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GSK3732394: a Multi-specific Inhibitor of HIV Entry.

David Wensel1, Yongnian Sun2, Jonathan Davis3

  • 1ViiV Healthcare, Branford, Connecticut, USA.

Journal of Virology
|August 4, 2019
PubMed
Summary

A new long-acting biologic, GSK3732394, offers a potential self-administered subcutaneous injection for HIV-1 treatment. This tri-specific molecule combines three distinct antiviral activities for enhanced efficacy and a higher resistance barrier.

Keywords:
CD4HIV entryadnectinsgp41inhibitorsynergy

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Area of Science:

  • Virology
  • Immunology
  • Drug Development

Background:

  • Daily oral antiretroviral therapy for HIV-1 infection presents challenges in adherence and potential drug-drug interactions.
  • Long-acting biologic inhibitors are being developed to address unmet medical needs in HIV-1 management.
  • Targeting viral entry through multiple mechanisms offers a strategy to overcome resistance.

Purpose of the Study:

  • To develop GSK3732394, a novel tri-specific biologic inhibitor for long-acting HIV-1 treatment.
  • To evaluate the synergistic antiviral activity and pharmacokinetic profile of GSK3732394.
  • To assess the potential for self-administration as a subcutaneous injection.

Main Methods:

  • Development of a bi-specific molecule targeting CD4 and gp41, further optimized with an α-helical peptide inhibitor.
  • In vitro assessment of inhibitor potency (nanomolar range) and spectrum of activity.
  • Evaluation of synergistic effects in a human CD4 T cell model and pharmacokinetic studies in human CD4 transgenic mice with human serum albumin addition.

Main Results:

  • GSK3732394 demonstrated synergistic advantages in potency and resistance barrier compared to individual components.
  • The molecule effectively inhibited HIV-1 infection at low CD4 receptor occupancy levels, functioning in trans.
  • Human serum albumin addition prolonged half-life in mice, indicating potential for long-acting formulation.

Conclusions:

  • GSK3732394 is a potent tri-specific inhibitor with potential as a long-acting, self-administered subcutaneous injection for HIV-1.
  • The synergistic combination of antiviral activities enhances efficacy and the resistance barrier.
  • Early clinical trials are underway to further evaluate this promising HIV-1 therapeutic candidate.