Island Pharmaceuticals (ASX:ILA): Interview with CEO David Foster

We spoke with Island Pharmaceuticals (ASX:ILA) CEO David Foster about the project the company is making with ISLA-101, a drug being repurposed for the prevention and treatment of dengue fever!

 

Transcription

Stuart: Hello. My name is Stuart Roberts, and I’m one of the co-founders of our publication. And with me today is Mr. David Foster, joining me from Dallas, Texas. It’s the 12th of October, 2021 in Sydney in the morning. That would make it the afternoon of the 11th of October in Dallas. Would that be right, David?

David: That is exactly right. We’re sitting here at about 6:45 p.m.

Stuart: Right. Now, David, you’ve been running Island Pharmaceuticals now for several years, a really great drug repurposing story, which had its origins here in Australia, out of Dr. David Jans’ laboratory at Monash University. Talk to us about how you have the next big thing in dengue.

David: Yeah. Thank you so much. It’s great to visit with you. We do believe we have the next big thing in dengue. Dengue is a huge problem literally half the world’s population is at risk of infection for dengue, and it’s problematic because there are four strains of the dengue virus that create problems with your immune system, making subsequent infections really problematic. It can be a lethal disease. So there’s a huge unmet medical need. We became aware of some technology out of Monash University where they had identified a molecule that had very good activity against not one but all four strains of the dengue virus.

As we began looking at this molecule, it became very clear that it was a well-known compound. It was actually initially developed for other indications, primarily cancer. It’s been studied in 45+ clinical trials, yet it’s never been approved for anything because it hasn’t demonstrated very good activity in cancer. So we’re now moving forward with the molecule. We’ve licensed a program out of Monash University, and we’re moving forward using this molecule, moving to a phase II clinical trial in a dengue infection model.

Stuart: Right. Now, many Australians won’t know dengue very well. There’s not much dengue on our shores, but it’s fair to say, in an environment where the world’s getting a little bit warmer and people move…well, people normally move around a bit more than they used to in usual times, we’re going to be hearing about a lot more. How serious a threat is dengue to the health and well-being of us all?

David: So it’s a significant problem, and you’re right. You hit the nail on the head. We typically think about dengue as an equatorial infection, an equatorial problem, but we’re seeing that, as the world’s becoming increasingly warm, the mosquitos are moving out of that equatorial band into the southern part of the United States, into the northern part of Australia. And we’re seeing locally acquired dengue infections occur in both places. Previously, you might have a sporadic case of dengue, but that was really because somebody traveled to an endemic region and brought it home. We’re now beginning to see endemic region in these, again, southern part of the U.S., northern part of Australia. So it’s a growing problem, and we need to find something about it.

Stuart: Right. Now, some of the more knowledgeable viewers might argue, “Well, there’s a vaccine now that Sanofi developed several years ago.” But as we’ve discovered with COVID, vaccines and antiviral drugs tend to work in harmony. Would you agree?

David: I agree 100%. So we applaud vaccine development. I think it’s a huge step in the right direction, but it’s not the only thing that is going to get us over any of these viruses that we’re concerned with, right? We’ve seen, with the COVID, we have fantastic vaccines. We still need antiviral drugs. We need small molecules. There’s vaccine hesitancy. Some people can’t take vaccines. There’s a lot of reasons that vaccines won’t be 100% effective. The same is going to hold true with dengue. We believe there is an approved vaccine. It’s got a very narrow label, primarily focused on treating children who have a prior confirmed dengue diagnosis and live in particular regions of the United States, at least when it’s approved in the United States. So it’s very narrow label, leaving a significant need for therapeutics or other molecules to treat or prevent a dengue infection.

Stuart: Right. Now, in your case, you got some powerful friends. The phase II is going to happen at SUNY Upstate, State University of New York at Syracuse, which is the medical school for the state university system in the state of New York. But it’s using some technology that was developed at Walter Reed, the big U.S. military hospital and research establishment. And it’s interesting, you’ve got a challenge model that you’re working with for your initial phase II. Talk to us about how unusual this study is.

