On the Couch with Dr Chris Burns - CEO and MD Amplia Therapeutics (ATX)

Welcome to the latest On the Couch. In this episode I am catching up with Chris Burns,  the CEO and MD of Amplia Therapeutics (ATX).

Chris is an experienced drug discovery leader having worked in various roles in pharma, biotech and academia for 25 years. 
 
 He has a Ph.D. from the University of Melbourne and is the inventor on over 30 patents and a co-author on over 60 scientific publications. He was co-recipient of the 2024 Prime Minister’s Prize for Innovation and is a Fellow of the Australian Academy of Health and Medical Sciences, the Royal Society of Chemistry (UK) and the Royal Australian Chemical Institute. 
 
 Dr Burns was originally appointed as a Non-Executive Director on 4 May 2018 and was subsequently appointed as Chief Executive Officer and Managing Director on 5 December 2022.

Amplia Therapeutics Limited (ATX) is an Australian, clinical-stage, drug development company focused on the development of two potent, orally-available inhibitors of Focal Adhesion Kinase (FAK) for the treatment of cancer and fibrotic diseases.​

Transcript

Henry Jennings: Welcome to another episode of On the Couch with myself, Henry Jennings from Marcus Today. Today I'm delighted to be joined by Dr Chris Burns, the CEO and Managing Director of Amplia Therapeutics (ATX).

Some of you may be familiar with ATX because it is part of one of the biotech baskets we put together around a year ago. I thought it would be great to get Chris on the podcast and get the story from the horse's mouth, as it were.

Chris, welcome. Thanks for coming on today.

Chris Burns: Thanks for having me, Henry. Looking forward to it.

Henry Jennings: Chris is an experienced drug discovery leader. He's got a PhD from the University of Melbourne, with postdoctoral studies in the USA. He's an inventor of more than 30 patents and co-author of more than 60 scientific publications.

He was appointed a non-executive director of Amplia in 2018 and became CEO and Managing Director in December 2022.

Amplia is an Australian clinical-stage drug development company, and we're going to hear a lot more about the progress they're making with what is a horrible disease, pancreatic cancer.

Thanks for coming on today, Chris. It's going to be a really interesting episode.

Chris Burns: Great.

Henry Jennings: And just before we kick off, as always, it is general advice only, so please do your own research and contact your own financial adviser regarding any thoughts, ideas or insights in this podcast.

How Amplia And Narmofotnib Began

Henry Jennings: Chris, many people probably haven't heard of Amplia. What do you do and how are you doing it? How are you progressing with your drug?

Chris Burns: That's a very open question.

Henry Jennings: Well, I thought we'd start open.

Chris Burns: Let's start.

Amplia is a drug development company. We're developing a pipeline of drugs, but really our focus is on one drug that we call narmofotnib.

Narmofotnib was discovered in Melbourne at the Cancer Therapeutics Cooperative Research Centre a little over ten years ago. It was an industry-academic partnership, and the drug itself had a fabulous profile from the preclinical studies that the team did at the cancer therapeutics group.

Myself and a couple of other people thought it was too good to have sitting on the shelf in an academic lab, so we started Amplia to develop the drug and take it into clinical study, which is what we did.

We started the company back in 2016 and reverse-listed onto the ASX in 2018. I was a board member at that time and moved into the CEO role at the end of 2022.

Since the start of the company, we've been developing the drug, making sure it is safe and tolerated, manufacturing it on a large scale, working out the formulation and conducting early clinical studies to show that the drug was safe in patients.

The drug is given as a capsule and is taken by mouth.

We're now at the point where we're reading out clinical data from a pancreatic cancer study that was run in Australia and Korea. We've still got a couple of patients on the study, but most patients have now been on the study, and some have stayed on it for the two years that the study was designed for before moving on to other therapies.

The Reality Of Pancreatic Cancer

Chris Burns: If I backtrack a little bit, Henry, and tell you about pancreatic cancer, metastatic or advanced pancreatic cancer is a terrible disease. It's highly aggressive.

Most patients, when they're diagnosed with pancreatic cancer, are diagnosed at the metastatic stage.

Under current therapies, you're looking at median survival of under 12 months, and more like six to eight months with standard therapy.

What we're doing with our study is giving patients our drug as a pill on top of their standard-of-care chemotherapy.

Based on all our preclinical work and the scientific literature, our logic is that by taking our drug, we can actually make the chemotherapy work better.

I'm really happy to say the data has panned out to show that.

We've seen improvements in survival, improvements in response rate and improvements in the durability of response compared with chemotherapy alone.

And all of that is on top of the fact that the drug itself is well tolerated by patients, so we don't add to the burden of the chemotherapy or the disease that the patients are already dealing with.

Henry Jennings: I'm really glad that you took the lead and made it much easier for me with the name of the drug, narmofotnib. That's good.

I know from personal experience that my mother-in-law tragically died from pancreatic cancer, so I know how horrible and aggressive it is. It's especially prescient on my mind in terms of this company.

So where are you now in terms of the trials and where are you heading? What milestones should we be looking at?

Because you've just done a deal with one of the world's biggest drug companies, haven't you?

Chris Burns: Yes, that's a really exciting deal with Eli Lilly. They are actually the world's largest drug company. The last time I looked, they were the 12th largest company in the world.

Clinical Results And Complete Responses

Chris Burns: Everyone knows Lilly because of its work in cardiometabolic drugs and the like, but they've also got quite a large effort in cancer generally. They've got a lot of oncology drugs, some approved and a number of them in development.

So we've got a partnership with them. I'll come back to that in a moment.

