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Zika virus vaccine - Protein Sciences Corporation

Drug Profile

Zika virus vaccine - Protein Sciences Corporation

Alternative Names: Zikavirus vaccine

Latest Information Update: 28 Feb 2021

At a glance

  • Originator Protein Sciences Corporation
  • Developer Immunobiological Technology Institute; Laboratorios Liomont; Mundo Sano; National Institute of Allergy and Infectious Diseases; Protein Sciences Corporation; Sinergium Biotech; UMN Pharma
  • Class 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

Highest Development Phases

  • No development reported Zika virus infection

Most Recent Events

  • 28 Feb 2021 No recent reports of development identified for preclinical development in Zika-virus-infection(Prevention) in USA
  • 28 Feb 2021 No recent reports of development identified for research development in Zika-virus-infection(Prevention) in Brazil
  • 28 Feb 2021 No recent reports of development identified for research development in Zika-virus-infection(Prevention) in Mexico

Development Overview

Introduction

Protein Sciences Corporation (a subsidiary of Sanofi) is developing a Zika virus vaccine, which is a purified protein formulated with alum and based on recombinant variations of E-protein from the virus. The vaccine uses a proprietary Baculovirus Expression Vector System (BEVS) protein expression technology and Spodoptera frugiperda insect cell lines (expresSF+ cells) to generate large quantities of desired recombinant proteins. Preclinical development is underway in the US. Early research is underway in Argentina, Brazil, Mexico and Japan.

In August 2017, Protein Sciences was acquired by Sanofi [1] .

As at May 2020, no recent reports of development had been identified for research development in Zika-virus-infection (Prevention) in Argentina.

As at July 2020, no recent reports of development had been identified for research development in Zika-virus-infection (Prevention) in Japan.

As at February 2021, no recent reports of development had been identified for preclinical development in Zika-virus-infection (Prevention) in USA, research development in Zika-virus-infection (Prevention) in Mexico, Brazil.

Company Agreements

In January 2017, Protein Sciences reported that the Institute of Technology in Immunobiologicals of the Oswaldo Cruz Foundation, also called Bio-Manguinhos/Fiocruz, had joined, in Brazil, the multinational consortium, that is sponsoring development of the Zika virus vaccine. The Zika consortium already consists of four other partners: Mundo Sano and Sinergium Biotech in Argentina, Liomont in Mexico, and UMN Pharma in Japan [2] .

In June 2016, Protein Sciences and UMN entered into an agreement to develop a Zika virus vaccine. Under the terms of the agreement, UMN will pay an upfront fee to fund the development and manufacture of the vaccine being produced at Protein Sciences and receive manufacturing and commercial rights to the vaccine in Japan and other countries to be determined. Further details of the agreement were not disclosed [3] .

In April 2016, Protein Sciences, Sinergium and Mundo Sano entered into an agreement to develop a Zika virus vaccine in Latin America and other countries. Under the terms of the agreement, Sinergium will pay an advance fee to fund the development and manufacture of the vaccine to Protein Sciences. In return, Sinergium will receive manufacturing and commercial rights for the development of the vaccine in Argentina and other countries [4] .

Key Development Milestones

In January 2017, Protein Sciences Corporation reported that its Zika virus vaccine demonstrated safety during a toxicology study sponsored by National Institute of Allergy and Infectious Disease, National Institutes of Health. The vaccine also induced strong neutralising antibodies against the Zika virus in outbred mice during preclinical trials. Based on these data the company is planning to initiate a phase I trial of Zika virus vaccine in the US in April 2017 [2] .

