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AlbuCatcher for Long-Acting Therapeutics.

Ji Hyun Rho1, Jae Hun Lee1, Inchan Kwon1

  • 1School of Materials Science and Engineering, Gwangju Institute of Science and Technology (GIST), Gwangju 61005, Republic of Korea.

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The AlbuCatcher strategy successfully extended the serum half-life of therapeutic proteins by conjugating them with human serum albumin (HSA). This method enhances protein efficacy by leveraging HSA

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Area of Science:

  • Biotechnology
  • Protein Engineering
  • Pharmacology

Background:

  • Therapeutic proteins offer high selectivity but suffer from short serum half-lives, limiting their efficacy.
  • Strategies to prolong protein half-life are essential for sustained therapeutic effects.
  • Human serum albumin (HSA) possesses a long intrinsic half-life due to Fc receptor (FcRn) recycling.

Purpose of the Study:

  • To introduce AlbuCatcher, a novel conjugate system for extending therapeutic protein serum half-life.
  • To demonstrate the general applicability of AlbuCatcher for diverse protein therapeutics.
  • To evaluate the impact of AlbuCatcher on protein activity and pharmacokinetics.

Main Methods:

  • Developed AlbuCatcher using SpyCatcher conjugated to HSA.
  • Utilized an inverse electron-demand Diels-Alder (IEDDA) reaction for site-specific HSA conjugation.
  • Fused SpyTag to urate oxidase (Uox) to create Uox-ST for conjugation with AlbuCatcher.

Main Results:

  • Successfully prepared HSA-conjugated Uox (Uox-HSA) via the AlbuCatcher reaction.
  • In vitro assays confirmed negligible impact of conjugation on Uox enzymatic activity.
  • Pharmacokinetic studies in mice showed Uox-HSA half-life extended to ~18 hours from ~2 hours for Uox-WT.

Conclusions:

  • The AlbuCatcher strategy effectively prolongs the serum half-life of therapeutic proteins.
  • FcRn-mediated recycling of conjugated HSA contributes to the extended half-life.
  • AlbuCatcher represents a promising approach for enhancing therapeutic protein pharmacokinetics.