Every day we hear about the challenges affecting industry and our broader society. La Trobe University as a leading university has a critical role to partner and collaborate with industry and the community to help solve those challenges. 

The industry engagement team enables that linking between the university and industry. 

Our collaborations aim to take research from the lab bench to the market and into the homes of our community. 

For business or industry, you can collaborate with universities for a number of reasons. By working with us, our industry partners have access to new ideas, new research, new technologies. 

They have the ability to partner with our researchers and collaborate on the development of their new products. Connecting with us also provides access to our talented student cohort for developing your future workforce.

Welcome to the frontiers and infectious disease innovation, a featured session in the

2025 La Trobe industry innovation series. 

Key discussion points will include advancing innovation with mRNA medicines accelerating the development of novel products to tackle antimicrobial resistance, Debiotech breaking through antifungal peptide and harnessing the power of antibody technology.

But before we begin, I'd like to take a moment to thank Dr. Richard Alm, Dr. Felicia Pradera, Emirates Professor Marilyn Anderson and Professor Begona Heras for joining us. 

I'd like to introduce our first speaker, Richard Alm. Richard serves as the chief scientist at CARB-X, a global non-profit organisation that supports products to prevent, diagnose, and treat infections caused by drug resistance bacterial pathogens. 

Please join me in welcoming Richard.

Thanks, Ash. I hope everyone can hear me. I will do my best to introduce CARB-X and some of the work that we've been doing to try and tackle AMR.

Bacterial infections cause about 7.7 million deaths per year globally and two thirds of those are actually associated with antimicrobial resistance. And the bugs are resistant to drugs that are currently used to try and treat those infections.

Five bacterial species account for over half of these deaths. And you can see from the map at the bottom that the rates of mortality are extremely unbalanced and we see most deaths in Southeast Asia and Sub-Saharan Africa. 

I like to think of anti-bacterials as the foundation of modern medicine. I think as a society we have taken them for granted, and now that's starting to run out and I think society is at the precipice of suffering the consequence of taking them for granted. 

Almost 10 million people a year globally undergo chemotherapy and we've seen recent data coming out from cancer groups showing that cancer patients are more susceptible to infections to drug resistant bacteria, and infection now is the second leading cause of death for people with cancer. 

Obviously transplants, dialysis, rely on antibiotics actually underpinning some of the advances that we've made in those areas. One in five people globally die of sepsis and so many of the sepsis deaths start from an infection and a large proportion of these are bacterial infections. 

It would it is wrong for me to ignore the impact of fungal infections here. In fact, the global burden of fungal mortality and morbidity is actually from some reports thought to be higher than bacterial and obviously surgery caesarean sections are becoming more common especially in Sub Saharan Africa now, and surgical sight infections are a leading cause of death and they rely on antibiotics. 

Without these antibiotics we risk going back to the dark ages where small cuts and then an infection can actually cause death.

And really the AMR paradox is because humans use and misuse antibiotics. On the left hand side of this slide you can see clear evidence that the more you use drugs the more resistance emerges. 

Antibiotics are one of the few classes of drugs that the more you use them, the less effective they become because of this emerging resistance. And there's been a lot of epidemiology data done to show that the more drug use increases, the level of resistance that circulates within the epidemiological clones in either hospitals or the communities. 

On the right, I've got some pictures to try and show how we don't value antibiotics enough and we abuse or misuse the antibiotics. Obviously, Australia does very well in terms of agriculture and the amount of antibiotics that are used in agriculture. The US is at the bottom of this chart. Doesn't do as well. That's where I'm sitting now. 

And I'm hoping that the US can actually improve and use less antibiotics in farming and agriculture. At the bottom you see low and middle income countries. 

Often you can buy antibiotics over the counter without prescriptions from kids that are running their parents store and these antibiotics are then subject to counterfeit. 

They're not necessarily at the right dose. People don't take the full prescription and that just drives more resistance. And then the billboard that you see there is actually taken in Massachusetts. 

I use this as an example to show how much we actually value antibiotics even in a high- income country like the US. Here is the opening of a new supermarket. They give away free antibiotics while you shop. So even though once you've got a prescription or a tele prescription, you don't even have to pay for the antibiotics. They give them to you for free. 

We don't value them enough. That's a sad state I think on where we are as a society that these life-saving drugs are just taken for granted.

The AMR crisis really comes in four parts. 

On the top left is the insufficient amount of new drug classes that are being developed. 

I think we've all seen those slides. Top right is the lack of investment in this space to drive R&D and I think any academic feels that pinch from national funding agencies as well as investment from venture capital firms.

Bottom left is access. The approved agents that are being discovered are not obtaining commercialisation broadly across the world. Obviously, this is an increasing challenge in low and middle income countries. But you can see even in high income countries at the top there like Canada and Australia. This is the last drugs that have been approved in the EU or the US. 

