Department of Chemistry, Massachusetts Institute of Technology, 77 Massachusetts Avenue, Cambridge, Massachusetts 02139, United States.
J Am Chem Soc. 2022 Dec 28;144(51):23332-23339. doi: 10.1021/jacs.2c07382. Epub 2022 Sep 20.
Polymer conjugation has been widely used to improve the stability and pharmacokinetics of therapeutic biomacromolecules; however, conventional methods to generate such conjugates often use disperse and/or achiral polymers with limited functionality. The heterogeneity of such conjugates may lead to manufacturing variability, poorly controlled biological performance, and limited ability to optimize structure-property relationships. Here, using insulin as a model therapeutic polypeptide, we introduce a strategy for the synthesis of polymer-protein conjugates based on discrete, chiral polymers synthesized through iterative exponential growth (IEG). These conjugates eliminate manufacturing variables originating from polymer dispersity and poorly controlled absolute configuration. Moreover, they offer tunable molecular features, such as conformational rigidity, that can be modulated to impact protein function, enabling faster or longer-lasting blood glucose responses in diabetic mice when compared to PEGylated insulin and the commercial insulin variant Lantus. Furthermore, IEG-insulin conjugates showed no signs of decreased activity, immunogenicity, or toxicity following repeat dosing. This work represents a significant step toward the synthesis of precise synthetic polymer-biopolymer conjugates and reveals that fine tuning of synthetic polymer structure may be used to optimize such conjugates in the future.
聚合物偶联已广泛用于提高治疗性生物大分子的稳定性和药代动力学;然而,生成此类偶联物的传统方法通常使用具有有限功能的分散的和/或手性聚合物。此类偶联物的异质性可能导致制造变异性、生物性能控制不佳以及优化结构-性能关系的能力有限。在这里,我们以胰岛素作为模型治疗性多肽,介绍了一种基于通过迭代指数增长 (IEG) 合成的离散、手性聚合物的聚合物-蛋白质偶联物的合成策略。这些偶联物消除了源自聚合物分散性和控制不佳的绝对构型的制造变量。此外,它们提供了可调节的分子特征,例如构象刚性,这可以调节来影响蛋白质功能,与聚乙二醇化胰岛素和商业胰岛素变体来得时相比,在糖尿病小鼠中可实现更快或更长时间的血糖响应。此外,IEG-胰岛素偶联物在重复给药后没有活性、免疫原性或毒性降低的迹象。这项工作代表了朝着精确合成的聚合物-生物聚合物偶联物的合成迈出的重要一步,并表明可以使用精细调整合成聚合物结构来优化此类偶联物。