®,
Engerix-B®, Recombivax HB®.
2 N D G E N E R AT I O N
3 R D GENERATION – VBI
 Design: Antigens of interest are
covalently attached to the surface
of a backbone protein.
 Design: Common protein
backbone and lipid membrane in
which the antigen of interest can
be expressed.
 Key Advantage: Can be applied to
multiple different target antigens;
VLP structure is not limited to the
properties of the antigen.
 Key Limitation: Antigen of interest
is artificially bound to the
structural protein and not
represented in a natural
configuration.
 Example: Qb VLP Platform.
 Key Advantage: Enables more
natural presentation of target
antigen within a membrane that
more closely mimics a virus; can
express multiple target antigens in
a single VLP.
 Limitation: More effort to meet
FDA/EMA purification standards.
 Ideal Candidates: CMV, HCV,
Dengue, RSV, West Nile.
9
eVLP Platform Overview
eVLPs are a third-generation class of
synthetic vaccines that closely resemble the
structure of the virus they mimic.
e V L P P L AT F O R M H I G H L I G H T S
 Same size and structure as enveloped viruses.
 Present antigens in their natural state (lipid
bilayer) to provoke an optimal immune response.
 Demonstrated ability to trigger strong, broadly
neutralizing antibodies in multiple preclinical
models (CMV, HCV, and Flu).1
Antigenic
Protein
Internal
Protein
Provides Viral
Structure
Natural Lipid
Bilayer
Antigenic protein
retains natural
conformation in
the Lipid Bilayer
 Suitable to a wide array of viruses including CMV,
HCV, Dengue, RSV, and West Nile.
 Strong intellectual property estate.
Top: eVLP Diagram – the foundation of the eVLP technology is a
stable, protein-based core on which additional vaccine antigens
of interest can be added; Bottom: Electron Microscopy image of
VBI’s CMV eVLP captured at Sripps Institute.
10
eVLP Platform Characteristics
eVLP Platform provides VBI with a novel technology designed to
address unmet vaccine needs.
KEY CHARACTERISTICS
 Highly Immunogenic: eVLP immune responses
comparable to or better than natural infection by
closely mimicking structure of target virus.1
 Customizable: eVLPs provide ability to rationally
design a vaccine by including different antigens and
controlling their relative expression.
 Safe: Unlike live-attenuated vaccines, eVLPs cannot
revert back to an infectious state.
 Commercially Viable: Manufactured and purified
using scalable methods (unlike some vectored
delivery approaches); demonstrated commercially
suitable yields.2
VBI’s Ottawa, Canada-based research facility.
11
eVLP Vaccine Candidates
Novel eVLP vaccines with the goal of creating first-in-class or best-inclass preventives or therapeutics.
C U R R E N T VA C C I N E C A N D I D AT E S
 Prophylactic Cytomegalovirus (CMV) Vaccine: CMV is a common virus that can cause
serious, life-threatening complications in persons with weakened immune systems.
Unborn babies whose mothers become infected with CMV during pregnancy are at
particularly high risk of suffering from developmental delays. There is currently no
commercially available preventative vaccine for CMV.1
 Therapeutic Hepatitis C (HCV) Vaccine: Hepatitis C is an infectious disease affecting
primarily the liver, caused by the hepatitis C virus. Chronic infection can lead to
scarring of the liver and ultimately to cirrhosis. Approximately 80% of those exposed
to the virus develop a chronic infection.2 VBI is seeking to partner or co-develop its
HCV therapeutic vaccine candidate.
12
CMV Vaccine Candidate
CMV Opportunity
Cytomegalovirus (CMV) is a common virus that can cause serious, lifethreatening complications in persons with weakened immune systems;
developing a CMV vaccine is a leading public health priority.1
C O N G E N I TA L I N F E C T I O N
 Unborn babies whose mothers
become infected with CMV during
pregnancy are at high risk.2
 In the U.S., congenital CMV causes
one child to become disabled every
hour.3
 Congenital CMV infection causes more
long-term problems and childhood
deaths than Down Syndrome or Fetal
Alcohol Syndrome.4
IMMUNOCOMPROMISED
 A primary CMV infection can cause
serious disease persons with
weakened immune systems5,
including:
 Organ and bone marrow
transplant recipients.
