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Research programme: infectious disease vaccines - Themis Bioscience

Drug Profile

Research programme: infectious disease vaccines - Themis Bioscience

Alternative Names: Cytomegalovirus vaccine - Themis Bioscience; Dengue vaccine - Themis Bioscience; MERS vaccine - Themis Bioscience; Norovirus vaccine - Themis Bioscience; Respiratory syncytial vaccine - Themis Bioscience; Yellow fever vaccine - Themis Bioscience

Latest Information Update: 19 Aug 2019

At a glance

  • Originator Themis Bioscience
  • Developer Institut Pasteur; Themis Bioscience
  • Class Attenuated vaccines; Cytomegalovirus vaccines; Dengue vaccines; Respiratory syncytial virus 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 Cytomegalovirus infections; Middle East respiratory syndrome coronavirus; Norovirus infections; Respiratory syncytial virus infections
  • No development reported Dengue
  • Discontinued Yellow fever

Most Recent Events

  • 28 Jul 2018 No recent reports of development identified for preclinical development in Dengue in Austria (Parenteral)
  • 13 Dec 2016 Themis Bioscience plans clinical trials for vaccine candidates in early 2017
  • 08 Aug 2016 Discontinued - Preclinical for Yellow fever in Austria (Parenteral)

Development Overview

Introduction

Recombinant, live attenuated, measles virus vector based vaccines are being developed by Themis Bioscience for prevention of infectious diseases, primarily virus infections. The vaccines, which are designed using Themaxyn™ vector technology licensed from Institut Pasteur, are intended for use in travellers as well as for individuals in endemic developing countries. The Themaxyn™ platform is based on an attenuated measles virus vector, based on based on the backbone of the measles Schwarz virus strain and which carries difficult-to-present antigens as ‘transgenes’. Themaxyn™ vaccines are designed to target the antigens directly to macrophages and dendritic cells, resulting in a potent antigen-specific immune responses, whilst avoiding immune responses to the vector. Preclinical development is underway for vaccine candidates against dengue, respiratory syncytial virus, norovirus infections, cytomegalovirus and Middle East respiratory syndrome coronavirus vaccines.

A lead candidate MV LASV for Lassa fever entered into clinical development [see ADIS Insight Drug profile 800056007].

Vaccine for the prevention of chikungunya infections was advanced into clinical development [see ADIS Insight Drug profile 800040811].

Earlier, preclinical development of a Yellow fever virus vaccine was underway; however, the candidate is not listed in Themis Bioscience's pipeline, August 2016, and therefore the development appears to be discontinued.

Themis Bioscience intends to out-license its vaccines once proof of concept has been established [1] .

As at July 2018, no recent reports of development had been identified for preclinical development in Dengue in Austria (Parenteral).

Company Agreements

In March 2018, Coalition for Epidemic Preparedness Innovations (CEPI) and Themis Bioscience entered a partnership for the development of vaccines against Lassa fever and Middle East respiratory syndrome coronavirus. Under the partnership, CEPI made an investment of $US37 500 000 in Themis Bioscience. The company will be responsible to apply its technology platform to discover the vaccines for Lassa fever and Middle East respiratory syndrome coronavirus and to advance the candidates up to human proof-of-concept and safety studies. Further details of the collaboration were not disclosed. [2]

Key Development Milestones

The proof of concept preclinical trial of MERS vaccine candidate is ongoing, against middle east respiratory syndrome, caused by the MERS-corona virus (Themis Bioscience pipeline, August 2019).

The company is also planning to advance its dengue fever vaccine candidate into clinical development. The development of the vaccine candidate will be funded by the Global Health Innovative Technology, until the completion of phase I development (Themis Bioscience pipeline, August 2016).

Preclinical development is underway for respiratory syncytial virus and norovirus vaccine candidates (Themis Bioscience pipeline, August 2016).

As of August 2019, cytomegalovirus vaccine candidate completed preclinical proof of concept trial (Themis Bioscience pipeline, August 2019). Previously, Themis Bioscience, in collaboration with the Institut Pasteur, was conducting early research development of its cytomegalovirus vaccine candidate (Themis Bioscience pipeline, August 2016).

In December 2016, Themis Bioscience reported the establishment of GMP manufacturing with an aim to initiate phase I trials in early 2017. The company initiated a toxicity preclinical study and tested vaccine candidates in animal models [3] .

