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Updated Nanobiotix corporate strategy designed to enable long-term growth through execution of the global NBTXR3 collaboration and platforms beyond NBTXR3Alignment 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 stepsAlignment 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 1H2026Received 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 applicationRobust pipeline of ongoing and completed studies that could inform development of new indications beyond immediate priorities in head and neck cancer and lung cancerOperational progress update on Nanobiotix nanoparticle-based therapy platforms beyond NBTXR3 expected in 2H2024 PARIS and CAMBRIDGE, Mass., May 21, 2024 (GLOBE NEWSWIRE) -- NANOBIOTIX (Euronext : NANO –– NASDAQ: NBTX – the ‘‘Company’’), a late-clinical stage biotechnology company pioneering nanoparticle-based therapeutic approaches to expand treatment possibilities for patients with cancer and other major diseases, today announced updates to its corporate strategy designed to enable long-term growth in view of significant progress in the Company’s collaboration for the co-development and global commercialization of lead therapeutic candidate NBTXR3.
更新了Nanobiotix公司战略,旨在通过执行全球NBTXR3合作和NBTXR3以外的平台实现长期增长。调整意向,转移正在进行的头颈部癌症3期关键试验的赞助,开始准备潜在的积极试验结果和随后的步骤调整为优化监管途径而进行的3期头颈部癌症研究修改,包括有意删除现在不必要的无效分析,并在2016年1月1日招聘结束后选择进行计划的中期分析。美国FDA“研究可能继续”一项新的随机2期研究评估NBTXR3在3期肺癌中的作用的信,该研究在审查了研究性新药应用后,正在进行和完成的研究的强大管道,可以为开发新的适应症提供信息,超越头颈癌和肺癌的直接优先事项。预计2024年2月21日,巴黎和剑桥,马萨诸塞州,2024年5月21日(全球新闻通讯社)——Nanobiotix(Euronext:NANO–NASDAQ:NBTX–the“公司”),一家临床后期生物技术公司,开创了基于纳米颗粒的治疗方法,以扩大癌症和其他重大疾病患者的治疗可能性,今天宣布了其公司更新鉴于该公司在合作开发和全球商业化主要治疗候选NBTXR3方面取得了重大进展,该战略旨在实现长期增长。
Nanobiotix is developing three nanoparticle-based therapy platforms in sequence. The first therapeutic candidate from the first platform, potential first-in-class radioenhancer NBTXR3, is bei.
Nanobiotix正在依次开发三种基于纳米粒子的治疗平台。来自第一个平台的第一个治疗候选物,潜在的一流放射增强子NBTXR3,是bei。