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| But a three-dose regimen has been quite successful overseas |
| For us we've been able to show that adjustments in dose yield improved immune responses |
| VAX-24 has a potential best-in-class profile in this population |
| Given the size and global nature of the infant market, we are particularly excited about the primary and booster data readouts expected in 2025 |
| Over the next year we look forward to several upcoming catalysts that will further define the profiles of our PCV franchise and I am confident in our ability to execute and further scale our business in 2024 and beyond |
| These results and the foundation we have carefully created have us well-positioned to advance our PCV franchise to potentially disrupt what has consistently done a crucial vaccine class, societally, and financially |
| So we're really excited about this program |
| This included a successful end of Phase 2 meeting with the FDA regarding the clinical design of the VAX-24 Phase 3 program, as well as encouraging feedback on CMC-related matters as we plan for future potential BLA submissions |
| But to the extent, we see higher immune responses, potentially once again after that primary series, that could set us up for a potentially better outcome to create even further competitive advantage relative to Prevnar 20 in Europe |
| We believe that would be a very positive amount |
| Based on the preclinical data for VAX-31 and clinical data for VAX-24, particularly the mixed dose arm for both adult Phase 2 studies, we are optimistic about the prospects for the VAX-31 data |
| I am incredibly proud of our many achievements, particularly across clinical, regulatory, and manufacturing for our PCV programs |
| And so, yes, for us, I think we're feeling good |
| We believe VAX-24 has a potential best-in-class profile for this vital population |
| As our adult programs continue to advance, we are also pleased with the progress we've made with our VAX-24 program in infants |
| First, ACIP-preferred recommendations are rare but Vaxcyte to be particularly well-positioned for a potential preferential recommendation for VAX-31 |
| Obviously, VAX-31, which contains for the most part, all the strains in both vaccines, will be in a strong position to increase coverage and really take a strong position if it gets approved |
| I think VAX-24 will have a strong position regardless |
| So yes, as we look forward to that data, that we expect to see in the third quarter, I mean, we're quite optimistic |
| This past year, we continued to make significant strides in advancing our potentially best-in-class pneumococcal conjugate vaccines for PCVs VAX-24 our lead 24-valent candidate, and VAX-31, our next-generation 31-valent candidate |
| Based on the totality results from the VAX-24 adult Phase 2 program that Grant referred to earlier, we believe we have the opportunity to set a new bar for pneumococcal vaccines by delivering broader coverage and higher immune responses relative to conventional PCVs |
| This financial strength provides us the capital to fund the company through several important milestones over the next few years, which Andrew will highlight later |
| Bringing the broadest PCVs to both infants and adults represents an opportunity to significantly reduce invasive disease across the entire population, is what drives our efforts every day |
| So for us the data that we generated with VAX-24 cohort demonstrated even at that mix dose level, really good comparative results across the 20, that are in Prevnar 20, and then the incremental 11, you know, four have already read out, the next seven will come with this study |
| In addition to the positive developments for VAX-24, we were pleased to initiate the adult clinical program for VAX-31 |
| The findings from our adult Phase 2 program support a potential best-in-class profile for VAX-24 and demonstrate how our novel cell-free technology platform has the capability to overcome the limitations of other conventional approaches |
| 2023 was another remarkable year for Vaxcyte, officially marking our 10th year of thoughtful and methodical research and development by the entire Vaxcyte team and our partners |
| From a financial perspective, we substantially strengthened our balance sheet, raising approximately $545 million in net proceeds in a follow-on financing last April |
| market is expected to accelerate due to the potential shift in universal adult vaccination from age 55 down to 50, which would both expand the market and open up the adult regimen to a prime-boost schedule, nearing the infant market |
| This strong momentum in this study continued into 2024 as we announced the start of the Phase 2 portion in early January and completion of enrollment less than a month later |
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| And those have turned out to be a bit problematic, as Sanofi has not decided to proceed in the adult indication, so it's unclear at the moment, but other attempts in a similar vein haven't worked out particularly well |
| and Europe, the impact of the one less dose was quite profound |
| AMR poses a serious global health threat, and if no action is taken, drug-resistant diseases are expected by the WHO to be a leading cause of death by 2050 |
| And the belief is that that population in terms of percentage in that age group, is only going to grow |
| So minimal competitive environment as well |
| Despite the widespread administration of effective vaccines, the global impact of disease remains significant and is associated with high case-fatality rates, antibiotic resistance, and meningitis |
| Due to the limitations of their technology, they had to remove nine strains that have been traditionally included and approved PCVs |
| Fortunately for us, at least for VAX-24, we didn't look like that was going to be required to push coverage |
| This is critical since previously controlled strains have rebounded in prior instances where vaccine coverage was withdrawn |
| And then the one area I haven't mentioned is there is high rates of invasive disease in older adults as well |
| And so that's been absolutely crucial to this whole story |
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