Company Interview / Immutep's clinical trial advancement

Marc Voight of Immutep (ASX: IMM) shares insights on their recent progress in breast cancer treatment. Immutep completes Phase 2 trials for a drug aimed at hormone receptor-positive metastatic breast cancer. This drug could offer hope in improving patients' quality of life alongside chemotherapy.

Marc highlights Immutep's plans to engage with regulatory bodies for advancing to Phase 3 trials. Concurrently, Immutep focuses on broader oncology efforts, such as non-small cell lung cancer, with a new trial involving Merck (NYSE: MRK) and Keytruda, aiming to set a new standard in global cancer care.

Voight reveals Immutep's strong financial standing, with $180 million supporting future clinical advancements and partnerships. This ensures the ongoing development of modern medicines in multiple cancer types, maintaining both ethical motivations and business growth.

Full unedited transcript below:

0:00

IMI temp has completed enrollment for its phase three trial for testing a new drug combination for advanced breast cancer. To get us across the details and what it means for the company going forward. IMI temp CEO Mark Voigt joins me now. Hi, Mark. Welcome back to Osborne's. Look, talk to me about the strides that are being made. Just give us the detail.

0:22

Yeah. First of all, thank you. I appreciate that I have the chance to talk about it here. So indeed, we completed the recruitment for phase two in metastatic breast cancer or the phase two part of a phase two stage three clinical trial, to be more precise. And this is of course, always exciting if you bring the last patient into the study. It's a randomized study, meaning there are two arms on the one hand side feed our drug 30 milligram plus conventional chemotherapy called paclitaxel versus flagging mode at 90 milligram. Also plus paclitaxel in to be technically a very precise here hormone receptor positive Her2 new negative metastatic breast cancer and triple negative breast cancer. So two tough indications that, of course, we hope to make on the one hand side, a good evaluation of the right dose moving forward. And also, of course, to make a difference in this setting, which is

1:21

typically after patients, have been exhausting the standard of care therapies in the first or second line. Well, that's what I was going to ask, because practically, I think a lot of us in the Australian population are familiar with breast cancer and the usual treatment methods for it being surgery, being chemotherapy, being radiation, or some combination of the above. So where does this potentially fit into that whole scenario?

1:52

Yeah, this fits in after surgery and after typically first or second line treatment. What does it mean. Typically um women get a so-called endocrine therapy, um, or reinforced endocrine therapy. Uh, like Cdk4 six inhibitors. So they practically exhausted the most common treatments in this disease, and they typically then go to hemo therapy. And chemotherapy, as we all know, comes with a few disadvantages. It's not most efficacious. Um, you see a number of side effects. And we have actually been showing in the past that when you add EFT mode to hemo therapy in breast cancer, your quality of life increases, your chance of living longer increases, and also your chance of seeing tumor shrinkage in this then metastasized disease. So it's not the primary tumor in the breast. It's metastasized, for instance,

2:52

to to liver or to lung or to the brain. So in a very, very tough setting with high unmet medical need, um, we can make a difference. This is what we have been showing and we now need to explore the right dose. And also in general, uh, the right way, the right combinations to move forward. It's so interesting. Um, you know, it's so complicated, isn't it? So if you get this, um, you know, the phase two trial completed, uh, when could you potentially be looking at stage three trials?

3:27

This will be a thereafter and subject to discussions, for instance, with the regulators. Everything in our business is heavily regulated. And that's an important, um, statement. It's good the way it is. So we will discuss, for instance, with the FDA, we will discuss with the EMA and identify the right way to move forward. Um, it's here about, uh, patients. So you really need to prepare carefully. And we have actually other, um, registration efforts ongoing in non-small cell lung cancer. That's actually our main effort and our focus. Uh, non-small cell lung cancer, an even bigger indication and even, um, uh, more terrible disease as it affects more, more human beings. And there we will start very soon, a phase three clinical trial with 750 patients. And we do that together with, uh, us, Merck, uh, and the top selling drug in the industry, which is Keytruda. Uh, so we are moving forward in

4:27

different indications besides metastatic breast cancer, which is an important indication, but non-small cell lung cancer being the most important one. And we have also clinical trials ongoing in head and neck cancer, in soft tissue sarcoma, in urothelial cancer. So in different cancer types, if you allow me why we are in the position to do that with one product. This is because we treat the patient's immune system. We talk here about a cancer immunotherapy or if you like immuno oncology, meaning we enable the patient's body to actively fight cancer because our own immune system, if equipped with the right information and if the right types of cells are active and they're at the tumor site can do the job. And this is a very, very important message and something we work on in a variety of different indications in phase one, phase two and phase three. Yeah I know and it's amazing the work that you guys do. You've been speaking with us for quite some time. Uh, you know,

5:27

spoken with you many times over the years.

5:30

Is it coming to fruition or is is it happening as you expected it would? Now, I know that there's a lot of unknowns. It's all down to the patients. It's all down to the trials. But you must, um.

5:43

You must find it rewarding to be on this journey if you continue to, to to go forward.

5:50

Oh, yes, indeed. It's an exciting journey, especially if you take your motivation out of, um, the difference you can make, uh, for patients and for the families of the patients. This is something which is motivating the team on an ongoing basis. Of course, it is also lucrative. Um, and if you develop modern medicines, the clinical benefit as well as the commercial positive outlook is coming together. One practical example in non-small cell lung cancer is if you get a drug registered, and this is what we aim to do. If trilogy mode should set a new standard of care. And the most important cancer indication globally, which is lung cancer, um, then you have a total addressable market of 24 billion USD annually. So that's, I believe, an important statement. And the two motivations, ethical side of things. On the one hand side, on the other hand side, we are running a business. Of course,

6:50

um, is quite motivating and this indeed takes also some time. Um, our business, I mentioned it earlier, is heavily regulated. So you need to go through so-called pre-clinical development. Phase one, phase two, phase three before you can be registered, because you need to make sure as this drug would change the day to day clinical care for cancer patients, that it's safe, that it's efficacious, and that you tested your drug very well. And we are now at the final stage in non-small cell lung cancer with a phase three. And we have also been able to convince the pharmaceutical industry to collaborate with us, to support us, to move forward so it can make a very, very big difference. And in between it's a lot of work. Yeah, yeah, I would imagine. Uh, how's the balance sheet looking? Are you well capitalised to take you through the next, uh, the next phase here?

7:43

Absolutely. So we have a very healthy, um, balance sheet. Um, we have, uh, um, according to our last foresee, if I recall correctly, round about 180 million AUD cash on bank. Um, so this is all looking very, very good, very healthy. We have a good cash life. We can focus on the execution and we will have, uh, um, quite a lot to talk about till end of this year. And then also in the next year, of course.