Vaxart, Inc. · OTC:VXRT
Vaxart — Technical Presentation (May 2021)
17 slides from Vaxart's technical presentation, May 2021
Slide 1: May 2021 KOL Event
May 2021 KOL Event U N LO C K I N G T H E F U L L P OT E N T I A L O F O R A L VAC C I N ES
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: Oral Vaccines Based on VAAST Platform
Oral Vaccines Based on VAAST Platform Selected Mucosal Adjuvant “Hard Wired” in Vector Delivery System Non-replicating adenovirus with molecular adjuvant ORAL VACCINES OFFERS IMPORTANT INNOVATIVE PLATFORM FOR ADVANTAGES SYSTEMIC AND LOCAL IMMUNITY • Potentially disruptive impact • Designed for wide
Slide 4: VAAST Oral Vaccines – Validated Platform In Humans
VAAST Oral Vaccines – Validated Platform In Humans Approximately 500 Subjects Dosed to Date Flu RSV Norovirus COVID-19 Clinical Trials SUBJECTS Tablet Vaccines 245 46 171 35 DOSED SAFETY Favorable safety and tolerability profile EFFICACY Purpose: Reduction in influenza illness comparable with the le
Slide 5: Vaxart – COVID Vaccine Issues
Vaxart – COVID Vaccine Issues • Covid-19 is a significant health problem. Vaccines can be highly effective against the original parental strain • Several limitations for roll-out of a needle solution during a pandemic – Need a qualified health care provider to administer – The first vaccines approve
Slide 6: Vaxart Takes Away the Needles
An Important Step is the time for injecting large populations: Vaxart Takes Away the Needles Vaxart’s solution Rapid Emergence of new SARS-CoV-2 strains - Room temperature IgA stable tablet, easy to produce, distribute, and administer Vaccine Rapid Distribution Development & Administration Get Off T
Slide 7: VXA-COV2-101 Phase 1 Study Design and Schema
VXA-COV2-101 Phase 1 Study Design and Schema • Single Dose, Oral Tablet Study at Low and Medium Doses • Small Sentinel Cohort that was boosted • Primary (Safety) and Secondary (Immunogenicity) Endpoints Met Treatment Group Vaccine Dose (±0.5 log) No. of Doses No. of Subjects Cohort 1 (Sentinels) VXA
Slide 8: Solicited Symptoms Post Vaccination – Phase I
Solicited Symptoms Post Vaccination – Phase I Solicited Symptom Low Dose High Dose Days (1 – 8) (n=20) (n=15) No. (%) with Solicited Symptoms 4 (20) 10 (66.7) Gastrointestinal Symptoms Diarrhea 0 (00) 4 (26.7) Nausea 0 (00) 5 (33.3) Vomiting 0 (00) 0 Abdominal Pain 1 (5.0) 2 (13.3) General Symptoms
Slide 9: Oral vaccine candidate shows preferential Th1 responses
Vaxart’s oral vaccine candidate shows preferential Th1 responses, inducing a strong CD8 cytotoxic response Spike protein (S) Nucleoprotein (N) 20 20 Fold change from baseline Fold change from baseline 15 15 10 10 5 5 0 0 -2 -4 -5 3 TN g C Fa 7a -2 -4 -5 3 TN g C Fa 7a -1 -1 N N IL IL IL IL IL IL 10
Slide 10: Oral Vaccine candidate generates robust CD8 T cell responses
Vaxart’s Oral Vaccine candidate generates robust CD8 T cell responses Vaxart’s Oral Vaccine candidate generates high numbers of S specific IFN-g, TNFa and CD107a producing T cells post immunization. IFN-g 30 10 ** P=0.0034 20 10 8 % CD8+ lymphocytes % CD8+ lymphocytes 5 6 4 4 3 2 2 1 0 0 IFNg TNFa C
Slide 11: CD8 T cell responses – Compares favorably to the mRNA vaccines
Vaxart’s Oral Vaccine candidate generates robust CD8 T cell responses – Compares favorably to the mRNA vaccines Induction of T cells responses measured 7 days after the first dose. Increase over day 1 for IFN-g and TNFa are shown 5 5 % TNFα+ CD8 lymphocytes % IFNγ+ CD8+ lymphocytes 4 4 3 3 2 2 Froze
Slide 12: Do Vaccine Induced T cells Cross React Against other huCoV?
Do Vaccine Induced T cells Cross React Against other huCoV? • Tarke, et al, (Biorxiv 2021) showed that mRNA vaccines create cross-reactive T cells against other SARS-CoV-2 variants of concern (see below) • What about other Coronaviruses? B.1.351 (South African S protein) CONFIDENTIAL AND PROPRIETARY
Slide 13: Future Proof: cross reactive T cells to endemic coronaviruses
Future Proof: Vaxart’s oral vaccine candidate generates cross reactive T cells to other endemic coronaviruses 5 4 3 2 % Identity compared to SARS-CoV-2 Virus Genus % identity % IFNγ+ CD8 lymphocytes 1.4 229E alpha 65 1.2 NL63 alpha 65 1.0 HKU1 beta 68 0.8 OC43 beta 68 0.6 SARS-CoV beta 82 0.4 0.2 0.
Slide 14: Why T cells may be important for COVID
Why T cells may be important for COVID • Cross-protective and long-lasting – N protein responses to SARS-CoV-1 last 17 years after infection and cross-react to SARS-CoV-2 (Hellerstein, et al, Vaccine, 2020) • People with agammaglobulinemia don’t die of COVID and have a mild course of infection (Quin
Slide 15: Cross-reactive nasal IgA response to other coronaviruses
Vaxart immunized subjects have increased cross-reactive nasal IgA response to other coronaviruses 80 60 40 20 10 Increased IgA antibodies to SARS-Cov-2 also leads to increased antibody responses to the S protein of 8 other coronaviruses including SARS-CoV-1, MERS, and endemic common cold viruses Fol
Slide 16: Vaxart – Next Steps
Vaxart – Next Steps • Dose ranging study to start around mid-year • Phase II efficacy study later this year • Evaluating new strain matched candidates in research – Made S only versions of the “California” and “South African” strains – Can our original vaccine approach provide protection as effectiv
Slide 17: Acknowledgements and Thanks
Acknowledgements and Thanks • Vaxart • Stanford University – Mario Cortese • Mark Davis – Susan Johnson • Lisa Wagar – Emery Dora • David McIIwain – Karen Lin – Nadine Peinovich – Clarissa Martinez • University College Cork – Sarah Tedjakusuma • Anne Moore – Damoun Torabi • Visimederi – Shaily Garg