INVESTOR PRESENTATION
August 2024
EXECUTIVE
SUMMARY
- Oral tablet vaccine platform designed to provide improved convenience as
well as generate substantial systemic and mucosal immunity
- Clinical proof-of-concept demonstrated in two challenge studies against both respiratory and GI viruses
- Three pipeline programs in norovirus, influenza and COVID-19
- Phase 2 challenge data in norovirus suggest compelling real-world profile for our bivalent vaccine candidate
- Demonstrated protective activity in a Phase 2 study for influenza, protection similar to market leading injectable
- BARDA Project NextGen award up to $452.9M ($65.7M available initially) to
prepare and execute a 10,000 participant Phase 2b trial for COVID-19 comparing our vaccine candidate head-to-head against an FDA approved mRNA vaccine comparator
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August 2024 |
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Vaxart Has Multiple Promising Clinical-Stage Programs
Preclinical
E N T E R I C V A C C I N E S
Norovirus Bivalent
R E S P I R A T O R Y V A C C I N E S
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S Protein (Wuhan) |
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COVID-19 |
S + N Protein (Wuhan) |
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S Protein (XBB)1 |
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Monovalent |
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Influenza |
Seasonal (Trivalent) |
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Universal |
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T H E R A P E U T I C |
V A C C I N E S |
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HPV |
HPV, cervical dysplasia and/or cancer |
Phase 1
Phase 2
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August 2024 |
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1. Currently a strain change filed under the S only IND. COVID-19 P2b trial may initiate as early as second half of 2024, pending regulatory alignment.
Vaxart's Oral Vaccine Candidates Have the Potential to Address Many of the Shortcomings of Injectable Vaccines
Cross-reactivity & Broad Immune Responses
- Broad immune responses in preclinical & clinical COVID-19 and influenza studies
- Cross-reactivityin COVID-19 and norovirus clinical trials
Reduction in Transmission
- Reduction in viral transmission in preclinical COVID-19 study
- Reduction in shedding in influenza and norovirus clinical trials
Long Duration of Protection and Immune Responses
- Long-lastingprotection demonstrated in influenza human vaccine study
- Long-lastingantibody responses in clinical norovirus and COVID-19 trials
Benign Safety and Tolerability to Date
- Benign safety and tolerability profile observed across 19 clinical trials against 7 different viruses, evaluating 800+ participants
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August 2024 |
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Vaxart's Proprietary VAAST® Platform is Unique
Proprietary Oral Vaccine Platform: VAAST
Room-temperature (25⁰C) stable enteric- coated tablets
VAAST: Vector-Adjuvant-Antigen Standardized Technology
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August 2024 |
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VAAST Platform Utilizes Mucosal Immunity to Generate IgA in Addition to IgG to Potentially Block Infection and Transmission
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August 2024 |
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Vaxart Has Shown IgA Mucosal Responses Have Greater
Cross-Reactivity Compared to IgG Systemic Responses
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ANTIBODY CROSS-REACTIVITY: IgG VS. IgA |
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IgG |
IgA |
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Characteristics: |
Characteristics: |
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• Major antibody isotype induced systemically |
• Predominantly present in the mucosal tissues |
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• Major isotype produced by mRNA vaccines |
• Efficiently produced through VAAST platform |
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• Binding affinity is significantly reduced when challenged with variants |
• Minimal decrease in binding affinity when challenged with variants |
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• Has shown poor cross-reactivity with respect to known variants1,2 |
• Shown to have greater cross-reactivity against both SARS-CoV-21 |
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and Influenza2 variants |
Cross-reactive nature of our platform - mucosal IgA responses may lead to high variant coverage
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August 2024 |
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Norovirus Program Has Generated Compelling Data for a Multi-Billion Dollar Opportunity, No Vaccine Approved
11. Norovirus
22. Influenza
33. COVID-19
Highlights:
- $10bn+ annual U.S. economic burden
- Norovirus human phase 2 challenge study results indicate potential of our vaccine candidate to reduce rates of norovirus infection, illness, and shedding
- Phase 1 data
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- Durable immune responses to 200 days
- Reponses in elderly similar to younger adults
- No interference observed for bivalent vaccine
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August 2024 |
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Norovirus has a $10 Billion+ Annual Economic Burden in the U.S.
Economic Burden
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Norovirus Annual Burden in the U.S. |
$10.6 billion |
$60.3 billion |
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Global economic burden annually2 |
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U.S. economic burden annually |
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19-21 Million |
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5x |
Total Norovirus Illnesses |
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1 in 2 |
2.3 Million |
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Outpatient Visits |
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1 in 9 |
465,000 |
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Emergency Department Visits |
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1 in 50 - 70 |
109,000 |
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Hospitalizations |
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1 in |
900 |
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5,000 - |
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Deaths |
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7,000 |
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Risk Groups
Elderly
Adults ≥65 years old are at high-risk for severe symptoms and clinical outcomes including longer disease duration and death3
Children
Children <5 years old have the highest incidence of norovirus; significant economic burden attributed to parental lost productivity to care for sick children1,4
Common Outbreak Settings5
- Healthcare facilities including long-termcare facilities and hospitals (most commonly reported setting in the U.S. and other industrialized countries)
- Schools and childcare centers
- Restaurants and catered events (leading cause of outbreaks from contaminated food)
- Cruise ships
Source: CDC website (https://www.cdc.gov/norovirus/data-research/)
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August 2024 |
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Norovirus Clinical Program Has Demonstrated Robust Immunogenicity, Promising Efficacy, and Benign Safety/Tolerability Profile
Trial ID
NVV-101
NVV-102
NVV-103
Phase
Phase 1
double blinded
Phase 1
open label
Phase 1
double blinded
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N |
Vaccine |
60 Placebo GI.1
60 GI.1
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80 |
Placebo |
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GI.1 monovalent |
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23* |
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GII.4 monovalent |
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12** |
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GI.1/GII.4 bivalent |
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Top line data
- Safety/dose escalation (GI.1)
- Safety/dose ranging and effective interval for boosting immunogenicity (GI.1)
- Safety/immunogenicity monovalent and bivalent formulations
- Duration of protection*
- boost response**
Completed
✓
✓
✓
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NVV-104 |
Phase 1b |
66 |
Placebo |
• Safety/dose in elderly adults (GI.1) |
✓ |
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double blinded |
GI.1 |
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NVV-105 |
Phase 1 |
30 |
GI.1 |
• Boost interval (GI.1) |
✓ |
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open label |
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Phase 2 |
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Placebo |
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✓ |
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NVV-201 |
141 |
GI.1 |
• Vaccine efficacy against GI.1 challenge (GI.1) |
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double blinded |
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Infectious virus (GI.1) |
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NVV-202 |
Phase 2 |
135 |
Placebo |
• Dose ranging study. Safety/immunogenicity of |
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double blinded |
GI.1/GII.4 bivalent |
the bivalent formulation |
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NVV-108 |
Phase 1 |
76 |
Placebo |
• Safety/immunogenicity of the bivalent formulation |
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double blinded |
GI.1/GII.4 bivalent |
in healthy lactating mothers |
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✓
Topline
Announced
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August 2024 |
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Attachments
Disclaimer
Vaxart Inc. published this content on 09 August 2024 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 09 August 2024 05:50:36 UTC.
