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 BioscienceLatest Information Update: 28 Apr 2023
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.
- New Molecular Entity No
Highest Development Phases
- Discontinued Cytomegalovirus infections; Dengue; Middle East respiratory syndrome coronavirus; Norovirus infections; Respiratory syncytial virus infections; Yellow fever
Most Recent Events
- 25 Apr 2023 Discontinued - Preclinical for Cytomegalovirus infections (Prevention) in Austria (Parenteral)
- 25 Apr 2023 Discontinued - Preclinical for Dengue in Austria (Parenteral)
- 25 Apr 2023 Discontinued - Preclinical for Middle East respiratory syndrome coronavirus (Prevention) in Austria (Parenteral)
Development Overview
Introduction
Recombinant, live attenuated, measles virus vector based vaccines were being developed by Themis Bioscience (a subsidiary of Merck and Co) 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 was underway for vaccine candidates against dengue, respiratory syncytial virus, norovirus infections, cytomegalovirus and Middle East respiratory syndrome coronavirus vaccines. However, as of April 2023, the development seemed to be discontinued for the indications.
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).
In June 2020, Themis Bioscience was acquired by Merck & Co [2] .
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. [3]
Key Development Milestones
As of April 2023, the development seemed to be discontinued for the all the indications.
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 [4] .
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 [5] .
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 | Discontinued (Preclinical) | Austria | Parenteral / unspecified | Institut Pasteur, Themis Bioscience | 25 Apr 2023 |
Dengue | - | - | Discontinued (Preclinical) | Austria | Parenteral / unspecified | Themis Bioscience | 25 Apr 2023 |
Middle East respiratory syndrome coronavirus | - | Prevention | Discontinued (Preclinical) | Austria | Parenteral / unspecified | Themis Bioscience | 25 Apr 2023 |
Norovirus infections | - | - | Discontinued (Preclinical) | Austria | Parenteral / unspecified | Themis Bioscience | 25 Apr 2023 |
Respiratory syncytial virus infections | - | - | Discontinued (Preclinical) | Austria | Parenteral / unspecified | Themis Bioscience | 25 Apr 2023 |
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 |
---|---|---|
25 Apr 2023 | Phase Change - Discontinued(Preclinical) | Discontinued - Preclinical for Cytomegalovirus infections (Prevention) in Austria (Parenteral) Updated 28 Apr 2023 |
25 Apr 2023 | Phase Change - Discontinued(Preclinical) | Discontinued - Preclinical for Dengue in Austria (Parenteral) Updated 28 Apr 2023 |
25 Apr 2023 | Phase Change - Discontinued(Preclinical) | Discontinued - Preclinical for Middle East respiratory syndrome coronavirus (Prevention) in Austria (Parenteral) Updated 28 Apr 2023 |
25 Apr 2023 | Phase Change - Discontinued(Preclinical) | Discontinued - Preclinical for Norovirus infections in Austria (Parenteral) Updated 28 Apr 2023 |
25 Apr 2023 | Phase Change - Discontinued(Preclinical) | Discontinued - Preclinical for Respiratory syncytial virus infections in Austria (Parenteral) Updated 28 Apr 2023 |
28 Sep 2020 | Phase Change - No development reported | No recent reports of development identified for preclinical development in Norovirus-infections in Austria (Parenteral) Updated 28 Sep 2020 |
28 Sep 2020 | Phase Change - No development reported | No recent reports of development identified for preclinical development in Respiratory-syncytial-virus-infections in Austria (Parenteral) Updated 28 Sep 2020 |
19 Jun 2020 | Company Involvement | Themis Bioscience has been acquired by Merck & Co Updated 25 Jun 2020 |
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 [3] Updated 13 Mar 2018 |
06 Mar 2018 | Phase Change | Early research in Middle East respiratory syndrome coronavirus (Prevention) in Austria (Parenteral) [3] Updated 13 Mar 2018 |
13 Dec 2016 | Trial Update | Themis Bioscience plans clinical trials for vaccine candidates in early 2017 [4] 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
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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 -
Merck Completes Acquisition of Themis.
Media Release -
CEPI Partners with Themis Bioscience to Advance Vaccines Against Lassa Fever and MERS.
Media Release -
Zika Virus: Top EU-Groups Join Forces in Quest for Vaccine. Themis Measles Vector Technology Central to Action Plan.
Media Release -
Themis Raises EUR 10 Million in Series C Financing to Advance Clinical Pipeline.
Media Release
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