This shows which countries they are now available in, and I think Australia is adding in about three of the last 24. And access to the right drug to try and treat the patient appropriately is key.

And then lastly on the bottom right, with all the exits especially with big pharma we are losing the workforce of people that know how to discover drugs and this is something that we'll never be able to get back. 

It's important that we still maintain research in this area to not lose the traction that we have made over the last 15 to 20 years by losing the people that know how to do it.

In response to these crisis, CARB-X is a global non-profit partnership that was formed out of the US government and Welcome trust in 2016. We have now expanded to be funded by six governments and three philanthropic organisations and they give CARB-X which is housed at Boston University. They give money to us to distribute globally to support the development of novel products. 

But I will say that CARB-X now is supporting a very fragile ecosystem. This is data taken from our inception in 2016. Since that time, we've had 1733 applications and almost one in two of those applications come from companies or groups that have got less than 10 employees. 

That's a really small group. And you'll see the bottom bullet point there is these small groups carry risk around the lack of breadth of discipline expertise needed to take drugs and products all the way from early discovery through to clinical development. 

Sadly, we also see significant attrition. Most of these groups that apply to us have a single asset or very small portfolios and so everything relies on that single project. And if you look back to the 2016 to 2019 funding rounds and looked at those companies that had applied to us in those three years and over a third of them now no longer exist. 

Now whether they have ceased to exist because their science wasn't good or because they just couldn't get funding that's hard to tell. But the point is that there's a huge turnover in the ecosystem. And that doesn't bode well for the novel innovation that is needed to bring these products to patients. 

So, CARB-X operates at a global scale.

Our goal is to accelerate research and development translationally into human clinical trials. 

We fund through to the end of phase one or first in human studies. We do support the development of therapeutics, pre preventatives and diagnostics to treat, manage and prevent bacterial infections caused by pathogens on the WHO priority pathogens list. 

We select our projects through open public funding calls and we focus on the performance characteristics of the products and the pathogens that have the largest morbidity and mortality globally. Because of the access concerns that I mentioned earlier, we do require stewardship and access obligations for groups that give our funding because we provide non-dilutive funding. 

But we also provide a different type of support model for these often very small companies that need it. 

You can see, from the 1733 applications we've funded 117 projects. We've deployed just over half a billion US dollars. Those projects have come from 14 countries. 

We currently have 42 in our portfolio and importantly, we've actually been able to move 17 products into phase one in both the preventative and the therapeutic space and five diagnostic products into late-stage clinical assessment. 

10 of our projects have had advanced development partnerships. We feel this is important because graduating a project out of the CARB-X portfolio at the end of phase one doesn't actually mean it gets to patients, if there's no one there to pick it up and help support it through to registration. 

And over 10 of our products now have got advanced development partnerships which is really important to drive these products closer to patients and we have three that are on the market.

Just a brief snapshot of the 42 projects currently in our portfolio. 

In the therapeutics portfolio, we have a lot of non-traditional projects, proteins, peptides, antiviral, a lot of this innovation that is coming largely from academic groups. 

Currently we have three therapeutics that are post IND and being evaluated in humans. In our preventative portfolio, we have 10 vaccines that cover six different pathogens. But we also invest in novel technologies like CRISPR engineered bacteria phage micro biomodifying consortia of bacterial strains, antibodies and also a slow release formulated peptide. 

And in the diagnostic space there we have five looking at bloodstream infections including four direct from whole blood to try and speed up that clinical decision making. 

We have four for sexually transmitted infections and three looking at novel specimens for detection of lower respiratory tract infections.

These are the projects that have moved under CARB-X support through the clinic and into the clinic.

You can see we have six there in phase one clinical trials. We have another six that have actually gone straight into or done phase 1B clinical trials. 

Depending on the indication, we will support studies directly into patients. If we're looking at something for prosthetic joint infections, the first in human does actually go into patients.

We have six in that category. We have one that we've supported that is now progressed on. 

We have additional BA support into phase three. That's the Vanta product. 

We have two diagnostic products looking at either rapid detection of bacterial infections in the lung or in the bloodstream that are in final verification and validation studies clinically. 

And then we have three marketed products over on the right-hand side.

I talked about our support model. We like to think that we are more than just giving away money. At the centre of our support model obviously, is a group of experience both in small biotech and also large pharma, a group of experts that build a company support team in conjunction with our large network of consultants to help those small companies have access to the discipline expertise they need without necessarily paying to have someone on staff. 

We also run clinical advisory boards specifically for each company as they need them to try and help them with their clinical development plans. 

I think the biggest differentiator in the success or failure of a small company is actually how well executed their clinical development plan is.

Pre-clinical development is hard, but the clinical development and picking that right patient population to show that differentiated profile of your product is key. 

