BiondVax Pharmaceuticals Ltd. Universal Flu Vaccinevaccination, partial TIV dose (15% or 50%). Phase...
Transcript of BiondVax Pharmaceuticals Ltd. Universal Flu Vaccinevaccination, partial TIV dose (15% or 50%). Phase...
One ● For All
BiondVax Pharmaceuticals Ltd.
Universal Flu VaccineOne ●For AllOne ●For All
BiondVax – TASE, May 2012
Forward Looking StatementsOne ● For All
AgendaIntroduction
Forward Looking Statements
This presentation includes “forward‐looking statements” within the meaning ofli bl iti l Th f d l ki t t t i l i k dIntroduction
ScienceClinical TrialsMarketValue Proposition
applicable securities laws. These forward‐looking statements involve risks anduncertainties, including those identified within the “Risk Factors” section of theCompany's Shelf Prospectus dated January 17, 2012.
pRoad Ahead
Although management of the Company believes the expectations reflected insuch forward‐looking statements are based on reasonable assumptions, theCompany cannot assure investors that these expectations will prove correct, andCo pa y ca ot assu e esto s t at t ese e pectat o s p o e co ect, a dthe actual results that the Company achieves may differ materially from anyforward‐looking statements, due to such risks and uncertainties.
BiondVax – TASE, May 2012 2
One ● For All
AgendaIntroduction►IntroductionScienceClinical TrialsMarketValue Proposition
►
pRoad Ahead
Introduction
BiondVax – TASE, May 2012
Flu: the Most Common Infectious DiseaseOne ● For All
AgendaIntroduction
5‐15% of world population get the flu each year►Introduction
ScienceClinical TrialsMarketValue Proposition
• The challenge of seasonal flu1:– 600 million to 1 billion cases of influenza globally– 3 to 5 million cases of severe illness
►
pRoad Ahead
3 to 5 million cases of severe illness– 300,000 to 500,000 deaths– Huge economic burden: $90 billion in US2
• Flu in elderly:– 1 in 4 people in OECD countries predicted to be elderly (65+)
i 20 03in 20503
– About 70% of elderly in US receive flu vaccines4
– Only a small % respond sufficiently5
– Elderly account for 90% of flu–related deaths in US2
1 WHO, Acute Respiratory Infections (Update September 2009)2 Poland and Mulligan JID 2009:200
BiondVax – TASE, May 2012 4
Poland and Mulligan. JID 2009:2003 OECD Factbook 2009 Economic, Environmental and Social Statistics 4 http://stats.oecd.org/Index.aspx?DataSetCode=HEALTH PROC5 Minimum seroconversion required for vaccine approval for elderly is 30%
BiondVax’s Road MapOne ● For All
AgendaIntroduction
p
BiondVax today►Introduction
ScienceClinical TrialsMarketValue Proposition
today
Prof. Ruth Arnon & Dr. Tamar Ben‐Yedidia
►
pRoad Ahead
Basic research W i
BiondVax Pharmaceuticals LtdWeizmann Institute Human Clinical Trials
Weizmann Institute
BiondVax Pharmaceuticals Ltd.
