Immutep (ASX:IMM) reports first subject dosed in autoimmune disease study

Immutep Limited (ASX:IMM) CEO and Executive Director Marc Voigt discusses progress with the company's IMP761 drug, which is potentially active in more than 90% of autoimmune diseases.

Peter Milios: I'm Peter Milios from the Finance News Network, and today we're talking with Immutep (ASX:IMM). Immutep is trading under the ASX code "IMM" and has a market capitalisation of approximately $487m. Immutep is a clinical-stage biotechnology company at the forefront of developing novel LAG-3 immunotherapy for cancer and autoimmune diseases. Joining us today is CEO Marc Voigt. Marc, welcome back to the network.

Marc Voigt: Thank you, Peter.

Peter Milios: Marc, let's start with talking about your most recent announcement — the first subject has been dosed in the Phase I study of IMP761. How significant is this news?

Marc Voigt: It's quite significant because it marks the end of the so-called preclinical development of this program. Before you can apply product and apply it to a human being, you need to test it for a long period of time. So for a few years, actually, you need to manufacture it in the right quality. And now we have been starting the so-called first-in-men study. So, up to 49 participants will be treated in the coming months.

Peter Milios: What are the benefits of the fact that the first subject is being dosed by the Centre for Human Drug Research?

Marc Voigt: It's a significant collaboration we have entered into because this is a centre of excellence. Typically, a Phase I study is centred around safety. That's of course also the case here. However, this centre has developed specific tests where you can already have a read-through to the biologic activity of the drug. We talk here about the space of autoimmune diseases, and the later part of a trial, the healthy volunteers will be challenged. So, we cause deliberate inflammation in the skin and then we give either placebo or IMP761 — that's the name of our drug — and see the difference or have a read into the pharmacokinetic, pharmacodynamic effects, have a read into the safety. So it's, for a Phase I, a very sophisticated setup. It's a so-called double-blind placebo-controlled Phase I, and total in 49 participants. So, this is a specialised exercise to have as much information as we can get out of this Phase I clinical trial.

Peter Milios: And, Marc, what are the next steps for IMP761?

Marc Voigt: Yeah. First of all, we will conduct this clinical trial, and we hope for a very, very good safety profile, it's ascending dose, as typically you would do it, then read through the biological activity. And then beyond that, for a potential Phase II clinical trial, we would need to make a choice in terms of indication. Could be, for instance, type one diabetes, could be rheumatoid arthritis, could be psoriasis, because our therapy is potentially active in more than 90 per cent of autoimmune diseases. It's an upstream approach; meaning we are dealing with the root cause of the disease, not a symptomatic cure, but we are addressing the root cause of the disease. This is why it's relatively broadly applicable, and the clinical reality needs to show where exactly we should make our first step and how we will broaden this program in the future.

Peter Milios: And looking at the broader company, how is the company progressing and what can we expect to see from the company over the next 6-12 months?

Marc Voigt: The company is progressing actually very well. We will have a number of news in the remainder of this year, important milestones to address among them, more data from head and neck cancer, more data from soft tissue sarcoma. Importantly, we will become a Phase III company. So, either by end of this year or first quarter next year, we will have the first patient in in a Phase III clinical trial in first-line non-small-cell lung cancer. This is the most important market in oncology. And we have been entering, eight weeks ago or so, into a collaboration with US Merck, and we combined another drug called Eftilagimod together with Keytruda, the top-selling brand in the whole industry, the whole pharmaceutical industry, to address the most important market, and the whole range of that market eligible for so-called anti-PD-1 treatment. So, we will aim to set a new standard of care in the most important market in oncology, something which has never been tried by any Australian company. And we will make this a reality in the next few months, to start this clinical trial. And then, in the first half of next year, we will see data from IMP761, the study we just have been discussing. We will see data from our additional clinical trials. We will recruit patients in the Phase III clinical trial. Also — I shouldn't forget — metastatic breast cancer. So, there's a lot going on. No shortage of milestones, catalysts, news flow, which is important in our industry.

Peter Milios: Marc, thank you for your time today.

Marc Voigt: Peter, thank you so much. It has been a pleasure.