Tufts Center for the Study of Drug Development, Boston, MA, USA.
MAbs. 2011 Jan-Feb;3(1):76-99. doi: 10.4161/mabs.3.1.13895. Epub 2011 Jan 1.
This overview of 25 monoclonal antibody (mAb) and 5 Fc fusion protein therapeutics provides brief descriptions of the candidates, recently published clinical study results and on-going Phase 3 studies. In alphanumeric order, the 2011 therapeutic antibodies to watch list comprises AIN-457, bapineuzumab, brentuximab vedotin, briakinumab, dalotuzumab, epratuzumab, farletuzumab, girentuximab (WX-G250), naptumomab estafenatox, necitumumab, obinutuzumab, otelixizumab, pagibaximab, pertuzumab, ramucirumab, REGN88, reslizumab, solanezumab, T1h , teplizumab, trastuzumab emtansine, tremelimumab, vedolizumab, zalutumumab and zanolimumab. In alphanumeric order, the 2011 Fc fusion protein therapeutics to watch list comprises aflibercept, AMG-386, atacicept, Factor VIII and Factor IX-Fc. Commercially-sponsored mAb and Fc fusion therapeutics that have progressed only as far as Phase 2/3 or 3 were included. Candidates undergoing regulatory review or products that have been approved may also be in Phase 3 studies, but these were excluded. Due to the large body of primary literature about the candidates, only selected references are given and results from recent publications and articles that were relevant to Phase 3 studies are emphasized. Current as of September 2010, the information presented here will serve as a baseline against which future progress in the development of antibody-based therapeutics can be measured.
这篇涵盖了 25 种单克隆抗体(mAb)和 5 种 Fc 融合蛋白治疗药物的综述,简要介绍了这些候选药物、最近发表的临床研究结果和正在进行的 3 期研究。按照字母数字顺序,2011 年值得关注的治疗性抗体列表包括 AIN-477、bapineuzumab、brentuximab vedotin、briakinumab、dalotuzumab、epratuzumab、farletuzumab、girentuximab(WX-G250)、naptumomab estafenatox、necitumumab、obinutuzumab、otelixizumab、pagibaximab、pertuzumab、ramucirumab、REGN88、reslizumab、solanezumab、T1h、teplizumab、trastuzumab emtansine、tremelimumab、vedolizumab、zalutumumab 和 zanolimumab。按照字母数字顺序,2011 年值得关注的 Fc 融合蛋白治疗药物列表包括 aflibercept、AMG-386、atacicept、VIII 因子和 IX 因子-Fc。本综述纳入了仅进展至 2/3 期或 3 期的商业赞助的 mAb 和 Fc 融合治疗药物。正在接受监管审查或已获得批准的候选药物也可能处于 3 期研究中,但这些药物未被纳入本综述。由于候选药物的主要文献数量庞大,本综述仅提供了部分参考文献,并强调了与 3 期研究相关的近期出版物和文章的结果。截至 2010 年 9 月,这里呈现的信息将作为未来抗体治疗药物开发进展的基准。
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