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Research programme: linear DNA based coronavirus vaccines - LineaRx/Takis

Drug Profile

Research programme: linear DNA based coronavirus vaccines - LineaRx/Takis

Alternative Names: 2019-nCoV coronavirus vaccine - LineaRx/Takis; Linear DNA based coronavirus vaccines - Takis/LineaRx

Latest Information Update: 12 May 2020

At a glance

  • Originator LineaRx; Takis
  • 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

Highest Development Phases

  • Preclinical COVID 2019 infections

Most Recent Events

  • 04 May 2020 Preclinical trials in COVID-2019 infections (Prevention) in Italy (Parenteral)
  • 04 May 2020 Preclinical trials in COVID-2019 infections (Prevention) in USA (Parenteral)
  • 03 Apr 2020 LineaRx and Takis expands joint development agreement for linear DNA based coronavirus vaccines to include a fifth vaccine candidate

Development Overview

Introduction

Linear DNA based coronavirus vaccines are being developed by Takis and LineaRx (a wholly owned subsidiary of Applied DNA sciences) for the prevention of COVID-2019 infections. The linear DNA vaccine candidates will be delivered via Takis' proprietary in vivo electro-gene-transfer technology. LineaRx will use its PCR methods for the production of linear DNA which is cleaner, faster and more easily modified in comparison with DNA produced using standard methods. Preclinical study is underway in the US and Italy.

Under this programme, five DNA vaccine candidates will be developed for preclinical animal testing. Takis will use the scaled-up LinearDNA™ synthetic genes produced by Applied DNA for each of the four putative vaccines to inoculate mice, whose sera will be tested for the presence of antibodies that bind to the purified spike proteins. The positive candidates that bind to spike will be tested for their ability to neutralize COVID-19 by preventing uptake of the virus in cells in culture and in animal models [1] .

Company Agreements

In March 2020, LineaRx (subsidiary of Applied DNA Sciences) expanded its joint development agreement with Takis for COVID-19 vaccine development program to include a fifth vaccine candidate. Under the terms of the companies’ amended Joint Development Agreement, Takis will use the scaled-up LinearDNA synthetic genes produced by Applied DNA for each of the five putative vaccines to inoculate mice whose sera will be tested for the presence of antibodies that bind to the purified Spike proteins. Those positive candidates that bind to Spike will be tested for their ability to neutralize COVID-19 by preventing uptake of the virus in cells in culture and in animal models. Previously in February 2020, LineaRx expanded its joint development agreement with Takis for the preclinical development of a linear DNA vaccine against COVID-2019 infections. Earlier in September 2018, LineaRx entered into a joint development agreement with Takis for the discovery and development of DNA based anti-cancer vaccines. Under the terms of the agreement, both companies will jointly develop linear DNA expression vectors for two of Takis anticancer vaccine candidates using LineaRx's linear DNA technology. Linear DNA amplicons carrying the DNA sequences for Takis vaccine candidates will be delivered to preclinical animal models via Takis's proprietary electroporation technology for measurement of the antigen-specific immune responses. Further details of the agreement were not disclosed. [2] [1] [3]

Key Development Milestones

In May 2020, Applied DNA sciences and Takis Biotech announced that nutralising antibodies have been produced in test animals after the first injections of the DNA vaccine candidates against the Spike protein (product of the S gene) of the SARS-CoV-2 virus that causes COVID-2019 infections [4] .

In April 2020, LineaRx announced that it has completed qualification, production and shipment of five vaccine candidates to Takis Biotech in Italy. In March 2020, LineaRx and Takis Biotech had announced expansion of their COVID-2019 vaccine development program to include a fifth vaccine candidate. Along with the planned Takis animal trials, LineaRx plans to prepare for cGMP production of selected vaccine candidate(s) to support human trials scheduled to begin in fall [5] [3] .

In March 2020, Italian Ministry of Health approved to test the linear DNA based coronavirus vaccines in animal models. The preliminary examination to test the tolerability and efficacy will be conducted at the Spallanzani Institute [6] .

Early research of linear DNA vaccines against COVID-2019 infections is ongoing [1] .

Drug Properties & Chemical Synopsis

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

    J07B-X (Other viral vaccines)

  • EPhMRA code

    J7A9 (Other specified single component)

Development Status

Summary Table

Indication Qualifier Patient Segment Phase Countries Route / Formulation Developers Event Date
COVID 2019 infections - Prevention Preclinical Italy, USA Parenteral / unspecified LineaRx, Takis 04 May 2020

Commercial Information

Involved Organisations

Organisation Involvement Countries
LineaRx Originator USA
Takis Originator Italy
Takis Owner Italy
LineaRx Owner USA
The Lazzaro Spallanzani National Institute for Infectious Diseases Collaborator Italy

Future Events

Expected Date Event Type Description Updated
30 Apr 2020 Trial Update Applied DNA Sciences and Takis Biotech plan Preclinical studies in COVID-2019 infections in late April 2020 [3] 12 May 2020

Development History

Event Date Update Type Comment
04 May 2020 Phase Change - Preclinical Preclinical trials in COVID-2019 infections (Prevention) in Italy (Parenteral) [4] Updated 12 May 2020
04 May 2020 Phase Change - Preclinical Preclinical trials in COVID-2019 infections (Prevention) in USA (Parenteral) [4] Updated 12 May 2020
03 Apr 2020 Licensing Status LineaRx and Takis expands joint development agreement for linear DNA based coronavirus vaccines to include a fifth vaccine candidate [3] Updated 08 Apr 2020
03 Apr 2020 Trial Update LineaRX and Takis plan clinical trials for for Linear DNA based coronavirus vaccines in COVID-19 infections [3] Updated 08 Apr 2020
02 Apr 2020 Trial Update Applied DNA Sciences and Takis Biotech plan Preclinical studies in COVID-2019 infections in late April 2020 [3] Updated 12 May 2020
17 Mar 2020 Regulatory Status Italian Ministry of Health authorizes to conduct preclinical tests on animal models for Linear DNA based coronavirus vaccine in COVID-19 infections [6] Updated 20 Mar 2020
07 Feb 2020 Licensing Status LineaRx and Takis expands joint development agreement for preclinical development of linear DNA based coronavirus vaccine [1] Updated 19 Feb 2020
07 Feb 2020 Phase Change Early research in COVID-2019-infections (Prevention) in Italy (Parenteral) [1] Updated 19 Feb 2020
07 Feb 2020 Phase Change Early research in COVID-2019-infections (Prevention) in USA (Parenteral) [1] Updated 19 Feb 2020

References

  1. Applied DNA Sciences Subsidiary, LineaRx, and Takis Biotech Collaborate for Development of a Linear DNA Vaccine Candidate Against Wuhan Coronavirus 2019-nCoV.

    Media Release
  2. LineaRx signs agreement with Takis/Evvivax to develop linear-DNA based anti-cancer vaccines.

    Media Release
  3. Applied DNA and Takis Biotech Expand COVID-19 Vaccine Development Program to Include 5th Candidate.

    Media Release
  4. Applied DNA and Takis Biotech Announce the Production of Neutralizing Antibodies Against SARS-CoV-2 After DNA Vaccination in Animals.

    Media Release
  5. Applied DNA Ships COVID-19 LinearDNA(T) Vaccine Candidates to Italian Development Partner to Begin Preclinical Animal Testing.

    Media Release
  6. Rome, 17 March 2020 - Takis, a biotech company in Castel Romano, Rome, announces that it is ready to test its Covid-19 vaccine on pre-clinical models.

    Media Release
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