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Research programme: viral vaccines - Valneva

Drug Profile

Research programme: viral vaccines - Valneva

Alternative Names: Metapneumovirus vaccine - Valneva; Yellow fever vaccine - Valneva

Latest Information Update: 28 Apr 2020

At a glance

  • Originator Valneva
  • Class 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

  • No development reported Metapneumovirus infections; Yellow fever

Most Recent Events

  • 28 Apr 2020 No recent reports of development identified for preclinical development in Yellow-fever(Prevention) in France
  • 28 Apr 2020 No recent reports of development identified for research development in Metapneumovirus-infections(Prevention) in France
  • 09 Nov 2017 Valneva plans a phase I trial for VLA 1553 for Chikungunya virus infections (Prevention, In volunteers) in USA (IM) (NCT03382964) in early 2018

Development Overview

Introduction

Valneva is developing vaccines against infections due to human metapneumovirus (hMPV), Zika virus and Yellow fever virus. The vaccines are developed using Valneva's EB66® cell line, which is based on a duck embryonic stem cell substrate platform. The vaccine for yellow fever is a second generation vaccine. Preclinical development for Zika virus and Yellow fever, and early research for hMPV vaccine candidates is underway in France.

VLA 1601, a highly purified inactivated vaccine, being developed in collaboration with Emergent BioSolutions for the prevention of Zika virus infections, has entered clinical development [see AdisInsight drug profile 800051396].

VLA 1553, a monovalent, live attenuated chikungunya vaccine candidate has entered clinical development [see Adis Insight profile 800051500].

Valneva is looking for partners to advance its pipeline vaccine candidates, which are developed using its propriety technologies.

As at April 2020, no recent reports of development had been identified for preclinical development in Yellow-fever (Prevention) in France, research development in Metapneumovirus-infections (Prevention) in France.

Key Development Milestones

Zika virus vaccine is undergoing preclinical proof-of-concept studies. In July 2016, Valneva generated Zika vaccine candidate, based on the IXIARO® platform, and the candidate demonstrated excellent purity and had a biological, chemical and physical profile comparable to the commercially available Japanese enchephalitis vaccine [see AdisInsight drug profile 800019333] [1] [2] .

Financing information

Valneva, in July 2016, secured a €25 million loan facility from European Investment Bank. Valneva plans to use the proceeds to support the research and development of vaccines including its Zika vaccine candidate [3] .

Drug Properties & Chemical Synopsis

  • Formulation unspecified
  • Class Viral vaccines
  • Mechanism of Action Immunostimulants
  • WHO ATC code

    J07B (Viral Vaccines)

    J07B-L (Yellow fever vaccines)

  • EPhMRA code

    J7E (Viral Vaccines)

Development Status

Summary Table

Indication Qualifier Patient Segment Phase Countries Route / Formulation Developers Event Date
Metapneumovirus infections - Prevention No development reported (Research) France unspecified / unspecified Valneva 28 Apr 2020
Yellow fever - Prevention No development reported (Preclinical) France unspecified / unspecified Valneva 28 Apr 2020

Commercial Information

Involved Organisations

Organisation Involvement Countries
Valneva Originator France
Valneva Owner France
Emergent BioSolutions Collaborator USA

Licensing Availability

Licensing Organisation Available Indication Available Phase Region Date
Valneva - Preclinical - 21 Mar 2016

Future Events

Expected Date Event Type Description Updated
31 Mar 2018 Trial Update Valneva and Emergent BioSolutions plan a phase I trial for VLA 1601 for Zika virus infection (In volunteers, Prevention) in USA in early 2018 (NCT03425149) (700287313) [4] 28 Feb 2018
26 Feb 2018 Trial Update Valneva plans a phase I trial for VLA 1553 for Chikungunya virus infections (Prevention, In volunteers) in USA (IM) (NCT03382964) (700283120) in early 2018 [4] 16 Mar 2018

Development History

Event Date Update Type Comment
28 Apr 2020 Phase Change - No development reported No recent reports of development identified for preclinical development in Yellow-fever(Prevention) in France Updated 28 Apr 2020
28 Apr 2020 Phase Change - No development reported No recent reports of development identified for research development in Metapneumovirus-infections(Prevention) in France Updated 28 Apr 2020
09 Nov 2017 Trial Update Valneva plans a phase I trial for VLA 1553 for Chikungunya virus infections (Prevention, In volunteers) in USA (IM) (NCT03382964) in early 2018 [4] Updated 16 Mar 2018
09 Nov 2017 Trial Update Valneva and Emergent BioSolutions plan a phase I trial for VLA 1601 for Zika virus infection (In volunteers, Prevention) in USA in early 2018 (NCT03425149) [4] Updated 28 Feb 2018
26 Jul 2017 Licensing Status Emergent BioSolutions in-licenses ZIKV technology from Valneva [5] Updated 28 Jul 2017
21 Mar 2016 Licensing Status Research programme: viral vaccines - Valneva is available for licensing as of 21 Mar 2016. http://www.valneva.com/en/technologies/91 Updated 07 Apr 2016
21 Mar 2016 Phase Change Early Research in Metapneumovirus-infections (Prevention) in France (unspecified route) before March 2016 (Valneva April-2016 presentation) Updated 29 Mar 2016
21 Mar 2016 Phase Change - Preclinical Preclinical trials in Chikungunya virus infections (Prevention) in France (unspecified route) before March 2016 (Valneva April-2016 presentation) Updated 29 Mar 2016
21 Mar 2016 Phase Change - Preclinical Preclinical trials in Yellow fever (Prevention) in France (unspecified route) before March 2016 (Valneva April-2016 presentation) Updated 29 Mar 2016
21 Mar 2016 Trial Update Valneva plans a phase I trial for Chikunguya virus infections (Prevention) [2] Updated 28 Mar 2016

References

  1. VALNEVA Announces Successful Generation of a Highly-purified Zika Vaccine Candidate Using its FDA-EMA Approved Japanese Encephalitis Platform.

    Media Release
  2. VALNEVA Announces FY 2015 Results and Confirms Positive Trend towards Strong Revenue Growth and EBITDA Break-even in 2016.

    Media Release
  3. VALNEVA : European Investment Bank Grants Valneva a EU25 Million Loan to Fund R&D Activities.

    Media Release
  4. VALNEVA Reports Strong Operational Performance for the First Nine Months of 2017.

    Media Release
  5. VALNEVA and Emergent BioSolutions Join Forces to Develop a Vaccine against the Zika Virus.

    Media Release
  6. VALNEVA Reports Strong Q4 and FY 2016 Business Performance; Expects Further Growth in Sales and EBITDA, R&D Progress in 2017.

    Media Release
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