Poly(HPMA-co-NIPAM) copolymer as an alternative to polyethylene glycol-based pharmacokinetic modulation of therapeutic proteins

[Display omitted] PEGylation is the standard approach for prolonging the plasma exposure of protein therapeutics but has limitations. We explored whether polymers prepared by Reversible Addition-Fragmentation chain-Transfer (RAFT) may provide better alternatives to polyethylene glycol (PEG). Four RA...

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Published inInternational journal of pharmaceutics Vol. 608; p. 121075
Main Authors Subasic, Christopher N., Ardana, Aditya, Chan, Linda J., Huang, Fei, Scoble, Judith A., Butcher, Neville J., Meagher, Laurence, Chiefari, John, Kaminskas, Lisa M., Williams, Charlotte C.
Format Journal Article
LanguageEnglish
Published Elsevier B.V 25.10.2021
Subjects
PEG
Pharmacokinetics
Polymer pharmacokinetics
Polymers
Reversible Addition-Fragmentation chain-Transfer (RAFT)
Ð
Mn
MWCO
PEG
Polymer pharmacokinetics
Mw
Polymers
Pharmacokinetics
Reversible Addition-Fragmentation chain-Transfer (RAFT)
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Abstract [Display omitted] PEGylation is the standard approach for prolonging the plasma exposure of protein therapeutics but has limitations. We explored whether polymers prepared by Reversible Addition-Fragmentation chain-Transfer (RAFT) may provide better alternatives to polyethylene glycol (PEG). Four RAFT polymers were synthesised with varying compositions, molar mass (Mn), and structures, including a homopolymer of N-(2-hydroxypropyl)methacrylamide, (pHPMA) and statistical copolymers of HPMA with poly(ethylene glycol methyl ether acrylate) p(HPMA-co-PEGA); HPMA and N-acryloylmorpholine, p(HPMA-co-NAM); and HPMA and N-isopropylacrylamide, p(HPMA-co-NIPAM). The intravenous pharmacokinetics of the polymers were then evaluated in rats. The in vitro activity and in vivo pharmacokinetics of p(HPMA-co-NIPAM)-conjugated trastuzumab Fab' and full length mAb were then evaluated. p(HPMA-co-NIPAM) prolonged plasma exposure more avidly compared to the other p(HPMA) polymers or PEG, irrespective of molecular weight. When conjugated to trastuzumab-Fab', p(HPMA-co-NIPAM) prolonged plasma exposure of the Fab' similar to PEG-Fab'. The generation of anti-PEG IgM in rats 7 days after intravenous and subcutaneous dosing of p(HPMA-co-NIPAM) conjugated trastuzumab mAb was also examined and was shown to exhibit lower immunogenicity than the PEGylated construct. These data suggest that p(HPMA-co-NIPAM) has potential as a promising copolymer for use as an alternative conjugation strategy to PEG, to prolong the plasma exposure of therapeutic proteins.
AbstractList [Display omitted] PEGylation is the standard approach for prolonging the plasma exposure of protein therapeutics but has limitations. We explored whether polymers prepared by Reversible Addition-Fragmentation chain-Transfer (RAFT) may provide better alternatives to polyethylene glycol (PEG). Four RAFT polymers were synthesised with varying compositions, molar mass (Mn), and structures, including a homopolymer of N-(2-hydroxypropyl)methacrylamide, (pHPMA) and statistical copolymers of HPMA with poly(ethylene glycol methyl ether acrylate) p(HPMA-co-PEGA); HPMA and N-acryloylmorpholine, p(HPMA-co-NAM); and HPMA and N-isopropylacrylamide, p(HPMA-co-NIPAM). The intravenous pharmacokinetics of the polymers were then evaluated in rats. The in vitro activity and in vivo pharmacokinetics of p(HPMA-co-NIPAM)-conjugated trastuzumab Fab' and full length mAb were then evaluated. p(HPMA-co-NIPAM) prolonged plasma exposure more avidly compared to the other p(HPMA) polymers or PEG, irrespective of molecular weight. When conjugated to trastuzumab-Fab', p(HPMA-co-NIPAM) prolonged plasma exposure of the Fab' similar to PEG-Fab'. The generation of anti-PEG IgM in rats 7 days after intravenous and subcutaneous dosing of p(HPMA-co-NIPAM) conjugated trastuzumab mAb was also examined and was shown to exhibit lower immunogenicity than the PEGylated construct. These data suggest that p(HPMA-co-NIPAM) has potential as a promising copolymer for use as an alternative conjugation strategy to PEG, to prolong the plasma exposure of therapeutic proteins.
ArticleNumber 121075
Author Ardana, Aditya
Subasic, Christopher N.
Meagher, Laurence
Huang, Fei
Scoble, Judith A.
Butcher, Neville J.
Chiefari, John
Williams, Charlotte C.
Chan, Linda J.
Kaminskas, Lisa M.
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  surname: Kaminskas
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  email: L.Kaminskas@uq.edu.au
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  givenname: Charlotte C.
  surname: Williams
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Snippet [Display omitted] PEGylation is the standard approach for prolonging the plasma exposure of protein therapeutics but has limitations. We explored whether...
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SubjectTerms PEG
Pharmacokinetics
Polymer pharmacokinetics
Polymers
Reversible Addition-Fragmentation chain-Transfer (RAFT)
Title Poly(HPMA-co-NIPAM) copolymer as an alternative to polyethylene glycol-based pharmacokinetic modulation of therapeutic proteins
URI https://dx.doi.org/10.1016/j.ijpharm.2021.121075
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