PERTH, Australia – Aussie biotech CSL Ltd. and the University of Queensland (UQ) have entered a development agreement with the Coalition for Epidemic Preparedness Innovations (CEPI) to accelerate development, manufacture and distribution of a COVID-19 vaccine candidate developed by the University of Queensland.

The agreement formalizes support provided by CSL to UQ and CEPI from the outset of the pandemic earlier this year.

The University of Queensland (UQ) announced in February that it was using its rapid response technology to develop a vaccine against the coronavirus that could be available in as little as six months.

The “molecular clamp” technology provides stability to the viral proteins that are the primary target of the immune defense system. The technology was designed as a platform approach to generate vaccines against a range of human and animal viruses.

Paul Young, head of UQ’s School of Chemistry and Molecular Biosciences, said the technology for rapidly generating vaccines is based on knowledge about the virus’ genetic sequence.

“We’ve had some extremely promising results so far from trials targeting viruses such as influenza, Ebola, Nipah and MERS coronavirus,” he said.

At the time, he said it would likely take the UQ team six months to develop the vaccine, which would then be distributed to first responders to help contain the virus.

Melbourne-based CSL partnered back in February with the University of Queensland’s COVID-19 vaccine development program and provided technical expertise as well as Seqirus’ adjuvant technology, MF59, to the preclinical development program.

“The devastating toll COVID-19 has inflicted on the world is being countered by an extraordinary effort from scientists who have crossed borders and boundaries to collaborate, pool together their resources and make progress at a rate not seen before,” said CSL’s chief scientific officer, Andrew Cuthbertson.

CSL will also manage advanced clinical trials and the large-scale manufacture of the recombinant vaccine, he said. Together CEPI and CSL will fund the development and manufacture of UQ’s COVID-19 vaccine. Funding contributions will be used to provide support for the pending phase I study led by UQ followed by subsequent late-stage trials.

CEPI and CSL will also fund manufacturing to allow the production of potentially millions of doses a year, should the product be approved. The initial phase of production of the UQ COVID-19 vaccine would take place at CSL’s manufacturing facilities in Melbourne, Australia.

CSL anticipates production could be scaled to produce up to 100 million doses toward the end of 2021. The biotech would also subcontract other global manufacturers to increase the number of doses to broaden the geographical distribution of the vaccine.

Vaccine entering clinic in July

UQ is aiming to take the vaccine into a phase I trial in July. A vaccine could be available for distribution in 2021 if trials are successful.

CEPI entered a framework agreement with UQ in January 2019 to provide up to $10.6 million to develop the rapid response molecular clamp vaccine platform, which is patented by Uniquest, UQ’s technology transfer arm.

Early preclinical results showed that the UQ COVID-19 vaccine candidate produced high levels of antibodies that could neutralize the virus.

Seqirus’ adjuvant technology, MF59, improves immune response by reducing the amount of antigen needed for each vaccine, enabling more doses to be manufactured more rapidly.

Should the UQ COVID-19 vaccine be successful, 100% of CEPI’s vaccine allocation will be distributed through the COVID-19 Vaccine Global Access Facility, an instrument of the Vaccines pillar of the ACT Accelerator in partnership with Gavi and the World Health Organization.

CSL’s allocation will be used to support its longstanding biosecurity commitment to the Australian community as well as other key regional neighbors. CSL has granted CEPI a first right of refusal to any surplus doses, to be distributed through the COVID-19 Vaccine Global Access Facility.

“This is an important step forward in our battle against this virus. We know that the only way to beat this pandemic is through collaboration, across countries and also across sectors,” said CEPI Chair Jane Halton.

“We also know that we cannot afford to wait until we know whether a vaccine works before ensuring we can produce it at scale. 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.”

Meanwhile, CSL Behring Australia, a subsidiary of CSL Ltd., announced separately that it would begin developing an anti-SARS-CoV-2 plasma product to treat people with serious complications of COVID-19 in Australia.

A small batch of COVID-19 Immunoglobulin will first be produced to develop tests that detect the presence of the antibodies that fight the SARS-CoV-2 virus. The second phase will involve a larger batch of COVID-19 Immunoglobulin that will be used in clinical trials in Australia.

The product will be developed using donations of plasma made in Australia by people who have recovered from COVID-19, as those donors have a high level of antibodies in their plasma. The antibodies will be pooled, purified and concentrated to make COVID Immunoglobulin.

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