To tell you where we are now, our clinical trial, as I said, is coming to an end. This is the first clinical study where we've seen this really promising data.

We're now starting to plan for a registrational study.

That's a three-stage study, and we're about to start dosing patients in the first stage of that study over the next couple of months.

Again, we'll be adding our drug on top of chemotherapy. We'll be looking to emulate what we've seen in our original study, but this time we'll have a placebo arm and a control arm, and it'll be a larger cohort of patients.

So we're just starting the first stage of that.

We're dealing with the regulators, with the US FDA being the main one that we engage with, but obviously the TGA and the European Medicines Agency are also groups we speak with.

The clinical study will run over a couple of years.

We're quietly confident based on the data we've seen to date.

Henry Jennings: And I think that's the key point for investors. We're now moving from the initial clinical evidence towards a much larger, controlled registrational study.

That's obviously where the stakes get higher, but also where the potential value of the company can change significantly if the results continue to support what you've seen so far.

Planning The Registrational Trial

Chris Burns: The registrational study is designed to give us the definitive data we need.

We've got the early evidence, but the next stage is about proving that result in a larger patient population with the appropriate control group.

That's the normal progression for a drug development company.

We've got a lot of work to do, but we're excited about where the programme is heading.

Eli Lilly Collaboration And KRAS Resistance

Henry Jennings: Let's talk about Lilly because I think that's another really important part of the story.

You've got one of the world's largest pharmaceutical companies involved. What does that mean for Amplia and for narmofotnib?

Chris Burns: The Lilly relationship is extremely important to us.

They're a sophisticated oncology company and they understand the science and the potential market.

The collaboration gives us access to their expertise and also provides independent validation of what we're doing.

One of the interesting areas is the potential role of narmofotnib in overcoming resistance mechanisms, including those associated with KRAS-driven cancers.

That's potentially a much larger opportunity than pancreatic cancer alone.

Fast Track And Orphan Drug Status

Henry Jennings: You've also received regulatory recognition for the programme. How important is that?

Chris Burns: Regulatory designations can be very helpful because they recognise the unmet medical need and can potentially streamline aspects of the development and review process.

Pancreatic cancer is exactly the sort of disease where there is a very significant unmet need.

We're continuing to work with regulators as we move towards the registrational programme.

Moving Into Lung And Ovarian Cancer

Henry Jennings: So pancreatic cancer is the immediate focus, but is this ultimately a much broader oncology opportunity?

Chris Burns: Absolutely.

The mechanism we're targeting isn't unique to pancreatic cancer.

We've got opportunities to investigate the drug in other cancers, including lung and ovarian cancer.

The important thing is that we're focusing our resources. We don't want to spread ourselves too thinly.

Pancreatic cancer is the lead indication, and if we can establish the drug there, that gives us a much stronger foundation for moving into other indications.

Where AI Helps Drug Development

Henry Jennings: AI is obviously everywhere at the moment. Is it having an impact on drug development?

Chris Burns: Yes, absolutely.

AI can help with areas such as drug discovery, analysing data, identifying potential targets and improving the efficiency of development.

But it doesn't replace the underlying science.

You still need good biology, good clinical trials and good data.

AI is a tool that can potentially make the process faster and more efficient.

Licensing Path And How It Pays

Henry Jennings: Let's talk about the commercial opportunity.

For investors looking at ATX, ultimately the question is how does this become a commercial drug?

Chris Burns: There are a number of potential pathways.

A company like Amplia can continue developing the drug itself, partner with a major pharmaceutical company, or ultimately license or sell rights to a larger company.

The Lilly relationship demonstrates that there is interest from major pharmaceutical companies.

Our job is to continue generating the clinical evidence and increasing the value of the asset.

Pipeline Risk And Fibrosis Mechanism

Henry Jennings: Of course, this is biotech, so we should talk about risk.

Chris Burns: Absolutely.

Drug development is inherently risky. You can have very promising preclinical or early clinical data and still encounter problems later.

That's why the next clinical trial is so important.

Our confidence is based on the data we've generated so far, but we're very conscious that the larger controlled study needs to reproduce those results.

The underlying mechanism also has applications beyond oncology, including fibrosis.

That's another area where the biology is potentially interesting.

Cash Runway, Funding And Investors

Henry Jennings: What about the balance sheet? Investors always want to know how long the cash lasts.

Chris Burns: The company has been disciplined with its cash and we're focused on ensuring we have the resources to execute the clinical programme.

Funding is obviously an important consideration for any clinical-stage biotech, particularly as the trials become larger.

Our objective is to create value through clinical development and make sure we have the capital required to reach the important milestones.

What The Market Misses And Wrap

Henry Jennings: Finally, what do you think the market might be missing about Amplia?

Chris Burns: I think the key thing is the potential of the drug beyond the immediate indication.

We're developing narmofotnib in pancreatic cancer because that's where we have the strongest clinical evidence.

But if the mechanism continues to demonstrate efficacy, there is potentially a much broader opportunity across other cancers and potentially other diseases.

The Lilly relationship is also important validation.

Ultimately, though, the clinical data is what matters.

Henry Jennings: Chris, thanks very much for joining us on On the Couch. It's been fascinating to hear the story directly from you.

Pancreatic cancer is obviously a terrible disease, and if Amplia can continue to demonstrate the sort of results we've seen to date, the potential is significant.

For investors, however, it is important to remember that this remains a clinical-stage biotech. There is enormous potential, but there is also enormous risk.

Chris, thanks again for your time.

Chris Burns: Thanks very much, Henry. It's been a pleasure.