Vaxcyte (PCVX) TD Cowen 46th Annual Health Care Conference summary

Recent highlights and clinical development

• Advancing VAX-31, a 31-valent pneumococcal conjugate vaccine, through three phase 3 studies supporting a BLA filing by end of next year.

• OPUS-1 pivotal study compares VAX-31 to 20- and 21-valent vaccines, with data expected in Q4 this year.

• Two additional phase 3 studies and an infant study will read out in the first half of next year.

• Entering clinical trials for a Group A Strep conjugate vaccine, expanding the pipeline.

Technology and competitive positioning

• Site-specific conjugation technology enables higher valency and improved immunogenicity compared to traditional methods.

• Ability to control conjugation site and amount allows for expanded serotype coverage without loss of immune response.

• Achieved 31-valent formulation, surpassing competitors limited to 20 or 21 conjugates.

Phase 3 trial design and expectations

• OPUS-1 designed for non-inferiority against standard of care, with 10 overlapping serotypes for direct comparison.

• Confident in immune response for incremental serotypes; missing a few non-inferiority endpoints is acceptable per FDA guidance.

• Higher non-inferiority threshold adopted based on strong phase 2 data showing improved immune responses.