ChAdOx1 MERS vaccine - Barinthus Biotherapeutics
Alternative Names: ChAdOx1 MERS vaccine; MERS vaccine - Barinthus Biotherapeutics; MERS-CoV vaccine – Barinthus Biotherapeutics; VTP-500Latest Information Update: 12 Dec 2023
At a glance
- Originator Korea Investment Partners; Vaccitech
- Developer Barinthus Biotherapeutics; University of Oxford
- Class COVID-19 vaccines; Viral vaccines
- Mechanism of Action Immunostimulants
-
Orphan Drug Status
No
Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.
- New Molecular Entity No
Highest Development Phases
- Phase I Middle East respiratory syndrome coronavirus
Most Recent Events
- 17 Jul 2023 Vaccitech plans a phase II trial for Middle East respiratory syndrome coronavirus (Vaccitech pipeline, July 2023)
- 24 Mar 2023 Phase- I development is ongoing in Saudi Arabia and UK (Vaccitech pipeline, March 2023)
- 28 Jan 2023 No recent reports of development identified for phase-I development in Middle-East-respiratory-syndrome-coronavirus(Prevention) in Saudi Arabia (IM)
Development Overview
Introduction
ChAdOx1 MERS vaccine (also known as VTP 500), a vaccine against Middle East respiratory syndrome (MERS) Coronavirus (MERS-CoV), is being developed by Barinthus Biotherapeutics (formerly Vaccitech), for the treatment of MERS infections. Vaccitech has in-licensed the ChAdOx1 MERS vaccine from the Jenner Institute, University of Oxford. Clinical development is underway in the UK and Saudi Arabia.
In November 2023, Vaccitech changed its name to Barinthus Biotherapeutics [1] .
Company Agreements
In September 2018, University of Oxford and Vaccitech (now Barinthus Biotherapeutics) entered into a licensing agreement for Middle East respiratory syndrome coronavirus (MERS) vaccine. Under the terms of agreement Vaccitech granted certain rights for this vaccine to Oxford for its development for non-profit public-health use. [2] [1]
In September 2018, Janssen Vaccines & Prevention BV entered into a research and development agreement with the Coalition for Epidemic Preparedness Innovations (CEPI) and the Jenner Institute at the University of Oxford, to develop and manufacture a vaccine against Middle East Respiratory Syndrome Coronavirus (MERS-CoV) infections. Under the terms of the agreement, Janssen will provide its expertise and technology for vaccines development to advance vaccines against the Lassa and Nipah viruses. CEPI will provide $US14.6 million to Janssen and the Jenner Institute for the ongoing clinical development of adenovirus-vectored MERS-CoV vaccine, ChAdOx1, through phase I studies and manufacturing of clinical trial supplies. CEPI will have the option to provide additional funding for phase II development and manufacturing of an investigational vaccine stockpile available for use in the event of a MERS outbreak, based on the phase I study results. Janssen's proprietary PER.C6® vaccine manufacturing platform will be used for manufacturing for multiple types of vaccines and the creation of this stockpile. CEPI will provide an additional $US4.1 million to fund early-stage, preclinical development of candidate vaccines for the Lassa and Nipah viruses. [3]
Key Development Milestones
In January 2023, University of Oxford initiated a phase-I trial to evaluate the safety and immunogenicity of ChAdOx1 MERS vaccine against the Middle East Respiratory Syndrome Coronavirus in Adults aged 50 to 70 years (ISRCTN17936606; EudraCT2022-002159-21). The double-blind, randomized, placebo-controlled trial intends to enrol approximately 84 healthy volunteers aged 50 to 70 years in the United Kingdom
In April 2022, Vaccitech received scientific advice from the European Medicines Agency (EMA) defining a licensure pathway for Middle East respiratory syndrome coronavirus vaccine (VTP 500) [4] .
In December 2019, Jenner Institute and the King Abdullah International Medical Research Center (KAIMRC) initiated a phase I trial to assess the immunogenicity and safety of Middle East respiratory syndrome coronavirus vaccine in 24 healthy volunteers in Saudi Arabia. In November 2021, data were released by the company [5] [6] [7] .
In April 2021, University of Oxford terminated a phase I trial due to COVID-2019 pandemic (MERS001; NCT03399578). The trial was initiated in March 2018 to evaluate the immunogenicity and safety of MERS vaccine in healthy volunteers. The open-label trial intended to enroll 48 participants in United Kingdom [8] .
In November 2021, Vaccitech released results of preclinical studies for MERS vaccine conducted by The King Abdullah International Medical Research Centre and Oxford University [9] .
ChAdOx1 MERS vaccine has showed its capacity of inducing antibodies to a level which are protective in animal models.