Established in 2003 Exclusive, worldwide license
agreement with the
Weizmann Institute
More than 15 years of R&D led by Prof. Arnon and her team
Human Clinical Trials
Positive safety & immunogenicity
FDA Pre‐IND (July 2008) Two Phase I/II clinical trials:g
Weizmann Institute Publicly‐traded on Tel Aviv
Stock Exchange since June 2007 (TASE:BNDX)
$
Established feasibility in animals prior to founding of BiondVax
Registration of initial patents
63 younger adults (18‐49) 60 older adults (55‐75) Two Phase II clinical trials: 200 younger adults (18‐49) 120 elderly (65+)
BiondVax – TASE, May 2012 5
Raised ~$18m since its inception
on universal influenza vaccine 120 elderly (65+) Next Phase II in EU, 150
elderly (65+) 2012‐13
One Recombinant Protein – Two ProductsOne ● For All
AgendaIntroduction►IntroductionScienceClinical TrialsMarketValue Proposition
Multimeric‐001 (M‐001)►
pRoad Ahead
Universal Flu Vaccine Combination Flu Vaccine
ONE VACCINE F l & d i fl
ENHANCER of TIV1
P i M 001 & B t TIV
Every 3‐5 years Yearly prior to TIV
For seasonal & pandemic flu strains
Multi‐year protection
Prime: M‐001 & Boost: TIV Elderly and other at‐risk populations (seasonal)
Pre‐pandemic primer
Requires new surrogate marker Existing HAI surrogate marker
BiondVax – TASE, May 2012 6
1TIV (trivalent influenza vaccine) is standard, injectable commercially available strain‐specific flu vaccine
One ● For All
AgendaIntroductionIntroductionScienceClinical TrialsMarketValue Proposition
►
pRoad Ahead
Science
BiondVax – TASE, May 2012
The Multimeric‐001 VaccineOne ● For All
AgendaIntroduction
M‐001 Concept: Common DenominatorThe Multimeric‐001 (M‐001) is comprised of a
i d i t bi ti f i
The Multimeric‐001 VaccineA single recombinant 50 kDa polypeptide
t i i h f th i li it iIntroductionScienceClinical TrialsMarketValue Proposition
unique and proprietary combination of nine selected linear B‐ and T‐cell epitopes that are conserved and common to most influenza strains
containing each of the nine linear epitopes in triplicate produced year‐round in E.coli at BiondVax cGMP facility.
The Influenza Virus
►
pRoad Ahead
Hemagglutinin (HA) x 5(B & T C ll)
The Influenza Virus
(B‐ & T‐Cell)
NucleoProtein x 3(T‐Cell)
M1 Matrix Protein x 1(T‐Cell)
S l t d it
BiondVax – TASE, May 2012 8
Selected epitopes from HA, NP and M
proteins
Clear Regulatory PathwayOne ● For All
AgendaIntroduction
g y y
• FDA Pre‐IND meeting in 2008IntroductionScienceClinical TrialsMarketValue Proposition
• Israeli MOH IRB & IND submissions and clinical trials 2009 – present
• Meeting with European regulators at Paul Ehrlich Institute in June 2010:– Prime‐boost regimen to be developed initially for the elderly and other high‐risk
►
pRoad Ahead
Prime‐boost regimen to be developed initially for the elderly and other high‐risk groups (e.g. chronic patients)
– Proposed label:
“For the enhancement of the active immunization offered by subsequent f ff y qadministration of a standard seasonal or pandemic influenza vaccine, against influenza disease caused by influenza virus”
• Meetings at NIH in April 2012:– Priming in elderly for TIV (seasonal)
– Priming in young adults for H5N1 avian flu vaccine (pandemic)
• Request for second pre‐IND meeting with FDA regarding universal priming indication; submitted April 2012
BiondVax – TASE, May 2012 9
One ● For All
AgendaIntroductionIntroductionScienceClinical TrialsMarketValue Proposition
►
pRoad Ahead
Clinical Trials
BiondVax – TASE, May 2012
4 Successful Clinical Trials – 440 participantsOne ● For All
AgendaIntroduction
p pBVX‐002, ‐004 : Younger Adults BVX‐003, ‐005 : Older Adults/Elderly
Phase I/II (BVX‐002): 63 participants ♀ ♂ Phase I/II (BVX‐003): 60 participants, ♀ ♂,IntroductionScienceClinical TrialsMarketValue Proposition
Phase I/II (BVX 002): 63 participants, ♀ ♂, 18‐49 years old. June – December 2009. Randomized, single‐blind, placebo‐controlled escalating double‐dose.
Phase II (BVX‐004): 200 participants ♀ ♂
Phase I/II (BVX 003): 60 participants, ♀ ♂, 55‐75 years old. Sept 2009 – April 2010. Randomized, single‐blind, placebo‐controlled escalating double‐dose, prime‐boost full TIV dose.
►
pRoad Ahead
Phase II (BVX 004): 200 participants, ♀ ♂, 18‐49 years old. Oct 2010 – June 2011. randomized, two stage, double‐blind, placebo‐controlled two‐dose, combined vaccination, partial TIV dose (15% or 50%).