And so we run clinical advisory boards with key disciplines and clinicians on there just to give advice of ways to think about how to set up your clinical trials.

We run portfolio acceleration tools which are scientific thesis and experiments that will support multiple companies to help answer questions that many companies are facing. 

If many companies in our portfolio are facing the same question, we will run experiments on our dollar and then provide the data back to all of the companies in the portfolio, and if appropriate, and this happened last year we will publish that data so that the whole ecosystem whether you're in the portfolio or not will benefit from that. 

We have expedited access to the NIA preclinical services when the US government is actually functional, our companies can get access to those. 

We have a collaboration with CHAI, the Clinton Health Access Initiative that helps us understand especially in low and middle income countries what product characteristics would be most welcomed by different ministries of health in these countries, so that companies get an idea of what they need to work on to actually be able to make that impact into the areas and the countries that need the product the most. 

And lastly, we have a business development council or an investment day where as I said as our projects are nearing graduation out of the CARB-X portfolio, we have investor days where we bring them together to pitch to a group of advanced developers and VC investors so that they can hear about our portfolio and make decisions about who they want to invest in.

In terms of our funding rounds, the way we work now is we have multiple research themes that are announced simultaneously. 

They used to be all comers. Anything to do with antibacterial infections we would take. Now they are prioritised to try and balance our investment portfolio in line with our funders’ interests. 

And you can imagine with 10 different funders there's often quite a balancing act you need to do. The scope of the funding rounds and the budget are approved by our CARB-X funders and then given to us to delegate and execute. 

And every two years we have a strategic review. The next one's coming up in 2026 where we survey large numbers of clinicians and epidemiologists and decision makers in the infectious disease space from around the world to say what are the gaps that are needed and so that's what helps drive our scope of funding rounds. 

Typically, we have two separate intact intake dates with the same funding themes. 

Sometimes we will expand it on the second one. But we'll always keep whatever was in the first one in the second one. And this is to enable groups to generate the data to meet our entry criteria which is listed on our website. 

Importantly, the second call for funding in 2025. The round opens on December the 1st. 

If you're interested, that's the website. Go there and understand what our funding themes are. You can drop me questions if you like before December the 1st. Once December the 1st starts, I'm not allowed to talk to people, but if you got questions, before December the 1st, my email on the last slide. 

I'm often asked what makes a successful application. 

It's never too early to think how your product will be used in the patient journey. 

Build a target product profile that will actually bring meaningful differentiation to clinicians that are treating patients and then incorporate experiments that will emphasise or demonstrate those key product changes. 

It's so important to understand how you will perform your clinical development, how you recruit your patients, how you will stratify your patients to demonstrate that clinical benefit. 

And it's never too early to start thinking about that data in your applications. Too often key data is missing or not included and therefore it's impossible to assess. 

This is particularly crucial in the non-confidential thousand word expression of interest phase. I tell people that if you have an MIC against pseudomonus that is not intellectual property. 

The structure of the compound is the intellectual property. But tell us that you've got the MIC. Don't just say it's active. And include as much non-confidential data you can in your expression of interest to make sure you pass that scope check. 

And lastly, this is a quote from one of our reviewers that extraordinary claims require extraordinary evidence.

And so often we have people come and make these bold claims without the underlying support. We know how hard drug discovery is. We've spent our careers doing it and we

don't mind risk and we want to understand where the warts are in your program. 

And we encourage groups to be scientifically critical and transparent and realistic about where their limitations and where their challenges are in their program and then embrace CARB-X as a collaborator to help solve those problems and think of us as more than just a bank that gives money out because our goal is to help you be successful and deliver a product to the patients that need it. 

With that, I will acknowledge all the companies that we have supported. Some of them obviously no longer exist. 

Some of them are no longer in our portfolio. But I will say that we learned something from all of them. They've all been in this space, which is a very tough space. 

These are the people that work at CARB-X, an extremely dedicated and extremely passionate group of people in this space and these are my coordinates. If you want to drop me a question if I fall asleep before the panel, but thank you to the LRO people for putting this on and giving me the opportunity. 

I would love to be there in Victoria at the moment I'm sure it's warmer than it is here in Boston but hopefully my next visit to Australia I can come and visit you. 

Thank you, Richard. That's great. And from my own research, I'm glad to see the bio microbiome engineering has made an appearance there because I personally think it's an important one, but it was very insightful. 

Now, I'd like to welcome our next speaker Professor Marilyn Anderson. Professor Anderson is internationally recognised for her pioneering work in the clinical application of antimicrobial peptides, particularly plant defences and their role in combating fungal pathogens. 

Please welcome Marilyn.

Well, thank you Ashley. I'm going to change and not talk about bacteria. I'm going to talk about fungal diseases. 

