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AMPLIA THERAPEUTICS LTD (ATX) - Pioneering Cancer Treatment: CEO & MD, Dr. Chris Burns on FAK Inhibitors, Pancreatic Cancer Breakthroughs, and the ACCENT Trial's Promise

• Andrew Musgrave

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Get ready to explore the cutting-edge world of cancer treatment with Dr. Chris Burns, CEO & MD of Amplia Therapeutics Limited and co-recipient of the 2024 Prime Minister's Prize for Innovation. Our latest episode of ASX Briefs takes you inside Amplia's groundbreaking work with Focal Adhesion Kinase (FAK) inhibitors, specifically their promising small molecule inhibitor, designed to tackle pancreatic cancer head-on. Dr. Burns shares the significant milestones in their ACCENT trial, including the recruitment of the first 26 patients and the remarkable achievement of six confirmed partial responses, which may signal a new frontier in cancer therapy.

Join us as Dr. Burns uncovers the science behind Amplia's innovative approach and how their treatment aims to enhance the effectiveness of existing therapies. He discusses the trial's progress, the potential for improved patient outcomes, and the exciting path forward with further recruitment underway. This episode is a compelling listen for anyone passionate about the future of oncology and the relentless pursuit of breakthroughs in cancer treatment. Don't miss the chance to hear firsthand from a leader at the forefront of medical innovation.

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, a pharmaceutical company focused on advancing a pipeline of focal adhesion kinase inhibitors for the treatment of cancer and fibrosis. Chris has also recently been announced as a co-recipient of the 2024 Prime Minister's Prize for Innovation. Chris, thanks for joining me today and welcome to the ASX Briefs podcast.

Chris Burns:

Thanks, Andrew, good to be here.

Andrew Musgrave:

Now, Chris, 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:

Yeah, so Amplia Therapeutics, a listed company with the ticker code ATX. We're a drug development company developing what's called small molecule inhibitors, so drugs that can be taken as a pill for the treatment of cancer and fibrotic disease. But our primary focus is in oncology at the moment, in cancer and in particular pancreatic cancer. So our drugs inhibit this protein called FAK that's overexpressed in cancer and drives a lot of the resistance pathways for treating pancreatic cancer.

Andrew Musgrave:

And the company has 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 this milestone and what it means for the company?

Chris Burns:

Yeah, certainly. So we've been running what's called the ACCENT trial in pancreatic cancer now for coming up to two years actually. It's a trial where we're combining our drug called narmafotinib with the standard of care treatment for pancreatic cancer, which is two drugs called gemcitabine and abraxane. So if you're unfortunate enough to be diagnosed with pancreatic cancer in Australia, they're the two drugs you will get. And what we're doing in the current ACCENT trial is adding our drug on top of the standard of care. So you're still getting standard of care, but you're getting our drug as well. And the hypothesis we're working on, based on a lot of preclinical data, is that our drug will make the gemcitabine and the abraxane work better and therefore give a better outcome. So we initially started the trial, as I said now two years ago, initially trying to find a dose that was appropriate and safe for patients, but appropriate enough that it blocked this activity of the protein FAK that I mentioned before and gave it enough coverage, enough exposure in the body that it would do that between the doses of the drug. So we give the drug once a day or the drugs taken by mouth once a day. We found a dose that was safe and appropriate for patients and then we've recruited now 26 patients. We started that recruitment at the beginning of the year, we completed the recruitment in July and we've been monitoring those 26 patients since that time for the safety, the tolerability but, importantly, signs of clinical activity. And yes, we very quickly showed that we saw three patients reporting what's called a partial response, and I'll come back to that in a minute. But in fact, even more recently, Andrew, we've actually now got to six confirmed partial responses from that 26 patient cohort and that's a sufficient response rate. That's now allowing us to say, yes, the drug is as effective, possibly better, more effective than the standard of care therapy alone and we can now go ahead and recruit a further 24 patients. So it'd be 50 patients all up.

Chris Burns:

We're at 26 now and we've, as I said, recorded six confirmed partial responses. So what does that mean? A partial response means we see a reduction in the patient's tumour size by 30% or more. So that's a significant shrinkage in tumour size. And this is a measure of the primary tumour in the pancreas, but also in metastatic disease as well, so where the tumours move to other parts of the body. And when we say it's a confirmed partial response, it means we've measured a reduction of greater than 30 percent at one time point and measured that again two months later. So it's a sustained reduction in that tumour size.

