Corporate Presentation
December 3, 2024
VAXCYTE MISSION STATEMENT
We are on a global mission to engineer high- fidelity vaccines that protect humankind from the consequences of bacterial diseases.
December 3, 2024
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Highlights: Potential Best-in-Class Pneumococcal Conjugate Vaccine (PCV) Franchise
Positive Phase 1/2 Adult Data for VAX-31 and VAX-24 Validate Potential of Site-Specific, Carrier-Sparing Platform
POTENTIAL BEST-IN-CLASS PCV
FRANCHISE
- Scalable, site-specific platform enabling broader-spectrumcarrier- sparing PCVs
- Adult Indication
- VAX-31: Advancing to Phase 3 program based on the positive Phase 1/2 data; received FDA Breakthrough Therapy designation
- Broadest-spectrumPCV in clinic; designed to cover >95% of IPD, including currently circulating and historically prevalent strains, in U.S. adults aged 50 and older
- Pediatric Indication: VAX-24 and VAX-31 advancing in parallel
- VAX-24: Enrollment complete in Phase 2 infant study
- VAX-31: Enrolling subjects in Phase 2 study
HIGHLY ATTRACTIVE
PCV MARKET
- Well-defined~$8B market segment poised for substantial growth
- Age range in US expanded to include adults ≥ 50 years of age; and
- As more developed countries adopt or expand universal vaccination of adults
- Leverages established surrogate immune endpoints as basis for full approval, negating need for field efficacy studies
- Serotype and disease spectrum of coverage is the primary adoption driver, yet incumbents limited by carrier suppression
EXCLUSIVE CELL-FREE | ALIGNED CRITICAL |
PLATFORM | RESOURCES |
• Vaxcyte PCV Franchise | • Strategic alignment with Lonza |
- Leverages site-specific conjugation to | - Global commercial manufacturing |
expose protective T- and B-cell antigens | agreement to produce VAX-31 and VAX-24 |
- Enables carrier-sparing conjugates that | key components |
honor well-understood PCV MOA | - Building out capacity to satisfy global PCV |
• Permits production of "tough-to- | demand for commercial markets |
make" antigens | • Seasoned management team, |
• Platform unlocks large market | directors and advisors |
opportunities | • $3.3 billion in cash, cash equivalents |
- VAX-A1: Novel Group A Strep vaccine | and investments as of 9/30/24 |
- VAX-PG: Novel periodontitis vaccine | |
- VAX-GI: Novel Shigella vaccine |
SOC = Standard-of-Care, IPD = Invasive Pneumococcal Disease, MOA = Mechanism of Action.
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Experienced Team with Track Record in Vaccines and Biopharma
Management Team
Grant Pickering, MBA | Andrew Guggenhime, MBA | Jim Wassil, MS, MBA | ||||||||
CEO & Co-Founder | President & CFO | EVP & COO | ||||||||
Jeff Fairman, PhD | Sally Bolmer | Harp Dhaliwal, MBA | Mark Wiggins, MBA | |||||||||||||
VP Research & Co-Founder | SVP Regulatory Affairs | SVP Commercial Mfg & Supply Chain | CBO | |||||||||||||
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Cell-Free Protein Synthesis Platform Unlocks Multiple Vaccine Applications
Design and Produce Proteins Beyond Reach of Conventional Methods
CELL-FREE PROTEIN
SYNTHESIS
-
Transcriptional & translational (ribosomal) machinery from E. coli stored as a frozen
"extract" - Produces singular protein of interest at high yields
- Enables site-specific conjugation via insertion of multiple nnAA conjugation anchors
- Permits protein production in non- physiological conditions
SPEED, FLEXIBILITY, SCALABILITY
- Rapidly screen vaccine candidates
- Flexible reaction conditions
- Scaled to 1000L using standard equipment
SUPERIOR CONJUGATE VACCINES
- Site-specificallyattach antigens onto protein carriers designed to:
- Enable consistent exposure of T-cell epitopes and/or B-cell epitopes on protein carrier
- Avoid off-target effects
- Enable use of less protein carrier without sacrificing immunogenicity
- Enable broader- spectrum vaccines
NOVEL PROTEIN
VACCINES
-
Able to produce
"tough-to-make" protein antigens that conform to target pathogens - Increased likelihood of protective immune response
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Pipeline of High-Fidelity Vaccines
Broad-Spectrum Conjugate and Novel Protein Vaccines to Prevent or Treat Bacterial Infectious Diseases
Preclinical | Phase 1 | Phase 2 | Phase 3 | Approved | |||
31-Valent | Adults 50+ | ||||||
VAX-31 | |||||||
PCV Candidate | |||||||
Infants |
24-Valent | VAX-24 | Infants |
PCV Candidate | ||
Novel Group A | VAX-A1 | Adults & Infants | |
Strep Vaccine | |||
Novel Therapeutic | VAX-PG | Adults | |
Periodontitis Vaccine | |||
Novel Shigella Vaccine | VAX-GI | Adults & Infants | |
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Clinical Development Next Steps and Anticipated Milestones1
Potential Best-in-Class PCV Franchise for Adult and Infant Segments
Population | Investigational PCV | Key Anticipated Milestones |
VAX-31
31-valent PCV candidate
- Following FDA End-of-Phase 2 meeting, initiate Phase 3 pivotal, non-inferiority study by mid-2025 and announce topline safety, tolerability and immunogenicity data in 2026.
