Vaxart, Inc. · OTC:VXRT
Vaxart — IDWeek 2024
21 slides from Vaxart's conference presentation, Oct 19, 2024
Slide 1: Evaluating Vaxart's oral bivalent norovirus vaccine in lactating females: VXA-NVV-108
Evaluating Vaxart’s oral bivalent GI.1/GII.4 norovirus vaccine in healthy lactating females and their nursing infants: VXA-NVV-108 A phase I, multicenter, randomized, double-blind, placebo-controlled single dose, dose-ranging study to evaluate the safety, tolerability, and immunogenicity of orally a
Slide 2: Forward looking statement
Forward looking statement This presentation contains forward-looking statements that involve substantial risks and uncertainties. All statements, other than statements of historical facts, included in this presentation regarding Vaxart’s strategy, prospects, plans and objectives, results from precli
Slide 3: Conflict of Interest Disclosure
Conflict of Interest Disclosure I am a Medical Director employed by Vaxart. As such, I have a financial relationship with the company, which may present a conflict of interest in the context of this presentation. Confidential 3
Slide 4: Norovirus is the leading cause of acute gastroenteritis worldwide
Norovirus is the leading cause of acute gastroenteritis worldwide Yearly Global Disease and Economic Burden • 699 million norovirus infections • 219,000 deaths • $4.2 billon in health system costs • $60.3 billion in societal costs annually Risk Groups • Elderly, young children • immunocompromised •
Slide 5: Vaxart Oral Vaccine Solution: VAAST platform
Vaxart Oral Vaccine Solution Vector-Adjuvant-Antigen Standardized Technology (VAAST TM) • Modular, Scalable and Standardized Vaccine Creation • Self Administered Oral Vaccine Proprietary Oral Vaccine Platform: VAASTTM • Room temperature stable • Immunogenic at mucosal surfaces • Rapidly deployed in
Slide 6: Background Studies
Background Studies • Labayo et al.1 Norovirus-specific immunoglobulin A in breast milk for protection against norovirus-associated diarrhea among infants What is the protective role of NV specific IgA (NV-IgA) in breast milk? Mothers with high positivity rates and titers of NV-IgA in breast milk
Slide 7: VXA-NVV-108 Study Design
VXA-NVV-108 Study Design: Phase 1 multi-center, double-blind, placebo-controlled single dose, dose ranging study to evaluate the bivalent vaccine safety and immunogenicity * * Subjects ≥ 18 y.o. & Nursing infants >30 days to 11 months of age. ** Demographics • 18-43 yo • BMI 17.5-54.4 kg/m2 • Race
Slide 8: Safety Analysis
Safety Analysis
Slide 9: Vaxart's oral norovirus vaccine is well tolerated: solicited adverse events
Vaxart’s oral bivalent GI.1/GII.4 norovirus vaccine is well tolerated VXA-NVV-108 Summary of Solicited Adverse Events of Reactogenicity Post-Vaccination (Day 1-Day 8) SSx Severity by Treatment Arm Cumulative SSx by Treatment Arm All Arms . Med Dose N=30 High Dose N=30 Placebo N=16 Med Dose High Do
Slide 10: Vaxart's oral norovirus vaccine is well tolerated: unsolicited adverse events
Vaxart’s oral bivalent GI.1/GII.4 norovirus vaccine is well tolerated . VXA-NVV-108 Summary of Unsolicited Treatment Emergent Adverse Event (Day1-Day 29) Active Period Cohort Subject Severity Causality N=76 1 DIARRHEA Moderate Not related Medium Dose 2 UPPER RESPIRATORY TRACT INFECTION Mild Not rela
Slide 11: Immunogenicity
Immunogenicity
Slide 12: Immunogenicity Endpoints: Mucosal and Serum Antibodies
Immunogenicity Endpoints: Mucosal and Serum Antibodies Study Overview: * *Image taken from <a href="https://www.vecteezy.com/free-vector/feeding">Feeding Vectors by Vecteezy</a> and modified 12
Slide 13: Serum immune response to oral bivalent norovirus vaccine
Serum immune response to oral bivalent GI.1/GII.4 norovirus vaccine Antibodies in serum remain above baseline through D29 IgA IgG Mean +/- SEM 13
Slide 14: Serum immune response: Norovirus Blocking Antibody Assay
Serum immune response to oral bivalent GI.1/GII.4 norovirus vaccine Norovirus Blocking Antibody Assay (NBAA): surrogate assay to measure functionality of serum antibodies Mean +/- SEM October 19, 2024 14
Slide 15: Breast milk immune response to oral bivalent norovirus vaccine
Breast milk immune response to oral bivalent GI.1/GII.4 norovirus vaccine IgA in breast milk increases through D29 post vaccination and remains above baseline through D60 Mean +/- SEM 15
Slide 16: Breast milk IgA induction not impacted by time post birth
Breast milk immune response to oral bivalent GI.1/GII.4 norovirus vaccine Breast milk IgA induction is not impacted by time of vaccination post birth GI.1 GII.4 Mean +/- SEM October 19, 2024 16
Slide 17: Infant response to breastmilk norovirus antibody
Infant response to breastmilk norovirus antibody Infant fecal IgA increases through D29 post vaccination and remains above baseline through D60 Infant fecal IgA increase mirrors Breastmilk IgA increase October 19, 2024 17
Slide 18: VXA-NVV-108 Summary: Safety
VXA-NVV-108 Summary • Safety Vaxart’s Bivalent Norovirus GI.1/GII.4 Vaccine side effect profile is similar to placebo and is well tolerated in post-partum, lactating subjects. Solicited and unsolicited AEs are not dose dependent and are similar between active treatment and placebo arms. To dat
Slide 19: VXA-NVV-108 Summary: Immunogenicity
VXA-NVV-108 Summary • Immunogenicity First description of Vaxart’s oral tablet vaccine showing immunogenicity in an emerging economy and in breast milk Immunization of lactating women can o induce norovirus-specific breast milk IgA Breastmilk IgA remained detectable above baseline through D60
Slide 20: VXA-NVV-108 Summary: Pending
VXA-NVV-108 Summary • Pending Breast milk and serum immunogenicity through D181 – durability of the immune response Nasal and saliva IgA responses Safety followed through D365 • In conclusion, these results are an important step in the development of a norovirus vaccine that is safe and immuno
Slide 21: Acknowledgments
Acknowledgments James F. Cummings, MD Grant number: INV-051351 Sean N. Tucker, PhD Susan N. Greco, MD MPH Omar Vandal, PhD Becca A. Flitter, PhD MPH Molly R. Braun, PhD Darreann Carmela M. Hailey, MS Colin A. Lester Nick D’Amato, MS October 19, 2024 21