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Coronavirus vaccine - CureVac

Drug Profile

Coronavirus vaccine - CureVac

Alternative Names: nCoV-2019 vaccine - CureVac

Latest Information Update: 20 May 2020

At a glance

  • Originator CureVac
  • Class RNA 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

Highest Development Phases

  • Preclinical COVID 2019 infections

Most Recent Events

  • 14 May 2020 Preclinical trials in COVID-2019 infections (Prevention) in Germany (unspecified route) before May 2020
  • 14 May 2020 CureVac plans a phase I/IIa trial for COVID 2019 infections (In volunteers) in June 2020
  • 06 Feb 2020 Coronavirus vaccine - CureVac is available for licensing as of 31 Jan 2020. https://www.curevac.com/partnering

Development Overview

Introduction

Coronavirus vaccines are mRNA based vaccines is being developed by CureVac in collaboration with Coalition for Epidemic Preparedness Innovations by using Curevac's mRNA technology for the prevention of COVID-2019 infections. The vaccine uses The RNA Printer™ technology, that delivers mRNA directly into the cell, to be translated against specific viral protein/antigen to induce immune response. To prevent mRNA degradation and improve it effectiveness the mRNA is encapsulated into the lipid nanoparticles. The RNA Printer™ technology is capable of producing several grams of LNP-formulated mRNA within few weeks, making it cost effective and time saving compared to traditional vaccine platforms. Preclinical trial is underway in Germany.

Company Agreements

In January 2020, CureVac and Coalition for Epidemic Preparedness Innovations (CEPI) extended their collaboration to develop vaccine against COVID-2019 infections. Initial funds up to $US8.3 miilion will be provided by CEPI to CureVac for the vaccine development, manufacturing and clinical tests. In February 2019, Coalition for Epidemic Preparedness Innovations (CEPI) and CureVac entered into a partnership agreement worth upto $US34 million for The RNA Printer™ prototype to develop lipid-nanoparticle (LNP)-formulated mRNA vaccine candidates. Under the terms of the three-year partnership agreement, CureVac will use its mRNA plaform to undertake preclinical development of vaccine candidates against coronavirus infections, Lassa Fever (which is listed on the WHO’s R&D blueprint for priority diseases), Rabies, and Yellow Fever. Following successful preclinical tests for the three named indications, two of the vaccine candidates will undergo phase I clinical trials in humans. [1] [2]

Key Development Milestones

In January 2020, CureVac launched pre-clinical tests with a variety of potential antigenic constructs based on the spike protein to elicit high immunogenicity. As of May 2020, in preclinical studies, vaccine showed a fast induction of a balanced immune response with high levels of virus neutralizing titers (VNTs) and T-cell responses [3] .

Financing information

A coronavirus vaccine received financial support from the Coalition for Epidemic Preparedness Innovations (CEPI), the Bill & Melinda Gates Foundation as well as from the Defense Advanced Research Projects Agency (DARPA), an agency of the US Department of Defense [3]

Drug Properties & Chemical Synopsis

  • Formulation unspecified
  • Class RNA 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 Germany unspecified / unspecified CureVac 14 May 2020

Commercial Information

Involved Organisations

Organisation Involvement Countries
CureVac Originator Germany
CureVac Owner Germany
Bill & Melinda Gates Foundation Funder USA
Defense Advanced Research Projects Agency Funder USA
Coalition for Epidemic Preparedness Innovations Collaborator Norway

Licensing Availability

Licensing Organisation Available Indication Available Phase Region Date
CureVac - Unspecified - 31 Jan 2020

Future Events

Expected Date Event Type Description Updated
30 Jun 2020 Trial Update CureVac plans a phase I/IIa trial for COVID 2019 infections (In volunteers) in June 2020 [3] 20 May 2020

Development History

Event Date Update Type Comment
14 May 2020 Phase Change - Preclinical Preclinical trials in COVID-2019 infections (Prevention) in Germany (unspecified route) before May 2020 [3] Updated 20 May 2020
14 May 2020 Trial Update CureVac plans a phase I/IIa trial for COVID 2019 infections (In volunteers) in June 2020 [3] Updated 20 May 2020
06 Feb 2020 Licensing Status Coronavirus vaccine - CureVac is available for licensing as of 31 Jan 2020. https://www.curevac.com/partnering Updated 17 Feb 2020
31 Jan 2020 Licensing Status CureVac and Coalition for Epidemic Preparedness Innovations (CEPI) entered into a research and development agreement to develop Coronavirus vaccine in Germany for COVID-2019 infections [2] Updated 17 Feb 2020
31 Jan 2020 Phase Change Early research in COVID-2019-infections (Prevention) in Germany (unspecified route) [2] Updated 17 Feb 2020

References

  1. CEPI awards US$ 34M contract to CureVac to advance The RNA Printer(Tm)a disruptive, transportable mRNA vaccine manufacturing platform that can rapidly combat multiple diseases.

    Media Release
  2. CureVac and CEPI extend their Cooperation to Develop a Vaccine against Coronavirus nCoV-2019.

    Media Release
  3. CureVac##180##s Optimized mRNA Platform Provides Positive Pre-Clinical Results at Low Dose for Coronavirus Vaccine Candidate.

    Media Release
  4. CureVac CEO Daniel Menichella Discusses Coronavirus Vaccine Development with U.S. President Donald Trump and Members of Coronavirus Task Force.

    Media Release
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