Vaxcyte's Advanced Vaccine Pipeline Targets Broad-Spectrum Pneumococcal Protection in 2024

Vaxcyte, Inc. - Vaccines Overview

Pneumococcal Conjugate Vaccines (PCVs)

• PCVs have been a key part of global immunization programs for decades.
• Vaxcyte is advancing broad-spectrum PCVs to address invasive pneumococcal disease (IPD), a leading cause of vaccine-preventable deaths in children under five.
• The global pneumococcal vaccine market is valued at approximately $8 billion annually, with the infant segment accounting for about $6 billion.
• Despite vaccination efforts, Streptococcus pneumoniae causes about 300,000 deaths annually in children under five worldwide.
• In the US, over 150,000 hospitalizations occur annually due to pneumococcal pneumonia.

Vaxcyte's PCV Pipeline

• VAX-31:

  • Demonstrated strong Phase 1/2 clinical data in adults aged 50+.
  • Showed robust opsonophagocytic activity (OPA) across 31 serotypes.
  • Met or exceeded non-inferiority criteria compared to PCV20 for shared serotypes.
  • Received FDA Breakthrough Therapy Designation in November 2024.
  • Phase 3 adult pivotal non-inferiority study expected to start mid-2025, with topline data in 2026.
  • Infant Phase 2 study underway; key data expected mid-2026.
  • Potential to cover ~94% of IPD and 93% of acute otitis media in children under five, significantly broader than current PCVs.

• VAX-24:

  • Phase 2 infant study fully enrolled with 802 participants.
  • Topline data from primary immunization series expected by end of current quarter; booster dose data expected by year-end.
  • Designed to provide broader coverage than PCV20.
  • Dose adjustments possible based on Phase 2 data to optimize immune responses.
  • Expected to advance to Phase 3 with potential best-in-class profile.

Broader Vaccine Pipeline

• Developing vaccines targeting other bacterial threats contributing to antimicrobial resistance (AMR), including:
  • Group A Streptococcus (VAX-A1)
  • Periodontitis
  • Shigella
• VAX-A1 is the most advanced non-PCV program, leveraging proprietary site-specific conjugation technology.
• AMR is a critical global health crisis; vaccines play a key role in reducing antibiotic reliance.

Clinical and Regulatory Highlights

• VAX-31 adult data showed statistically higher immune responses for several serotypes compared to PCV20.
• VAX-31 and VAX-24 programs aim to set new standards in pneumococcal disease prevention.
• ACIP (Advisory Committee on Immunization Practices) discussions indicate support for broader spectrum vaccines like VAX-24 and VAX-31.
• Multiple vaccine doses in adults (e.g., at ages 50 and 65) are consistent with current practice, with no reimbursement controls observed.
• Vaxcyte expects preferred ACIP recommendations based on vaccine profiles and historical precedents.

Manufacturing and Financial Position

• Partnership with Lonza to build a dedicated large-scale manufacturing suite, expected completion early next year.
• Manufacturing scale-up supports anticipated US launch of VAX-31 for adults and future pediatric indications.
• Strong financial position with $3.13 billion in cash and investments as of year-end 2024.
• Increased R&D and G&A expenses in 2024 due to clinical development and manufacturing investments.

Market and Public Health Impact

• Vaccines provide significant economic benefits, with every dollar spent returning $7 to $11 in healthcare savings.
• Vaccination reduces hospitalizations, disease burden, and antibiotic use.
• Vaxcyte's vaccines aim to address unmet needs in bacterial diseases with broad-spectrum coverage.

Summary Table: Key Vaccine Programs

Additional Insights

• Vaxcyte is confident in the translatability of adult immune response data to infants.
• The company plans to explore efficacy studies post-approval, such as for otitis media, to further demonstrate vaccine benefits.
• Regulatory and public health bodies recognize the critical role of vaccines in combating bacterial diseases and AMR.
• Vaxcyte maintains active engagement with FDA, CDC, ACIP, and policymakers to support vaccine innovation and adoption.

This comprehensive vaccine pipeline and strategic approach position Vaxcyte as a leader in developing broad-spectrum bacterial vaccines with significant potential public health impact.