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GLS 5700

Drug Profile

GLS 5700

Alternative Names: GLS5700; INO-4600

Latest Information Update: 28 Apr 2020

At a glance

  • Originator GeneOne Life Science; Inovio Pharmaceuticals
  • Class DNA vaccines; Monoclonal antibodies; Viral vaccines; Zika virus 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 - Zika virus infection

Highest Development Phases

  • Phase I Zika virus infection

Most Recent Events

  • 28 Feb 2020 No recent reports of development identified for preclinical development in Zika-virus-infection in South Korea (Intradermal)
  • 31 Dec 2019 Phase I development in Zika-virus-infection (Prevention) is still ongoing in Canada and USA (Intradermal) (NCT02809443)
  • 31 Dec 2019 Phase I development in Zika-virus-infection (In adults, In the elderly, Prevention) is still ongoing in Puerto Rico (Intradermal)

Development Overview

Introduction

GLS 5700, a DNA-based synthetic vaccine, is being developed by GeneOne Life Science and Inovio Pharmaceuticals, for prevention and treatment of Zika virus infections, utilising Inovio's SynCon® technology. The vaccine encodes the pre-membrane and envelope antigens of Zika and has indicated protective antibody and therapeutic T cell responses against the indication. Inovio’s optimised DNA-based immunotherapy platform targets both immediate therapy through delivery of dMAb products as well as long-term immunity via DNA vaccination. Phase I development of intradermal formulation is underway in Puerto Rico, US and Canada.

As at February 2020, no recent reports of development had been identified for preclinical development in Zika-virus-infection in South Korea (Intradermal).

Company Agreements

In January 2016, GeneOne Life Science and Inovio Pharmaceuticals entered into a collaboration to develop a DNA-based vaccine for Zika virus infections [1] .

Key Development Milestones

As at April 2020, GLS 5700 was in phase I development for prevention of zika virus infections in Canada, Puerto Rico and the US [2] .

In June 2017, Inovio announced that a phase II trial for the prevention of Zika virus infection has been planned [3] .

In June 2018, Inovio Pharmaceuticals and GeneOne Life Science completed a phase I trial that evaluated the safety, tolerability and immunogenicity of GLS 5700 with Inovio's CELLECTRA®-3P device, for the prevention of Zika virus infection (Zika-002; NCT02887482). The randomised, double blind, placebo control trial was initiated in August 2016, and enrolled 160 patients in Puerto Rico [4] [5] [6] [7] .

Updated results from the phase I trial that evaluated the safety, tolerability, and immunogenicity of GLS 5700 for the prevention of Zika virus infection were released in June 2017 (NCT02809443; Zika001). The trial was completed in November 2016 and preliminary results were presented in December 2016 [3] [8] . The first-in-man phase I study enrolled 40 volunteers, administered with GLS 5700 with Inovio's proprietary DNA delivery device, CELLECTRA® in the US and Canada. In July 2016, the company received approval from Health Canada’s Health Products and Food Branch to conduct the phase I trial in Canada. Earlier, in June 2016, Inovio had received the US FDA approval to initiate the study. Inovio Pharmaceuticals released data from the trial in October 2017 [9] [10] [6] [11] [12] [13] [14] [15] .

In non-human primate models, two doses of the Zika DNA vaccine delivered either intramuscularly or intradermally resulted in seroconversion, or the development of detectable specific antibodies in the blood, in all vaccinated animals. The DNA vaccine developed using SynCon constructs were administered using Inovio's CELLECTRA® electroporation delivery technology [16] .

Zika virus DNA vaccine produced a robust antibody and killer T cell response in preclinical mice models and detectable specific antibodies were identified in all vaccinated mice [14] .

Immunogenicity of the Zika virus vaccine candidate is being evaluated in animal studies [1] .

Financing information

In July 2017, Inovio completed an underwritten public offering of common stock, raising net proceeds of $US70.2 million after the discounts and estimated offering expenses. The company expects to use the net proceeds for the development of GLS 5700 [17] .

In December 2016, Inovio received a sub-grant of $US6.1 million from the Wistar Institute, who had received the grant from the Bill & Melinda Gates Foundation, to develop a mononoclonal antibody therapy for the for the prevention of Zika virus infection [18] .

Drug Properties & Chemical Synopsis

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

    J07B-X (Other viral vaccines)

  • EPhMRA code

    J7E (Viral Vaccines)

Development Status

Summary Table

Indication Qualifier Patient Segment Phase Countries Route / Formulation Developers Event Date
Zika virus infection - In adults, In the elderly, Prevention Phase I Puerto Rico Intradermal / unspecified GeneOne Life Science, Inovio Pharmaceuticals 29 Aug 2016
Zika virus infection - Prevention Phase I Canada, USA Intradermal / unspecified GeneOne Life Science, Inovio Pharmaceuticals 01 Jul 2016
Zika virus infection - - No development reported (Preclinical) South Korea Intradermal / unspecified GeneOne Life Science, Inovio Pharmaceuticals 28 Feb 2020

Commercial Information

Involved Organisations

Organisation Involvement Countries
GeneOne Life Science Originator South-Korea
Inovio Pharmaceuticals Originator USA
GeneOne Life Science Owner South-Korea
Inovio Pharmaceuticals Owner USA
Wistar Institute Funder USA
Universite Laval Collaborator Canada

Licensing Availability

Licensing Organisation Available Indication Available Phase Region Date
Inovio Pharmaceuticals Zika virus infection Phase II - 15 Jun 2017

Scientific Summary

Adverse Events

Results from the phase I ZIKA-001 study showed that the GLS 5700 vaccine was well tolerated and no significant safety concerns were observed [4] [15] .

