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AMPLIA THERAPEUTICS LIMITED (ATX) - Revolutionizing Cancer and Fibrosis Treatment: CEO Dr. Chris Burns on Groundbreaking FAK Inhibitors and Promising Clinical Trials

August 01, 2024 • Andrew Musgrave

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What if you could revolutionize the treatment of cancer and fibrosis with a simple pill? Join us as we sit down with Dr. Chris Burns, CEO and Managing Director of Amplia Therapeutics Limited, to explore how their groundbreaking small molecule inhibitors are poised to change the medical landscape. Chris takes us behind the scenes of their innovative work targeting focal adhesion kinase (FAK), a protein overexpressed in many solid tumors and fibrotic diseases. Learn why Amplia's orally-administered FAK inhibitors stand out in terms of potency, tolerability, and selectivity, and how they offer new hope for patients battling pancreatic cancer and pulmonary fibrosis.

Chris also shares exciting updates on Amplia's Phase 2a ACCENT trial, which is testing their lead agent, Narmafotinib, in combination with standard chemotherapy. With recruitment completed for the first 26 patients and three confirmed partial responses already reported, the trial's early results are promising. Listen in to understand the significance of these milestones and what they mean for the future of Amplia’s drug development. This episode offers a comprehensive look at the potential impact of Amplia Therapeutics' innovative treatments on cancer and fibrosis therapies.

Andrew Musgrave:

Welcome to another episode of ASX Briefs, and joining me today is Dr Chris Burns, the CEO and Managing Director of Amplia Therapeutics Limited, an innovative pharmaceutical company focused on advancing a pipeline of Focal Adhesion Kinase inhibitors for the treatment of cancer and fibrosis. Chris, thanks for joining me today and welcome to the podcast.

Chris Burns:

Thanks very much for having me, Andrew Nice, to speak.

Andrew Musgrave:

Now, just to get things started, can you give our listeners an overview of the company and its key areas of focus, particularly in the realm of FAK inhibitors?

Chris Burns:

Sure Amplia Therapeutics. We're a drug development company. We are based in Melbourne and we're developing what are called small molecule inhibitors of focal adhesion kinase. So what I mean by small molecule inhibitors or small molecule drugs, these are drugs that can be formulated into a pill or a capsule and taken orally. So, unlike a lot of cancer medications that are given intravenously, our drug is given as a pill, which is obviously much more convenient for patients.

Chris Burns:

And we're developing these drugs to actually block a particular protein called focal adhesion kinase, or FAK, which is a protein that's overexpressed in cancers, many cancers, in particular solid tumors, and it's also present in a group of cells that lead to overactive scarring or what we technically term as fibrosis. So our drugs have the potential to treat, by inhibiting this particular protein, FAK, to treat diseases that are solid tumors and particularly those solid tumors that have a scar tissue around them, and those cancers are things like pancreatic cancer and can also be used to treat fibrotic diseases like pulmonary fibrosis, which is a scarring of the lung, for instance. So we have a number of different therapeutic potential for the drugs we're developing and you know we believe that our FAK inhibitor. There are a number in development, three actively in development. We believe ours is the best of those three in terms of its level of potency, its tolerability in patients and its selectivity, so in terms of off-target effects.

Andrew Musgrave:

Now you've recently completed the recruitment of the first 26 patients for the Phase 2a ACCENT trial and have reported three confirmed PRs, so can you just elaborate on the significance of these milestones and what it means for the company?

Chris Burns:

So our trial is currently underway in Australia at six sites and in Korea at five hospitals in Korea. So the trial is a combination of our lead agent, a drug called Narmafotinib, with the standard of care therapy for pancreatic cancer which is called are in Abrax Abraxane therapy alone. study is to demonstrate first of all that Narmafotinib can be combined with Gemcitabine and Abraxane and be safe and well tolerated on top of the Gemcitabine and Abraxane therapy alone and hopefully we can prove that it is efficacious that it adds to the benefit of those two, two um standard of care chemotherapies. Um. So to do that trial, we're we're recruiting 50 patients all up, but we're adopting a a methodology called assignments to stage design, which is essentially saying let's recruit a subset of patients and see how that subset of patients respond to the drug, see if the drug is on track, if you like, to improve the activity of the Gemcitabine and the Abraxane. So to do that, rather than recruiting all 50 patients, we have to recruit 26 patients. That's a number worked out by statisticians and we need to show that we can get six or more partial responses that are confirmed. So what does that mean? That means that we see a reduction in the size of their tumours by 30% or more and that reduction is maintained for over two months. So we do image these patients' tumours every two months, two months, four months, six months. So what we want to show is that we can see a reduction of 30% or more and we can confirm that two months later on.