Drug Properties & Chemical Synopsis

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

    J07B (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 - Prevention No development reported (Preclinical) USA unspecified / unspecified National Institute of Allergy and Infectious Diseases, Protein Sciences Corporation 28 Feb 2021
Zika virus infection - Prevention No development reported (Research) Argentina unspecified / unspecified Mundo Sano, Sinergium Biotech, Protein Sciences Corporation 28 May 2020
Zika virus infection - Prevention No development reported (Research) Japan unspecified / unspecified Protein Sciences Corporation, UMN Pharma 28 Jul 2020
Zika virus infection - Prevention No development reported (Research) Brazil unspecified / unspecified Immunobiological Technology Institute, Protein Sciences Corporation 28 Feb 2021
Zika virus infection - Prevention No development reported (Research) Mexico unspecified / unspecified Laboratorios Liomont, Protein Sciences Corporation 28 Feb 2021

Commercial Information

Involved Organisations

Organisation Involvement Countries
Protein Sciences Corporation Originator USA
Protein Sciences Corporation Owner USA
Sinergium Biotech Licensee Argentina
Mundo Sano Collaborator Argentina
Immunobiological Technology Institute Collaborator Brazil
National Institute of Allergy and Infectious Diseases Collaborator USA
UMN Pharma Collaborator Japan
Laboratorios Liomont Collaborator Mexico

Development History

Event Date Update Type Comment
28 Feb 2021 Phase Change - No development reported No recent reports of development identified for preclinical development in Zika-virus-infection(Prevention) in USA Updated 28 Feb 2021
28 Feb 2021 Phase Change - No development reported No recent reports of development identified for research development in Zika-virus-infection(Prevention) in Brazil Updated 28 Feb 2021
28 Feb 2021 Phase Change - No development reported No recent reports of development identified for research development in Zika-virus-infection(Prevention) in Mexico Updated 28 Feb 2021
28 Jul 2020 Phase Change - No development reported No recent reports of development identified for research development in Zika-virus-infection(Prevention) in Japan Updated 28 Jul 2020
28 May 2020 Phase Change - No development reported No recent reports of development identified for research development in Zika-virus-infection(Prevention) in Argentina Updated 28 May 2020
28 Aug 2017 Company Involvement Protein Sciences Corporation has been acquired by Sanofi Updated 05 Sep 2017
12 Jan 2017 Licensing Status Protein Sciences and Immunobiological Technology Institute (Bio-Manguinhos/Fiocruz) agree to co-develop Zika virus vaccine in Brazil for Zika virus infection (Prevention) [2] Updated 16 Jan 2017
12 Jan 2017 Licensing Status Protein Sciences and Laboratorios Liomont agree to co-develop Zika virus vaccine in Mexico for Zika virus infection (Prevention) before January 2017 [2] Updated 16 Jan 2017
12 Jan 2017 Phase Change Early research in Zika virus infection (Prevention) in Brazil (unspecified route) [2] Updated 16 Jan 2017
12 Jan 2017 Phase Change Early research in Zika virus infection (Prevention) in Mexico (unspecified route) [2] Updated 16 Jan 2017
12 Jan 2017 Phase Change - Preclinical Preclinical trials in Zika virus infection (Prevention) in USA (unspecified route) before January 2017 [2] Updated 16 Jan 2017
12 Jan 2017 Trial Update Protein Sciences plans a phase I trial for Zika virus infection (Prevention) in USA [2] Updated 16 Jan 2017
29 Jun 2016 Phase Change Early research in Zika virus infection (Prevention) in Japan (unspecified route) [3] Updated 16 Jan 2017
29 Jun 2016 Licensing Status Protein Sciences and UMN Pharma agree to co-develop Zika virus vaccine in Japan [3] Updated 05 Jul 2016
19 Apr 2016 Phase Change Early research in Zika virus infection (Prevention) in Argentina (unspecified route) [4] Updated 16 Jan 2017
19 Apr 2016 Licensing Status Protein Sciences, Sinergium and Mundo Sano enters into an agreement to develop a Zika virus vaccine [4] Updated 25 Apr 2016
19 Apr 2016 Phase Change - Research Research in Zika virus infection (Prevention) in USA (unspecified route) [4] Updated 25 Apr 2016

References

  1. Sanofi completes the acquisition of Protein Sciences.

    Media Release
  2. Protein Sciences Zika Vaccine Shows Good Results in Preclinical Testing.

    Media Release
  3. UMN Pharma Joins Protein Sciences' International Zika Vaccine Consortium.

    Media Release
  4. Protein Sciences Corporation, Sinergium Biotech and Mundo Sano Announce Zika Vaccine Partnership.

    Media Release
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