Nanobiotix Reports Updates For Global NBTXR3 Development Collaboration Highlighting Robust Pipeline And Pathway To Long-Term Growth
Nanobiotix Reports Updates For Global NBTXR3 Development Collaboration Highlighting Robust Pipeline And Pathway To Long-Term Growth
Nanobiotix 報告了全球 NBTXR3 開發合作的最新情況，重點介紹了穩健的產品線和長期增長之路
- Updated Nanobiotix corporate strategy designed to enable long-term growth through execution of the global NBTXR3 collaboration and platforms beyond NBTXR3
- Alignment of intent to transfer the sponsorship of the ongoing Phase 3 pivotal trial in head and neck cancer to begin preparations for potentially positive trial results and subsequent steps
- Alignment to Phase 3 head and neck cancer study modifications designed to optimize the regulatory pathway, including intended removal of the now unnecessary futility analysis, and opting to conduct the planned interim analysis after the end of recruitment in 1H2026
- Received US FDA "Study May Proceed" letter for a new randomized Phase 2 study evaluating NBTXR3 in stage 3 lung cancer after review of the Investigational New Drug application
- Robust pipeline of ongoing and completed studies that could inform development of new indications beyond immediate priorities in head and neck cancer and lung cancer
- Operational progress update on Nanobiotix nanoparticle-based therapy platforms beyond NBTXR3 expected in 2H2024
- 更新的 Nanobiotix 企業戰略旨在通過執行 NBTXR3 以外的全球 NBTXR3 合作和平台來實現長期增長
- 意向一致，將正在進行的頭頸癌3期關鍵試驗的贊助權轉移到開始爲可能的陽性試驗結果和後續步驟做準備
- 與旨在優化監管途徑的 3 期頭頸部癌症研究修改保持一致，包括計劃刪除現在不必要的徒勞分析，以及選擇在 1H2026 招募結束後進行計劃中的中期分析
- 在對研究性新藥申請進行審查後，收到美國食品藥品管理局關於一項評估 NBTXR3 處於第 3 階段肺癌的新隨機 2 期研究的 “研究可能繼續” 信函
- 大量正在進行和已完成的研究，這些研究可以爲頭頸癌和肺癌的當務之急之外的新適應症的開發提供信息
- NBTXR3 以外的基於 Nanobiotix 納米顆粒的治療平台預計將在 2H2024 中更新運營進展