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A Phase 2/3 Efficacy Study of INO-4800

Trial Profile

A Phase 2/3 Efficacy Study of INO-4800

Status: Planning
Phase of Trial: Phase II/III

Latest Information Update: 20 May 2020

At a glance

  • Drugs INO 4800 (Primary)
  • Indications COVID 2019 infections
  • Focus Therapeutic Use
  • Most Recent Events

    • 20 May 2020 According to an Inovio Pharmaceuticals media release, this study is anticipated to start in July/August pending regulatory approval.
    • 30 Apr 2020 According to an Inovio Pharmaceuticals media release, INOVIO plans to produce one million doses of INO-4800 by the end of 2020.
    • 30 Apr 2020 According to an Inovio Pharmaceuticals media release, INOVIO today announced that it has entered into an agreement to expand its manufacturing partnership with the German contract manufacturer Richter-Helm BioLogics GmbH & Co. KG, to support large-scale manufacturing of INOVIOs investigational DNA vaccine INO-4800, which currently is in Phase 1 clinical testing in the U.S. (NCT04336410) for COVID-19 and could potentially advance to Phase 2/3 efficacy trial (CT profile 320589) this summer.

Trial Overview

Purpose

This phase II/III study will evaluate the efficacy of INO-4800.

Diseases Treated

Indication Qualifiers Patient Segments
COVID 2019 infections prevention -

Subjects

  • Subject Type patients
  • Sex male & female

Trial Details

Organisations

  • Affiliations Inovio Pharmaceuticals

Trial Dates

Other Details

  • Design prospective
  • Phase of Trial Phase II/III
  • Location Unknown
  • Focus Therapeutic Use

Interventions

Drugs Route Formulation
INO 4800Primary Drug
-
-

INO-4800

Trial History

Event Date Event Type Comment
20 May 2020 Other trial event According to an Inovio Pharmaceuticals media release, this study is anticipated to start in July/August pending regulatory approval. Updated 24 May 2020
30 Apr 2020 Other trial event According to an Inovio Pharmaceuticals media release, INOVIO plans to produce one million doses of INO-4800 by the end of 2020. Updated 08 May 2020
30 Apr 2020 Other trial event According to an Inovio Pharmaceuticals media release, INOVIO today announced that it has entered into an agreement to expand its manufacturing partnership with the German contract manufacturer Richter-Helm BioLogics GmbH & Co. KG, to support large-scale manufacturing of INOVIOs investigational DNA vaccine INO-4800, which currently is in Phase 1 clinical testing in the U.S. (NCT04336410) for COVID-19 and could potentially advance to Phase 2/3 efficacy trial (CT profile 320589) this summer. Updated 08 May 2020
08 Apr 2020 New trial record New trial record Updated 08 Apr 2020
06 Apr 2020 Other trial event According to an Inovio Pharmaceuticals media release, upon attaining initial safety and immunogenicity data from Phase 1 studies, the company plans to advance INO-4800 to Phase 2 efficacy studies as rapidly as possible. Updated 08 Apr 2020

References

  1. Inovio Pharmaceuticals. INOVIO Initiates Phase 1 Clinical Trial Of Its COVID-19 Vaccine and Plans First Dose Today. Media-Rel 2020;.

    Media Release
  2. Inovio Pharmaceuticals. INOVIO Completes Enrollment in the Phase 1 U.S. Trial of INO-4800 for COVID-19 DNA Vaccine; Interim Results Expected in June. Media-Rel 2020;.

    Media Release
  3. Inovio Pharmaceuticals. INOVIO and Richter-Helm BioLogics will expand existing DNA manufacturing agreement to support large-scale manufacturing of INO-4800INO-4800 Phase 2/3 U.S. clinical trial being prepared to start this summer. Media-Rel 2020;.

    Media Release
  4. Inovio Pharmaceuticals. INOVIO's COVID-19 DNA Vaccine INO-4800 Demonstrates Robust Neutralizing Antibody and T Cell Immune Responses in Preclinical Models. Media-Rel 2020;.

    Media Release
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