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ADALTA LIMITED (1AD) - Revolutionizing Biotechnology: CEO Tim Oldham on i-body Platform and Breakthroughs in Fibrotic Disease Therapeutics

August 04, 2024 • Andrew Musgrave

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What if you could harness the secrets of the shark immune system to combat diseases that have stumped traditional medicine? On this episode of ASX Briefs, we sit down with Tim Oldham, CEO of AdAlta Limited, to uncover how his team is revolutionizing biotechnology with their pioneering i-Body platform. From the depths of shark biology to cutting-edge drug discovery, Tim unfolds the extraordinary journey of creating ultra-small, highly specific protein therapeutics aimed at tackling fibrotic diseases.

Join us as Tim dives into the progress of AD-214, AdAlta’s promising candidate currently in clinical trials for idiopathic pulmonary fibrosis (IPF). With half a million people affected worldwide and no therapies to halt fibrosis progression, AD-214 offers genuine hope. We also explore the strategic directions of AdAlta's subsidiaries, AdSolis and Adcella, and how they’re pushing the boundaries of therapeutic development. Whether you’re a biotech enthusiast or just curious about ground-breaking medical innovations, this conversation is packed with insights you won’t want to miss.

Andrew Musgrave:

Welcome back to ASX Briefs, and joining me today is Tim Oldham, the CEO of AdAlta Limited. Adalta is a clinical stage biotechnology company based in Australia focused on discovering and developing protein therapeutics through their unique i-body platform. Their lead product, AD-214, is preparing for clinical trials for treating fibrotic diseases, and today we'll discuss their innovative i-body technology, current projects and future goals. Tim, thanks for joining me today and welcome to the podcast.

Tim Oldham:

Thanks for having me, Andrew.

Andrew Musgrave:

All right if we can just start, if you can provide a quick overview of AdAlta and its primary focus areas.

Tim Oldham:

Adalta is a drug discovery company. Our mission in life is to produce antibody-like drugs that address diseases where traditional antibodies have been unsuccessful. We go where antibodies cannot go, if you like. We have a proprietary technology platform, which we call our i-bodies, which provides a really powerful drug discovery tool. And then we develop drug candidates, either in partnership with other companies or ourselves, through to early stages of clinical trials. So today we have essentially three different business units. We have our i-body discovery business under the parent company, AdAlta. We have a subsidiary we call AdSolis, which is progressing our most advanced internal candidate AD-214, into phase two clinical trials for fibrotic diseases. And we have our brand new subsidiary, AdCella, which is focused on cellular immunotherapies, which is another area where we think our i-bodies are particularly advantaged.

Andrew Musgrave:

Okay, and the i-body platform is central to the company's therapeutic development. So can you explain what an i-body is and its unique advantages over traditional antibodies?

Tim Oldham:

So let's start with antibodies themselves. These are very, very large molecules. They're the key component of our immune system and about 30 years ago the pharmaceutical industry worked out how to harness these as therapeutics to do things beyond what our endogenous immune system did, and from that day onwards that's become wildly successful because of their unparalleled ability to be very, very specific and very, very selective in terms of their effect on the body. But they're very large, cumbersome molecules, and the search has been on from day one to find smaller versions of these molecules that confer that same capability in a much smaller package. And we need that because we often want to engage what we call drug targets, which are hidden from a full-size antibody, what we call sterically hindered (think about trying to get into a small cave) or we're trying to add other functions onto them and that would make a traditional antibody much bigger.

Tim Oldham:

So AdAlta was founded out of basic research on the shark immune system, and it turns out that sharks evolved a very rudimentary immune system which has very, very tiny antibody-like molecules. They're about a tenth of the size of a human antibody. We found a human protein that looks exactly like the shark antibody backbones and we were able to engineer in the unique binding loops to create a library of billions of variants that we could use for drug discovery. So, essentially, the i-body technology has very long binding loops that enable us to get into those little caves and caverns of receptors, and is very, very small, which enables us to use it in combination with modalities and combine them into what we call bispecifics or cellular immunotherapies, which we may talk about later, and the net result is that we have something that looks and behaves very much like a traditional antibody, but in an ultra-small package and in a format that's been proven to be antibody-like in an animal system but is totally human.

Andrew Musgrave:

And your lead product, AD-214, is currently in clinical trials for fibrotic diseases, so can you provide an update on the progress of these trials and what the next steps?

Tim Oldham:

So let's talk about the opportunity here. So fibrotic disease is a scarring of internal organs that results, just as a scar on skin does, in a reduced function. One of our lead indications is a disease called idiopathic pulmonary fibrosis. This is scarring at the lungs, which prevents them expanding and contracting. This is a progressive and degenerative disease. There are half a million people around the world living with IPF today, but essentially they're living under a death sentence because we have no therapies that will slow, that will prevent the progression of fibrosis. The existing therapies slow it but have some very, very serious side effects that make them intolerable for long periods of time. So these patients are desperate for a better outcome.

