NOXOPHARM LTD (NOX) - A New Immune System Discovery Could Change Drug Development

A single scientific insight can open up an entire pipeline, and that’s what makes this conversation with Noxopharm Limited so compelling. We’re joined by CEO Olivier Laczka to talk about Sofra™, the company’s RNA technology platform built on a breakthrough discovery about how the immune system triggers inflammation, developed alongside the Hudson Institute of Medical Research in Melbourne and published in a leading journal. If you care about where ASX biotech is heading, this is a clear look at how platform science turns into real drug programs.

We dig into SOF-SKN™, Noxopharm’s lead asset aimed at cutaneous lupus, a skin disease with a growing global market and no specific designed treatments. Olivier explains why a topical cream that blocks lupus-linked inflammation could be a meaningful shift for patients, and he shares the latest progress including a completed safety trial in healthy volunteers and the practical next step of moving into a trial with lupus patients. We also touch on how the same approach could expand into broader inflammatory skin diseases and chronic conditions where inflammation drives long-term damage.

Then we move into immuno-oncology, where Sofra™ isn’t used to dampen inflammation but to deliberately boost targeted immune activation for cancer treatment. Olivier walks us through newly released breakthrough data, including a 200-fold increase in immune activation when combined with a clinical stage TLR8 agonist in human skin biopsies ex vivo, plus supportive animal model results, and why IP protection and US patents matter when scaling a platform globally. Finally, we cover validation through an Australian Government MRFF grant linked to pelvic floor disorders and birth injury repair, and the key 6 to 12 month milestones investors watch: manufacturing, FDA engagement for IND preparation, cancer program progress, and growing international partnerships.

If you enjoyed this deep dive into RNA therapeutics, inflammation research, and clinical stage biotech execution, subscribe, share the episode with a mate, and leave a review to help more listeners find the show.

Transcript

Andrew Musgrave

Welcome again to ASX Briefs, the podcast discussing insights with leaders of ASX listed companies. And today we're joined by Olivier Laczka, the CEO of Noxopharm Limited, an Australian clinical stage drug development company at the cutting edge of RNA technology and inflammation research. Olivier, thanks for joining me today and welcome to the ASX Briefs podcast.

Olivier Laczka

Thank you, Andrew. Nice to meet you.

Andrew Musgrave

Now, for those that are new to the Noxopharm story, can you just provide a brief overview of the company?

Olivier Laczka

Sure, Andrew. So, we're a clinical stage Australian biotech discovering and developing novel treatments for inflammation, autoimmune diseases, and cancer. This is important because 50% of all deaths worldwide are linked to inflammation. It's a huge contributor to many diseases. We also have the ability to improve the safety profile and effectiveness of a wide range of mRNA medicines and vaccines. Also, important as this is the next big wave of medical technology. All of our assets come from a core technology platform known as Sofra™ and this platform is based on a breakthrough discovery about how the immune system works that we made in conjunction with our partner, Hudson Institute of Medical Research, based in Melbourne. We recently published our research in one of the world's leading journals and are now busy translating it into the real-world drugs. The fundamental idea here is that we can control the onset of inflammation by targeting the specific switches in the immune system that cause it. Think of it like blocking inflammation before it even begins.

Andrew Musgrave

And you've recently had a series of announcements about your leading asset, SOF-SKN™. Can you tell us more about that and how you see its future development and potential?

Olivier Laczka

Of course. We're very excited by that. So, SOF-SKN™ is the name of our drug candidate for cutaneous lupus, which is a skin disease. The market for cutaneous lupus is expected to grow to 6 billion US dollars in a few years' time. But there are currently no specific treatments designed to treat it. We're trying to change that by developing a new skin cream that could block the inflammation associated with lupus. As far as we are aware, there's only this is the only skin cream of its type being developed anywhere in the world for lupus. We recently successfully concluded a safety trial on healthy volunteers, which did not reveal any issues. Our next step will be to take SOF-SKN™ into a trial with lupus patients, and we're currently putting plans together just to do that. It's important to note that SOF-SKN™ is just the beginning. There's a potential here to expand our approach to a broader range of skin inflammatory diseases in the future, such as well-known like psoriasis. Because the technology is so versatile, we can also apply it to other chronic inflammatory diseases, such as rheumatoid arthritis, for example, where inflammation plays a leading role.

