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COVID eVax - Takis

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Drug Profile

COVID eVax - Takis

Alternative Names: 2019-nCoV coronavirus vaccine - Takis; Coronavirus vaccine - Takis; COVID-eVax

Latest Information Update: 02 Oct 2021

Print Profile Download Citation

At a glance

  • Originator Takis
  • Developer Rottapharm Biotech; Takis
  • Class COVID-19 vaccines; DNA vaccines; Synthetic 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 - COVID 2019 infections

Highest Development Phases

  • Phase I/II COVID 2019 infections

Most Recent Events

  • 03 Feb 2021 The Italian Medicines Agency approves clinical trial application for COVID-eVax in COVID-2019 infections (Prevention)
  • 03 Feb 2021 Phase-I/II clinical trials in COVID-2019 infections (Prevention, In volunteers) in Italy (IM, Injection) (EudraCT2020-003734-20) (NCT04788459)
  • 22 Sep 2020 Pharmacodynamics data from a preclinical study in COVID-2019 infections released by Takis

Development Overview

Introduction

COVID eVax is a synthetic DNA vaccine being developed by Takis, in collaboration with Rottapharm Biotech and Evvivax (a spin-off of Takis), for the prevention of COVID-2019 infections. Takis and Evvivax developed vaccines based on genetic technologies capable of inducing immune responses. The technologies are based on genetic engineering techniques and on the use of viruses and DNA fragments that can be used both for gene therapy and for vaccination. Clinical development is underway in Italy.

COVID eVax is based on a DNA fragment injected into the muscle that promotes the production of a specific portion of the spike protein and stimulates a strong immune reaction against the virus. The efficiency of the process is increased by the electroporation technique, which allows the faster passage of DNA inside the cells, with a light and short electrical stimuli, which also acts as an adjuvant, without side effects. Takis is collaborating with IGEA, using the latter company's electroporator for this electroporation technique for product development.

The company is seeking collaboration and financing partners, for the development of COVID eVax (Takis website, February 2020).

Company Agreements

In July 2020, Takis entered in a research agreement with Fondazione Melanoma for clinical development of COVID eVax for COVID-2019 infections [1]

Key Development Milestones

In February 2021, Takis initiated the phase I/II trial to evaluate safety and immunogenicity of COVID eVax in healthy volunteers (EudraCT2020-003734-20; COV1/2-01; NCT04788459). The phase I part will include 80 healthy volunteers divided into four groups with different doses administered with or without booster, while phase II part will dose up to 160 subjects. The open label, dose escalating trial will enroll approximately 160 participants in Italy [2] . In February 2021, Takis and Rottapharm Biotech received authorisation from the Italian Medicines Agency (AIFA) for the phase I/II trial of COVID-eVax against COVID-2019 infections [3] . In March 2021, the first healthy volunteers were dosed in the study [4] .

In September 2020, Takis presented preclinical data from animal models [1]

In April 2020, Takis presented preclinical data where COVID eVax in animal models induced strong antibody response against the Covid-19 Spike protein in just 14 days [5] .

In January 2020, Takis and Evvivax initiated research on COVID eVax [6] .

Drug Properties & Chemical Synopsis

  • Route of administration IM
  • Formulation Injection
  • Class COVID-19 vaccines, DNA vaccines, Synthetic vaccines, Viral vaccines
  • Mechanism of Action Immunostimulants
  • WHO ATC code

    J07B-X (Other viral vaccines)

  • EPhMRA code

    J7E (Viral Vaccines)

Biomarkers Sourced From Trials

Indication Biomarker Function Biomarker Name Number of Trials

cOVID 2019 infections

Outcome Measure

phosphatidylinositol-4-phosphate 3-kinase catalytic subunit type 2 alpha

Interferon Gamma (IFNg)

Creatine

1 more biomarker names

Show less

1

1

1

Biomarker

Drug Name Biomarker Name Biomarker Function
COVID eVax - Takis Creatine Outcome Measure
Interferon Gamma (IFNg) Outcome Measure
phosphatidylinositol-4-phosphate 3-kinase catalytic subunit type 2 alpha Outcome Measure
For more detail, check out BiomarkerBase: the leading source of information about biomarkers used in drug development and diagnostic tests, tracking a comprehensive list of biomarker uses worldwide by over 800 companies

Trial Landscape

Indication Phase 0 Phase I Phase II Phase III Phase IV
COVID 2019 infections - - 1 - -

Development Status

Summary Table

Download Data (CSV)
Indication Qualifier Patient Segment Phase Countries Route / Formulation Developers Event Date
COVID 2019 infections Device: Cliniporator® and EPSGun In volunteers, Prevention Phase I/II Italy IM / Injection Rottapharm Biotech, Takis 25 Feb 2021

Commercial Information

Involved Organisations

Organisation Involvement Countries
Takis Originator Italy
Takis Owner Italy
IGEA Technology Provider Italy
Evvivax Collaborator Italy
Fondazione Melanoma Collaborator Italy
Rottapharm Biotech Collaborator Italy

Licensing Availability

Licensing Organisation Available Indication Available Phase Region Date
Takis COVID 2019 infections Unspecified - 11 Feb 2020

Scientific Summary

Pharmacodynamics

Results from preclinical studies in animal models demonstrated that a single administration of COVID eVax generated a significant immune response which was observed to be increased following a second injection. Neutralising antibodies were observed to be generated in blood and lungs. Also, a cellular response was observed following COVID eVax administration [1]

Development History

Event Date Update Type Comment
16 Mar 2021 Biomarker Update Biomarkers information updated Updated 02 Oct 2021
03 Feb 2021 Regulatory Status The Italian Medicines Agency approves clinical trial application for COVID-eVax in COVID-2019 infections (Prevention) [3] Updated 03 Mar 2021
03 Feb 2021 Phase Change - I/II Phase-I/II clinical trials in COVID-2019 infections (Prevention, In volunteers) in Italy (IM, Injection) (EudraCT2020-003734-20) (NCT04788459) Updated 25 Feb 2021
22 Sep 2020 Scientific Update Pharmacodynamics data from a preclinical study in COVID-2019 infections released by Takis [1] Updated 28 Sep 2020
18 Jul 2020 Licensing Status Takis and Fondazione Melanoma agree for clinical trial development of COVID eVax for COVID-2019 infections [1] Updated 28 Sep 2020
11 Feb 2020 Licensing Status Coronavirus vaccine - Takis is available for licensing as of 11 Feb 2020. http://www.takisbiotech.it/index.php/en/ Updated 11 Feb 2020
27 Jan 2020 Phase Change Early research in COVID-2019-infections (Prevention) in Italy [6] Updated 06 Feb 2020

References

  1. Takis and the Melanoma Foundation together towards the vaccine against COVID-19.

    Media Release

  2. A Phase I/II Study to Assess the Safety and Immunogenicity of COVID-eVax, a Candidate Plasmid DNA Vaccine for COVID-19, in Healthy Adult Volunteers

    ctiprofile

  3. 3 February 2021 - Takis and Rottapharm Biotech announce the authorization of the clinical trial by the Italian Medicines Agency (AIFA) of COVID-eVax.

    Media Release

  4. 1 March 2021 - The phase I/II Clinical Study of the first European DNA Vaccine against Covid-19 has started today in Italy.

    Media Release

  5. 10 April 2020 - Takis candidate vaccines against Covid-19 induces a strong antibody response.

    Media Release

  6. Takis and Evvivax developing a 2019-nCoV Coronavirus vaccine.

    Media Release
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