ANU seeks commercial partner to bid for government mRNA deal

In an audacious move to leverage the combined 250 years of experience between the 14 lead researchers at the university's RNA research and development hub, Professor Thomas Preiss and his team are talking to players like existing drug manufacturers and biotech start-ups to show how their research and projects could be the key to ensuring a new sovereign mRNA facility has life beyond vaccines and the current pandemic.

While the university won't be bidding for such a contract on its own, the staff at the hub, led by Professor Preiss, believe they could offer one of the big commercial players the research and development heft needed to make a well-rounded joint pitch to the government.

"We are quite open to who might be looking for someone like us, we're not targeting a specific subset of industries or companies," Professor Preiss tells The Canberra Times.

"Some of these players could be interested in reaching out to the local Australian RNA biology community and we here at ANU would be one of the sizeable centres in this community."

Announced in the federal budget, the government has put the call out to the pharmaceutical industry, offering the potential for 10 years of contracts to produce mRNA vaccines on-shore.

New vaccines for COVID-19 such as the BioNTech Pfizer and Moderna vaccines have been the first examples of the technology to successfully use mRNA - or messenger RNA - technology. Unlike traditional vaccines that use part of a virus to create an immune response in the body, mRNA injects genetic instructions into the body on how to fight a disease.

RNA stands for ribonucleic acid, and is a molecule similar to DNA, a "close cousin," Professor Preiss says.

"RNA is like a close cousin to DNA, it's almost the same chemically, it's like a photocopy of the gene in DNA, if DNA is a chapter in a book then RNA is a photocopy of that chapter."

The success of mRNA vaccines is just the start for the field, Professor Preiss says.

"The companies that have made these successful vaccines, they really were formed to make mRNA therapies for other more difficult to achieve therapeutic purposes, for cancer, to treat genetic disease, etc.

"The success of the mRNA vaccine will mean that there will be many more mRNA vaccines for other infectious disease, but also mRNA therapies for non infectious diseases will come to the fore."

At ANU there are researchers working on different parts of RNA technology, targeting the ribosome, or on microRNA, how RNAs are involved in organising DNA, and even computational biology.

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It's this range of work, beyond just mRNA, that the university is pitching to the private sector.

"We are a world-recognised aggregation of people with this focus, with concentrated academic excellence in RNA biology, and we're propagating novel uses of RNA science. We have the established infrastructure to provide screening and testing of RNA molecules or molecules targeting RNA. And because of the way we are situated here, we also have early phase clinical trial capability," Professor Preiss says.

The university's record with pre-clinical projects with major companies already will also be part of the selling point.

They may not be household names outside of the science world, but Professor Preiss names John Shine and Lynn Dalgarno as his heroes. In 1973, the pair discovered the Shine-Dalgarno sequence at the ANU, described by Professor Preiss as "one of the important foundation findings of understanding protein synthesis, it's in every textbook, and it's the basis of a lot of the biotech industry that we know nowadays".

Their legacy continues at the university, both in research that builds on their discovery, and in the drive to continue to break ground with more discoveries that become the building blocks of future medicines and other uses.

Shine and Dalgarno discovered how bacterial ribosomes recognise bacterial mRNA, work that Professor Preiss and his colleagues are building on, studying the equivalent process in human cells.

His team has made significant discoveries in that area, and Professor Preiss said he was aspiring for a discovery on the same level as what Shine and Dalgarno achieved.

A partnership between a research and development hub like that at ANU and a commercial outfit is a two-way street, Professor Preiss says.

"It is all about translating discoveries into a product, whether it's a medical treatment or another biotechnology, technical, technological application and agriculture, for example."

It's not just about the financial transactions, although the jobs and investment it could bring to the university is an important element.

"What we need is the commercial partners to engage with us to, to scope out early on what our findings might be useful for in terms of commercial applications. Or else if they already have a commercial application in mind, and they need expertise that we can provide, we can partner up with them and assist them in their early product development."

Another leader at the hub, Professor Ross Hannan, Centenary Chair in Cancer Research and head of the ACRF Department of Cancer Biology and Therapeutics at the university, says such a partnership would be an injection of funds that would benefit the university and Canberra more widely. It would also give the drug companies access to people with the deepest knowledge of the science.