Phase II (BVX‐005): 120 participants, ♀ ♂, 65‐91 years old. Aug 2011 – Feb 2012. Multicenter, randomized, double‐blind, placebo‐controlled , prime‐boost full TIV dose.
Younger Adults Older Adults / ElderlyClinical Trial BVX‐002 BVX‐004 BVX‐003 BVX‐005Endpoints:
Safety
Immunogenicity
Humoral M‐001 TBD
Primary endpoint:Safety
Secondary (exploratory)endpoint: Humoral
(antibodies) HAI N/A (partial TIV) (full TIV) (full TIV)
Cellular
IFN‐g
IL 2 N/D N/D
endpoint: Immunogenicity
BiondVax – TASE, May 2012 11
Cellular IL‐2 N/D N/D
FACS N/D N/D
M‐001: Good Safety Profile & Well‐ToleratedOne ● For All
AgendaIntroduction
No significant differences between treatment and control groups
y
IntroductionScienceClinical TrialsMarketValue Proposition
Trial Year Population (age) N (M‐001) N (Placebo) Total N
BVX‐002 2009 Younger Adults (18‐49) 3 + 40 20 63
►
pRoad Ahead BVX‐003 2010 Older Adults (55‐75) 40 20 60
BVX‐004 2011 Younger Adults (18‐49) 112 88 200
BVX‐005 2012 Elderly (65+) 90 30 120
285 158 443
No treatment related Severe Adverse Events
285 158 443
No treatment‐related Severe Adverse Events
Most adverse events were mild
All adverse events observed were transient All adverse events observed were transient
BiondVax – TASE, May 2012 12
Design of Latest Phase II in Elderly (BVX‐005)One ● For All
AgendaIntroduction
g y ( )Prime‐Boost in Elderly
• 120 participants, ♀♂, 65+ years old (mean age: 72.2±5.5, range: 65‐91Y)IntroductionScienceClinical TrialsMarketValue Proposition
120 participants, ♀♂, 65+ years old (mean age: 72.2±5.5, range: 65 91Y)• Multicenter, randomized, placebo‐controlled and double‐blind• Aug 2011‐Feb 2012• Identity between 2010/11 and 2009/10 TIV strains
►
pRoad Ahead
Group DAY 0 DAY 21 DAY 42 N
y / /• Participants screened for seronegativity to at least two TIV strains
Legend
A M‐001 (500μg) M‐001 (500μg) TIV 30
B M‐001 (500μg) TIV 30
C Alum Adj M‐001 (500μg) TIV ‐ 30Legend
Adj M‐001 Adjuvanted Multimeric Vaccine (Alum)
PBS Phosphate‐
D PBS TIV ‐ 30
TOTAL 120
Study endpoints:buffered saline (placebo)
TIV Trivalent Inactivated Vaccine
1. Safety2. Immunogenicity
• HAI• FACS analysis for CD4+/CD8+ cells secreting IFN gamma
BiondVax – TASE, May 2012 13
Vaxigrip 2010/11
y g g• Ab to M‐001
M‐001 Improves Immunity to All Tested TIV StrainsOne ● For All
AgendaIntroduction TIV T i M 001 TIV
StrainsMore People Seroconverted1 to TIV viruses (HAI)
BVX‐003IntroductionScienceClinical TrialsMarketValue Proposition 50
60
70
80
ersio
n
TIV Twice M‐001 + TIVBVX 003
Priming with M‐001 results in increased
►
pRoad Ahead
20
30
40
50
% se
roconve
HAI seroconversion for ALL tested TIV
strains
0
10
A/Brisbane/59/07 A/Brisbane/10/07 B/Brisbane/60/08
70 TIVMinimum required for regulatory approval BVX‐005
40
50
60
70
version
TIVM‐001 + TIVTwice M‐001 + TIV
*
1. Seroconversion: % of individuals with mean fold increase in HAI ≥4x and HAI
regulatory approval
10
20
30
40% Serocon≥ 1:40 post‐immunization
2. In BVX‐003: 500 mcg M‐001, TIV (Vaxigrip 2009) and Placebo (either PBS or adjuvanted PBS)
3. In BVX‐005: 500 mcg M‐001, TIV
BiondVax – TASE, May 2012 14
0