 Cancer patients.
 Persons receiving
immunosuppressive drugs.
14
CMV Opportunity Cont.
In the U.S., approximately 40,000 cases of congenital CMV infection
occur each year. As a result, approximately 5,000 infants are born with
or develop permanent complications, some of them severe.1
C O M P L I C AT I O N S
Children Born With or Developing Long-Term Medical Conditions Each
Year in the U.S.
 Hearing Loss
 Vision Loss
 Mental Disability
6,000
5,000
5,000
4,000
4,000
 Lack of Coordination
3,000
 Small Head
2,000
 Seizures
1,000
 Death
5,500
3,000
200
60
0
Congenital Fetal Alcohol
Down
Spina Bifida / Pediatric
CMV Disease Syndrome Syndrome Anencephaly HIV/AIDS
Invasive Hib
Cannon, M. J., and K. F. Davis. 2005. Washing our hands of the congenital cytomegalovirus
disease epidemic. BMC Public Health 5:70
15
CMV Vaccine Landscape
VBI’s CMV vaccine candidate (VBI-1501A) addresses limitations
(potency, durability) within the field of past prospects.
N O TA B L E C M V VA C C I N E C A N D I D AT E S
 Competing vaccine candidates tested in earlier Phase I trials have stalled or reverted
to preclinical development.
 A 2009 Phase II Study of a prophylactic CMV vaccine had projected 50% efficacy.1
 Natural immunity imparts ~90% protection,2 but vaccine-induced nAb titers
against epithelial cell infection were 10X lower.3
 Efficacy appeared to wane quickly after the first year.4
16
CMV Vaccine Candidate: VBI-1501A
Strong proof of concept demonstrated in animal studies.
PRECLINICAL HIGHLIGHTS
 Neutralization of CMV up to 32X greater than natural immunity in multiple preclinical
animal models.1
 Structure of the eVLP platform generates stronger neutralizing antibodies than does
immunization with the same (gB) target protein alone.2
 gB antigen is a major antigen for the induction of neutralizing antibodies against
CMV.3
 Potent neutralization in fibroblasts and epithelial cells, two clinically-relevant cell
types that are susceptible to CMV infection.4
 Durable and high titer antibodies anticipated to impart long-lasting immunity in
vaccine recipients.5
 Potent immunity alone or in combination with alum, a safe, FDA-approved adjuvant.6
17
CMV Vaccine Candidate: Proof of Concept
eVLP presentation of the gB antigen improves responses relative to
recombinant gB protein; modified form of gB (gB-G) further improves
responses beyond that conferred by the eVLPs alone.1
 In comparison to standard gB
recombinant protein, gB eVLPs
demonstrate enhanced potency
and improved consistency of
responses in epithelial cells.
 Modified gB-G antigen further
enhances the consistency of
responses in epithelial cells.
Neutralizing antibody titers for individual mice immunized with
comparable doses of Recombinant gB, gB eVLPs, or optimized
gB-G eVLPs (VBI-1501).
1,000
50% Epithelial cell nAb Titer (1/x)
P R E C L I N I C A L R E S U LT S
100
10
1
Recombinant gB
gB eVLPs
gB-G eVLPs
(VBI-1501)
18
CMV Vaccine Candidate: Proof of Concept Cont.
After two vaccinations, VBI-1501A induces immunity that greatly exceeds
a benchmark for naturally acquired CMV immunity (Cytogam®).1
 Pooled sera from vaccinated mice
(n=8) tested for the ability to
neutralize CMV infection in both
Fibroblast and Epithelial cells, two
clinically relevant cell types
susceptible to CMV infection.
