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Middle East respiratory syndrome coronavirus vaccine - GeneOne Life Sciences/Inovio Pharmaceuticals

Drug Profile

Middle East respiratory syndrome coronavirus vaccine - GeneOne Life Sciences/Inovio Pharmaceuticals

Alternative Names: GLS 5300; INO-4301; INO-4700; MERS vaccine - GeneOne Life Sciences/Inovio Pharmaceuticals

Latest Information Update: 04 May 2020

At a glance

  • Originator Inovio Pharmaceuticals
  • Developer GeneOne Life Science; Inovio Pharmaceuticals; Walter Reed Army Institute of Research
  • Class Antivirals; 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

Highest Development Phases

  • Phase I/II Middle East respiratory syndrome coronavirus

Most Recent Events

  • 29 Apr 2020 Immunogenicity and adverse events data from a phase I/II trial in Middle East respiratory syndrome coronavirus released by Inovio Pharmaceuticals
  • 28 Feb 2019 No recent reports of development identified for phase-I development in Middle-East-respiratory-syndrome-coronavirus(Prevention) in USA (IM)
  • 05 Sep 2018 Inovio Pharmaceuticals plans a phase II trial for Middle East respiratory syndrome (Prevention) in the Middle East and Africa (Intradermal), in 2019

Development Overview

Introduction

Middle East respiratory syndrome coronavirus vaccine (INO 4700 also called GLS 5300) is a DNA vaccine targeting MERS coronavirus (MERS-CoV) spike S glycoprotein, being developed by GeneOne Life Sciences and Inovio Pharmaceuticals, for the prevention of middle-east respiratory syndrome [MERS] virus infection. The DNA vaccines is being developed by utilising Inovio's ASPIRE™ (Antigen SPecific Immune REsponses) platform. This platform delivers optimised synthetic antigenic genes into cells, to be translated into protein antigens that activate an individual's immune system to generate robust targeted T cell and antibody responses. The vaccine is delivered intradermally using the CELLECTRA® delivery device. Clinical development is underway in South Korea.

INOVIO's DNA vaccine deliver optimized plasmids directly into cells intramuscularly or intradermally using INOVIO's proprietary hand-held smart device called CELLECTRA®. CELLECTRA® uses a brief electrical pulse to open small pores in the cell reversibly to allow the plasmids to enter, overcoming a key limitation of other DNA and mRNA approaches. Once inside the cell, the plasmids are used by the cell's own machinery to generate coded antigens, which then stimulate an immune response, thereby strengthening the body's own natural defense mechanisms. Administration with the CELLECTRA device ensures that the DNA medicine is delivered directly into the body's cells, where it can go to work immediately mounting an immune response.

Inovio Pharmaceuticals in-licensed the intellectual property from the University of Pennsylvania. The programme was originally developed by VGX Pharmaceuticals, which was acquired and integrated into Inovio Biomedical, and later renamed Inovio Pharmaceuticals. The company is developing vaccines for various cancers (including HPV) and viral infections (including HIV, hepatitis C virus [HCV], smallpox, cytomegalovirus, and Chikungunya virus), and for the prevention of malaria [see AdisInsight drug profile 800026209].

As at February 2019, no recent reports of development had been identified for phase-I development in Middle-East-respiratory-syndrome-coronavirus (Prevention) in USA (IM).

Company Agreements

In April 2018, Inovio Pharmaceuticals entered into a partnership agreement with Coalition for Epidemic Preparedness Innovations (CEPI) under which, the former will develop vaccine candidates, INO 4500 and INO 4700, against Lassa fever and Middle East Respiratory Syndrome (MERS), respectively, by securing funding of up to $US56 million from the latter, to support Inovio’s preclinical and clinical advancement through phase II of INO 4500 and INO 4700. The funding will support development up to the end of phase II, providing clinical safety and immunological data, and the establishment of investigational stockpiles that will be ready for clinical efficacy trial testing during outbreaks. The two companies intend to make the vaccines available as soon as possible for emergency use. The agreement is expected to fund Inovio’s development efforts over a five-year period and also includes options, not counted in the total above, to establish investigational stockpiles of both vaccines. [1]

Inovio Pharmaceuticals entered into a collaboration with GeneOne Life Science for conducting a phase I trial of the former's DNA vaccine for MERS. Under the terms of the agreement, GeneOne will conduct and fund the study, and in return it will get milestone-based co-ownership of the immunotherapy. Following successful completion of the study, both the companies will seek for a third party for supporting and financing further development and commercialisation of the vaccine [2] .