Tim Oldham:

AD-214 is the first antibody like therapeutic, or the most advanced antibody like therapeutic, in the pipeline for IPF. We have just completed our second phase one clinical trial that's demonstrated that this molecule is safe in healthy volunteers and has enabled us to identify the target dosing for phase two clinical trials. This is on the back of preclinical work that shows it's effective in multiple animal models of fibrosis. And in parallel with that we're also doing some work to identify a more convenient route of administration. The drug is currently administered by intravenous infusion. We think we can eventually administer this by subcutaneous injection, which would mean a patient could do it at home, just as a diabetic does with their insulin. So we've completed the phase one program. Now we're in the process of negotiating partnerships to enable us to progress this asset into phase two clinical trials (they would most likely be in IPF) and to, in parallel with those phase two clinical trials, develop that subcutaneous formulation of the drug. So the next steps will be a partnering transaction to enable that to happen and we're deep in those conversations now.

Andrew Musgrave:

Okay and the company recently announced a new initiative and subsidiary, AdCella, focused on cellular therapies for cancer, and two strategic collaborations supporting this with Synthesis BioVentures and Cell Therapies Pty Ltd. How does this initiative fit into your overall strategy?

Tim Oldham:

So it's really important as a listed biotechnology company that we have a robust clinical stage pipeline. It's clinical milestones that significantly de-risk assets and these are the opportunities that provide a significant value increase for our shareholders, which is what their obvious expectation is. So when we were looking around for what happens, where do we focus beyond AD-214, we identified that the field of cellular immunotherapy was ideally suited to our i-body technology. So by cellular immunotherapy, what I'm talking about here is the use of a patient's own immune cells as a living drug to fight cancer and other diseases. We take the patient's own cells, we expand and in many cases, modify them in a laboratory and give them back to the patient to enable their immune system to now find cancer which has previously been hiding from it.

Tim Oldham:

i-bodies are ideally suited to this application because of their small size they're half the size of the traditional building blocks we use for these cellular immunotherapies, and that means we can cram more functions into these cellular therapies than you can do with traditional technology.

Tim Oldham:

And that's really important if we want to take the amazing advances that have happened in blood cancers and translate those into solid tumors. So we started the journey around post-AD-214 clinical stage pipeline, looking at where i-body was particularly advantaged. We then realized that Australia has a very, very good ecosystem for delivering clinical trials and manufacturing of these complex therapies, and that the innovation in this space was happening around the world is centered in Asia, and particularly in China. So what we're doing with AdCella is creating a pathway for Asian-originated cellular immunotherapies, a hub of innovation in this space, to progress those therapies into Western-regulated clinical trials via Australia and with the potential then to leverage the i-body technology in their future pipelines. And so the objective for us is to build a clinical stage pipeline rapidly by licensing these clinic-ready assets, many of which already have clinical data behind them, as well as then providing a pipeline of future applications of the i-body technology.

Andrew Musgrave:

And the company also has collaborative partnerships with GE Healthcare and Carina Biotech. So can you tell us more about these partnerships and how they enhance your research and development efforts?

Tim Oldham:

So let's go back to the i-body platform as a powerful drug discovery tool. There are multiple different applications of this technology and we can't exploit them all, so these collaborations such as we have with GE and Carina are about finding other applications for that technology and being able to progress them using expertise and skill sets that we may not have in-house or that we may not have the capital to fund. So in the case of GE Healthcare, we're working with them to develop an i-body-enabled PET imaging agent for cancer treatment or diagnosis and treatment. We don't have PET imaging capability, but GE do. They also funded that research so effectively it became a product in our pipeline for free.

Tim Oldham:

In the Carina Biotech case, this was the work we did that actually enabled us to demonstrate the credentials of i-body in the CAR-T or cellular immunotherapy space. Carina is an Australian biotechnology company with a very impressive CAR-T manufacturing platform. CAR-T cells are a specific type of cellular immunotherapy and that platform, something again that we don't have in-house, combined with the i-body technology, allows us together to build CAR-T products against these solid tumor candidates that neither of us could have done alone. So we jointly own the results of the collaboration we're working on with them. We have three products we're working on right now, with up to five in the collaboration, and that really was the proof point for us to say actually the unique capabilities of the i-bodies are well suited to this cellular immunotherapy field. So these strategic collaborations add additional products to our pipeline where we couldn't necessarily afford them or didn't have the capabilities ourselves, but leverage the power of this i-body drug discovery tool and in addition, as in the Carina case, they help us validate other areas for focus for our internal programs.

Andrew Musgrave:

Okay, and just to wrap things up, are there any other market opportunities that the company is looking at and what are some of the key milestones investors can keep an eye on over the next 12 months?

Tim Oldham:

So we're a relatively small company today it's important that we retain a high degree of focus.

Tim Oldham:

We are very, very clear that the future of the company now is built around AdSolis, our vehicle for progressing AD-214, and AdCella are our vehicle for progressing our cellular immunotherapy strategy. And the milestones in the near term that we're looking towards are transactions: outlicensing or asset financing, phase two clinical trials of AD-214, which we believe will unlock the value of that asset, which we don't believe is reflected in our share price today, and give investors confidence that this asset is genuinely having the potential to transform outcomes for those half a million IPF patients around the world; and then the other side is obviously building out our AdCella business again through in licensing transactions, which will give people, give shareholders, visibility on the value of the capabilities we've assembled, both ourselves plus Synthesis, plus Cell Therapies, to really build a pretty special business that brings new hope to patients with solid cancers. So the near-term focus for us is all about the transactions that enable progression of AD-214 and the AdCella business business unit and then, following on from that, will be the execution milestones associated with commencing clinical trials in both of those units.

Andrew Musgrave:

All right, Tim. 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 upcoming months.

Tim Oldham:

Thanks, Andrew, look forward to it.

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.