 Durable responses to the vaccine
observed more than six months after
the second immunization.
10,000
10,000
Cytogam®
VBI-1501A [alum]
VBI-1501
Epithelial cell nAb Titre (1/x)
 gB-G eVLPs produced using a GMP
compliant HEK 293 cell line and
purified to meet FDA standards.
VBI-1501A elicits rapid, potent, and durable neutralizing
antibody titers, which exceed naturally acquired levels of
immunity (Cytogam®) after two immunizations (weeks 0 and 8)
in mice.
Fibroblast cell nAb Titre (1/x)
P R E C L I N I C A L R E S U LT S
1,000
100
10
1
0
4
8
12
16
20
24
28
32
0
4
8
12
16
20
24
28
32
1,000
100
10
1
Time (weeks)
19
CMV Vaccine Candidate: Phase I Trial Design
VBI will follow a well-defined clinical development path; initial human
proof of concept is anticipated during Phase I clinical trials.
A N T I C I PAT E D T R I A L D E S I G N
 Target Population: 125 CMV-Negative Healthy Adults
 Duration: 12 Months with Interim Data at Six Months
 Q4 2015: Expected IND Approval and Phase I Start
 Q1 2016: Interim Phase I Data Expected
 Q3 2016: Final Phase I Data Expected
 Primary Endpoint: Safety and Tolerability
 Secondary Endpoint: Anti-CMV nAb Effective in Fibroblasts / Epithelial Cells
 nAb are neutralizing antibodies that indicate acquired CMV immunity.1
 Estimated Cost: $7M
20
CMV Vaccine Candidate: Development Plan
VBI’s CMV Vaccine Candidate may demonstrate immunologic proof of
concept in humans at an early stage; VBI may have multiple pathways
to further product development.
C L I N I C A L D E V E L O P M E N T A N D PA R T N E R S H I P O P T I O N S
 Interim Phase I data is expected in Q1 2016, at which time VBI expects to
demonstrate safety, tolerability, and also immunological proof of concept in humans
by measuring CMV neutralizing antibodies in fibroblasts and epithelial cells.
 Upon the receipt of Phase I data, VBI may explore partnering with a major
vaccine franchise on a Phase II trial.
 Phase II human proof of concept can also be achieved with shorter duration
trials in the transplant setting.
21
Thermostable Platform
Thermostable LPV™ Technology
Enables thermostable vaccine delivery, which is expected to increase
vaccine access, safety, and efficacy.
IMPROVED ACCESS
D O S E S PA R I N G
U N LO C K S VA LU E
Enables safe storage and
transfer outside of the
refrigerator / freezer
“cold chain”.1
Improved stability and
immunogenicity makes it
possible to deliver a
lower effective dose.2
Adds convenience and
portability to improve
vaccine developer value
proposition.
23
LPV™ Market Opportunity
Without a constant temperature in a very narrow range above freezing,
many vaccines lose their potency, become ineffective, or hazardous.
MARKET HIGHLIGHTS
TECHNOLOGY BENEFITS
 Currently, more than 90% of all
vaccines require “cold chain” shipment
at 4°C.1
 Reduced moisture content during
lyophilization cycles to prevent
moisture ingress – critical to providing
stability and thermostability; can
reduce protein aggregation.5
 Reliance on a cold chain can increase
vaccine costs by up to 20%.2
 The World Health Organization (WHO)
estimates that the global vaccine
market was $24B in 2013.3
 Proprietary combination of lipids ratios
(MPG, DCP and Cholesterol) and
methods can be tailored for desired
formulation properties.
 Nearly 50% of lyophilized and 25% of
liquid vaccines are wasted each year;
one of the biggest contributors to this
wastage is disruption of the cold chain.
 Patent-pending production method –
simple and scalable; production
consistency indicates commerciallyviable process and technology.6
24
LPV™ Development Plan
LPV™ technology can confer thermostability to commercially-available
vaccines and to vaccines under development.1
C O M M E R C I A L I Z AT I O N
 VBI’s formulation team has expertise working
with multiple vaccine types.