In November 2015, GeneOne entered into a clinical development agreement with the Walter Reed Army Institute of Research for advancing the development of an MERS vaccine. Under the terms of the agreement, GeneOne and WRAIR will test the GLS 5300 vaccine in a first-in-human phase I clinical study to be executed at the WRAIR’s Clinical Trials Center while WRAIR will be responsible for all relevant MERS vaccine clinical trial procedures and costs at the Walter Reed Army Institute of Research [3] [4] .

Inovio Pharmaceuticals has a licensing agreement with the University of Pennsylvania covering technology and intellectual property for novel DNA vaccines and therapeutics. Inovio has exclusive worldwide rights to develop a number of DNA plasmids and constructs for the treatment and/or prevention of HIV, HCV, HPV and influenza. The original licence agreement was formed in 2007 between VGX Pharmaceuticals and the University [5] . In January 2010, the agreement was expanded to add exclusive worldwide licences for DNA vaccines against pandemic influenza, Chikungunya virus infections and foot-and-mouth disease, and also includes new chemokine and cytokine molecular adjuvant technologies. An amendment was made to the licensing agreement in June 2014 to add global rights to intellectual property and technology for synthetic therapies for the treatment of cancer, infectious diseases including tuberculosis and Middle East respiratory syndrome (MERS), and immune activators. The expanded agreement also includes rights to IL-12 encoded DNA plasmids. Inovio has made upfront and milestone payments to the University of Pennsylvania and the University is eligible for future milestone and royalty payments [6] .

Key Development Milestones

In September 2018, the first volunteer was dosed with MERS vaccine in a phase I/IIa trial, for the prevention of Middle East respiratory syndrome. The open label trial will enrol 60 patients in South Korea (NCT03721718; MERS-002) Earlier, in September 2017, GeneOne Life Science and Inovio Pharmaceuticals jointly initiated the trial in South Korea, following approval for initiation of the trial by the Korean Ministry of Food and Drug Safety. The study will assess vaccine dosing through an intradermal administration, which showed better tolerability and equal immunogenicity, compared with intramuscular administration of Inovio’s Ebola and HIV vaccines, in the previous studies. The study will also evaluate whether a two-dose vaccine regimen is comparative to a three-dose regimen [7] [8] . In April 2020, Inovio Pharmaceuticals released interim results from the trial [9] [10] .

In September 2017, GeneOne Life Sciences and Inovio Pharmaceuticals, in collaboration with the Walter Reed Army Institute of Research (WRAIR) completed a phase I trial that evaluated the safety and immunogenicity of GLS 5300 intramuscular, in healthy volunteers (NCT02670187; WRAIR 2274). The open label trial was initiated in January 2016, and enrolled 75 volunteers in the US. In October 2015, GeneOne and Inovio filed an IND application with the FDA to conduct the phase I study, which was subsequently approved in November 2015 [11] [4] [12] [13] . Interim immune response and safety data from the trial were reported in February 2017. Additional data from the trial were released by the company in September 2017 [14] [15] [16] . Updated immuogenicity data from the trial were released by the company in June 2018 [17] .

In November 2013, Inovio reported that preclinical tests of its MERS DNA vaccine produced robust and durable immune responses, demonstrating its potential to prevent and treat this virulent coronavirus infection. Inovio requires external funding to develop this vaccine further [18] . Additional preclinical study results, reported in August 2015, showed that the MERS DNA-vaccine induced 100% protection from a live virus challenge in animals. When administered in mice, camels and monkeys, the vaccine induced a robust immune response capable of preventing the virus from infecting cells. All the vaccinated monkeys in the study were protected from symptoms of MERS disease when challenged with a live MERS virus. The preclinical studies were conducted in collaboration with University of Pennsylvania, Public Health Agency of Canada, National Institutes of Health, University of Washington, and University of South Florida [19] .