Financing information
In December 2023, CEPI announces intention to invest funding of up to $US 34.8 million to Barinthus Bio in addition to funds previously committed to the University of Oxford to develop VTP 500 [10] .
In December 2018, Vaccitech received £6 million investment from GeneMatrix and Korea Investment Partners and plans to use the investment to advance ongoing clinical projects and expand its research and development [11] .
In September 2018, The Coalition for Epidemic Preparedness Innovations (CEPI) awarded $US14.6 million to Oxford and Janssen to support manufacturing of a phase II batch and prepare for stockpiling of a MERS-CoV vaccine candidate [2] .
In January 2018, Vaccitech secured £20 million ($US27.1 million) in Series A financing, and plans to use the funding to expand its business, and to progress its influenza and prostate cancer programmes through phase II by the end of 2019, and advance three other research programmes into clinical development [12] .
Drug Properties & Chemical Synopsis
- Route of administration IM
- Formulation unspecified
- Class COVID-19 vaccines, Viral vaccines
- Mechanism of Action Immunostimulants
-
WHO ATC code
J07B-X (Other viral vaccines)
-
EPhMRA code
J7E9 (All other viral vaccines)
Development Status
Summary Table
| Indication | Qualifier | Patient Segment | Phase | Countries | Route / Formulation | Developers | Event Date |
|---|---|---|---|---|---|---|---|
| Middle East respiratory syndrome coronavirus | - | Prevention | Phase I | Saudi Arabia, United Kingdom | IM / unspecified | Barinthus Biotherapeutics, University of Oxford | 23 Dec 2019 |
Commercial Information
Involved Organisations
| Organisation | Involvement | Countries |
|---|---|---|
| Vaccitech | Originator | United-Kingdom |
| Korea Investment Partners | Originator | South-Korea |
| Barinthus Biotherapeutics | Owner | United-Kingdom |
| University of Oxford | Licensee | England |
| Department of Health & Social Care | Funder | United-Kingdom |
| GeneMatrix | Funder | South-Korea |
| Coalition for Epidemic Preparedness Innovations | Funder | Norway |
| Jenner Institute | Collaborator | United-Kingdom |
| Janssen Vaccines and Prevention B.V | Collaborator | Netherlands |
| King Abdullah International Medical Research Center | Collaborator | Saudi-Arabia |
| Janssen Vaccines | Collaborator | South-Korea |
Scientific Summary
Adverse Events
Treatment with single doses of ChAdOx1 MERS (at dose levels of 5 x 109 viral particles (VP), 2.5 x 1010 VP and 5 x 1010 VP), was safe and generally well tolerated, in healthy volunteers (n=24), in a phase I trial. The most common adverse event was headache (58% of volunteers), followed by muscle pain (54%) [5] .
Results of preclinical studies for MERS vaccine, VTP 500, demonstrated that it was generally well tolerated [9] .
Immunogenicity
Summary
Treatment with single doses of Middle East respiratory syndrome coronavirus vaccine (ChAdOx1 MERS) (at dose levels of 5 x 109 viral particles (VP), 2.5 x 1010 VP and 5 x 1010 VP), was effective, in healthy volunteers (n=24), in a phase I trial. The vaccine candidate induced robust antibody and T cell immune responses in all volunteers. Antibodies peaked at day 28 and T cell responses peaked at day 14, both of which were maintained until the end of follow-up at six months [5] .
Results of preclinical studies for MERS vaccine, VTP 500, demonstrated that it induced both humoral and cellular immune responses [9] .