Pharmacodynamics

Summary

Preclinical data showed that the GLS 5700, zika vaccine induced robust and durable immune responses. The vaccine resulted in seroconversion, or the development of detectable specific antibodies in the blood, and robust and broad T cell responses in all vaccinated mice. GLS 5700 protected 100% of mice from infection, brain damage and death after exposure to the virus. The vaccinated mice were protected from degeneration in the cerebral cortex and hippocampal areas of the brain while un-vaccinated mice showed significant degeneration of the brain after Zika infection. The vaccine was administered using Inovio's CELLECTRA® electroporation delivery technology (Inovio Pharmaceuticals, Form 10-K, March 2016) [3] .

A single dose of GLS 5700 provided 100% protection from the virus in a study of non-human primates from death and neurological or testicular effects of Zika virus [3] .

Mice treated with serum samples from GLS 5700 vaccinated subjects from the phase I ZIKA-001 trial, were found to be protected from death and illness in more than 90% of the animals, after they were administered a lethal dose of the zika virus [9] .

Immunogenicity

Summary

In the phase I ZIKA-001 trial, high levels of binding antibodies were measured in 100% of evaluated subjects, after three doses of GLS 5700 vaccine regimen, and in 95% after two doses of vaccine. Further, neutralizing antibodies were observed in more than 95% of the serum samples that were assayed on neuronal-cell targets. Earlier reported data showed a robust antibody response in 95% and 40% of the volunteers by two doses or a single dose of vaccine, respectively. The parallel-assignment trial enrolled 40 volunteers for the prevention of zika virus infection [9] [3] [5] [15] .

Development History

Event Date Update Type Comment
28 Feb 2020 Phase Change - No development reported No recent reports of development identified for preclinical development in Zika-virus-infection in South Korea (Intradermal) Updated 28 Feb 2020
31 Dec 2019 Active Status Review Phase I development in Zika-virus-infection (Prevention) is still ongoing in Canada and USA (Intradermal) [2] (NCT02809443) Updated 28 Apr 2020
31 Dec 2019 Active Status Review Phase I development in Zika-virus-infection (In adults, In the elderly, Prevention) is still ongoing in Puerto Rico (Intradermal) [2] Updated 28 Apr 2020
28 Oct 2019 Phase Change - No development reported No recent reports of development identified for phase-I development in Zika-virus-infection(In the elderly, In adults, Prevention) in Puerto Rico (Intradermal) Updated 28 Oct 2019
28 Aug 2019 Phase Change - No development reported No recent reports of development identified for phase-I development in Zika-virus-infection (Prevention) in Canada (Intradermal) Updated 28 Aug 2019
28 Aug 2019 Phase Change - No development reported No recent reports of development identified for phase-I development in Zika-virus-infection (Prevention) in USA (Intradermal) Updated 28 Aug 2019
01 Jun 2018 Trial Update Inovio completes the phase I ZIKA-002 trial for Zika virus infection (In adults, In the elderly, Prevention) in Puerto Rico (Intradermal) (NCT02887482) Updated 21 Dec 2018
05 Oct 2017 Scientific Update Immunogenicity data from a phase I trial in Zika virus infection (Prevention) released by Inovio Pharmaceuticals [9] Updated 13 Oct 2017
05 Oct 2017 Scientific Update Pharmacodynamics data from a preclinical trial in Zika virus infection released by Inovio Pharmaceuticals [9] Updated 13 Oct 2017
15 Jun 2017 Scientific Update Adverse events data from the phase I ZIKA-001 trial in Zika virus infection released by Inovio [4] Updated 06 Jul 2017
15 Jun 2017 Trial Update Inovio completes enrolment in the phase I ZIKA-002 trial for Zika virus infection (In adults, In the elderly, Prevention) in Puerto Rico (Intradermal) [4] Updated 23 Jun 2017
07 Jun 2017 Scientific Update Immunogenicity data from a phase I trial in Zika virus infection (Prevention) released by Inovio [3] Updated 22 Jun 2017
07 Jun 2017 Scientific Update Pharmacodynamics data from preclinical studies in Zika virus infection released by Inovio Pharmaceuticals [3] Updated 22 Jun 2017
07 Jun 2017 Trial Update Inovio plans a phase II trial for Zika virus infection (Prevention) [3] Updated 22 Jun 2017
15 Mar 2017 Scientific Update Immunogenicity data from phase I tria in Zika virus infections released by Inovio Pharmaceuticals [5] Updated 17 Mar 2017
01 Nov 2016 Trial Update GeneOne Life Science and Inovio Pharmaceuticals complete a phase I trial (Prevention) for Zika virus infections in USA and Canada (NCT02809443) Updated 06 Mar 2017
29 Aug 2016 Phase Change - I Phase-I clinical trials in Zika virus infection (Prevention, In adults, In the elderly) in Puerto Rico (Intradermal) [6] Updated 01 Sep 2016
29 Aug 2016 Trial Update Inovio Pharmaceuticals completes enrolment in its phase I trial for Zika virus infections (Prevention) in USA and Canada (NCT02809443) [6] Updated 01 Sep 2016
26 Jul 2016 Regulatory Status Health Canada approves IND application for GLS 5700 in Zika virus infection [12] Updated 27 Jul 2016
01 Jul 2016 Phase Change - I Phase-I clinical trials in Zika virus infection (Prevention) in Canada after July 2016 (Intradermal) (NCT02809443) [6] Updated 01 Sep 2016
01 Jul 2016 Phase Change - I Phase-I clinical trials in Zika virus infection (Prevention) in USA (Intradermal) (NCT02809443) Updated 27 Jul 2016
17 Feb 2016 Trial Update Inovio Pharmaceuticals plans a phase I trial for Zika virus infections in USA [14] , NCT02809443) Updated 18 Feb 2016
08 Feb 2016 Regulatory Status Inovio Pharmaceuticals intends to launch Zika virus vaccine in early 2018 Updated 28 Apr 2020
08 Feb 2016 Regulatory Status Inovio Pharmaceuticals intends to submit regulatory application for approval of Zika virus vaccine in 2017 Updated 28 Apr 2020
01 Feb 2016 Scientific Update Preclinical data released by Inovio Pharmaceuticals and GeneOne Life Sciences (Inovio Pharmaceuticals, Form 10-K, March 2016) Updated 28 Mar 2016
22 Jan 2016 Phase Change - Preclinical Preclinical trials in Zika virus infection in USA (unspecified route) Updated 19 Feb 2016
22 Jan 2016 Phase Change - Preclinical Preclinical trials in Zika virus infection in South Korea (unspecified route) [1] Updated 28 Jan 2016
22 Jan 2016 Licensing Status GeneOne Life Science and Inovio Pharmaceuticals agree to co-develop Zika virus vaccine for Zika virus infections [1] Updated 27 Jan 2016