David: So we’re really excited about this study. It is a challenge model. And what that means is we’re going to enroll healthy individuals, people who don’t have a prior infection with any of the flaviviruses such as dengue, Zika, or some of the other flaviviruses. We then infect those healthy individuals with a weakened version of the dengue virus. What this does is it gives them a dengue infection, but they’re only mildly sick. They will feel some of the symptoms associated with dengue. We can take blood samples, and we can observe the body’s reaction to the dengue virus, and so we can monitor the infection. One of the beautiful things that we get to do because we know exactly when somebody’s being infected with exactly what virus, we can use a very small number of patients. So our clinical trial is going to be up to 16 people. We’re looking at four cohorts of four individuals, looking at different doses of the dengue virus. So it’s incredibly powerful. The study that we’re going to be doing is a prophylactic or preventative study where we will pretreat the individuals with ISLA-101, our lead compound, then infect them and see if we can suppress that infection.

Stuart: Right. And, obviously, it’s early days here. Will you test out all four strains of dengue, or will that come in subsequent studies?

David: Those will come in subsequent studies. So right now, we don’t have challenge strains for all four strains of dengue. We have just a couple with the challenge strains. So our strategy is to do the phase II clinical trial with the challenge study. We’ll likely need to move into a more typical environmental clinical trial for a phase III study where we’ll have to deal with different environmental impacts and different strains of dengue that would be in the wild.

Stuart: Right. And you’ve talked previously about the potential to get a priority review voucher. So obviously, at some stage, we’ll be looking at the use of this in pediatric patients. When can we see that as a possibility?

David: Yeah. So that’s a very good question, and I want to draw the distinction between two types of priority review vouchers. You mentioned pediatrics. We’re actually not pursuing a pediatric priority review voucher. We are pursuing a tropical disease priority review voucher. And the way that works is if your drug gets priority review itself when it’s being evaluated by the FDA, and it’s first approved in a disease on a list of diseases for which you can get a tropical disease PRV, then you get it. Okay. So it doesn’t have anything to do with pediatrics. There is a defined list, and it’s a growing list. For us, dengue is on that list. Zika also is on that list, and Chikungunya also is on the list of diseases for which a PRV can be granted. We would only be able to get one upon approval, but we would have multiple chances with these different viruses.

Stuart: What really impresses me about Island right now is that you’re in the process of building pipeline. You’ve got a collaboration with Griffith University, which has some pretty good expertise in drug discovery. And you get to work with them on systematizing a drug reprofiling program. I think that’s really exciting. Talk to us about what you’ve got in mind.

David: Yeah. So we’re also really excited about that. The lead program that we have, ISLA-101, our molecule shows activity, as we’ve said, with dengue and Zika and Chikungunya, preclinically, of course.

Stuart: Right.

David: But we recognize that we would like to expand our pipeline, and the beauty of the system that enabled us to identify ISLA-101 is we were looking at relevant biology in the virus space and we screened our collaborators at Monash University, screened the library of molecules, and identified a hit. Turns out that hit was ISLA-101 with a significant clinical history. We want to repeat that. So we now have a new collaboration in place with Monash University and one with Griffith University. We’re using different systems. We’ll be screening libraries of molecules that have a clinical history, maybe drugs that have been approved or not yet approved but have been in men, and screen those against different viruses, so now expanding beyond mosquito-borne viruses to other viruses with significant unmet medical needs.

Stuart: That’s impressive. Now, for visitors who know life sciences down under, they might not necessarily know you very well. Now, you and I were talking previously. Yeah, you were once on the payroll at Medarex, that wonderful antibody pioneer that gave us the first of the checkpoint inhibitors ultimately. But tell us about where you’d come from before you arrived at Island Pharmaceuticals.

David: Yeah. So before I arrived at Island Pharmaceuticals, I’m a native Texan. I had my Ph.D. from UT Southwestern Medical Center.

Stuart: Okay. You can’t tell that from your accent, David. I got to tell you.

David: Well, fair enough, fair enough. When I left Texas, I spent 12 years in California where I really cut my teeth working with emerging biotherapeutic companies. I was in different law firms there. I’m an attorney. Then I was in-house at Medarex, which was a phenomenal opportunity to work in-house at a very exciting biotech company. And then I’m back in Texas now where I’ve been, and we’re able to start Isla Pharmaceuticals while I was living here. And then moved to Australia just a few months ago.

Stuart: All right. Well, we look forward to having you back in our country as soon as travel restrictions become a little less onerous.

David: That makes two of us. I’m very excited to get back.

Stuart: David Foster at Island Pharmaceuticals, well done on what you’ve achieved, and here’s to a heck of a lot more shareholder value as we work towards making dengue a history.

David: Thank you very much. We appreciate it. And we’re working hard to do that.

 

 

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