"There's more to this than just fabricating and making RNA," Professor Hannan says.

"You have to understand what you're going to use the RNA for in research and development, you need people that have deep understanding of the RNA and the biology. And without that there, you can't develop it. So we have that understanding."

In this month's federal budget, the government finally announced it would look to partner with the private sector to build an mRNA vaccine manufacturing facility. Exactly how much the government would spend was not published, but experts have estimated at least $250 million is needed to get a project off the ground.

According to the documentation provided to the industry, the government wants companies to submit a fully costed proposal for "end-to-end onshore population-scale mRNA capability" for a minimum of 10 years from the start of operation.

As well as ensuring access to prospective vaccines and providing security of supply, the government says such a facility could also be used "to strengthen Australia's biopharmaceuticals sector, including through enabling potential translation and commercialisation paths for Australian-based research and development".

That's where ANU can see its moment to shine, adding its research and development hub to a private company's manufacturing capability.

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The researchers at ANU's RNA hub already have projects that could benefit from manufacturing capability in Australia, beyond vaccines for COVID-19.

Professor Hannan and his team are on the precipice of turning years of RNA research into effective treatments for cancer, with two projects in clinical trials showing promising results.

One of the drugs, about to go into phase two clinical trials, will be tested on prostate cancer patients, but if successful, could be used in any solid tumour cancers.

The class of drugs Professor Hannan and his team is trialling target ribosomal RNA. He describes ribosomes as "the factory" of a cell, with a backbone made out of an RNA. The drugs aim to interfere with the ribosome, "which sends the cells into suicide".

"What we've done is to make drugs to artificially destroy this factory."

Crucially, the pre-clinical data shows that normal, non-cancerous cells are more resilient to the drug than cancerous cells, meaning it's only the cancer cells that are destroyed.

"Because we've gone after a generic target, which is found in every cancer cell, it should have application to a broad range of cancers, it's like a smart person's chemotherapy," he says.

It could be life-changing for people with cancer across the world, and it's taking research like that to a commercial partner that the university wants to do, Professor Hannan says.

"It's not just research and development, what we're doing, we're translating those outcomes."

Just how much money the federal government could pay to the potential winner of an mRNA manufacturing facility is unclear, but some state governments have already put millions of dollars on the table for such a facility.

In Victoria, where pharmaceutical giant CSL already has a factory pumping out a million doses of the AstraZeneca vaccine each week, the state government has pledged $50 million and this week announced a new government agency, mRNA Victoria, would oversee the establishment of a facility in the state in the next 12 months.

The responsible minister in that state, Jaala Pulford, is already saying Victoria is the "national home for mRNA".

In NSW, Premier Gladys Berejiklian met with experts to discuss her state's capacity to manufacture mRNA vaccines before the federal government announced it would also put money into a project. Unlike Victoria, the NSW government hasn't put a dollar figure on its commitment.

It's not just state governments trying to get in on the first floor of mRNA manufacturing in Australia. In South Australia, international biotech company BioCina is looking to partner with the University of Adelaide on such a facility, after buying a biologics manufacturing plant in Adelaide formerly owned by Pfizer. That group believes they could be manufacturing in the short-term.

American company Moderna has told the stock exchange in the US that it is in talks with the Australian government about its COVID-19 vaccine being produced locally, and could be a party putting in a bid for the government work.

Australian company CSL has also expressed interest in the idea, after already investing heavily in its facilities to take on production of the AstraZeneca vaccine, which uses a different technology.

In such hot competition, the ACT government is yet to put up its hand to be part of a bid, without the ability to throw the same sums of money at the private sector as bigger states.

But Professor Hannan says the ACT does have a role to play.

"If you look at the other states and territories, they've all been partners in this - it's been a government-industry partnership, the government has put some seed funding in to enable these partnerships to happen," he says.

"We're a much smaller government, of course, but there's still a place for some support for that, given that we've got a proven track record, and one of the best teams in Australia. I think there's absolutely a place for that."

On the potential ANU bid, an ACT government spokeswoman said "ANU involvement may meet the eligibility requirements for certain ACT government economic development programs such as the Future Jobs Fund".