A/California/7/09 A/Perth/16/09 B/Brisbane/60/08
(Vaxigrip 2011) and Placebo (PBS). * = P<0.05
Superiority Criteria: Fluzone HD Case StudyOne ● For All
AgendaIntroduction
p y yFluzone HD (Sanofi Pasteur) licensed in 2009 in USA for elderly
IntroductionScienceClinical TrialsMarketValue Proposition
• Contains 4 times more HA than standard TIVs (60 mcg of each strain)• Phase III trial: 2541 participants receiving HD, 1240 participants receiving SD• Overall superiority = superiority for each measure for at least 2 strains without
►
pRoad Ahead inferiority for any strain”
Superiority (Falsey et al. JID (2009) 200)> 1.5*Ratio of GMTs (Fluzone HD/Fluzone)
> 10%*Difference in SCR (Fluzone HD ‐ Fluzone)* Lower Bound of 2-sided 95% Confidence Interval (CI)
Non Inferiority (FDA)≤ 1 5Ratio of GMTs (US licensed vaccine / New vaccine)
( )
≤ 1.5 Ratio of GMTs (US licensed vaccine / New vaccine)
≤ 10%Difference in SCR (US licensed vaccine ‐ New vaccine)
BiondVax – TASE, May 2012 15
M‐001: A Universal Primer for TIVOne ● For All
AgendaIntroduction
>10% Elevation in Seroconversion
IntroductionScienceClinical TrialsMarketValue Proposition
BVX‐003Non‐Adjuvanted M‐001 500mcgPrime twiceTIV: Vaxigrip 2009/10 Sanofi
Mean of 95% confidence interval
Ratio of GMT increaseGroups given (M‐001 followed by
TIV) divided by (TIV alone)
Difference in seroconversion rates (%)
Groups given (M‐001 followed by TIV) minus (TIV alone)
►p
Road AheadTIV) minus (TIV alone)
A/Brisbane/10/07 H3N2 0.9 non‐inferior 25% SUPERIORA/Brisbane/59/07 H1N1 1.3 non‐inferior 35% SUPERIORB/Brisbane/60/08 1.0 non‐inferior 25% SUPERIOR
BVX‐005Non‐Adjuvanted M‐001 500mcgPrime onceTIV: Vaxigrip 2011/12 Sanofi
Mean of 95% confidence interval
Ratio of GMT increaseGroups given (M‐001 followed by
TIV) divided by (TIV alone)
Difference in seroconversion rates (%)
Groups given (M‐001 followed by TIV) i (TIV l )g p / ) y ( ) TIV) minus (TIV alone)
A/Perth/16/09 H3N2 1.3 non‐inferior 13% SUPERIORA/California/7/09 H1N1 1.7 SUPERIOR 20% SUPERIORB/Brisbane/60/08 1.0 non‐inferior 7% non‐inferior
Considerations:• Small trial size• Relatively early day of immune evaluation (21 days post TIV immunization)• Identity between 2011/12 and 2009/10 TIV strains (BVX‐005)
BiondVax – TASE, May 2012 16
Identity between 2011/12 and 2009/10 TIV strains (BVX 005)• Screening of subjects for seronegativity to at least two TIV strains
2nd Phase II (BVX‐005) Summary: SuccessOne ● For All
AgendaIntroduction
( ) y
BiondVax’s M‐001 vaccine has a good safety profile and is well‐IntroductionScienceClinical TrialsMarketValue Proposition
BiondVax s M‐001 vaccine has a good safety profile and is well‐tolerated
M‐001 vaccine enhanced the elderly (65+) participants’ responses to
►
pRoad Ahead
y ( ) p p pseasonal flu vaccine (TIV) confirming previous results in older adults
This improved immunity to influenza in the elderly was generated by single priming with M‐001 vaccine without any added adjuvant
