GP120-depleted HIV-1 vaccine

Drug Profile

GP120-depleted HIV-1 vaccine

Alternative Names: AG-1661; gp120 depleted HZ321 HIV-1; HIV vaccine - Immune Response; IR-8101; REMUNE; Remune Paediatric; RG-83894

Latest Information Update: 09 Mar 2017

Price : $50

At a glance

  • Originator Salk Institute
  • Developer Immune Response BioPharma
  • Class AIDS vaccines; Antivirals
  • Mechanism of Action Immunostimulants
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

    Yes - HIV-1 infections
  • On Fast track

    Fast track status is assigned by the US FDA so therapies with the potential to address unmet needs can move faster through development.

  • New Molecular Entity No
  • Available For Licensing Yes - HIV-1 infections

Highest Development Phases

  • Preregistration HIV-1 infections

Most Recent Events

  • 09 Mar 2017 Immune Response BioPharma announces intention to submit BLA to US FDA for HIV-1 infections (In paediatric population) on 31st March, 2017 (Immune Response BioPharma website, March 2017)
  • 13 Feb 2016 Immune Response BioPharma receives complete response letter from the FDA for GP120-depleted HIV-1 vaccine in HIV-1 infections
  • 27 Mar 2015 The US FDA reaccepts BLA for GP120-depleted HIV-1 vaccine for HIV-1 infections for review
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