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INO 4800

Drug Profile

INO 4800

Alternative Names: INO 4800

Latest Information Update: 04 May 2020

At a glance

  • Originator Inovio Pharmaceuticals; University of Pennsylvania
  • Developer Inovio Pharmaceuticals
  • Class DNA vaccines; Viral vaccines
  • Mechanism of Action Immunostimulants
  • Orphan Drug Status

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

    No
  • New Molecular Entity No
  • Available For Licensing Yes - Coronavirus infections

Highest Development Phases

  • Phase I COVID 2019 infections

Most Recent Events

  • 11 May 2020 Inovio plans a phase I/II trial for COVID-2019 infections in China and South Korea (Parenteral) in May 2020
  • 30 Apr 2020 Inovio plans a phase II/III trial for COVID-2019 infections in USA in September 2019
  • 28 Apr 2020 Inovio completes enrolment in its phase I trial for COVID-2019 infections (Prevention) in USA (Parenteral) (NCT04336410)

Development Overview

Introduction

INO 4800 is a vaccine candidate, being developed by Inovio Pharmaceuticals using DNA medicine platform, for the prevention of COVID-2019 infections. This one-of-a-kind platform delivers optimised DNA into cells, where it is translated into proteins that activate an individual's immune system to generate a robust targeted T cell and antibody response. The technology platform has two key elements which comprises of SynCon® DNA sequence design process and CELLECTRA® DNA delivery technology. The SynCon DNA immunotherapy is injected into the muscle or skin and CELLECTRA delivers 3-4 rapid electrical pulses which lasts only for milliseconds. Clinical development is underway in the US.

Inovio Pharmaceuticals and Beijing Advaccine Biotechnology are seeking partnership to develop INO 4800 for COVID-2019 infections in China [1] .

The CELLECTRA® DNA delivery technology uses a brief electrical pulse to open small pores in the cell reversibly to allow the plasmids to enter. Once inside the cell, the plasmids begin replicating, thereby strengthening the body's own natural response mechanisms.

Company Agreements

In March 2020, Inovio Pharmaceuticals entered into a manufacturing agreement with Ology Bioservices to manufacture Inovio’s DNA vaccine INO 4800 for prevention of infection with the COVID-19 virus. The Department of Defense (DOD) awarded Ology Bioservices with a contract valued at $US11.9 million to work with Inovio on DNA technology transfer to rapidly manufacture the DNA vaccine. [2]

In January 2020, Inovio Pharmaceuticals entered into a collaboration with Beijing Advaccine Biotechnology to advance the development of INO 4800 in China against COVID-2019 infections. Under the collaboration, the expertise of Advaccine will be utilised to conduct a phase I trial in China for COVID-2019 infections. Inovio Pharmaceuticals and Beijing Advaccine Biotechnology will also seek additional grant funding and further collaborations with vaccine companies in China to increase the speed of future testing of INO 4800. Financial details were not disclosed. [1]

Key Development Milestones

In April 2020, INOVIO initiated and dosed first volunteer in a phase I trial to evaluate the safety, tolerability and immunological profile of INO 4800 administered by intradermal (ID) injection followed by electroporation (EP) using CELLECTRA® 2000 device in healthy adult volunteers (NCT04336410; COVID19-001). The open-label trial, later in April 2020, completed enrolment of 40 volunteers in the US [3] [4] [5] .

In April 2020, INOVIO announced that the US FDA has accepted the Investigational New Drug (IND) application for INO 4800 for the prevention of COVID-19 infection [4] .

As of April 2020, Inovio is evaluating INO 4800 in many challenge studies in multiple animal models. The company also reported that they intend to deliver INO 4800 for additional studies and emergency use [3] .

In preclinical studies, IN0 4800 demonstrated robust neutralizing antibody and T cell immune responses against coronavirus SARS-CoV-2 in mice and guinea pigs [6]

Administration of INO 4800, generated immune response in animal models. The preclinical studies were initiated in January 2020 and is ongoing [7] .

Financing information

In April 2020, Coalition for Epidemic Preparedness Innovations (CEPI) granted $US6.9 million funding to Inovio to support a phase I/II trial of INO 4800 for COVID-2019 infections in South Korea [8] .

In March 2020, Inovio received $US5 million grant from the the Bill & Melinda Gates Foundation to accelerate the testing and scale up of CELLECTRA® 3PSP proprietary smart device for the intradermal delivery of INO 800, for the prevention of COVID-2019 infections [9] .

In February 2020, Twist Bioscience completed an offering of approximately 2.24 million shares of its common stock at an average price of approximately $US22.32 per share, raising approximately $US48.2 million in net proceeds [10] .

In January 2020, Coalition for Epidemic Preparedness Innovations (CEPI) awarded a grant of $US9 million to Inovio, to support preclinical and clinical development of INO 4800 for COVID-2019 infections [11] .

