Kazia Therapeutics (ASX:KZA) glioblastoma Phase II trial results


by Rachael Jones

Kazia Therapeutics (ASX:KZA) CEO & MD, Dr. James Garner talks about its Phase II interim results for its glioblastoma drug candidate paxasilib, its pivotal GBM AGILE Phase II clinical study to commence 2H20 and value drivers as the company moves toward registration.

Rachael Jones:
Hello. I'm Rachael Jones for the Finance News Network. Joining me from Kazia Therapeutics today is MD and CEO, Dr. James Garner. James, welcome back to the network.

James Garner: Rachael, thanks for having me. It's great to be here.

Rachael Jones: Now, Kazia licenses a drug development candidate with the aim of taking them through to commercialization. How's progress?

James Garner: Rachael that's right. We set up our company really to focus on one very specific thing, which was to take great quality promising drugs that didn't fit with their original company's strategy and to build value around those. And our first drug was licensed in from Genentech, which of course is the world's most successful cancer drug developer. And we've taken that into now a phase two clinical trial. We're getting some fantastic data out of it and frankly, it's looking so exciting for us that we've really been focusing around that for the last year or two. So some of those ambitions to continue broadening the portfolio have taken a little bit of a back seat for now. We've just got so much on our hands with paxalisib. But I think in the medium term we'd like to get back to some of those growth aspirations.

Rachael Jones: Thanks James. And before we talk about your portfolio, can you tell us about your recently announced phase two interim results for paxalisib?

James Garner: Yeah, so we reported some data just recently and it's looking really promising. We focused on two measures of the efficacy of the drug. The first of them is a measure called progression free survival and this really gives us a measure of, "Does the drug delay growth of the tumor?" And on that score it looks really promising. We're seeing a progression free survival of about 8.5 months for our drug versus 5.3 months for the existing standard of care, the only existing drug. So it looks like there's something like several months of advantage in there. But the really big news is we've also been able to report some survival data. So this tells us essentially, "Does the drug extend life for patients with this very, very aggressive cancer?" And on that score, we've seen a figure of 17.7 months versus 12.7 months, the existing drug, which is a fantastic result. That's a knockout. So we're really excited by this stage but it's still, the study is still ongoing. We're still learning more but I think if these kinds of numbers hold up, we're going to have a very promising drug candidate on our hands.

Rachael Jones: And now let's talk about your portfolio in a little more detail. Can you tell us a bit more about the glioblastoma candidate paxalisib?

James Garner: Yes. So glioblastoma is the most common and the most aggressive form of brain cancer. It's about half of all primary brain cancers. And it's got one of the worst prognoses of any cancer. So even with best available treatment, patients typically pass away with about 12 to 15 months of diagnosis. There's only one drug out there for these patients. It's a drug called temozolomide. It's been around for 20 years or more so it's really quite an old drug now. And the trouble with temozolomide is it only works for one third of patients. So for two thirds of the patients, there is no effective drug available. Those are the patients we're targeting with paxalisib. So they're patients with a really, really aggressive cancer who have no other treatment options. That's what we're trying to answer with our program.

Rachael Jones: Thanks James. And can you tell me about the paxalisib trials in other brain cancers?

James Garner: Yeah, this has been one of the most exciting things about the drug, as glioblastoma remains our primary focus, but there's a lot of potential applications, the drug in other forms of brain cancer and indeed in other cancers in other parts of the body. And so we've had several trials going on now for a little while, some of it have been underway for a year or more looking at the drug and [inaudible 00:03:57] brain cancer and in cancer that's spread from other parts in the body to the brain. And what's been great is most of those studies are primarily funded by the hospitals that are running them. So it's a great value for money option for us. And we're expecting to see some data out of at least a couple of those studies in coming months. And I think, potentially that really starts to give us access to a much, much broader group of patients, which of course will be very exciting news.

Rachael Jones: And now let's talk about the ovarian cancer candidate, Cantrixil?

James Garner: We've been developing Cantrixil now for the better part of two years in ovarian cancer, been running a phase one study, that's the first round of human trials, looking at the strucken patients with very, very advanced ovarian cancer. And we similarly have been seeing some great results there. We've had so far, three patients that have shown either a complete response or a partial response. Now complete response is when we really eradicate all traits of the cancer, a partial response is where there's still some left, but we dramatically shrink the tumors. So we're getting very, very clear data that this drug works. So I think we've got some complex strategic decisions to make about it as the year progresses and we're talking to potential partners that could help take us take that drug forward alongside us. So hopefully, there'll be lots more to say as the year progresses from the Cantrixil program.

Rachael Jones: Thanks James. And to a question now that investors are asking every company, especially those conducting trials, what impact is COVID-19 having?

James Garner: I think we were fortunate in some ways that cancer studies tend to be the last studies affected in these sort of situations. Obviously, patients with cancer can't just come back in six months. Their care has to continue. And we're also fortunate that our two main studies, both the paxalisib study and the Cantrixil study are fully recruited, they're not looking for new patients. So we're hopeful that we'll see only very modest impacts, but like every company we're watching this carefully, we've put in place a range of mitigation plans and we have to see how things unfold.

Rachael Jones: Now let's talk about your financials. Can you provide us with some details?

James Garner: We just raised 7.2 million Australian dollars in an oversubscribed institutional placement, and that's put us in really good shape now to see through the ongoing COVID-19 uncertainty and to progress our work through probably three to four more data readouts over the course of calendar 2020 so we're very, very fortunate that we've had great support from our investors. And I think that puts us in very, very robust condition now to weather the storm. So we're lucky that we can now just get on with the business of drug development, look at progressing the clinical trials and look at reporting more data as it comes through during the year.

Rachael Jones: Dr. James Garner, thanks so much for the update.

James Garner: Rachael, it's a pleasure. Thanks very much indeed.


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