BiondVax Company Presentation BioMed 2014 final.pdf

ייייי

1. Universal Flu Vaccine - One • For All
Universal Influenza Vaccine
One ● For All
MIXiii Conference, May 2014

2. Universal Flu Vaccine - One • For All
Forward Looking Statements
This presentation includes “forward-looking statements” within the meaning of applicable
securities laws. These forward-looking statements involve risks and uncertainties, including those
identified within the “Risk Factors” section of the Company's Shelf Prospectus dated January 17,
2012.

Although management of the Company believes the expectations reflected in such forward-
looking statements are based on reasonable assumptions, the Company cannot assure investors
that these expectations will prove correct, and the actual results that the Company achieves may
differ materially from any forward-looking statements, due to such risks and uncertainties.
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3. Universal Flu Vaccine - One • For All
BiondVax at a glance
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One • For All: against A & B-Type, seasonal & pandemic strains
Broad & Safe: young adults to elderly (65+), no adjuvant
Active: induces cellular responses and enhances HAI responses
One Protein – two products:
Universal: Multi billion public heath saving potential
Pandemic Primer: preparedness AHEAD of ANY flu pandemic

4. Universal Flu Vaccine - One • For All
BiondVax at a Glance
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Phase 3

BiondVax
Operational
2005
Phase 1/2
2008
BiondVax
today
2010
Phase 2
Pivotal Phase 3 clinical trials likely require strategic partner
Goes public
TASE:BNDX

Weizmann Institute
Prof Ruth Arnon

Mid 90’s
Milestones Achieved 2013:
EU Qualified Person (QP) GMP Audit
Submitted US IND
EU FP7 Consortium
Milestones 2014:
Partnering with:
Companies
Government
ADR1 in OTCQX (US)

5. Universal Flu Vaccine - One • For All
BiondVax’s M-001
Developing a universal vaccine to
protect against ALL flu strains

6. Universal Flu Vaccine - One • For All
BiondVax’s Universal Flu Vaccine (M-001)
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HemAgglutinin (HA)
Matrix protein (M
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NucleoProtein (NP)
Design: Targets Common Regions
Nine common regions are connected to make
one recombinant protein called M-001
Production: Quick and Robust
Produced easily and quickly all year-round
within 6-8 weeks via fermentation in E.coli
The Influenza Virus

7. Universal Flu Vaccine - One • For All
High Homology with Seasonal & Pandemic Strains
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Homology to influenza strains was determined by Blast search in NCBI data base
Homology

to Influenza Type & Strains (representative list)

Epitope in M-001
H3N2, H5N1, H5N8, H7N9, H10N8

A HA (T-helper)

H1N1, H3N2, H5N1, H5N8, H7N7, H7N9, H10N8

A NP (T-helper)

H1N2, H2N2, H3N2, H5N8, H7N7, H7N9, H10N8

A NP (CTL)
H1N1, H1N2, H2N2, H3N8, H5N1, H5N2, H5N8, H5N9, H6N1, H6N2,
H6N9, H7N7, H7N9, H9N2, H10N8, H11N1, H11N8, H11N9, H14N5
A NP (CTL)
H1N1, H3N2, H4N6, H5N1, H5N2, H5N3, H5N8, H6N1, H7N3, H7N7,
H7N9, H9N2, H10N8
A M1 (B-cell & CTL)
H3N2 A HA (B-cell)
H1N1 A HA (B-cell)
H3N2 A HA (B-cell)
Both Victoria and Yamagata lineages: B/Hong Kong/330/2001;
B/Beijing/1/87; B/Singapore/222/79; B/Oregon/5/80;
B/Shangdong/7/97; B/Memphis/13/03; B/Los Angeles/1/02;
B/Nebraska/1/01; B/Hong Kong/548/2000 B/Hong Kong/156/99;
B/Vienna/1/99;strain B/Lee/40 And many more (over 100)
B HA (B-cell)

8. Universal Flu Vaccine - One • For All
BiondVax’s Facility: GMP Production of M-001
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Fermentation (E. coli) 2 days
M-001 purification 3 days
Fill and finish 2 days
QC testing 5-7 weeks
Product Release 6-8 weeks

Stability (ongoing): 33 months
Fermentation
Lysis
Ultrafiltration
Fill & Finish Chromatography
IB Solubilization



Inoculation
Cultivation
Heat induction
Batch termination
Harvest
Storage
Lysis
Homogenize
Centrifuge
Storage
Washes
Solubilize
Inclusion bodies
Centrifuge
Filtration
Column 1
Cation Exchange
Elute
Column 2
Hydrophobic
Interaction
Elute
Ultrafiltration
Hollow fiber
Concentration
Buffer Exchanges
Drug Substance
Dilution
Vial Dispensing
Capping &
Crimping
Visual Inspection
Drug product
storage

9. Universal Flu Vaccine - One • For All
Universal Flu Vaccine
Clinical Data

10. Universal Flu Vaccine - One • For All
No treatment-related Severe Adverse Events
Most adverse events were mild
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All adverse events observed were transient
M-001: Clinical Trials in Young Adults to Elderly
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Total N Population (age) Year Trial
63 Younger Adults (18-49) 2009 BVX-002