Our new company, two years old now, is called Debiotech and our mission is to commercialise a novel and effective treatment for topical fungal diseases.

Why fungal diseases? Well, Richard already outlined that fungal diseases are also a really large problem, not only in humans, also animals and plants. The estimates of the incidence of fungal disease vary, but it's up to 3% of the population of every country.

For the US alone, medical costs are estimated to be up to 7.5 billion annually. And that doesn't include treatments for fungal toenail disease which I'm going to talk about. 

And like the antibiotics used for bacteria, there's a problem because the widespread use of chemical treatments to control fungal disease in agriculture has led to an alarming emergence of multi-drug-resistant fungal pathogens. 

And it's interesting that many of the pathogens in agriculture are also human pathogens. So we often find in the clinic that people have infections with fungi that are resistant to all known antifungal drugs. 

There is an immediate need for new treatments for fungal diseases with different mechanisms of action. 

We are working with plant defences. Here's a structure of a plant defence. They're just plant proteins that are naturally occurring. They've evolved with plants. They've been around probably about 400 million years and they're exquisitely adapted for control of fungal diseases which affect plants more than bacterial diseases. 

We've been working on defences for a very long time. We've got a detailed knowledge of how it works, how it kills fungal pathogens. And one of the benefits of these peptide drugs over current antifungal drugs used in the clinic is that unlike current drugs, it doesn't just slow down the growth of fungi. It actually kills them very rapidly. 

And we don't have time to go through all of them, but it's active against a very wide range of fungal pathogens. And that's very important because providing protection against one is not very helpful if you're susceptible to infection by a second fungal disease. 

It's got a unique mechanism of action as I said. This molecule recognises and binds specifically to the polysaccharides which are in the cell wall of the fungus. These are yeast cells here or candida species. 

The defence here is labelled green. Once it binds to the cell wall, it can enter the cells and these red areas here are the vacuoles and the defence interferes with the structure and the function of the vacuoles. Ultimately the cells start to leak and the blue here just shows that the cell wall and the membrane has broken. 

Focus on the bottom two cells here. The outside of the cell is labelled with our green defence. Here's the vacuole in the middle. You can see the defence. It's the green thing. The vacuoles are all changing shape. And here it is, the cells dead all within about 10 minutes. 

We've decided for our company to go for a market that is large and the largest market for fungal infections are fungal infections of toenails. 

It's an infectious disease. People often don't realise that when they have infected toenails. 

And one of the interesting things is that the current therapies are very ineffective or they're even toxic. It's particularly bad for people who are immuno-compromised or for diabetics and we've already done a market survey and clinicians confirm that there is a desperate need for an effective treatment of Onychomycosis and that they would use it if one we found one. 

Our solution as I've said is this peptide called Pezadeftide. We've already done a lot of work as I've said. It reaches the side of infection better than the competitors. It rapidly kills a wide range of fungi that infect nails. It has a unique mechanism of action which I briefly described. We have a strong patent position. 

Interestingly we haven't been able to create drug resistance in the lab, even as we've been trying to force it, in conditions where we find the other commercial antifungals you get rapid resistance development. 

We've already done phase one and phase 2 trials and in both sets of trials it was safe. There were no adverse effects.

We've got the formulation solved. It's relatively easy, largely because our molecule is very water soluble. Has a long shelf life at room temperature and we can actually make it. 

It's a peptide. One of the things that often limits the development of peptides as drugs is they are expensive to make. But we can make ours in yeast and we've been doing it reproducibly now in 3,000 litre fermenters. 

Here's the fermenters under GMP conditions. Here is our one-step purification process.

We have a reasonable cost of goods that makes us competitive with other drugs. Now let's go back to the market for Onychomycosis. The numbers vary because not everyone is diagnosed but it's known to affect at least more than 500 million people globally but probably one in every 10 people on earth. 

The market is predicted to grow currently at about 5.7 billion per annum and is expected to grow to 9.5 in the next 7 years or so. 

There's a huge market for a more effective and affordable treatment than the current topical treatments. The best topical treatment now for Onychomycosis at best only offers a 17% cure and the oral treatments at best 38% cure. 

But many people can't take it because it's toxic to the kidneys and to the liver and you have to have careful monitoring to make sure it's safe. Consequently, only a small proportion of people actually get treated for this disease. 

Only about 3 million of the 23 to 40 million people in the USA undergo treatment. 

Because they know it's very expensive up to $8,000 per year for the current best topical drug and this drug is ineffective as well. 

What's the story about Debiotech? 

Debiotech has evolved. It's a phoenix that has arisen from the ashes of Hexima. So Hexima was a company embedded here at La Trobe University actually for over 20 years but the last 10 years was spent on studying antifungal molecules. 

