RUBY® - - 一种四价 (2+2) 双特异抗体格式,具有卓越的功能性和类似IgG的稳定性,药理学和发育性质
Barnabas Nyesiga1,2, Mattias Levin1, Anna Säll1
1Alligator Bioscience AB, Medicon Village, Lund, Sweden.
mAbs
|March 26, 2024
概括
我们开发了RUBY,一种新的双特异抗体 (bsAb) 格式,提供mAb类属性,以方便开发. 红宝石bsAbs表现出高功能性,有利的药理动力学和有效的瘤透,克服了常见的bsAbs挑战.
科学领域:
- 生物技术是生物技术.
- 免疫学 免疫学 免疫学
- 蛋白质工程是指蛋白质工程.
背景情况:
- 现有的双特异性抗体 (bsAb) 格式面临着开发和生物处理的挑战.
- 需要新的bsAb格式来克服这些局限性并提高治疗潜力.
研究的目的:
- 介绍了新的RUBY双特异抗体格式.
- 评估RUBY bsAbs.的可开发性,功能性和药理动力学特性.
- 展示RUBY格式对现有的bsAb策略的优势.
主要方法:
- 设计了一种新的2+2几何双特异抗体格式 (RUBY),并优化了链路配对.
- 评估了小规模和大规模生产的兼容性,产量和纯度.
- 评估了bsAb聚合,可溶性,稳定性,Fc受体结合和FcRn相互作用.
- 在小鼠和非人类灵长类动物中确定体内药理动力学.
- 在体外功能和体内瘤透和局部化得到证实.
主要成果:
- 鲁比可以快速生成具有单克隆抗体 (mAb) 样属性的bsAbs.
- 从稳定的细胞系获得高产量 (>3 g/L) 和低总量水平.
- 红宝石bsAbs表现出良好的溶解性,稳定性和量身定制的Fc受体结合.
- 小鼠和非人类灵长类动物的药理动力学与mAb对照组相比较.
- 在体内透和定位瘤被证明,此前已经显示出优异的抗瘤效果.
结论:
- RUBY格式提供了一个可行的解决方案,以减轻与双特异抗体相关的开发挑战.
- RUBY bsAbs具有有吸引力的mAb类属性,促进了高功能性和更好的可开发性.
- 这种新型格式对推进双特异性抗体疗法具有重大前景.
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