In preclinical challenge studies, MERS vaccine protected 100% of vaccinated rhesus macaques from a lethal MERS virus challenge with two doses [7] .

Financing information

The International Vaccine Institute (IVI) is funding a trial [see above] [10] which is evaluating an intradermal formulation of GLS 5300 against the MERS virus. IVI will provide full financial assistance for the trial by utilising a $US34 million grant that Samsung Foundation had committed to IVI in 2015 for the development of a MERS vaccine [14] .

Drug Properties & Chemical Synopsis

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

    J07B-X (Other viral vaccines)

  • EPhMRA code

    J7C (All Other Vaccines)

Development Status

Summary Table

Indication Qualifier Patient Segment Phase Countries Route / Formulation Developers Event Date
Middle East respiratory syndrome coronavirus - Prevention Phase I/II South Korea Intradermal / unspecified GeneOne Life Science, Inovio Pharmaceuticals 09 Nov 2017
Middle East respiratory syndrome coronavirus - Prevention No development reported (I) USA IM / unspecified GeneOne Life Science, Walter Reed Army Institute of Research, Inovio Pharmaceuticals 28 Feb 2019

Commercial Information

Involved Organisations

Organisation Involvement Countries
Inovio Pharmaceuticals Originator USA
Inovio Pharmaceuticals Owner USA
GeneOne Life Science Licensee South Korea
University of Pennsylvania Technology Provider USA
International Vaccine Institute Funder South-Korea
Coalition for Epidemic Preparedness Innovations Funder Norway
Public Health Agency of Canada Collaborator Canada
University of Washington Collaborator USA
National Institutes of Health (USA) Collaborator USA
Walter Reed Army Institute of Research Collaborator USA
University of South Florida Collaborator USA

Scientific Summary

Adverse Events

Interim results from the phase I trial demonstrated that the vaccine was well tolerated and no significant safety concerns were noted to date [15] [13] .

Interim data through week 16 from a phase I/IIa trial showed that middle East respiratory syndrome coronavirus vaccine was well-tolerated and no vaccine-associated severe adverse events were observed in the trial [9] [10] .

Immunogenicity

Summary

Updated data from a phase I trial demonstrated that antibody responses by ELISA in 94% of subjects at week 14 (two weeks post-third dose). Also, broad-based t cell responses were observed in 88% of participants. No statistically significant dose-dependent differences in antibody response rates (91%, 95%, and 95% at doses of 0.67, 2, and 6 mg, respectively) were reported. Durable antibody responses to the vaccine were also maintained through 60 weeks following dosing. Earlier results demonstrated that after a three dose vaccine regimen with GLS 5300 intramuscular, high levels of binding antibodies were measured in 92% (57 of 62) of evaluated subjects. Earlier reported interim results showed that single or two doses of the vaccine generated a robust antibody response in 84% or 44% of evaluated participants, respectively. Significant antigen-specific cytotoxic T-lymphocyte (CTL) responses were observed and 98% of subjects generated an antibody and/or T cell response against the MERS vaccine. Results were presented from the 75 healthy volunteers [20] [17] [14] [15] [13] .

Interim results through week 16 from the phase I/IIa trial showed strong antibody and T cell immune responses after 2 or 3 doses with 0.6 mg of middle East respiratory syndrome coronavirus vaccine. 100% binding and 92% neutralizing antibody responses against MERS-CoV was observed. Seroconversion after a 2 dose regimen at 0 and 8 weeks was observed in 88% of patients, as compared to 84% and 100% seroconversion after 2 doses and 3 doses respectively in patients receiving a 3 dose regimen given at 0, 4 and 12 weeks. Additionally, 92% of the vaccine recipients in both groups displayed the ability to neutralize the virus using a neutralization assay. Robust T cell responses were observed in 60% of vaccine recipients after the 2 dose regimen and 84% of those in the 3 dose group. A binding antibody response rate of 74% and neutralization antibody response rate of 48% was demonstrated by a single dose of 0.6 mg of middle east respiratory syndrome coronavirus vaccine intradermal vaccination [9] [10] .