Hexima completed a successful phase 1 and phase 2A trial. It looked really promising in that trial but then we had a phase 2B trial which unfortunately coincided with the COVID epidemic where we weren't able to give the appropriate monitoring of patients. So we had

inconclusive results. Some patients look great, some didn't seem to improve at all, but we didn't know whether they were consistently taking the drug. 

So Debiotech was established in 2023 after Hexima decided to terminate this project and we're in the fortunate position that we could accept all the IP from Hexima and we were convinced that the technology was sound. 

The IP includes all patents, trade secrets, formulation, manufacture, all standard operating procedure data protocols etc. toxicology testing and most importantly the successful IND application that we had with the FDA. 

So successful IND normally means that you're free to go ahead with a phase three trial but when Hexima decided not to go ahead with phase three, Debiotech re-examined all

the data and we feel very confident that we have improved the technology. 

We'd like to do another phase two clinical trial to test our new our new dosing and management regime. 

But here's some photos of improvements we have seen. These are five separate patients and you can see rather dramatic appearances improvement within 20 to 33 weeks. 

The current standard treatment is at least one year. 

We think that we may get improvement much faster than the than the current competition. 

There are two types of treatments that I talked about topical and oral. 

Of the oral treatments, only this one called Lamisil, which is based on a compound called terbinafine is available in Australia. 

It's only available on prescription. This looks reasonably good after taking the drugs which are quite toxic. Here are some topical drugs many of them are not available in Australia. 

Here are two that are available in Australia, but you could see that the cure rate is very low, 6 to 9% or 0 to 2.9%. 

For our drug to be successful, we need to have a cure rate better than 18% which we feel confident we can achieve.

This is market value for this drug. USA 1.9 billion, Japan 238 million. 

You can see it's a large market.

What do we want to do? 

We're trying to raise $1.5 million so that we can do this phase 2 trial and show that we can get really good cure rates. And if we get those results, that will put us in an inflection point to continue with commercial development and get a partner to go with us to phase three trials.

Our team. I don't know why Janice is coloured red. Something happened during transition, but you will see this is an unusual company. It's rather female dominant. 

We have a team of dedicated people and we certainly will employ some men when we get some money.

I think that's all about it. We don't intend only to deal with toenail infections. The reason we're doing this early is to try and get some cash flow, but we're also developing this drug for other topical fungal infections. 

The market is not as big for that. When you're a company, you need to go for the biggest market first. Thank you, Ashley.

Thank you, Marilyn. 

It was wonderful to hear wonderful hear about the success of the company and the continued work that's going on. 

Our next speaker is Dr. Felicia Pradera. Dr. Pradera is director of Moderna's regional research centre and strategic alliance in Melbourne, leading R&D collaboration strategies across Australia and Indo-Pacific. 

With 20 years experience in research, policy and product development, she has advised national and international governments on the health security and medical counter measures, including briefing the US National Security Council on emerging bio threats. 

Welcome Felicia.

Good evening, everyone. I'm Felicia Pradera from Moderna. We became a household name during COVID 19. 

I want to give you an overview of what we're doing here in Australia and how we're growing. 

I'll start with our vision.

We were established with that goal of utilizing mRNA to treat and prevent disease. The full name of the regional research centre is for respiratory medicine and tropical diseases. 

It's quite a mouthful, but that's a real focus particularly here in Australia and where we sit in the Indo-pacific region and our mission is really to deliver that greatest possible impact to people through mRNA medicines.

And what makes us different to other companies that work within mRNA and mRNA technologies and we are solely focused on that platform capability.

You might think we're an overnight sensation. But the company was founded in 2010 and a lot of work was undertaken prior to the COVID19 pandemic.

But what it means by having a platform technology is there is a possibility for that to be adapted not only of course to viral pathogens but to be utilised in oncology rare diseases, latent vaccines and other diseases which need to be treated.

Most of you in the room if you've got a science background will understand the processes here, but effectively when we're developing assets, the mRNA enables either the generation of intracellular proteins, transmembrane proteins or those that are secreted and depending on the target it's really important to then protect that mRNA for use as a vaccinated therapeutic in a medicine. 

When we look at the way that we constitute this platform technology, it's highly adaptable as I mentioned, with lots of applications across infectious diseases and today I'll talk about that viral component, because we've had a great talk from Richard around bacterial and just now on fungal, but we can tailor that target and insert that particular coding region into the platform to enable us to target those emerging and priority pathogens.

When we look at mRNA and its approach for fighting infectious diseases, it enables us to have a rapid turnaround to begin the process, but then also the way that we do our manufacturing and clinical trials we're able to quickly switch between pathogens. 

I think what's really quite remarkable for the work that we've done here in Australia. 

Three years ago, we broke ground over at the Clayton site. It was green fields. 