Financing information

In January 2018, Themis Bioscience closed a Series C round totalling €10 million. The proceeds will be used to advance Themis’ clinical and preclinical vaccine development programmes [4] .

Patent Information

The Themaxyn™ vaccine technology is patent-protected.

Drug Properties & Chemical Synopsis

  • Route of administration Parenteral
  • Formulation unspecified
  • Class Attenuated vaccines, Cytomegalovirus vaccines, Dengue vaccines, Respiratory syncytial virus vaccines, Viral vaccines
  • Mechanism of Action Immunostimulants
  • WHO ATC code

    J07B-L (Yellow fever vaccines)

    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
Cytomegalovirus infections - Prevention Preclinical Austria Parenteral / unspecified Institut Pasteur, Themis Bioscience 14 Aug 2019
Dengue - - No development reported (Preclinical) Austria Parenteral / unspecified Themis Bioscience 28 Jul 2018
Middle East respiratory syndrome coronavirus - Prevention Preclinical Austria Parenteral / unspecified Themis Bioscience 14 Aug 2019
Norovirus infections - - Preclinical Austria Parenteral / unspecified Themis Bioscience 08 Aug 2016
Respiratory syncytial virus infections - - Preclinical Austria Parenteral / unspecified Themis Bioscience 08 Aug 2016
Yellow fever - - Discontinued (Preclinical) Austria Parenteral / unspecified Themis Bioscience 08 Aug 2016

Commercial Information

Involved Organisations

Organisation Involvement Countries
Themis Bioscience Originator Austria
Themis Bioscience Owner Austria
Institut Pasteur Technology Provider France
Coalition for Epidemic Preparedness Innovations Funder Norway
Paul-Ehrlich-Institut Collaborator Germany
Institut Pasteur Collaborator France

Development History

Event Date Update Type Comment
14 Aug 2019 Phase Change - Preclinical Preclinical trials in Cytomegalovirus infections (Prevention) in Austria before August 2019 (Parenteral) (Themis Bioscience pipeline) Updated 19 Aug 2019
14 Aug 2019 Phase Change - Preclinical Preclinical trials in Middle East respiratory syndrome coronavirus (Prevention) in Austria before August 2019 (Parenteral) (Themis Bioscience pipeline) Updated 19 Aug 2019
28 Jul 2018 Phase Change - No development reported No recent reports of development identified for preclinical development in Dengue in Austria (Parenteral) Updated 28 Jul 2018
06 Mar 2018 Licensing Status Coalition for Epidemic Preparedness Innovations (CEPI) and Themis Bioscience enter partnership to develop vaccines for Lassa fever and Middle East respiratory syndrome coronavirus [2] Updated 13 Mar 2018
06 Mar 2018 Phase Change Early research in Middle East respiratory syndrome coronavirus (Prevention) in Austria (Parenteral) [2] Updated 13 Mar 2018
13 Dec 2016 Trial Update Themis Bioscience plans clinical trials for vaccine candidates in early 2017 [3] Updated 22 Dec 2016
08 Aug 2016 Phase Change - Discontinued(Preclinical) Discontinued - Preclinical for Yellow fever in Austria (Parenteral) Updated 08 Aug 2016
08 Aug 2016 Phase Change Early research in Cytomegalovirus infections in Austria (Parenteral) Updated 08 Aug 2016
08 Aug 2016 Phase Change - Preclinical Preclinical trials in Norovirus infections in Austria (Parenteral) Updated 08 Aug 2016
08 Aug 2016 Phase Change - Preclinical Preclinical trials in Respiratory syncytial virus infections in Austria (Parenteral) Updated 08 Aug 2016
01 Jun 2014 Phase Change - Preclinical Preclinical trials in Yellow fever in Austria (Parenteral) Updated 19 Jun 2014
01 Jan 2014 Phase Change - Preclinical Preclinical trials in Dengue in Austria (Parenteral) Updated 19 Jun 2014

References

  1. Threat of Emerging Virus can be Stopped: Interim results of First Clinical Trial of Themis Bioscience's Vaccine Candidate Against Chikungunya Fever Prove Successful.

    Media Release
  2. CEPI Partners with Themis Bioscience to Advance Vaccines Against Lassa Fever and MERS.

    Media Release
  3. Zika Virus: Top EU-Groups Join Forces in Quest for Vaccine. Themis Measles Vector Technology Central to Action Plan.

    Media Release
  4. Themis Raises EUR 10 Million in Series C Financing to Advance Clinical Pipeline.

    Media Release
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