M‐001 vaccine alone induced cellular responses to several influenza strains including H1N1 and H3N2 strains providing the rationale for astrains including H1N1 and H3N2 strains, providing the rationale for a mechanism of action that supports both indications: the current combination vaccine as well as its future potential to serve as a universal vaccineuniversal vaccine
BiondVax – TASE, May 2012 17
One ● For All
AgendaIntroductionIntroductionScienceClinical TrialsMarketValue Proposition
►p
Road Ahead
Market
BiondVax – TASE, May 2012
Flu Vaccines: Large & Growing MarketOne ● For All
AgendaIntroduction
g g
Seasonal Flu Vaccine Market Flu Vaccine MarketIntroductionScienceClinical TrialsMarketValue Proposition $1,077m
Others$446m
• Seasonal Flu: 2010 sales: ~$3bn worldwide2
~500m doses supplied2►
pRoad Ahead
38%3%
16%$91m
Forecasted CAGR of 6‐10% over next 5 years
Expected 2016 sales: ~$5 bn38%
7%
4%
$200m
$104m• Pandemic Flu:Swine Flu (A/H1N1), 2009 sales: ~ $3.6 bn worldwide3 (in addition to seasonal
14%18%
$flu vaccine sales)
$378m1
$516m2http://www.sanofipasteur.com/sanofi‐pasteur2/sp‐media/SP_CORP/EN/222/1758/EN_Factsheet%20SP%20world%20manufacturer_2011.pdf3http://www.gsk.com/investors/presentations/2011/2011‐03‐23‐
ti d iti df
BiondVax – TASE, May 2012 19
Source: Datamonitor, BCC Research1BiondVax estimate. Actual Novartis 2008 Influenza Vaccine sales data are not publicly available
martin‐andrews‐citi.pdf
M&A Activity – Vaccine MakersOne ● For All
AgendaIntroduction
ySignificant Vaccine Transactions
($m, log‐scale)IntroductionScienceClinical TrialsMarketValue Proposition $5.4bn
$15.6bn
$68bn
$6.6bn10,000
100,000
►p
Road Ahead $1.5bn$888m
$1,5bn
$480m $380m $364m$550m $781m
$2.4bn
1,000
10
100
12002 2003 2005 2006 2007 2008 2009 2010
BiondVax – TASE, May 2012 20
M&A Activity: Phase II Biotech BenchmarksOne ● For All
AgendaIntroduction
M&A Activity: Phase II Biotech Benchmarks
IntroductionScienceClinical TrialsMarketValue Proposition
CompanyCerexa1 Novexel2 BiPar3 Facet
Biotech4 BioVex5Description
Anti‐ Anti‐ Multiple►
pRoad Ahead Activity Anti‐
bacterialAnti‐bacterial Anti‐cancer Multiple
Sclerosis Anti‐cancer
Buyer Forrest Lab AstraZeneca Sanofi‐
Aventis Abbott AmgenLab Aventis
M&A($millions)
$480 cash$100 MS
$430 cash$75 MS
$500 cash + MS $450 cash $425 cash
$475 MS
MS - milestone
1 (2006) http://www.domainvc.com/PDF/Cerexa%20Forest%201.05.pdf2 (2009) http://www.antiinfectivesconsulting.com/PDF/Novexel_Press_Release.pdf3 (2009) http://www.fiercebiotech.com/story/hungry‐sanofi‐snaps‐bipar‐500m‐deal/2009‐04‐154 (2010) http://www.nature.com/nbt/journal/v28/n5/full/nbt0510‐387.html5 (2011) h // l h k/fi / b / h i l d h i l /8280114/A b
BiondVax – TASE, May 2012 21
5 (2011) http://www.telegraph.co.uk/finance/newsbysector/pharmaceuticalsandchemicals/8280114/Amgen‐to‐buy‐experimental‐cancer‐drug‐maker‐Biovex‐in‐1bn‐deal.html
BiondVax Leads the WayOne ● For All
AgendaIntroduction
y
Company Product Technology Phase Last News
Universal Flu Vaccines in DevelopmentIntroductionScienceClinical TrialsMarketValue Proposition
Company Product Technology Phase Last News DatePre-clinical Phase I Phase II
BiondVax Multimeric-001 Multi-epitope (B&T)recombinant protein Feb-2012►
pRoad Ahead Dynavax N8295 NP-M2e fusion protein