Within two years the building was constructed and this year we received our GMP licenses for drug substance and drug product, which means that we have a sovereign capability in this country to address the issues and the threats that may face us in the future. 

It's quite remarkable and the team over there has worked exceedingly hard to achieve the goals that they have. 

I think the other thing from a health security and capability perspective, is Moderna had really strategically thought about where it made most sense to develop a manufacturing capability, but also where R&D could be used across the globe to support our broader objectives. 

And we've created what we call the resilience network made up of our counterparts from Australia, the UK, Canada and global which is based in the United States.

We have a really ambitious portfolio and the plan is 10 registrations in three years. 

It's quite an extensive portfolio and we're tracking very well. You can see in the red we have our respiratory antigens. SARS, KV2, RSV and of course flu and flu combo are in the pipeline. 

We have both CMV and Norovirus. We have two rare diseases. Propionate metabolism and methylmalonic acid, and in our cancer portfolio is our individualised neo antigen therapy which we're working on. It's a rather broad portfolio and very ambitious but for Moderna itself we have 44 assets in development across a broad range. 

These are our priorities at the moment.

I'll show you a little bit of our priority pathogen pipeline. 

SARS KB2 is there but you'll have heard of Ebola and Marburg and Zika. We're working very actively and developing what could be the next generation of vaccinations against these infectious disease targets. 

Whilst currently our main focus is in that respiratory space and we're seeing an uplift of course in our oncology portfolio. Moderna still has a commitment to global public health and that was one of the foundational reasons that Moderna was stood up in the first place. 

We are developing a preparedness strategy where we have regional manufacturing.

We identify those priority path pathogens and then a program that I want to talk about is mRNA access. And this is a program that we're doing collaboratively with academics across the globe and it enables labs to gain access to mRNA and mRNA LMP which we provide for free to undertake work in any of those priority pathogens that I've listed. 

This is an overview of some of the global partners that have been involved in this program and what we look at those promising programs that leveraged that early development engine to accelerate vaccine development to the clinic. 

We can't do it all by ourselves. We are 4 and a half thousand people globally. 

Within Australia, we actually don't have R&D positions. We work with academia, we work with other organisations to meet those needs and gaps that we have in our development pipeline and to identify really new innovative creative researchers that can become part of our innovation programs. 

What this access and the mRNA access program gives people the ability to utilise if they join

Up, is we have our unique mRNA design studio. And we work with those teams on the particular pathogen of interest and working out what is the right mRNA fragment that they're interested in. 

We have high throughput production which we do primarily in Norwood for research grade capability and then we do iterative rounds so people can come back multiple times for modifications of their sequence of interest. That could be another pathogen of interest. 

But when we look at the massive number of pathogens that you are able to look at as part of this program, what I will say is that those that are in bold are those where we already have programs actively being undertaken. 

But if you're doing work in any of those bolded pathogens of interest, it doesn't mean that we won't do another project. We just want to make sure that it is a separate or a different target associated with that particular pathogen. 

To broaden the potential to find a vaccine. And this really just gives you an understanding of where that research has gone. 

We have a comprehensive approach combining that internal R&D, global partnerships and open access to our platform. And this positions us to respond rapidly and effectively to the infectious disease challenges of today and the unknowns of tomorrow. 

While not all candidates are advanced to the clinic or registration, the purpose of this research is really to develop and characterise them in those early stage so that they can quickly be activated if the proverbial was to hit the fan. 

I think that being prepared is a critical part of what we're trying to achieve here in

Australia. But to bring the best innovations and the best possible medicines in our respiratory and oncology portfolio for the public. 

With that I'll say thank you.

Thank you, Felicia.

And our final speaker tonight represents what we are building at La Trobe at the moment with some of the new things that are coming through. 

And we'll be hearing from the innovation company Biobreak Therapeutics led by the CEO Professor Begonia Harris. 

Biobreak is on a bold mission to harness the power of antibiotic technology to tackle one of medicine's most stubborn challenges chronic and recurrent urinary tract infections. 

With the global market estimated at 20 billion, their work is not only timely, but it's actually transformative. 

Please join me in welcoming Begonia for her talk.

Yes, I have three minutes to tell you about Biobreak therapeutics which is our new venture which focuses on developing novel therapeutics for recurrent and chronic urinary tract infections addressing a global market valued at 19 billion US. 

UTIs, urinary tract infections are the third most common bacterial infections in bacterial infections in humans. 

There are over 400 million cases globally per year and these infections disproportionately affect women and the elderly. Uropathogenic E. coli is the leading cause of these infections. 

This pathogen come from biofilms. These are bacterial structures that shield bacteria from antibiotics and the immune system, leading to chronic infections and recurrent infections. 

It is estimated that between 20 and 30% of UTI will become recurrent or chronic and currently we don't have effective treatments for these infections.

