UQ, CSL and CEPI partner on COVID-19 vaccine development
The University of Queensland (UQ), the Coalition for Epidemic Preparedness Innovations (CEPI) and biotech company CSL have entered into a new partnering agreement to accelerate the development, manufacture and distribution of a COVID-19 vaccine candidate pioneered by researchers at UQ. The agreement formalises the support provided by CSL to UQ and CEPI from the outset of the pandemic earlier this year.
CEPI and CSL will fund the development and manufacture of UQ’s molecular clamp-enabled vaccine for COVID-19. Funding will be used to provide support for the pending phase 1 safety study being led by UQ, followed by subsequent late-stage clinical trials and industrial-scale manufacturing to allow the production of potentially millions of doses a year. Should clinical trials be successful, a vaccine could be available for distribution in 2021.
CEPI entered into a framework agreement with UQ in January 2019 to provide up to US$10.6 million to develop a rapid response ‘molecular clamp’ vaccine platform — a transformative technology patented by UQ’s technology transfer company, UniQuest, that enables rapid vaccine design and production against outbreak viral pathogens. In January 2020, CEPI expanded its partnership with UQ to use the rapid response molecular clamp vaccine platform to produce a vaccine candidate for COVID-19. UQ is now aiming to take the vaccine candidate into a phase 1 clinical trial in July.
Enveloped viruses have proteins on their surface that drive fusion of the virus and host cell membranes — a key process in infection. These proteins are also the major target of a protective immune response. Although they are able to induce an immune response, they are inherently unstable and can change shape when expressed on their own. This means that the immune response induced does not efficiently recognise the protein on the virus surface and so does not provide protection from subsequent infection.
Molecular clamp technology overcomes this problem by locking the unstable, prefusion version of the surface proteins in their native virus surface form, allowing the immune system to respond more effectively. This synthetic protein can then be purified and rapidly manufactured into a vaccine.
Early preclinical results of the UQ COVID-19 vaccine candidate showed that it produced high levels of antibodies that can neutralise the virus. The vaccine will be combined with CSL subsidiary Seqirus’s well-established adjuvant technology, MF59, to improve immune response, reduce the amount of antigen needed for each vaccine and enable more doses to be manufactured more rapidly.
“We are very pleased to be able to provide our scientific expertise and platform technologies to make a strong contribution to this critical joint effort with CEPI, The University of Queensland and others,” said CSL’s Chief Scientific Officer, Professor Andrew Cuthbertson.
“CSL will contribute to UQ’s promising vaccine with our proprietary adjuvant, MF59, made by Seqirus, along with expertise in process science and scale-up from our Australian facilities, managing advanced clinical trials and the large-scale manufacture of the recombinant vaccine. Should trials be successful, this vaccine holds the potential to provide protection against this urgent public health emergency for Australians and those around the world vulnerable to this devastating virus.”
The initial phase of large-scale production of the UQ COVID-19 vaccine is planned to take place at CSL’s biotech manufacturing facilities in Melbourne. While there are a number of critical milestones to be met before the vaccine can be considered successful, CSL anticipates that the production technology can be scaled to produce up to 100 million doses towards the end of 2021. CSL would also subcontract other global manufacturers to increase the number of doses that can be produced and broaden the geographical distribution of vaccine production.
“This partnership will benefit enormously from CSL’s experience and capabilities in vaccine development and large-scale manufacturing, which is why this is such an important development,” said CEPI Chair Jane Halton. “If this vaccine is successful, the partnership model we have established will enable CEPI to provide a significant number of doses to the COVID-19 Vaccine Global Access Facility for those who need them most, while allowing CSL to fulfil its own longstanding biosecurity commitments.”
BioMelbourne Network is holding a virtual forum on 26 June enabling attendees to learn about the challenges involved in moving the UQ vaccine through translation, clinical planning, scale-up and manufacturing at lightning speed. For more information and to register, click here.
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