Company Interview / Noxopharm targets trial for innovative autoimmune drug

Dr Gisela Mautner, CEO of Noxopharm (ASX: NOX) shares insights into the biotech firm's highly anticipated clinical trial for a groundbreaking autoimmune skin disease drug. Gisela underlines that the distinguishing factor of this novel drug is its capacity to treat the disease directly at the source, in stark contrast to traditional treatments that solely manage symptoms. The drug will offer an innovative solution to diseases such as skin lupus by effectively targeting inflammation in the body.

The new drug will be trialled in Australia, a strategic decision highlighting the country's prowess in clinical trials and benefiting from government tax incentives. Gisela details the structure of the trial, stating that it will consist of two elements. The first part involves administering a single dose of the drug to patients, followed by a second stage testing multiple dosages.

Noxopharm (ASX: NOX) is also making strides towards innovative cancer treatments. Alongside its efforts in autoimmune diseases, it recently released promising data related to a pancreatic cancer drug. The results indicate a considerable decrease in tumour growth rate, reduction in barrier cells (which protect the tumour) and a significant reduction in cancer spread. Although hesitant to disclose details about the company's funding, Gisela reassures that they are exploring various options and that the trial is relatively affordable as far as clinical trials go.

Full unedited transcript below:

0:11

Aussie biotech Knox Farm is planning to start a human trial in early 2025 for its new drug, aimed at treating autoimmune skin disease, for the details. Noxopharm (ASX: NOX) chief executive doctor Gisella molnar joining us now. Welcome to hospice. Thanks for joining us again. All right. Tell us a little more then what this, um, trial will involve.

0:36

Well, thanks. Thanks for having me. So our trial is with a very novel drug, and this drug is developed for autoimmune diseases, specifically for skin lupus. And what it does is it's it's it, um, affects the disease right at the source. So lupus and many other autoimmune diseases are diseases of inflammation, and we basically can treat the inflammation right at the source, which is a very normal way of, uh, of treating this disease. So up until this point is the case that it's about controlling symptoms, where this is actually about treating, as you say, the the source of that disease. Exactly. You you've you've you've said it very correctly. It's up to now the treatments that are currently available, like corticosteroids or anti-malarial drugs, they treat the symptoms of the

1:36

disease but they don't treat the disease itself. We are changing that treatment paradigm with this new drug candidate in actually treating the disease itself. All right. So this is yeah. Sorry. You know I was just going to say so that trial is known as Heracles. What does that stand for.

1:54

Oh it stands for arm testing. You know what I

1:59

It's a it's a it's actually a complicated acronym. Yes. Very scientific. So I don't want to go into the details. It stands for harnessing endogenous receptor antagonists or CLI. So we're very hot. But we believe it's a very nice um, it basically shows strength. It shows that we are back in the clinic and um, that and we believe this will be a hopefully very successful trial. All right. And what's the trial actually involved? Where are you doing it? Uh, how many candidates are involved? Yes. Um, so we are doing it here in Australia because we want to take, um, advantage of the, of our Australian expertise that we have, but also that Australia in general, uh, brings to the table Australia is very good with clinical trials. We also want to take advantage of the tax incentives by the Australian government. So that's why it will, um, take party and Australia and

2:59

the trial will be in two parts actually. So there will be one part where we will administer our drug as a single dose, and we will administer it up to the maximum dose that we are allowed to use by ethics. And then there will be a part two where we will use multiple doses, um, per per participant and again go up in the doses. So um, but it's a, it's a, it's a relatively compact trial. So we believe we can actually do it quite quickly. Can you quantify the addressable market? How many people globally actually suffer from this condition? Yes, it's actually more than one would think. So. Autoimmune disease is actually growing. And in the US alone there are about 14 to 24 million cases, um, um, that have autoimmune disease. And so the market translates then to about nearly Um, $100 billion US dollars

3:59

currently, and it will grow to about $160 billion until 2028. So, Giselle, are you not just doing, uh, this, uh, treatment of inflammation as autoimmune diseases, but also you're focusing on cancer as well. And just recently you've also announced some encouraging data in regards to the treatment or a drug that would treat pancreatic cancer. Can you tell us a little more on that?

4:28

Yes. You're right. So we have two technology platforms. One we just talked about is called the software platform. It's our inflammation platform. Um, and then we have another platform technology platform. It's called chroma. And chroma is our cancer platform. And you're right, we just announced some very exciting results in pancreatic cancer. And basically what we what we announced is that we had three significant results. We had a significant decrease in the tumor Humor volume growth rate. We had a significant decrease in the what we call the barrier cells. So this is basically the cells that are around the tumor and actually protect the tumor. So you also need to affect them. And then we had a significant reduction in the cancer spread. So what we call metastasis so so these were the results that we currently announced.

5:21

How has your funding I don't think you've reported yet but without obviously um going there. Obviously these trials um any trial cost money. Um, how well are you finding at the moment.

5:37

Yes. Well, um, obviously you can imagine we are um, we are very aware of funding and our company is exploring a range of options. But you'll understand I can't go into any details, but but I have to say, as far as clinical trials go, this one is actually relatively inexpensive.