In the lab, we investigated antigen 43, a surface protein on the bio on Uropathogenic E.coli that promotes bacteria sticking together and forming biofilms. We also showed that when we block this antigen, we break up bacterial biofilms.

Using this knowledge, we developed a breakthrough antibody technology that inhibits Uropathogenic E. coli biofilms.

This technology can prevent biofilm formation at nanomolar concentrations, dismantles existing biofilms and can enhance the activity of antibiotics that are not effective against biofilm infections.

The competitive advantages of our technology include broad clinical applicability. We are addressing 80% of UTI. 

This technology aligns with the WH innovation criteria for new anti-infectives. It is expected that this technology will lead or will not enhance resistance development because we are targeting virulence not viability and the technology has therapeutic flexibility as it can be used as a standalone therapeutic or in combination with antibiotics. 

Therefore, our technology addresses both clinical efficacy and commercial viability. Our founding team includes experts in protein chemistry, biophysics, biofilms and UTI from La Trobe University and also the University of Queensland. 

Our advisory team has experts in antibody technology, clinical translation and commercialisation. We have strong support from our patient partners which come from different patient advocacy groups including chronic UTI Australia and live UTI free. 

We recently secured $1.5 million dollars from the Australian economic accelerator program and from private investment to take this technology to preclinical stage and we also have a strong intellectual property protection we which covers us internationally. We think we have a technology that can change how we treat urinary tract infections, can rescue antibiotics that are not efficient against biofilm infections and can reduce developmental resistance. Thank you.

Thank you for this. It was very a very good but a very important one to show that connection of what is actually happening with basic research into innovation. 

But let's give a warm welcome to all our speakers joining us on stage once again. 

And I'll start with the first question to help get things going. 

Richard, we have researchers working on early-stage projects in the antimicrobial resistance space. We are currently preparing work plans for early-stage grants and non-funding schemes with longer term goals of applying for CARB-X funding.

What are things you look for with data and evidence that will need to be really competitive in those CARB-X funding applications? 

Yeah, that's a question we often get. 

I think because we fund at different stages, we fund in stages. A program can come into the CARB-X portfolio if it's within scope of the funding round at any stage. 

And for it to lead, it doesn't need to have a lot of people say, well, does that mean you have to show efficacy in an animal model? 

No, that's not true.

We will take programs before that stage. What we do require, if it's a direct acting molecule, we do require wholesale activity against a wild type pathogen. 

That's within the scope of the call.

We'd like to know what the target is. We have taken programs where the target is unknown if the hit has come from a wholesale screen and we will work with the company to set up an experimental plan to try and determine that target. 

But we like to know the target. 

I think the key is how differentiated is the product going to be and that's what you need to highlight and think about what your end product will look like and how that will bring value.

Are there any questions from the audience?

Hey Richard, I'll ask you another question. Thanks for coming out before you fall asleep.

Are pharma companies keen to pick up on new technology such as biologics, peptides and proteins or are they still stuck on antibiotics and vaccines?

I think there are certainly companies that are willing to take more risks. That's really embedded within the culture of the individual company. 

I think if you take one of the largest companies that are still actively in the discovery space, they're focused on a pathogen and an indication rather than the modality. 

They may be really interested in lung infections and so as long as you can provide data to show that you are targeting that pathogen, the specific modality is less of a concern to them. 

But what they will require is evidence that you understand your molecule, how it will be used and will it bring value either as a standalone product or in combination. 

I think while some companies are still focused on vaccines there's more companies that are looking at other preventative modalities. 

I think that in certain populations and certain indications the use of monoclonal antibodies as a short-term preventative measure will be extremely valuable especially if the price can come down and open up the markets into lower resource settings. 

I think companies are looking at non-traditional technologies.

Thank you. Any other questions?

Felicia, I'm wondering about Donald Trump's antipathy to messenger RNA technology and Robert Kennedy's antipathy to vaccines in general. Is that going to make any difference to what Moderna plans to achieve? 

Sure. It's a great question and I was expecting that we'd probably have something like that come up. 

It's during the first term of Donald Trump's administration that mRNA technology really came to the forefront as part of COVID 19. 

I think it's public knowledge we had a contract for pandemic influenza which got cancelled. 

The truth of the matter is Moderna is still committed to develop what it needs to support the globe. 

I think there's an opportunity and what we we're seeing is the resilience markets. In the UK, Canada and Australia the support is there and the belief in vaccines and I must say the belief in the technology as a platform beyond vaccines. 

As I mentioned we have the respiratory portfolio but we're seeing an uplift in oncology and I think that when we see products coming out in the oncological space, you hope that there will be a change to some of the rhetoric.