Andrew Musgrave

And in late May, you released breakthrough data demonstrating how your SOFRA technology platform is being leveraged in immuno oncology. So, can you talk us through the significance of this?

Olivier Laczka

Sure. So earlier I said our technology can control inflammation by blocking it. However, we can also use the same technology to turn on these immune switches and boost the immune system, which is potentially very useful in the fight against cancer. This is a type of immuno oncology, and the market for this is already significant. It is expected to grow to around 185 billion US dollars in the next decade. The advantage we have is that our assets can be used to amplify existing drugs that are used in chemotherapy and radiotherapy, for example, making them more potent.

Andrew Musgrave

And the data highlights a massive 200-fold boost in immune activation activity when combined with a clinical stage TLR8 agonist in human skin biopsies, ex vivo, alongside a three-fold increase in animal models. What do these results mean for the clinical potential of your technology in the global cancer treatment market?

Olivier Laczka

Yeah, so we're very encouraged by these studies as they show the potential of our assets and the results they can deliver. Because we made this scientific breakthrough, we now have a deep understanding of how certain immune sensors work. When it comes to cancer, we can precisely target those sensors. When we ran these studies, we could dramatically increase the amount of immune activation. That shows this technology has real potential to boost the human immune system in the context of cancer. It would do this in a really targeted way. So, we can reduce the side effects of some of these treatments and hopefully improve the overall outcomes. A technology like this would be something new in the market, and our approach is protected by a very strong intellectual property strategy. We just had a patent awarded, as a matter of fact, in the US for this use of our technology, and we'll continue to develop it as quick as we can.

Andrew Musgrave

And in early July, your strategic partner, the Hudson Institute of Medical Research, was awarded a $1 million Australian Government Medical Research Future Fund grant. How does this project validate the overall versatility of the platform?

Olivier Laczka

Yes, so Andrew, this is a really interesting project because it again clearly demonstrates the versatility of our Sofra™ technology. I already mentioned autoimmune diseases and cancer, but this project is all about repairing the damage caused by birth injuries. Specifically, it's about pelvic floor disorders, which affect large numbers of women and for which there is no cure. It is a burden of over $17 billion for the Australian government alone health system. Preliminary exploratory work has generated encouraging results, and that has allowed us to obtain this government grant. Again, it's a sizable market, about 3 billion US dollars now, and expected to grow by another billion in the next few years. In terms of details, this project will look at using our assets in a skin treatment to reduce these birth injuries, again by reducing inflammation. Taking a step back, once you start thinking about all the ways it would be useful to control inflammation, a whole new world opens up. For example, we're already working with several overseas companies on everything from inhalable technology to tackle lung diseases, as well as new ways to treat nematoid arthritis.

Andrew Musgrave

And finally, Olivier, what does success look like for Noxopharm over the next six to 12 months? What are the key clinical manufacturing and data milestones that retail investors and fund managers should be watching out for?

Olivier Laczka

Yes, so there are several important milestones coming up that are important for investors. In the near term, we're looking to test soft skin in actual lupus patients. That will be a key milestone, and we're working on these plans right now. Also, in the near term, we'll meet with the US Food and Drug Administration to prepare for an investigational new drug application, which is a major step along the regulatory pathway. We'll also complete soft skin manufacturing for the upcoming trial. Additionally, we'll progress our cancer program to build on the promising data we have generating so far, and we are very excited about this prospect. We can also expect further progress with our external partnerships around the world. So yes, Andrew, it's looking like a very busy year ahead for us.

Andrew Musgrave

Okay, Olivier, by leveraging breakthrough discovery in the immune system and strategic research collaborations, Noxopharm is establishing itself as a pioneer in the next generation of RNA-based therapeutics for chronic inflammatory and autoimmune diseases as well as cancer. So, thanks for your time today. It's been great to get an update on the company, and we look forward to further updates in the upcoming months.

Olivier Laczka

Thank you very much, Andrew.

Andrew Musgrave

That concludes this episode of ASX Briefs. Don't forget to subscribe, and we look forward to catching you on our next episode.