Future Events
| Expected Date | Event Type | Description | Updated |
|---|---|---|---|
| 31 Jan 2018 | Trial Update | University of Oxford plans a phase I trial for Middle East respiratory syndrome coronavirus (Prevention) in United Kingdom in January 2018 (NCT03399578) (700292434) | 10 Aug 2018 |
Development History
| Event Date | Update Type | Comment |
|---|---|---|
| 06 Nov 2023 | Company Involvement | Vaccitech is now called Barinthus Biotherapeutics [1] Updated 12 Dec 2023 |
| 17 Jul 2023 | Trial Update | Vaccitech plans a phase II trial for Middle East respiratory syndrome coronavirus (Vaccitech pipeline, July 2023) Updated 17 Jul 2023 |
| 24 Mar 2023 | Active Status Review | Phase- I development is ongoing in Saudi Arabia and UK (Vaccitech pipeline, March 2023) Updated 24 Mar 2023 |
| 28 Jan 2023 | Phase Change - No development reported | No recent reports of development identified for phase-I development in Middle-East-respiratory-syndrome-coronavirus(Prevention) in Saudi Arabia (IM) Updated 28 Jan 2023 |
| 16 Jan 2023 | Trial Update | University of Oxford initiates phase-I trial in Middle East respiratory syndrome coronavirus (Prevention) in United Kingdom (IM) (ISRCTN17936606) Updated 27 Apr 2023 |
| 12 Nov 2021 | Scientific Update | Safety and immunogenicity data from preclinical studies in Middle East respiratory syndrome coronavirus released by Vaccitech [9] Updated 22 Nov 2021 |
| 04 Nov 2021 | Scientific Update | Safety and immunogenicity data from a phase I trial in Middle East respiratory syndrome coronavirus released by Vaccitech [5] Updated 12 Nov 2021 |
| 28 Apr 2021 | Phase Change - No development reported | No recent reports of development identified for phase-I development in Middle-East-respiratory-syndrome-coronavirus(Prevention) in United Kingdom (IM) Updated 28 Apr 2021 |
| 19 Apr 2021 | Trial Update | University of Oxford terminates a phas I trial in Middle East respiratory syndrome coronavirus (Prevention) in United Kingdom due to COVID-2019 pandemic (IM) (NCT03399578) Updated 29 Apr 2021 |
| 23 Dec 2019 | Phase Change - I | Phase-I clinical trials in Middle East respiratory syndrome coronavirus (Prevention) in Saudi Arabia (IM) [6] Updated 27 Dec 2019 |
| 27 Sep 2018 | Licensing Status | Janssen Vaccines & Prevention B.V., the Coalition for Epidemic Preparedness Innovations and The Jenner Institute at the University of Oxford enter into a collaboration to develop and manufacture ChAdOx1 vaccine against Middle East Respiratory Syndrome Coronavirus [3] Updated 08 Oct 2018 |
| 27 Sep 2018 | Licensing Status | Oxford University in-licenses certain rights to Middle East respiratory syndrome coronavirus vaccine from Vaccitech [2] Updated 05 Oct 2018 |
| 14 Mar 2018 | Phase Change - I | Phase-I clinical trials in Middle East respiratory syndrome coronavirus (Prevention) in United Kingdom (IM) (NCT03399578) Updated 10 Aug 2018 |
| 25 Jan 2018 | Trial Update | University of Oxford plans a phase I trial for Middle East respiratory syndrome coronavirus (Prevention) in United Kingdom in January 2018 (NCT03399578) Updated 10 Aug 2018 |
| 15 Jan 2018 | Trial Update | Vaccitech plans a phase I trial for Middle East respiratory syndrome coronavirus (Prevention) in United Kingdom Updated 18 Jan 2018 |
| 10 May 2016 | Phase Change - Preclinical | Preclinical trials in Middle East respiratory syndrome coronavirus in United Kingdom (Parenteral) Updated 21 Oct 2016 |
References
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Vaccitech Renames as Barinthus Biotherapeutics to Highlight Strategic Evolution into a T Cell Immunotherapy Company Targeting Chronic Infectious Diseases, Autoimmunity, and Cancer .
Media Release -
Vaccitech licenses MERS rights to Oxford University: CEPI Awards Contract Worth Up To USD$19 million to Oxford University and Janssen Vaccines to Develop MERS, Lassa, and Nipah Vaccines.
Media Release -
Johnson & Johnson Announces New Collaboration to Advance Novel Vaccine for MERS.
Media Release -
Vaccitech Reports Second Quarter 2022 Financial Results and Recent Corporate Developments.
Media Release -
Vaccitech Announces Publication of Second Phase 1 Clinical Trial Results of ChAdOx1 Vaccine in Development for the MERS Coronavirus.
Media Release -
New MERS vaccine clinical trial starts in Saudi Arabia.
Media Release -
A Phase Ib Study to Determine the Safety and Immunogenicity of the Candidate Middle East Respiratory Syndrome Coronavirus (MERS-CoV) Vaccine ChAdOx1 MERS in Healthy Adult Middle Eastern Volunteers
ctiprofile -
A Phase I Study to Determine the Safety and Immunogenicity of the Candidate Middle East Respiratory Syndrome Coronavirus (MERS-CoV) Vaccine ChAdOx1 MERS in UK Healthy Adult Volunteers
ctiprofile -
Vaccitech Reports Third Quarter 2021 Financial Results and Recent Corporate Developments.
Media Release -
New partnership aims to advance vaccine against MERS coronavirus.
Media Release -
Vaccitech receives Lstg6M investment from GeneMatrix and Korea Investment Partners.
Media Release -
Vaccitech secures Lstg20m Series A with GV, OSI and Sequoia China.
Media Release
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