Drug Properties & Chemical Synopsis

  • Route of administration Intradermal
  • Formulation unspecified
  • Class DNA vaccines, Viral vaccines
  • Mechanism of Action Immunostimulants
  • WHO ATC code

    J05 (Antivirals for Systemic Use)

  • EPhMRA code

    J5 (Antivirals for Systemic Use)

Development Status

Summary Table

Indication Qualifier Patient Segment Phase Countries Route / Formulation Developers Event Date
COVID 2019 infections Followed by Electroporation Prevention Phase I USA Intradermal / unspecified Inovio Pharmaceuticals 06 Apr 2020

Commercial Information

Involved Organisations

Organisation Involvement Countries
Inovio Pharmaceuticals Originator USA
University of Pennsylvania Originator USA
University of Pennsylvania Owner USA
Inovio Pharmaceuticals Owner USA
Bill & Melinda Gates Foundation Funder USA
Department of defence Funder USA
Coalition for Epidemic Preparedness Innovations Funder Norway
Twist Bioscience Collaborator USA
Fudan University Collaborator China
Beijing Advaccine Biotechnology Collaborator China
University of Texas Collaborator
Universite Laval Collaborator Canada
International Vaccine Institute Collaborator South-Korea
Wistar Institute Collaborator USA

Licensing Availability

Licensing Organisation Available Indication Available Phase Region Date
Inovio Pharmaceuticals Coronavirus infections Unspecified China 30 Jan 2020

Future Events

Expected Date Event Type Description Updated
15 Sep 2020 Trial Update Inovio plans a phase II/III trial for COVID-2019 infections in USA in September 2019 (700320589) [13] 04 May 2020
31 May 2020 Trial Update Inovio plans a phase I/II trial for COVID-2019 infections in China and South Korea (Parenteral) in May 2020 [12] 16 May 2020
30 Apr 2020 Trial Update Inovio plans a clinical trial for COVID-2019 infections (In volunteers) in USA (Parenteral) in April 2020 (700318014) [7] 13 Apr 2020

Development History

Event Date Update Type Comment
11 May 2020 Trial Update Inovio plans a phase I/II trial for COVID-2019 infections in China and South Korea (Parenteral) in May 2020 [12] Updated 16 May 2020
30 Apr 2020 Trial Update Inovio plans a phase II/III trial for COVID-2019 infections in USA in September 2019 [13] Updated 04 May 2020
28 Apr 2020 Trial Update Inovio completes enrolment in its phase I trial for COVID-2019 infections (Prevention) in USA (Parenteral) (NCT04336410) [3] Updated 04 May 2020
06 Apr 2020 Phase Change - I Phase-I clinical trials in COVID-2019 infections (Prevention) in USA (Parenteral) (NCT04336410) [4] Updated 13 Apr 2020
06 Apr 2020 Regulatory Status US FDA accepts IND application for INO 4800 for COVID-19 [4] Updated 13 Apr 2020
06 Apr 2020 Trial Update INOVIO plans a phase II trial [4] Updated 13 Apr 2020
03 Mar 2020 Trial Update Inovio plans a clinical trial for COVID-2019 infections (In volunteers) in USA (Parenteral) in April 2020 [7] Updated 13 Apr 2020
03 Mar 2020 Trial Update Inovio plans a clinical trial for COVID-2019 infections in China and South Korea (Parenteral) [7] Updated 09 Mar 2020
30 Jan 2020 Licensing Status INO 4800 is available for licensing in China as of 30 Jan 2020. https://www.inovio.com/about#partnerships [1] Updated 04 Feb 2020
30 Jan 2020 Licensing Status Inovio Pharmaceuticals and Beijing Advaccine Biotechnology collaborates to develop INO 4800 in China for COVID-2019-infections [1] Updated 03 Feb 2020
30 Jan 2020 Trial Update Inovio Pharmaceuticals and Beijing Advaccine Biotechnology plans a phase I trial for COVID-2019-infections in China [1] Updated 03 Feb 2020
24 Jan 2020 Phase Change - Preclinical Preclinical trials in COVID-2019 infections (Prevention) in USA (Parenteral) [7] Updated 09 Mar 2020
23 Jan 2020 Phase Change Early research in COVID-2019-infections (Prevention) in USA (Parenteral) [11] Updated 28 Jan 2020
23 Jan 2020 Trial Update Inovio Pharmaceuticals plans a phase I trial for COVID-2019-infections [11] Updated 28 Jan 2020

References

  1. Inovio Collaborating With Beijing Advaccine To Advance INO-4800 Vaccine Against New Coronavirus In China.

    Media Release
  2. Ology Bioservices, Inovio Partner To Manufacture COVID-19 DNA Vaccine With $11.9 Million Department of Defense Grant.

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

    Media Release
  4. INOVIO Initiates Phase 1 Clinical Trial Of Its COVID-19 Vaccine and Plans First Dose Today.

    Media Release
  5. Phase I, Open-label, Dose Ranging Study to Evaluate the Safety, Tolerability, and Immunogenicity of GLS-5300, Administered IM Followed by Electroporation in Healthy Volunteers

    ctiprofile
  6. INOVIO's COVID-19 DNA Vaccine INO-4800 Demonstrates Robust Neutralizing Antibody and T Cell Immune Responses in Preclinical Models.

    Media Release
  7. Inovio Accelerates Timeline for COVID-19 DNA Vaccine INO-4800.

    Media Release
  8. IVI, INOVIO, and KNIH to Partner with CEPI in Phase 1/2 Clinical Trial of INOVIO's COVID-19 DNA Vaccine in South Korea.

    Media Release
  9. INOVIO Receives New $5 Million Grant to Accelerate Scale Up of Smart Delivery Device for Its COVID-19 Vaccine.

    Media Release
  10. Twist Bioscience Reports First Quarter Fiscal 2020 Financial Results.

    Media Release
  11. Inovio Selected by CEPI to Develop Vaccine Against New Coronavirus.

    Media Release
  12. INOVIO Reports First Quarter 2020 Financial Results; Provides Business Update.

    Media Release
  13. Richter-Helm Biologics and INOVIO will expand existing DNA manufacturing agreement to support large-scale manufacturing of Inovio's investigational DNA vaccine for COVID-19.

    Media Release
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