 Demonstrated pilot scale manufacture at a GMP
compliant contract facility.
 Currently pursuing LPV™ collaborations with
undisclosed potential prospects.
 All partnerships are expected to be self funding,
with upfront and royalty payments anticipated.
VBI’s Ottawa, Canada-based research facility.
25
LPV™ Technology Proof of Concept
Preclinical proof of concept data has been collected using commercial
products acquired through retail channels and through undisclosed
collaborations with prospects.
PROOF OF CONCEPT
 Protein subunit vaccine (Influenza)1
 12 Months at 40° C
 Live Biologic Vaccine (MMR)2
 8 Weeks at 37° C
 Monoclonal Antibody Therapeutics3
 8 Weeks at 40° C
 Complex Protein Vaccine (Rabies)4
 18 Months at 40° C
VBI’s Ottawa, Canada-based research facility.
26
LPV™ Technology Proof of Concept Cont.
C O M M E R C I A L F L U VA C C I N E
Six month of stability at 40°C was achieved for an LPV ™ formulation of H3N2 seasonal flu vaccine formulated at pilot scale by a
contract manufacturing organization.1
1024
HAI Titer (1/x)
512
256
128
64
32
16
8
Storage Condition
Formulation
Antigen
1
2
3
FLU LPV™
Reference Vaccine
6 Months @ 4°C
Reference Vaccine
6 Months @ 40°C
4
FLU LPV™
H3N2 Component of Seasonal Flu Vaccine
27
VBI Opportunity
VBI Opportunity Summary
Emerging company with experienced leadership, innovative vaccine
assets, and runway to meet anticipated near-term milestones.
HIGHLIGHTS
 CMV vaccine candidate with $1B annual market potential.1,2
 Additional ‘catch-up’ cohorts could increase initial market size significantly.
 CMV Phase I clinical development program has the potential to provide human proof
of concept by benchmarking against naturally acquired immunity (Cytogam™).3
 VBI’s LPV™ technology can confer thermostability to vaccines and biologics; currently
more than 90% of all vaccines require “cold chain” shipment at 4°C.4
 Strong intellectual property portfolio.
 World-class leadership team.
29
Anticipated CMV Program Milestones
Forecast Timing
Milestone
Q4 2014
Complete GMP Tech Transfer of VBI-1501A; Initiate GMP Production for
Toxicology
Q1 2015
Complete GMP Manufacturing for VBI-1501A
Q2 2015
Initiate Formal Toxicology
Q3 2015
Complete Formal Toxicology
Q4 2015
VBI-1501A - IND Approval and Phase I Start
Q1 2016
Interim Phase I Data
Q3 2016
Final Phase I Data
30
VBI Vaccines, Inc.
222 Third Street, Suite 2241
Cambridge, MA 02142
(617) 830-3031
[email protected]
Appendix
Intellectual Property
IP strategy protects core platforms; CMV IP extends to 2032 and LPV™
IP extends to 2030.
IN T ELLEC T UAL PROPERT Y PORT FOLIO
 Platform IP


Licensed eVLP Patents

Internally developed LPV Patents
Product Specific Embodiments

eVLP: HCV, CMV Compositions

LPV: Flu, Live Attenuated, Tx Proteins, Etc.
