Molecular Engineering of Efficacious Mono-Valent Ultra-Long Acting Two-Chain Insulin-Fc Conjugates

J Med Chem. 2022 Feb 10;65(3):2633-2645. doi: 10.1021/acs.jmedchem.1c02039. Epub 2022 Feb 1.

Abstract

Here, we describe molecular engineering of monovalent ultra-long acting two-chain insulin-Fc conjugates. Insulin-Fc conjugates were synthesized using trifunctional linkers with one amino reactive group for reaction with a lysine residue of insulin and two thiol reactive groups used for re-bridging of a disulfide bond within the Fc molecule. The ultra-long pharmacokinetic profile of the insulin-Fc conjugates was the result of concertedly slowing insulin receptor-mediated clearance by (1) introduction of amino acid substitutions that lowered the insulin receptor affinity and (2) conjugating insulin to the Fc element. Fc conjugation leads to recycling by the neonatal Fc receptor and increase in the molecular size, both contributing to the ultra-long pharmacokinetic and pharmacodynamic profiles.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Amino Acid Sequence
  • Animals
  • Cell Line
  • Diabetes Mellitus, Experimental / drug therapy
  • Humans
  • Hypoglycemic Agents / chemical synthesis*
  • Hypoglycemic Agents / pharmacokinetics
  • Hypoglycemic Agents / therapeutic use
  • Immunoconjugates / chemistry*
  • Immunoconjugates / pharmacokinetics
  • Immunoconjugates / therapeutic use
  • Immunoglobulin Fc Fragments / chemistry*
  • Immunoglobulin Fc Fragments / pharmacology
  • Immunoglobulin Fc Fragments / therapeutic use
  • Insulin, Long-Acting / chemical synthesis*
  • Insulin, Long-Acting / pharmacokinetics
  • Insulin, Long-Acting / therapeutic use
  • Male
  • Mesocricetus
  • Protein Engineering
  • Rats
  • Rats, Sprague-Dawley

Substances

  • Hypoglycemic Agents
  • Immunoconjugates
  • Immunoglobulin Fc Fragments
  • Insulin, Long-Acting