INSERM U624; GDR 3260; Marseille, France.
MAbs. 2009 Nov-Dec;1(6):539-47. doi: 10.4161/mabs.1.6.10015.
With 23 approvals in the US and other countries and four approvals outside US, antibodies are now widely recognized as therapeutic molecules. The therapeutic and commercial successes met by rituximab, trastuzumab, cetuximab and other mAbs have inspired antibody engineers to improve the efficacy of these molecules. Consequently, a new wave of antibodies with engineered Fc leading to much higher effector functions such as antibody-dependent cell-mediated cytotoxicity or complement-dependent cytotoxicity is being evaluated in the clinic, and several approvals are expected soon. In addition, research on a different class of antibody therapeutics, bispecific antibodies, has recently led to outstanding clinical results, and the first approval of the bispecific antibody catumaxomab, a T cell retargeting agent that was approved in the European Union in April 2009. This review describes the most recent advances and clinical study results in the field of bispecific antibodies, a new class of molecules that might outshine conventional mAbs as cancer immunotherapeutics in a near future.
在美国和其他国家获得了 23 项批准,在美国以外的国家获得了 4 项批准,抗体现在被广泛认为是治疗性分子。利妥昔单抗、曲妥珠单抗、西妥昔单抗和其他 mAbs 的治疗和商业成功激发了抗体工程师提高这些分子的疗效。因此,正在临床中评估具有工程化 Fc 的新一代抗体,这些抗体具有更高的效应功能,如抗体依赖性细胞介导的细胞毒性或补体依赖性细胞毒性,预计很快会有几个批准。此外,针对不同类型的抗体治疗药物——双特异性抗体的研究最近取得了出色的临床结果,首个双特异性抗体 catumaxomab 的批准,这是一种 T 细胞重定向剂,于 2009 年 4 月在欧盟获得批准。本文描述了双特异性抗体领域的最新进展和临床研究结果,这是一类新的分子,在不久的将来可能会超过传统的 mAbs 成为癌症免疫疗法。