- Initiate remaining Phase 3 studies in 2025 and 2026.
Adults
VAX-24 | • Announce topline safety, tolerability and immunogenicity data from |
24-valent PCV candidate | primary three-dose immunization series of Phase 2 study, which is |
fully enrolled with 802 healthy infants, by end of 1Q:2025, followed | |
by topline data from booster dose by end of 2025. |
VAX-31 | • Announce topline safety, tolerability and immunogenicity data | |
Infants | 31-valent PCV candidate | from primary three-dose immunization series of Phase 2 study, |
which is enrolling subjects, in mid-2026, followed by topline data | ||
from booster dose approximately nine months later. | ||
(1) Guidance as of November 12, 2024. | ||
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PCV Opportunity
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Global Health Impact of Pneumococcal Disease Remains Significant
ABOUT STREPTOCOCCUS
PNEUMONIAE
Streptococcus pneumoniae is the
most common pathogen causing
pneumococcal disease (PD)
A
- Non-invasivePD includes otitis media, sinusitis, pneumonia
- Invasive PD (IPD) includes bacteremia, meningitis
- Pneumococci cause over 50% of bacterial meningitis cases in the U.S.
CURRENT ~$8 BILLION GLOBAL VACCINE CATEGORY
Vaccinations are recommended globally for infants and adults to prevent PD1,2
Routine SOC schedule in the U.S.:
- Infants :
- Prevnar 20® (PCV20) x 4 doses; or
- Vaxneuvance (PCV15) x 4 doses
- Adults aged 50 and older (single dose):
- PCV20 or CapvaxiveTM (PCV21); or
- PCV15 & Pneumovax® 23 (PPV23)
GLOBAL INCIDENCE & IMPACT
OF PD STILL SUBSTANTIAL
Global incidence driven by emerging serotypes not covered by currently available vaccines
- In the U.S. alone, over 150K hospitalizations occur annually3
- Streptococcus pneumoniae is the leading cause of vaccine preventable deaths globally in children under five4
- ~300k children under five years old die annually worldwide due to Streptococcus pneumoniae5
- https://www.cdc.gov/pneumococcal/hcp/vaccine-recommendations/,(2) https://www.cdc.gov/pinkbook/hcp/table-of-contents/chapter-17-pneumococcal-disease.html.
- GBD 2019 Diseases and Injuries Collaborators.. Lancet 2020; 396: 1204-22. Supplementary Appendix 2.
- https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8677503/table/T2/,https://www.cdc.gov/pneumococcal/php/surveillance/index.html#:~:text=Global%20trends,deaths%20occur%20in%20developing%20countries.
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ACIP Recommendations Reinforce Need for Broader-Spectrum PCVs
Advisory Committee on Immunization Practices (ACIP)
Pneumococcal Vaccine Recommendations
PREVNAR 20 (PCV20)
Infant Routine Use | Children Catch-Up | Risk Conditions1 | Adult Routine Use | Adult Catch-Up2 |
Ages 2 - 23 months | Ages 2 - 6 years | Ages 6 - 49 years | Ages 50+ years | Ages 65+ years |
CAPVAXIVE (PCV21) ADULTS ONLY
Risk Conditions1 | Adult Routine Use | Adult Catch-Up2 |
Ages 19 - 49 years | Ages 50+ years | Ages 65+ years |
VAXNEUVANCE (PCV15)
Infant Routine Use
Ages 2 - 23 months
Children Catch-Up
Ages 2 - 6 years
Risk Conditions1
Ages 6 - 49 years
Adult Routine Use
Ages 50+ years
Continued Inclusion of PPSV23 | |
PLUS PNEUMOVAX 23 (PPSV23) | Driven by Lack of Broader- |
Spectrum PCV | |
(1) No prior vaccination with PCV13, PCV15 or PCV20. | |
(2) Shared clinical decision-making is recommended regarding use of a supplemental PCV21 or PCV20 dose for adults aged ≥65 years who have completed their recommended vaccine series with both PCV13 and PPSV23. |
Sources: 1. https://stacks.cdc.gov/view/cdc/133252, 2.https://www.cdc.gov/pneumococcal/hcp/vaccinerecommendations/index.html?CDC_AA_refVal=https%3A%2F%2Fwww.cdc.gov%2Fvaccines%2Fvpd%2Fpneumo%2Fhcp%2Frecommendations.htm,
3. https://www.cdc.gov/pneumococcal/hcp/vaccine-recommendations/,4. https://www.cdc.gov/mmwr/volumes/72/rr/rr7203a1.htm.
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Vaxcyte Inc. published this content on December 03, 2024, and is solely responsible for the information contained herein. Distributed by Public, unedited and unaltered, on December 03, 2024 at 13:11:07.273.