Universal Influenza Vaccine One For All

Size: px

Start display at page:

Download "Universal Influenza Vaccine One For All"

Chester Garrett
5 years ago
Views:

1 Universal Influenza Vaccine One For All MIXiii Conference, May 2014

Forward Looking Statements 2 This presentation includes forward-looking statements within the meaning of

These forward-looking statements involve risks and uncertainties, including those identified within the Risk

Although management of the Company believes the expectations reflected in such forwardlooking statements are

2 Forward Looking Statements 2 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, Although management of the Company believes the expectations reflected in such forwardlooking 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.

3 BiondVax at a glance 3 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 BiondVax at a Glance 4 Weizmann Institute Prof Ruth Arnon Goes public TASE:BNDX BiondVax today Milestones 2014: Partnering with: Companies Government ADR1 in OTCQX (US) Mid 90 s Phase 1/2 Phase 2 Phase 3 BiondVax Operational Milestones Achieved 2013: EU Qualified Person (QP) GMP Audit Submitted US IND EU FP7 Consortium Pivotal Phase 3 clinical trials likely require strategic partner

5 BiondVax s M-001 Developing a universal vaccine to protect against ALL flu strains

and Robust Produced easily and quickly all year-round within 6-8 weeks via

6 BiondVax s Universal Flu Vaccine (M-001) 6 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 HemAgglutinin (HA) NucleoProtein (NP) Matrix protein (M 1 )

7 High Homology with Seasonal & Pandemic Strains 7 Epitope in M-001 Homology to Influenza Type & Strains (representative list) HA (T-helper) NP (T-helper) NP (CTL) NP (CTL) M1 (B-cell & CTL) HA (B-cell) HA (B-cell) HA (B-cell) HA (B-cell) A A A A A A A A B H3N2, H5N1, H5N8, H7N9, H10N8 H1N1, H3N2, H5N1, H5N8, H7N7, H7N9, H10N8 H1N2, H2N2, H3N2, H5N8, H7N7, H7N9, H10N8 H1N1, H1N2, H2N2, H3N8, H5N1, H5N2, H5N8, H5N9, H6N1, H6N2, H6N9, H7N7, H7N9, H9N2, H10N8, H11N1, H11N8, H11N9, H14N5 H1N1, H3N2, H4N6, H5N1, H5N2, H5N3, H5N8, H6N1, H7N3, H7N7, H7N9, H9N2, H10N8 H3N2 H1N1 H3N2 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) 1 Homology to influenza strains was determined by Blast search in NCBI data base

BiondVax s Facility: GMP Production of M-001 8 Inoculation Cultivation Heat induction Batch termination Solubilize Inclusion bodies Centrifuge Filtration Ultrafiltration Hollow fiber Concentration

8 BiondVax s Facility: GMP Production of M Inoculation Cultivation Heat induction Batch termination Solubilize Inclusion bodies Centrifuge Filtration Ultrafiltration Hollow fiber Concentration Buffer Exchanges Fermentation (E. coli) 2 days M-001 purification 3 days Fill and finish 2 days QC testing 5-7 weeks Harvest Drug Substance Product Release 6-8 weeks Storage Lysis Homogenize Column 1 Cation Exchange Elute Dilution Vial Dispensing Stability (ongoing): 33 months Centrifuge Storage Column 2 Hydrophobic Interaction Capping & Crimping Visual Inspection Washes Elute Drug product storage Fermentation IB Solubilization Ultrafiltration Lysis Chromatography Fill & Finish

9 Universal Flu Vaccine Clinical Data

10 10 M-001: Clinical Trials in Young Adults to Elderly No significant differences between treatment and control groups No treatment-related Severe Adverse Events Most adverse events were mild 1 All adverse events observed were transient Trial Year Population (age) Total N BVX Younger Adults (18-49) 63 BVX Older Adults (55-75) 60 BVX Younger Adults (18-49) 200 BVX Elderly (65+) Mild Side Effects: Local reactions: injection site pain, erythema (skin redness), swelling Systemic reactions: myalgia (muscle ache), malaise (general discomfort), fever

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

12 M-001 as Pandemic Primer Pandemic Preparedness Plan: Immediate vaccination upon any pandemic declaration from stockpile

13 13 M-001 Fits BARDA Model of Pandemic Preparedness Source: HHS Pandemic Influenza Vaccine Program VRBPAC Meeting November 14, 2012 Robin Robinson, PhD Director of BARDA s/vaccinesandrelatedbiologicalproductsadvisorycommittee/ucm pptx

14 BiondVax s Pandemic Preparedness Plan (PPP) 14 Pandemic Declaration Today's situation: Inter pandemic Phase BiondVax's PPP: mos 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 % Seroconversion (HAI) % Seroconversion (HAI) 15 M-001 Efficacy Measured After Viral Ag Exposure Enhanced HAI responses to pandemic strains Swine H1N1 Avian H5N * * TIV M TIV H5N1 vaccine M H5N1 vaccine Human clinical trial: Age 65+ Mouse Model In human: 500mcg M-001 twice, TIV (Vaxigrip 2011) and Placebo (PBS). * P<0.05 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

16 % Seroconversion (HAI) Priming Broadens Immunity to Drift Strains Security net: Response to NON H5N1 vaccine strains * PBS+H5N1 M-001 +H5N1 clade 2.1 clade 2.2 clade 2.3 * P<0.05 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)

17 Take Home Message 17 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 שרותי פרמנטציה, ניקוי חלבונים ומילוי אספטי מתקן GMP מאושר ע"י QP אירופאי מתאים לניסויים קליניים פאזה א', ב' בקרת ואבטחת איכות

19 GMP Production Facility EU Approved 19 Upstream Fermentation Downstream Aseptic Process Fill & Finish

20 20 20 A Game Changer for Influenza Vaccines Thank You! Contact Information Website: info@biondvax.com Phone: Fax:

The Universal Flu Vaccine

1 The Universal Flu Vaccine Corporate Presentation Dr. Ron Babecoff, CEO Uri Ben-Or, CFO Issuer Free Writing Prospectus Filed pursuant to Rule 433 Registration No. 333-201283 Forward Looking Statements