 Coverage of Manufacturing Processes

eVLP: Purification Process

LPV: Inverse Melt Process, Lipid Ratios
Extension IP
Analytical Tools
Manufacturing
Product IP
 Coverage of Proprietary Analytical Tools

Proprietary Potency Assay

Proprietary Reagents
Platform IP
 Second Generation Platform Extension IP

Undisclosed Future Efforts
33
LPV™ Technology Proof of Concept
C O M M E R C I A L M M R VA C C I N E
Eight weeks of stability at 37°C was achieved with an LPV™ formulation of a commercial MMR vaccine. Potency was measured in
quadruplicate in VERO cells in vitro after eight weeks of storage. VBI LPV™ formulations (orange) provided greater stability than
standard sucrose lyophilized control (blue) or off-the-shelf reference vaccine (green).1
100,000
TCID50/ml
10,000
1,000
100
10
Storage Temperature
Formulation
Lyophilization Cycle
1
2
4°C
37°C
3
4
4°C
37°C
5
6
4°C
37°C
VBI LPV™ Formulation
NO LPV™ Formulation Control
Reference (Commercial Vaccine)
2 LYO Cycle
2 LYO Cycle
1 LYO Cycle
34
LPV™ Technology Proof of Concept Cont.
LPV™ formulation of a HER-2 mAb reduces moisture, increases purity,
and maintains potency under stress conditions.1
THERAPEUTIC mAb
Liquid bulk drug substance (Her-2-mAb-liquid) was compared to lyophilization in sucrose in the absence (Her-2-mAb-lyo) or
presence of the LPV™ lipids (Her-2 mAb-LPV™).
Moisture Content
Purity (SEC Test)
0.5
100
100
99
90
98
80
Potency (%)
1
Purity (%)
Moisture Content (%)
1.5
97
96
0
70
60
95
Her-2mAb Her-2mAb Her-2mAb
(liquid)
(lyo)
(LPV)
Potency (After 8 weeks at 40° C)
50
Her-2mAb Her-2mAb Her-2mAb
(liquid)
(lyo)
(LPV)
Her-2mAb Her-2mAb Her-2mAb
(liquid)
(lyo)
(LPV)
35
Sources
PAGE 4: OPPORTUNITY HIGHLIGHTS
1.
VBI Studies: 15BC04, 15BC19; Garrone, P (2011) Sci Transl Med 3, 94ra71;
Bellier, B (2009) Vaccine 25, 5772; Szecsi, J (2006) Virol J 3, 70.
2.
Estimates adapted from Vakzine Analytics, CMV Marketview, August 2012
3.
Vaccine prices adapted from CDC published pricing:
http://www.cdc.gov/vaccines/programs/vfc/awardees/vaccinemanagement/price-list/archive.html
4.
Biopharma Cold Chain Sourcebook 2010
PAGE 7: PLATFORM TECHNOLOGIES
PAGE 12: eVLP VACCINE CANDIDATES
1.
http://www.cdc.gov/cmv/trends-stats.html
2.
Nelson, PK; Mathers BM; Cowie B; Hagan H; Des Jarlais D; Horyniak D;
Degenhardt L (2011-08-13). "Global epidemiology of hepatitis B and
hepatitis C in people who inject drugs: results of systematic reviews".
Lancet 378 (9791): 571–83.
PAGE 14: CMV OPPORTUNITY
1.
Stratton KR et al, Committee to Study Priorities for Vaccine Development,
Inst. of Med.; Washington, DC
2.
http://www.cdc.gov/cmv/trends-stats.html
3.
http://www.cdc.gov/CMV/index.html
1.
VBI Studies: 15BC04, 15BC19; Garrone, P (2011) Sci Transl Med 3, 94ra71;
Bellier, B (2009) Vaccine 25, 5772; Szecsi, J (2006) Virol J 3, 70.
2.
Stratton KR et al, Committee to Study Priorities for Vaccine Development,
Inst. of Med.; Washington, DC
4.
Cannon, M. J., and K. F. Davis. 2005. Washing our hands of the congenital
cytomegalovirus disease epidemic. BMC Public Health 5:70
3.
VBI Studies: 12BC04 (Flu), 07CH12 (MMR), 07CH17 (Rabies), undisclosed
partner feasibility study (biologic)
5.
http://www.cdc.gov/CMV/risk/weak-immune.html
PAGE 15: CMV OPPORTUNITY CONT.
PAGE 10: eVLP PLATFORM OVERVIEW
1.