plusTLR9ag DNA seq Feb-2011
Vaxinnate M2e-Flagellin M2e-flagellin fusion protein Apr-2009
Colby Cationic lipid withColby(Juvaris) JVRS-100 M2e Cationic lipid with
Tetrameric M2e peptides May-2009
Bionor Vacc-flu NP and M2e domains plusGM-CSF (ID) 2011
Sanofi Pasteur ACAM-FLU-A M2e protein Dec-2009(Acambis) ACAM FLU A M2e protein Dec 2009
Immune Targeting Sys. FP-01 Fluoro-conj. peptides (PA,
PB1, PB2, NP, M1) T-cell 2011
Seek Flu-v 6 T-cell epitopes 28 people challenge Sep-2011g
Crucell / J&J flu-mAb MAbs Jan 2010
PeptiVir PVI-1000 Conformational HA stempeptides 2011
BiondVax – TASE, May 2012 22
Inovio INO-3510 HA DNA constructs (ID) Sep-2010
Sources: Respective company web sites and press releases.
Competitive Advantages of Multimeric‐001One ● For All
AgendaIntroduction
p g
BiondVax’s M‐001 universal flu vaccine is the most advanced inIntroductionScienceClinical TrialsMarketValue Proposition
BiondVax s M‐001 universal flu vaccine is the most advanced in clinical development
In all 4 clinical trials BiondVax’s M‐001 vaccine has demonstrated a ►
pRoad Ahead good safety profile and was well‐tolerated
M‐001 vaccine induces cellular and humoral immune responses without any added adjuvant
M‐001 vaccine has two indications: (1) universal flu vaccine, (2) universal primer for seasonal and pandemic flu vaccinesuniversal primer for seasonal and pandemic flu vaccines
BiondVax is the first to develop the priming in elderly model using existing surrogate marker for flu protection (HAI) currently acceptedexisting surrogate marker for flu protection (HAI) currently accepted by FDA and EMA
BiondVax – TASE, May 2012 23
One ● For All
AgendaIntroductionIntroductionScienceClinical TrialsMarketValue Proposition► pRoad Ahead
Value Proposition►
BiondVax – TASE, May 2012
Value Proposition: Combination VaccineOne ● For All
AgendaIntroduction
pMedicare Part B Payment Allowances Given yearly with TIV
OECD Peak Sales Potential: IntroductionScienceClinical TrialsMarketValue Proposition os
e ($)
$630 ‐ $3,800m
Peak Sales ($ )
Uptake in Elderly► p
Road AheadPrice pe
r Do ($ m) 35% 70%
5.00 $630 $1,300
10.00 $1,300 $2,500e pe
r se ($
)
►
Assumptions for Peak Sales:
P 10.00 $1,300 $2,500
15.00 $1,900 $3,800 Pric
Do s
Assumptions for Peak Sales:• Uptake is proportion of elderly that receive M‐
001 as well as TIV• Of note, today in US TIV uptake in elderly is 70% • Assuming elderly population in OECD in 2050 is
Note: The Medicare Part B payment allowance limits for seasonal influenza and pneumococcal vaccines are 95% of the • Assuming elderly population in OECD in 2050 is
~360 million (OECD Factbooks 2009 and 2011)Source: US Dept of Health and Human Services, CMS (Centers for Medicare and Medicaid Services) accessed at https://www.cms.gov/mcrpartbdrugavgsalesprice/10_vaccinespricing.asp
pAverage Wholesale Price (AWP)
BiondVax – TASE, May 2012 25
Assuming pricing of Combination Vaccine similar to Fluzone HD and a TIV price of $12, the Multimeric‐001 component could be priced up to $18
Value Proposition: Pandemic PreparednessOne ● For All
AgendaIntroduction
p p
