September 3, 2024 - $Vaxcyte (PCVX.US)$shares surged 36.58% to $110.30 in pre-market trading on Tuesday. The company today announced positive topline results from the Phase 1/2 study evaluating the safety, tolerability and immunogenicity of VAX-31, the Company’s 31-valent pneumococcal conjugate vaccine (PCV) candidate designed to prevent invasive pneumococcal disease (IPD), in 1,015 healthy adults aged 50 and older.
VAX-31 generated strong immune responses for all 31 strains of pneumococcus it targets. For the 20 strains it shares with Prevnar 20, VAX-31 met or exceeded immune response criteria at medium and high doses. For the additional 11 strains unique to VAX-31, it met all superiority criteria at all doses.
Based on these promising results, Vaxcyte plans to move VAX-31 to a larger Phase 3 study by mid-2025, with results expected in 2026. The company aims to provide broader protection against pneumococcal disease in adults over 50, addressing an important public health need.
About Vaxcyte
Vaxcyte is a vaccine innovation company engineering high-fidelity vaccines to protect humankind from the consequences of bacterial diseases. The Company is developing broad-spectrum conjugate and novel protein vaccines to prevent or treat bacterial infectious diseases. VAX-31 is a Phase 3-ready 31-valent, carrier-sparing PCV being developed for the prevention of IPD in adults and infants and is the broadest-spectrum PCV candidate in the clinic today. VAX-24, the Company’s 24-valent PCV candidate, is designed to cover more serotypes than any infant PCV on-market and is currently being evaluated in a Phase 2 infant study. Both VAX-31 and VAX-24 are designed to improve upon the standard-of-care PCVs by covering the serotypes in circulation that are responsible for a significant portion of IPD and are associated with high case-fatality rates, antibiotic resistance and meningitis, while maintaining coverage of previously circulating strains that are currently contained through continued vaccination practice.
新しいワクチンを開発しているVaxcyte, Inc.(Nasdaq:PCVX)は、新しい31価肺炎球菌ワクチン、VAX-31に関する初期段階の研究から肯定的な結果を発表しました。この研究には、50歳以上の1,015人の健康な成人が参加しました。このワクチンは耐容性が高く、既存のワクチンであるPrevnar 20®(PCV20)と同様の安全性プロファイルを示しました。
VAX-31は、標的とする31株の肺炎球菌すべてに対して強い免疫応答を示しました。Prevnar 20と共有している20株について、VAX-31は中用量および高用量で免疫反応基準を満たしたか、それを上回りました。VAX-31に固有の追加の11株については、すべての用量ですべての優越基準を満たしていました。
これらの有望な結果に基づいて、Vaxcyteは2025年半ばまでにVAX-31をより大規模な第3相試験に移行することを計画しています。結果は2026年に発表される予定です。同社は、公衆衛生上の重要なニーズに応えて、50歳以上の成人の肺炎球菌感染症に対するより広範な保護を提供することを目指しています。