Chris Burns:

And if we can see that in six or more patients out of 26 patients, we are well on track to demonstrating activity of the drug and then we can recruit the remaining 24 patients. So we wanted to recruit 26 patients as quickly as possible. We started the recruitment in January. We completed it in early July, so we recruited 26 patients quite quickly and we reported last week that of those patients that we had recruited and been able to image at two months and four months so still early days in this particular phase of the trial we've imaged six patients today and three of them already have shown confirmed partial responses. So they've shown a reduction in the tumour size by more than 30% at both the two-month and the four-month time points. So that's really positive that we've seen that data and you know we believe we're on track to get and report to the market the six confirmed partial responses by the end of September.

Andrew Musgrave:

Okay, and the company has been collaborating with several institutions for its R&D. So how have these partnerships contributed to the progress of the clinical trials and the overall research?

Chris Burns:

Yeah, look, we've had a close association with academic institutes both in Australia and overseas. In fact the drugs themselves were discovered in Australia. So the company is translating Australian medical research, which I'm a big believer in and a big supporter of. We're licensed in these assets and particularly our lead drug from what was called the Cancer Therapeutics Cooperative Research Centre. So that was a group of drug discoverers out of you know industry and academia, including things like the Walter and Eliza Hall Institute, Peter MacCallum Cancer Center, Monash University, St Vincent's Institute of Medical Research so really top quality scientists from you know very well world-renowned research institutes.

Chris Burns:

Since we've in-licensed that company, we've continued to dialogue with those teams. But we're also working with the Garvin Institute in Sydney, done a lot of work in pancreatic cancer with that team and that's really helped us inform how we run our clinical trial. And we've been working more recently with the team at the University of California in San Diego to do some work in ovarian cancer. And again, you know this is identifying opportunities for a drug like ours, a FAK inhibitor that can work in solid cancers that have this fibrotic scar tissue associated with them. So yeah, the collaborations we've had and continue to develop actually have been very, very, very, very beneficial for the company.

Andrew Musgrave:

Okay, and are there any other plans to expand the application of the FAK inhibitors beyond pancreatic cancer to other types of cancers or diseases?

Chris Burns:

Yeah, Well, I just mentioned the work we've done at UC San Diego where we're looking at ovarian cancer. That's really a clear area of unmet medical need, just like pancreatic cancer in its own right. So ovarian cancer is a terrible disease, often identified quite late in its disease and, like pancreatic cancer, it's quite fibrotic. We know that the FAK levels are very high in ovarian cancer and that contributes to disease resistance. So we are very excited about the opportunity in ovarian cancer and are working with specialists and clinicians around the world at the moment to map out a clinical trial. We've spoken previously about working in other fibrotic diseases and non-cancerous diseases, but still severe diseases like pulmonary fibrosis. This is a scarring of the lung that makes it very difficult to breathe. At the moment we've sort of put that work on the back burner a little bit while we focus on the cancer indications, because we're a small company we can't do everything, but there are absolute opportunities in fibrotic diseases outside of cancer and that's something that we will come back to and do further development in due course.

Andrew Musgrave:

And, given the promising results so far, what do you see as the market potential for FAK inhibitors?

Chris Burns:

We are very bullish about the long-term potential of a FAK inhibitor. To date our clinical data shows that our FAK inhibitor is well tolerated by patients and that early data, of course, but that it's showing signs of efficacy on top of the standard care therapy. So we think there's real potential for our drug. Initially we're focusing in pancreatic cancer. We'll start doing some work in ovarian cancer. But we see the broader potential that a FAK inhibitor could combine with a whole range of different therapeutic approaches for a whole range of different cancers. So this is not just a single shot play for one cancer. There's a lot of opportunity in a range of cancers and in combination with a range of different treatment styles anything from biological cell therapy, even radiotherapy, a FAK inhibitor could combine with. So the market potential is really very, very large.

Andrew Musgrave:

Okay, and just to wrap things up, what are some of the key milestones you're hoping to achieve in the next 12 to 18 months?

Chris Burns:

Yes. So the first thing that we're looking to is to complete the interim analysis, which is getting to the point where we show six or more partial responses that are confirmed in our current ACCENT trial. That hopefully will be by the end of September. That's the sort of timeline we're looking looking to. Then we will re-enroll the remaining patients. That should happen over a period of about six months. We'll be reporting the re-enrollment and then, as data starts coming out from the trial, we'll be reporting that , so that's into the new year, into 2025. And at that time we also hope, with some additional fundraising, to initiate a study in the US in pancreatic cancer, slightly different to the trial we're running here, but still in pancreatic cancer and, assuming that we identify the right group to work with, we'll do a study, an early study, in ovarian cancer as well. That's something we're actively pursuing. So a lot of new studies that will be coming online and some data from our ACCENT trial that really will add a lot of value, I think, to the program and the potential for the program to be partnered or licensed.

Andrew Musgrave:

Well, Chris, thanks for your time today. It's been great to get an update on the company and we look forward to further updates from Amplia Therapeutics in the upcoming months.

Chris Burns:

Thank you very much. All the best.

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.