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宣佈了VAX-31的一/二期研究的頂線結果，這是該公司的31價肺炎球菌結合疫苗候選的全部劑量，VAX-31顯示出了對所有31個血清型的強大的噬菌和吞噬活性免疫反應。
- 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.
- 在中等和高劑量下，VAX-31符合或超過了所有31種血清型的監管免疫學標準。
- 在所有研究劑量下，VAX-31被觀察爲耐受良好，並且表現出與Prevnar 20相似的安全性。
- 最新結果進一步驗證了vaxcyte的節省載體平台的潛力，可提供對當前循環和歷史上流行的血清型都具有保護作用的最廣譜的肺炎球菌結合疫苗候選人。
- 對於成人適應症，VAX-31被選中進入第三階段項目；vaxcyte計劃在2025年中期開始進行第三階段關鍵的非劣效性研究，並於2026年公佈最新的安全性、耐受性和免疫原性數據。
- 對於兒童適應症，在進行VAX-24研究的同時，公司計劃在2025年第一季度遞交併獲得IND申請批准後，啓動VAX-31嬰兒第2階段研究。