60 Older Adults (55-75) 2010 BVX-003
200 Younger Adults (18-49) 2011 BVX-004
120 Elderly (65+) 2012 BVX-005
443
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Mild Side Effects:
•Local reactions: injection site pain, erythema (skin redness), swelling
•Systemic reactions: myalgia (muscle ache), malaise (general discomfort), fever
No significant differences between treatment and control groups

11. Universal Flu Vaccine - One • For All
1 Protein, 2 Products
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•Trial: M-001 + pandemic vaccine vs. pandemic vaccine
•Endpoint: current antibody immune marker (HAI)
Pandemic
Primer
Enhancer of
pandemic strain
specific vaccines
•Trial: M-001 vs. placebo
•Endpoints: clinical efficacy
Universal
Flu Vaccine
Standalone
multi-strain,
multi-season

12. Universal Flu Vaccine - One • For All
M-001 as Pandemic Primer
Pandemic Preparedness Plan:
Immediate vaccination upon any pandemic
declaration from stockpile

13. Universal Flu Vaccine - One • For All
M-001 Fits BARDA Model of Pandemic Preparedness
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Source:
HHS Pandemic Influenza
Vaccine Program
VRBPAC Meeting November 14, 2012
Robin Robinson, PhD
Director of BARDA
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http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/BloodVaccinesandOtherBiologic
s/VaccinesandRelatedBiologicalProductsAdvisoryCommittee/UCM330392.pptx

14. Universal Flu Vaccine - One • For All
BiondVax’s Pandemic Preparedness Plan (PPP)
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1 2 3 4 5 6 7 8 9 mos
Inter pandemic Phase
Pandemic
Declaration
Today's situation:
BiondVax's PPP:
Saving time = Saving lives
Key benefits:
Vaccination schedule starts IMMEDIATELY upon ANY pandemic
declaration (instead of 6 months later)
More subjects reach level of protection to pandemic and
evolving strains after ONE boost

15. Universal Flu Vaccine - One • For All
Swine H1N1
M-001 Efficacy Measured After Viral Ag Exposure
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Enhanced HAI responses to pandemic strains

In human: 500mcg M-001 twice, TIV (Vaxigrip 2011) and Placebo (PBS).
In mice: 150mcg M-001 thrice, 0.67mcg H5N1 once (A/Vietnam/1203/04 Clade 1, Aventis Pasteur, non adjuvanted)
Seroconversion: % of subject with mean fold increase in HAI GMT ≥4x and HAI GMT≥ 1:40 post-immunization
Hemagglutination Inhibition (HAI): is used as marker of efficacy for influenza vaccines
* P<0.05
Human clinical trial: Age 65+
0
10
20
30
40
50
60
70
TIV M-001 + TIV
%
Seroconversion (HAI)
*
Avian H5N1
Mouse Model
0
10
20
30
40
50
60
70
80
90
100
H5N1 vaccine M-001 + H5N1 vaccine
%
Seroconversion (HAI)

*

16. Universal Flu Vaccine - One • For All
In mice: 250mcg M-001 twice, partial dose of H5N1 vaccine (A/Vietnam/1194/04)
Seroconversion: % of mice with mean fold increase in HAI GMT ≥4x and HAI GMT≥ 1:40 post-immunization
Hemagglutination Inhibition (HAI): is used as marker of efficacy for influenza vaccines
Strains: Clade 2.1 (A/Duck/Hunan/795/02); Clade 2.2 (A/Bar headed goose/Qinghai/1A/05); Clade 2.3
(A/Duck/Laos/3295/06)
Priming Broadens Immunity to Drift Strains
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0
10
20
30
40
50
60
70
80
90
100
clade 2.1 clade 2.2 clade 2.3
% Seroconversion (HAI)

PBS+H5N1
M-001 +H5N1
*
Security net: Response to NON H5N1 vaccine strains
* P<0.05

17. Universal Flu Vaccine - One • For All
Take Home Message
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One • For All: against A & B-Type, seasonal & pandemic strains
Safe: young adults to elderly (65+), no adjuvant
Active: induce cellular responses and enhances HAI responses
One Protein – two products:
Universal: Multi billion public heath saving potential
Pandemic Primer: preparedness AHEAD of ANY flu pandemic

18. Universal Flu Vaccine - One • For All
היצטנמרפ יתורש , יוקינ
יטפסא יולימו םינובלח
• ןקתמGMP ע רשואמ" יQP יאפוריא
• םייוסינל םיאתמא הזאפ םיינילק ,'ב '
•תוכיא תחטבאו תרקב

19. Universal Flu Vaccine - One • For All
GMP Production Facility EU Approved
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Downstream
Upstream
Fermentation
Aseptic Process
Fill & Finish

20. Universal Flu Vaccine - One • For All
Contact Information
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Website: www.biondvax.com
Email: [email protected]
Phone: [phone]
Fax: [phone]
A Game Changer for
Influenza Vaccines

Thank You!
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