Chris Burns:

So to see six confirmed partial responses early in the trial is really positive. That's positive enough for us to say right, let's recruit a further 24 patients, and that's now underway. In addition to the six confirmed partial responses, we've also seen seven patients with what's called stable disease, so not as significant a response in terms of tumour shrinkage, but the fact is that these patients haven't progressed in their disease and that's really important when you're talking about an aggressive disease like pancreatic cancer. Just stopping the disease growing is a huge win. So you know we've seen some good responses to date. We're now expanding out the number of patients so that we can get a really good number of patients and good statistical data to compare against historical data and other clinical trials that are underway.

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 your clinical trials and overall research?

Chris Burns:

Yeah.

Chris Burns:

So the clinical trial that we're running, the ACCENT trial, is based on a lot of research that's come out, probably the last 10 years, showing that FAK this protein our drug inhibits and blocks the activity of is overexpressed in pancreatic cancer and drives an immunosuppressive effect.

Chris Burns:

So it blocks the immune system from working against the cancer and also causes a scar tissue around that tumour. A lot of that work has come out of studies at the Garvin Institute in Sydney and we work very closely with Professor Paul Timpson and his team there and we have shown that by combining our drug with standard of care therapy in his models of pancreatic cancer that we can extend survival, say in a mouse model of disease, by up to 40, 50 percent. So we it's not a cure we don't talk about cures in cancer but it's definitely an extension of survival. And you know we're now in the clinic in advanced pancreatic cancer patients. Patients there, unfortunately, will succumb to disease in less than 12 months. So if we can extend survival by an extra four to five months, that would be a huge, huge win for us and I think, a huge, huge development in the field and obviously real value to patients.

Andrew Musgrave:

Now. Are there any other plans to expand the application of FAK inhibitors beyond pancreatic cancer to other types of cancers or diseases?

Chris Burns:

Yeah, absolutely.

Chris Burns:

We know that FAK is expressed in a lot of solid tumours and causes this sort of scar-like tissue that protects a lot of solid cancers.

Chris Burns:

In particular, ovarian cancer is one area where we see a real potential for FAK inhibitors, as ovarian cancer, like pancreatic cancer, is often diagnosed quite late. As that disease progresses, the dependency on FAK is increased. So by blocking the activity of FAK we have got a lot of good data again through a different academic partnership, this time with a group in San Diego at the University of California there that by blocking FAK that we have a significant effect, a beneficial effect on that cancer. So we think there's a real opportunity in ovarian cancer. That's. That's the next thing where we're starting to focus on, though there's opportunities in other solid tumors as well, like like liver cancer, like head and neck cancer and these. These are areas that we'll come to in due course, but it really points to the fact that our drugs have a lot of potential benefit and it's, if you like, a pipeline in a product, so that there's opportunities, or we're very excited about what we're seeing in pancreatic cancer. There's opportunities beyond that.

Andrew Musgrave:

And I think at a more macro level, what do you see as the market potential for FAK inhibitors?

Chris Burns:

Well, I think that ties in with what I was saying there. You know, the market for pancreatic cancer medications currently is about $2.5 billion. That's US dollars too. You know. Unfortunately, pancreatic cancer is increasing in prevalence around the world. There's something like four and a half thousand diagnoses here in Australia, over 60,000 diagnoses in the US. So the market is unfortunately growing because of the increase in prevalence in the cancer. It's predicted by the mid 2030s to be well over $12 billion market. So in pancreatic cancer alone we think there's a big opportunity. But if we can show the drug is efficacious in a pancreatic cancer setting, that it's safe and well tolerated by patients, which today the data indicates then we've got this opportunity in a range of other cancers. So I think the opportunities here are immense. I don't want to give you an actual number, but there's big opportunities in a range of these cancers that, unfortunately, are not particularly well treated at this point in time.

Andrew Musgrave:

Okay, and just to wrap things up, Chris, what can investors look forward to around some of the milestones in the next 12 to 18 months?

Chris Burns:

Yeah, so, as I said, we've just started recruiting the remaining 24 patients, so we'll finish that recruitment in. We predict the end of Q1 2025. At that point we'll be releasing some early data from that clinical trial. We think that will be quite interesting. Top line data will come out mid-year next year and then a more complete data set probably by the end of 2025. We've got some preclinical studies going on with some other opportunities which I think open up potential for partnerships with pharma in the shorter term. So that's some data we'll be releasing before the end of the year. Plus, we've got this opportunity in ovarian cancer and we expect to start some clinical work there, funding dependent, in the new year. So there's a lot of things happening, a lot of opportunity ahead of us, and we'll be obviously reporting those developments to the market as soon as we can.

Andrew Musgrave:

All right, Chris. Well, 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 coming months.

Chris Burns:

Thank you very much, Andrew. 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.