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Vaxcyte (PCVX) investor relations material
Vaxcyte Cantor Global Healthcare Conference 2025 summary
Complete event summary combining all related documents: earnings call transcript, report, and slide presentation.
Technology and pipeline overview
Proprietary cell-free protein synthesis platform enables precise conjugation and broader-spectrum vaccines with improved immunogenicity compared to existing options.
Lead program, Vax 31, has shown compelling results in adults and is in phase 2 for infants, with phase 3 initiation planned soon.
The pneumococcal conjugate vaccine (PCV) franchise is the current focus, with plans to expand technology to other vaccines.
Clinical development and regulatory progress
Phase 3 pivotal study for Vax 31 in adults to begin in Q4, with additional studies starting before year-end and into next year.
Data from phase 3 studies expected in 2026 and 2027, with a BLA filing targeted for late 2027 and potential approval in 2028.
FDA interactions have been constructive, with no new requirements for placebo or efficacy studies and consistent guidance across administrations.
Phase 3 program will include non-inferiority, safety, and label-expanding studies, with sequencing of data readouts to be clarified after enrollment begins.
Manufacturing and CMC strategy
FDA has approved initiation of phase 3 based on robust CMC data, confirming the process for commercial-scale production.
Manufacturing investment is seen as critical for long-term success in the $8B pneumococcal vaccine market.
While the platform is novel, most manufacturing and assay requirements align with established standards, with only minor adjustments.
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