References

  1. GeneOne Life Science and Inovio Pharmaceuticals to Collaborateon Zika Virus Vaccine Development.

    Media Release
  2. Inovio Pharmaceuticals - Form 10K - December 2019. Internet-Doc 2020;.

    Available from: URL: https://www.sec.gov/Archives/edgar/data/1055726/000105572620000012/ino-12312019x10k.htm
  3. Inovio Zika Vaccine Prevents Persistence of Virus and Damage in Male Reproductive Tract in Pre-Clinical Study.

    Media Release
  4. Inovio Fully Enrolls 160 Subjects in Puerto Rico for Second Zika Vaccine Phase 1 Trial; Continues Leadership to Advance an Effective Preventive Solution.

    Media Release
  5. Inovio Pharmaceuticals Reports 2016 Fourth Quarter and Year End Financial Results.

    Media Release
  6. Inovio Launches Zika Vaccine Trial in Midst of Puerto Rico Epidemic to Explore Early Signals of Vaccine Efficacy.

    Media Release
  7. Phase I, Placebo-Controlled, Double-Blind Study To Evaluate The Safety, Tolerability, AND Immunogenicity Of GLS-5700, Administered ID Followed By Electroporation In Dengue Virus-Seropositive Adults

    ctiprofile
  8. Inovio Reports New Positive Clinical Data on Vaccine Advances in the Fight Against Emerging Infectious Diseases.

    Media Release
  9. Inovios Positive Zika Vaccine Clinical Study Data Published in New England Journal of Medicine.

    Media Release
  10. Inovios Zika VaccineGenerates Robust Immune Responses in First Human Study.

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

    Media Release
  12. Inovio Pharmaceuticals Doses First Subject in Zika Vaccine Clinical Trial.

    Media Release
  13. Inovio Pharmaceuticals and GeneOne Life Science Receive Approval for First-in-Man Zika Vaccine Clinical Trial.

    Media Release
  14. Inovio Pharmaceutical's DNA Vaccine for Zika Virus Induces Robust Immune Responses in Preclinical Study.

    Media Release
  15. Phase I, Open-label, Dose-Ranging Study to Evaluate the Safety, Tolerability, and Immunogenicity of GLS-5700 Administered ID Followed by EP in Dengue Virus-Naïve Adults

    ctiprofile
  16. Inovio Pharmaceuticals Zika VaccineProduces Robust Immune Responses in Non-Human Primates.

    Media Release
  17. Inovio Pharmaceuticals Reports 2017 Second Quarter Financial Results.

    Media Release
  18. Inovio Pharmaceuticals Awarded $6.1 Million Sub-grant Through Wistar Institute to Develop DNA-based Monoclonal Antibodies Against Zika Virus.

    Media Release
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