1.
VBI studies 15BC04, 15BC19 (CMV); Garrone, P (2011) Sci Transl Med 3,
94ra71 (HCV); Szecsi, J (2006) Virol J 3, 70 (Flu)
Demmler GJ. Congenital cytomegaloviral infection and disease. Semin
Pediatr Infect Dis 1999;10:195-200.
PAGE 16: CMV VACCINE LANDSCAPE
PAGE 12: eVLP PLATFORM CHARACTERISTICS
1.
VBI Studies: 15BC04, 15BC19
2.
VBI Studies: 15CH19, 15CH38
1.
Pass RF (2009) N Eng J Med 360, 1191-1199
2.
Adler SP (1995) J Infect Dis 171, 26-32
3.
Cui X (2008) Vaccine 26, 5760-5766
4.
Lilja AE (2013) Vaccine 30, 6980-6990
36
Sources Cont.
PAGE 17: CMV VACCINE CANDIDATE: VBI-1501A
PAGE 24: LPV™ MARKET OPPORTUNITY
1.
VBI Studies: 15BC19
1.
Biopharma Cold Chain Sourcebook 2010
2.
VBI Studies: 15BC04
2.
World Health Organization (WHO)
3.
http://www.ncbi.nlm.nih.gov/pubmed/10466818
3.
VBI Studies: 12BC04
4.
VBI Studies: 15BC04, 15BC19, 15BC39
4.
Thermostability of vaccines, A. Galazka, J. Milstien, M. Zaffran, World
Health Organization 1998.
5.
VBI Studies: 15BC19
5.
VBI Studies: 12BC01, undisclosed partner feasibility study
6.
VBI Studies: 15BC19, 15BC3
6.
VBI Studies: 12BC04
PAGE 18: CMV VACCINE CANDIDATE: PROOF OF
CONCEPT
1.
VBI Studies: 15BC04
PAGE 19: CMV VACCINE CANDIDATE: PROOF OF
CONCEPT CONT.
1.
1.
VBI Studies: VBI Studies 12BC04 (Flu), 07CH12 (MMR), 07CH17 (Rabies)
PAGE 26: LPV™ TECHNOLOGY PROOF OF CONCEPT
1.
VBI Studies: 12BC04
2.
VBI Studies: 07CH12
3.
Undisclosed partner feasibility study
4.
VBI Studies: 07CH17
VBI Studies: 15BC19
PAGE 20: CMV VACCINE CANDIDATE: PHASE I
TRIAL DESIGN
1.
PAGE 25: LPV™ DEVELOPMENT PLAN
Nozawa, N (2009) J Clin Virol 46S4, S58-63.
PAGE 23: THERMOSTABLE LPV™ TECHNOLOGY
1.
VBI Studies: 12BC04 (Flu), 07CH12 (MMR), 07CH17 (rabies), undisclosed
partner feasibility study (biologic)
2.
VBI Studies: 12BC07, 12MK01
37
Sources Cont.
PAGE 27: LPV™ TECHNOLOGY PROOF OF CONCEPT
CONT.
1.
VBI Studies: 12BC04
PAGE 29: VBI OPPORTUNITY SUMMARY
1.
Estimates adapted from Vakzine Analytics, CMV Marketview, August 2012
2.
Vaccine prices adapted from CDC published pricing.
http://www.cdc.gov/vaccines/programs/vfc/awardees/vaccinemanagement/price-list/archive.html
3.
Potency of Cytogam™, live-attenuated Towne vaccine and adjuvanted gB
subunit vaccine adapted from Cui, et al., 2008
4.
Biopharma Cold Chain Sourcebook 2010
PAGE 34: LPV™ TECHNOLOGY PROOF OF CONCEPT
CONT.
1.
VBI Studies: 07CH12
PAGE 35: LPV™ TECHNOLOGY PROOF OF CONCEPT
CONT.
1.
Undisclosed partner feasibility study
38

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