Novel Platform Technology for Developing Therapeutic Human mAbs

用于开发治疗性人类单克隆抗体的新型平台技术

基本信息

项目摘要

DESCRIPTION (provided by applicant): Despite significant advances in treatment and early detection, cancer remains a significant disease threat to society. Therapeutic monoclonal antibodies are effective new treatments that have recently been developed as targeted therapies against many types of cancer. Over 17 monoclonal antibodies have been approved in the US for treating a variety of diseases. The advantages are high specificity, predictable side effects, and more rapid and less expensive advancement through clinical trials. Significant hurdles remain, however, including the low efficiency of antibody development, instability of hybridoma cell lines, adverse patient immune responses to foreign protein or carbohydrate sequences, and commercially, royalty stacking issues from the need to access the multiple technologies required to develop an efficacious antibody therapeutic. There is currently no technology platform that allows one to develop human monoclonal antibody producing cell lines by direct transformation of human immune cells. Such antibodies can be tested for specific therapeutic characteristics and the cell lines directly scaled for larger antibody manufacturing without the use of additional platform technologies. The approach described herein is one that allows for more rapid discovery of high value therapeutic products, that will both personalize and revolutionize the therapeutic human monoclonal antibody as the new era of genomics and proteomics continues to provide enormous opportunity for the discovery of druggable targets. The objective of this Phase I proposal is utilize the ABL-MYC retroviral transformation technology for the development of fully human monoclonal antibodies. NeoClone has utilized this approach commercially since 1999 to develop murine antibodies for research and diagnostic use. If successful in this proposal, the advantages of our murine antibody technology would hold true: rapid, efficient, cost effective development of high affinity monoclonal antibodies. Additional advantages for therapeutics would be fully human antibody sequence, stable cell lines, accurate post-translational modifications and no need for further maturation to improve affinity. Additionally, this technology would have the potential to use the patient's own cells for antibody development. A more rapid and efficacious therapeutic antibody technology would be a welcome addition to the arsenal of approaches to combat cancer and other deadly diseases. Therapeutic monoclonal antibodies are emerging as one of the most effective targeted drug approaches for cancer. NeoClone is proposing to adapt it's successful monoclonal antibody technology to enable rapid development of fully human therapeutic monoclonal antibodies. The potential advantages of this approach are more rapid and efficient drug development with less potential for deleterious side effects.
描述(由申请人提供):尽管在治疗和早期发现方面取得了重大进展,但癌症仍然是对社会的重大疾病威胁。治疗性单克隆抗体是有效的新疗法,最近已开发为针对多种癌症的有针对性疗法。在美国已批准了17种单克隆抗体治疗各种疾病。优点是高特异性,可预测的副作用以及通过临床试验更快,更便宜的进步。然而,仍然存在重大障碍,包括抗体发育的低效率,杂交瘤细胞系的不稳定性,患者对异物蛋白质或碳水化合物序列的不良免疫反应,以及在商业上,从需要访问有效的多种技术来开发有效的抗体疗法所需的多种技术。当前没有技术平台可以通过直接转化人类免疫细胞来发展人类单克隆抗体,从而产生细胞系。可以测试此类抗体的特定治疗特性,并在不使用其他平台技术的情况下直接缩放大型抗体生产的细胞系。本文描述的方法是一种可以更快地发现高价值的治疗产品的方法,它既可以个性化和彻底改变治疗性人类单克隆抗体,因为基因组学和蛋白质组学的新时代继续为发现可毒靶标提供了巨大的机会。该阶段I建议的目的是利用ABL-MYC逆转录病毒转化技术来开发完全人类的单克隆抗体。自1999年以来,Neoclone已商业地利用这种方法来开发用于研究和诊断使用的鼠抗体。如果在此提案中取得成功,我们的鼠抗体技术的优势将成立:高亲和力单克隆抗体的快速,高效,有效的开发。治疗剂的其他优势将是人类抗体序列,稳定的细胞系,准确的翻译后修饰,并且不需要进一步成熟以提高亲和力。此外,该技术有可能将患者自己的细胞用于抗体开发。更快,有效的治疗抗体技术将是对抗癌症和其他致命疾病的方法的可喜补充。治疗性单克隆抗体正在成为癌症最有效的靶向药物方法之一。 Neoclone提议改编其成功的单克隆抗体技术,以便能够快速开发完全人类的单克隆抗体。这种方法的潜在优势是更快,有效的药物开发,其有害副作用的潜力较小。

项目成果

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Rachel Hannah Kravitz其他文献

Rachel Hannah Kravitz的其他文献

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{{ truncateString('Rachel Hannah Kravitz', 18)}}的其他基金

Reactivation of human cells for novel fully human Ab platform
新型全人抗体平台重新激活人体细胞
  • 批准号:
    8319829
  • 财政年份:
    2012
  • 资助金额:
    $ 14万
  • 项目类别:
A novel platform for mining the repertoire of antigen-specific B cells
挖掘抗原特异性 B 细胞库的新平台
  • 批准号:
    7292854
  • 财政年份:
    2007
  • 资助金额:
    $ 14万
  • 项目类别:

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