Holgate Robert G E, Weldon Richard, Jones Timothy D, Baker Matthew P
Antitope Limited, Babraham Research Campus, Cambridge, United Kingdom.
PLoS One. 2015 Sep 15;10(9):e0138123. doi: 10.1371/journal.pone.0138123. eCollection 2015.
Anti-CD52 therapy has been shown to be effective in the treatment of a number of B cell malignancies, hematopoietic disorders and autoimmune diseases (including rheumatoid arthritis and multiple sclerosis); however the current standard of treatment, the humanized monoclonal antibody alemtuzumab, is associated with the development of anti-drug antibodies in a high proportion of patients. In order to address this problem, we have identified a novel murine anti-CD52 antibody which has been humanized using a process that avoids the inclusion within the variable domains of non-human germline MHC class II binding peptides and known CD4+ T cell epitopes, thus reducing its potential for immunogenicity in the clinic. The resultant humanized antibody, ANT1034, was shown to have superior binding to CD52 expressing cells than alemtuzumab and was more effective at directing both antibody dependent and complement dependent cell cytotoxicity. Furthermore, when in the presence of a cross-linking antibody, ANT1034 was more effective at directly inducing apoptosis than alemtuzumab. ANT1034 also showed superior activity in a SCID mouse/human CD52 tumour xenograft model where a single 1 mg/Kg dose of ANT1034 led to increased mouse survival compared to a 10 mg/Kg dose of alemtuzumab. Finally, ANT1034 was compared to alemtuzumab in in vitro T cell assays in order to evaluate its potential to stimulate proliferation of T cells in peripheral blood mononuclear cells derived from a panel of human donors: whereas alemtuzumab stimulated proliferation in a high proportion of the donor cohort, ANT1034 did not stimulate proliferation in any of the donors. Therefore we have developed a candidate therapeutic humanized antibody, ANT1034, that may have the potential to be more efficacious and less immunogenic than the current standard anti-CD52 therapy.
抗CD52疗法已被证明在治疗多种B细胞恶性肿瘤、造血系统疾病和自身免疫性疾病(包括类风湿性关节炎和多发性硬化症)方面有效;然而,目前的治疗标准——人源化单克隆抗体阿仑单抗,在很大比例的患者中会引发抗药抗体的产生。为了解决这个问题,我们鉴定出一种新型鼠抗CD52抗体,该抗体已通过一种方法进行人源化,该方法避免了在可变域中包含非人类种系MHC II类结合肽和已知的CD4 + T细胞表位,从而降低了其在临床中的免疫原性潜力。所得的人源化抗体ANT1034与表达CD52的细胞的结合能力优于阿仑单抗,并且在介导抗体依赖性和补体依赖性细胞毒性方面更有效。此外,在存在交联抗体的情况下,ANT1034比阿仑单抗更有效地直接诱导细胞凋亡。在SCID小鼠/人CD52肿瘤异种移植模型中,ANT1034也表现出更高的活性,与10 mg/Kg剂量的阿仑单抗相比,单次1 mg/Kg剂量的ANT