Vaxcyte Announced Topline Results From Phase 1/2 Study Of VAX-31, The Company's 31-valent Pneumococcal Conjugate Vaccine Candidate; At All Doses, VAX-31 Demonstrated Robust Opsonophagocytic Activity Immune Responses For All 31 Serotypes
Vaxcyte Announced Topline Results From Phase 1/2 Study Of VAX-31, The Company's 31-valent Pneumococcal Conjugate Vaccine Candidate; At All Doses, VAX-31 Demonstrated Robust Opsonophagocytic Activity Immune Responses For All 31 Serotypes
vaxcyte宣布了VAX-31的一/二期研究的顶线结果，这是该公司的31价肺炎球菌结合疫苗候选的全部剂量，VAX-31显示出了对所有31个血清型的强大的噬菌和吞噬活性免疫反应。
- At Middle and High Doses, VAX-31 Met or Exceeded Regulatory Immunogenicity Criteria for All 31 Serotypes
- At All Doses Studied, VAX-31 Was Observed to be Well Tolerated and Demonstrated a Safety Profile Similar to Prevnar 20.
- Topline Results Further Validate Potential of Vaxcyte's Carrier-Sparing Platform to Deliver Broadest-Spectrum Pneumococcal Conjugate Vaccine Candidates that Provide Protection Against Both Currently Circulating and Historically Prevalent Serotypes.
- For Adult Indication, VAX-31 Selected to Advance to Phase 3 Program; Vaxcyte Plans to Initiate Phase 3 Pivotal, Non-Inferiority Study by Mid-2025 and Announce Topline Safety, Tolerability and Immunogenicity Data in 2026.
- For Pediatric Indication, in Parallel with Ongoing VAX-24 Study, Company Plans to Initiate VAX-31 Infant Phase 2 Study in First Quarter of 2025 Following IND Application Submission and Clearance.
- 在中等和高剂量下，VAX-31符合或超过了所有31种血清型的监管免疫学标准。
- 在所有研究剂量下，VAX-31被观察为耐受良好，并且表现出与Prevnar 20相似的安全性。
- 最新结果进一步验证了vaxcyte的节省载体平台的潜力，可提供对当前循环和历史上流行的血清型都具有保护作用的最广谱的肺炎球菌结合疫苗候选人。
- 对于成人适应症，VAX-31被选中进入第三阶段项目；vaxcyte计划在2025年中期开始进行第三阶段关键的非劣效性研究，并于2026年公布最新的安全性、耐受性和免疫原性数据。
- 对于儿童适应症，在进行VAX-24研究的同时，公司计划在2025年第一季度递交并获得IND申请批准后，启动VAX-31婴儿第2阶段研究。