WHO Global Influenza Preparedness Plan
IntroductionScienceClinical TrialsMarketValue Proposition► pRoad Ahead
►
BiondVax M‐001 Priming Period Pandemic VaccineM‐001 ReleaseRelease from
Stockpile
Potential Pre‐Pandemic Sales
OECD Sales ($m)OECD Population Penetration Rate
Assumptions:
OECD Sales ($m)
25% 75%
5.00 $1,500 $4,500 pe
r ($)
BiondVax – TASE, May 2012 26
Assumptions:• Current population in OECD is 1.2bn (OECD
Factbook 2011)
10.00 $3,000 $9,000
15.00 $4,500 $13,500 Price
Dose
BiondVax’s Intellectual PropertyOne ● For All
AgendaIntroduction
Solid, Comprehensive IP Protection
p y
IntroductionScienceClinical TrialsMarketValue Proposition
Subject Matter Priority & Assignee Status Expiry1– US
& EUROPE
P tid B d V i30/11/1998Y d R&D
Granted: USA, Israel, Australia, Korea, M i N Z l d E ( ll d)► p
Road AheadPeptide‐Based Vaccine for Influenza
Yeda R&D licensed to BiondVax
Mexico, New Zealand, Europe (allowed)Under Examination: CanadaFiled: Hong Kong
Nov 2019
Improved Peptide Based6/12/2005Yeda R&D Granted: USA, Europe
►
Improved Peptide‐Based Influenza Vaccine
Yeda R&D licensed to BiondVax
Under Examination: Israel, AustraliaFiled: Canada
Dec 2026
Multimeric Multi‐ / /
Filed: Brazil, Canada, Hong Kong, India, Japan, Korea, USAMultimeric Multi
Epitope Polypeptide Influenza Vaccines
2/8/2007BiondVax
Japan, Korea, USAUnder Examination: Europe, Eurasia, Mexico, Israel, ChinaGranted: Australia
Aug 2028
Multimeric Multi‐Epitope Polypeptides as Primer to Improve Seasonal and Pandemic Influenza Vaccines
BiondVax Filed: PCT Unpublished
BiondVax – TASE, May 2012 27
1. NOTE: The expiry dates shown do not reflect any potential extensions that may be granted in the respective jurisdictions (potentially up to a maximum of 5 additional years in the US or 5½ years in some EU countries)
One ● For All
AgendaIntroductionIntroductionScienceClinical TrialsMarketValue PropositionpRoad Ahead
The Road Ahead►
BiondVax – TASE, May 2012
Combination Vaccine Regulatory PathwayOne ● For All
AgendaIntroduction
Combination Vaccine Regulatory Pathway
IntroductionScienceClinical TrialsMarketValue PropositionpRoad Ahead
Fourth Phase II1
Third Phase II
Pivotal Phase III2
Regulatory Submissions
►
Phase II
•2‐300 elderly (65+)
•Worldwide
• 150 elderly (65+)
• EU: multicenter
Phase III
• 3,000 – 4,000 elderly (65+)
• Worldwide
Submissions
• US BLA
• EU MAA
•$ 2.5m• $1m • $20 – 25m
1Additi l Ph II ill lik l b f d i i M 001 i i b f H5N1
BiondVax – TASE, May 2012 29
1Additional Phase IIs will likely be performed e.g., examining M‐001 priming before H5N1 avian flu vaccine2Pivotal Phase III clinical trials likely require strategic partner
One ● For All
AgendaIntroduction One ●For AllIntroductionScienceClinical TrialsMarketValue Proposition
One ●For All
A G Ch fp
Road Ahead A Game Changer for Flu Vaccines
Thank You!
For further details:
Dr. Ron Babecoff, DVMPresident & CEOBiondVax Pharmaceuticals Ltd.T 972 8 9302529
Tanya Gottlieb, PhDBusiness DevelopmentBiondVax Pharmaceuticals Ltd.T 972 8 9302529
BiondVax – TASE, May 2012 30
T: +972‐8‐9302529E: [email protected]
T: +972‐8‐9302529E: [email protected]