A DNA vaccine construct targeting multiple Middle Eastern respiratory syndrome (MERS) coronavirus antigens was immunogenic and seroconversion was observed in mice. The antibodies generated in 100% of the mice (n = 20) were able neutralise the MERS virus infection; unvaccinated mice (n = 10) did not produce neutralising antibodies. The vaccine also elicited a robust and broad T cell response in mice, producing CD8+ and CD4+ T cells responses against multiple epitopes of the MERS spike protein [18] .

The DNA-based MERS vaccine when administered in mice, camels and monkeys, induced a robust immune response capable of preventing the virus from infecting cells [19] .

Future Events

Expected Date Event Type Description Updated
31 Dec 2019 Trial Update Inovio Pharmaceuticals plans a phase II trial for Middle East respiratory syndrome (Prevention) in the Middle East and Africa (Intradermal), in 2019 [7] 08 Jan 2020
30 Sep 2018 Trial Update Inovio Pharmaceuticals and GeneOne Life Science plan a phase I/II trial for Middle east respiratory syndrome in South Korea, in the third quarter of 2018 [17] 07 Sep 2018
31 Dec 2017 Trial Update Inovio Pharmaceuticals plans a phase I/IIa trial for Middle east respiratory syndrome in South Korea in 2017 [14] 05 Jul 2018

Development History

Event Date Update Type Comment
29 Apr 2020 Scientific Update Immunogenicity and adverse events data from a phase I/II trial in Middle East respiratory syndrome coronavirus released by Inovio Pharmaceuticals [9] Updated 04 May 2020
28 Feb 2019 Phase Change - No development reported No recent reports of development identified for phase-I development in Middle-East-respiratory-syndrome-coronavirus(Prevention) in USA (IM) Updated 28 Feb 2019
05 Sep 2018 Trial Update Inovio Pharmaceuticals plans a phase II trial for Middle East respiratory syndrome (Prevention) in the Middle East and Africa (Intradermal), in 2019 [7] Updated 08 Jan 2020
27 Jun 2018 Trial Update Inovio Pharmaceuticals and GeneOne Life Science plan a phase I/II trial for Middle east respiratory syndrome in South Korea, in the third quarter of 2018 [17] Updated 07 Sep 2018
27 Jun 2018 Scientific Update Updated immunogenicity data from phase I trial in Middle East respiratory syndrome coronavirus infections released by Inovio Pharmaceuticals [17] Updated 05 Jul 2018
11 Apr 2018 Licensing Status Inovio Pharmaceuticals signs partnership agreement with Coalition for Epidemic Preparedness Innovations (CEPI) for development of Middle East respiratory syndrome coronavirus vaccine [1] Updated 13 Apr 2018
09 Nov 2017 Phase Change - I/II Phase-I/II clinical trials in Middle East respiratory syndrome coronavirus (Prevention) in South Korea (Intradermal) [8] Updated 14 Nov 2017
18 Sep 2017 Trial Update Inovio Pharmaceuticals plans a phase I/IIa trial for Middle east respiratory syndrome in South Korea in 2017 [14] Updated 05 Jul 2018
18 Sep 2017 Scientific Update Immunogenicity data from a phase I trial in Middle east respiratory syndrome released by Inovio Pharmaceuticals [14] Updated 25 Sep 2017
18 Sep 2017 Trial Update Inovio Pharmaceuticals receives approval from the Korean Ministry of Food and Drug Safety for a phase I/IIa trial of GLS 5300 for Middle east respiratory syndrome in South Korea [14] Updated 19 Sep 2017
01 Sep 2017 Trial Update GeneOne Life Science completes a phase I trial in Middle East respiratory syndrome coronavirus (Prevention) in USA (IM) (NCT02670187) Updated 16 Aug 2018
23 Feb 2017 Scientific Update Interim immunogenicity and safety results from the phase I trial were released by Inovio Pharmaceuticals [15] Updated 02 Mar 2017
08 Aug 2016 Trial Update GeneOne completes enrolment in its phase I trial for Middle East respiratory syndrome coronavirus (Prevention) in USA [11] Updated 09 Aug 2016
28 Jan 2016 Phase Change - I Phase-I clinical trials in Middle East respiratory syndrome coronavirus (Prevention) in USA (IM) (NCT02670187) Updated 02 Feb 2016
19 Nov 2015 Regulatory Status FDA approves a phase I trial of GLS 5300 for Middle Eastern respiratory syndrome coronavirus infections in USA [4] Updated 02 Feb 2016
10 Nov 2015 Licensing Status GeneOne enters into an agreement with Walter Reed Army Institute of Research for clinical development of Middle Eastern respiratory syndrome coronavirus vaccine [3] Updated 02 Feb 2016
19 Oct 2015 Regulatory Status Inovio files an IND application for GLS-5300 with the US FDA in USA for Middle East respiratory syndrome [12] Updated 02 Feb 2016
08 Sep 2015 Scientific Update Interim immunogenicity data from a preclinical trial in MERS coronavirus infections released by Inovio [19] Updated 02 Feb 2016
27 May 2015 Licensing Status Inovio Pharmaceuticals enters into a collaboration with GeneOne Life Science for a phase I trial of MERS vaccine [2] Updated 02 Feb 2016
27 May 2015 Trial Update Inovio Pharmaceuticals and GeneOne Life Science plan a phase I trial for MERS Coronavirus infections in USA [2] Updated 02 Feb 2016
20 Nov 2013 Phase Change - Preclinical Preclinical trials in Middle East respiratory syndrome coronavirus (Prevention) in USA (Intramsucular) Updated 02 Feb 2016