I think another thing, we were projecting that we'd get a reduced rate of vaccinations in the United States. We actually exceeded our expectations. Whilst the rhetoric out of the government is a particular way, I think people are making their own choices for the protection of their health.

You got a very impressive R&D portfolio. Can you share some of the road blocks in getting your products to market? I think when you have a platform that is capable of being changed and picking what next you do? 

Look the priority for us at the moment is the respiratory portfolio, because that's where we'll be able to generate income that will enable us to then feed more funds back into the other assets and targets that we have there. 

We look at our success rates from transitioning from phase one to phase two and phase three. 

If you look at industry standards, we're actually significantly higher traveling through those because we're gaining information on the platform, each time we do a clinical trial. 

And when we're not seeing the same level of failure rates that you see with traditional methodologies around phase one, phase 2, phase three. And you really have to pick what's the one that makes the most sense to push forward. 

That’s a real concerted effort from our leadership to know what's right for the markets that they're looking to tackle. 

I think having the broad capability, particularly in some of the rare oncology, respiratory and infectious diseases it comes down to funders. Like the world health organisation and Welcome Trust that might be interested in that infectious diseases space.

Hi Felicia.

My question is around the regulatory environment and how things have progressed. It's great to see Moderna and Bayer moving through new technologies, but we know that the regulatory environment took a while to adjust with the platform approach. I'm just wondering if you can comment on how things have gone and how that impacts pandemic preparedness for future. 

Sure. I think you've got to realise they're learning as we're learning, and we're in a journey together, and I must say with the TGA that there are really strong relationships that have been formed and all decisions that they're making are evidence-based which is critical for acceptance. 

I think there's a lot of work that can be done across harmonisation globally when it comes to regulation, but I think those regulators are really open to conversations, particularly

around platform technologies and the capabilities. So the more data that we generate the more applications across a broad portfolio, people start to become comfortable. 

I ask you Marilyn, you've been straddling academia and industry, what advice would you give to people? 

Well, first of all one has to know how to set up a company, and how to deal with regulators and be realistic before you start. 

I think when we started, we had a blue-sky approach that we would save the world but going through the regulators has been the hardest thing, and you need to know how to raise money, because the further you get along the track, the more and more and more expensive it gets and the more difficult. 

Thanks. That was excellent.

I actually have a question for Marilyn and Begonia. I think this might be relevant for the pair of you with regards to where your therapies are operating. How do you see yourself fitting into the clinical treatment of your respective target illnesses? 

And do you feel concerned about almost being too good, and being put on the shelf in that reserve category of therapeutics where perhaps you might not get the same kind of return that potential companies might be expecting from your respective therapies? 

Are you too good at what you're doing?

In terms of our technology, one of the advantages of our technology is that it's not killing bacteria. The expectation is that it will not lead to resistance development and in fact it's helping antibiotics work against the biofilm infections. 

It shouldn't be a technology that would be put in the shelf. It should be a technology that we could be used as on itself or together with antibiotics that have become obsolete for therapeutic treatment. 

I think it depends what you're trying to do. If you come up with the new world's best antibiotic, the worry has always been that it'll be put on the shelf for when there's a real emergency and it's really needed. They'll try everything else first and they'll use that as a last resort because it needs to be protected. 

And that's been one of the reasons why the big pharmas haven't put a lot of money into developing new antibiotics.

Thank you. for Marilyn and Begonia, I I just wanted to get a sense of what scaling might look like for you both. Are you looking to stay on shore or likely go offshore? 

I'll answer first this time. Okay. With Hexima, with a board, a senior board, they thought it was best to go offshore and do all work in the United States.

The innovation happens here, but commercialisation in the US because that's where the big market was, US and Japan. 

However, today I've been talking to this new scheme, industry growth scheme run by the Australian government and they want us to try and do our best to develop products onshore. 

So, with our new little company, we are probably going to try to start to work in Australia, but hoping that it gets big enough to go international. 

Once you want to work with the FDA, it costs a fortune. We spent a lot of money trying to satisfy the FDA requirements. We'll still have to do a lot of that. We hope that we don't have to do it again here in Australia with the TGA, but we will have to do more.

I guess our vision was to follow FDA regulations because if we get approval in that jurisdiction that would apply to others, but it is expensive and so that's our initial thought. 

Well, the final thing was to fund FDA, you really need venture capitalist money. That's normally in the US. And normally people those investors in the US like the work to be done in the US and don't really trust work that's done in Australia. 

That's what they told us. And I'll do one final quick question for the night for Begonia. 

You've had a very successful 2025 and had all the grants and all the other success. What's your hope for 2026?

I don't even want to say anything, but just maintaining what we are Jason, and what we are trying to get is further funding to be able to support the technology to the next stage. 

We have a few grants and fellowships on the go as well.

Thank you to all our panellists for sharing such valuable insights and expertise.