References

  1. Inovio Awarded up to $56 Million from CEPI to Advance DNA Vaccines Against Lassa Fever and MERS.

    Media Release
  2. Inovio Pharmaceuticals Partners with GeneOne Life Science for MERS Immunotherapy Clinical Development. 27-May-2015.

    Media Release
  3. GeneOne Life Science and the Walter Reed Army Institute of Research Partner to Develop MERS Vaccine.

    Media Release
  4. GeneOne Life Science and Inovio Pharmaceuticals MERS Vaccine Approved for First-in-Human Study.

    Media Release
  5. VGX Pharmaceuticals Announces DNA Vaccines License Agreement with University of Pennsylvania.

    Media Release
  6. Inovio Pharmaceuticals Broadens its Intellectual Property Portfolio from the University of Pennsylvania.

    Media Release
  7. Inovio Doses 1st Subject in Phase 1/2 Clinical Trial For Vaccine Against Deadly MERS Infection.

    Media Release
  8. Inovio Pharmaceuticals Reports 2017 Third Quarter Financial Results.

    Media Release
  9. INOVIO and GeneOne Life Science Report Positive Phase 1/2a Clinical Data With DNA Vaccine INO-4700 for MERS Coronavirus at the American Society of Gene & Cell Therapy (ASGCT) Conference.

    Media Release
  10. Phase I/IIa, Open-label, Dose Ranging Study to Evaluate the Safety, Tolerability and Immunogenicity of GLS-5300, Administered ID Followed by CELLECTRA 2000 (Electroporation, EP)

    ctiprofile
  11. GeneOne Life Science Announces Full Enrollment of First-In-Human Study of MERS Vaccine.

    Media Release
  12. Inovio and Partner Advance MERS Vaccine.

    Media Release
  13. 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
  14. Inovio and Partners Initiate Phase 1/2a Clinical Trial To Further Advance Its Vaccine Against Deadly MERS Infection.

    Media Release
  15. Inovio Reports New Positive Clinical Data on Vaccine Advances in the Fight Against Emerging Infectious Diseases.

    Media Release
  16. Inovio Pharmaceuticals Reports 2016 Second Quarter Financial Results.

    Media Release
  17. Inovios MERS Vaccine Generates High Levels of Antibodies and Induces Broad-based T Cell Responses in Phase 1 Study.

    Media Release
  18. Inovio Pharmaceutical's DNA Vaccine for the Deadly MERS Virus Induces Robust Immune Response in Preclinical Trial.

    Media Release
  19. Inovio Pharmaceuticals DNA Vaccine Protects 100% Against Deadly MERS Virus in Non-Human Primates.

    Media Release
  20. Inovio's Positive First-in-Human MERS Vaccine Results Published in The Lancet Infectious Diseases.

    Media Release
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