Kazia Ready to Release Results from Ongoing Trials in 2019

Glioblastoma is a tough disease to treat, says Dr. James Garner, CEO of Kazia Therapeutics (NASDAQ:KZIA,ASX:KZA).

With GDC-0084, a drug from Genentech developed specifically for the disease, Garner believes his company has what it takes to fight this unique brain cancer. Last year, the company received Orphan Drug Designation from the US Food and Drug Administration (FDA).

This is one of two programs in Kazia’s pipeline, with the other being for ovarian cancer. This second drug was developed in collaboration with Yale University and via Australian research. It works on addressing the resistance and recurrence paradigm of the cancer, where other ovarian cancer drugs fall short.

“The research done at Yale is showing really good activity against these cancer stem cells,” Garner said, explaining that this contributes to its efficacy.

The company plans to release data for both programs over the course of 2019 calendar year. Garner said the results from the glioblastoma trial are likely to come out around the end of Q1 or early Q2 of this year. Although the company is Australia based, the bulk of these programs are taking place in the US.

2018 represented a fruitful year of financing for Kazia. The company raised about AU$4 million, which Garner said will take the company through 2019. He added that Kazia is in a unique position of developing drugs where there are a lot of opportunities for grant funding and partnering interests.

Already in 2019, Kazia has revealed yet another funding announcement in the form of a research and development cash rebate. This brought in about AU$2.2 million from the Australian Taxation Office under an incentive program.

To find out more about Kazia and what’s on the go for the company, listen to the audio above or check below for the full interview transcript.

INN: This is Gabrielle with the Investing News Network. I’m here in San Francisco at the Biotech Showcase. Today I’m speaking with James Garner, who is the CEO of Kazia Therapeutics. Thank you for being here today.

JG: Thanks Gabrielle. It’s great to be with you.

INN: That’s great. So your company has had a lot of positive news this year, including starting the Phase 2 study for glioblastoma this year as well as for ovarian cancer, which are a couple of very difficult-to-treat cancers. Did you want to give a quick rundown on your company?

JG: Absolutely. We’re a publicly listed, oncology-focused biotech company and we have two programs in the pipeline. Our lead program GDC-0084 is looking at glioblastoma which is the most common and the most aggressive form of brain cancer. Really tough disease to treat and so we’re really excited to be trying to make a contribution there. And then our second program as you’ve said is looking at ovarian cancer and both of these programs are in clinical trials right now. We’re largely doing that work in the United States and we’ll be seeing data out of both of them over the course of calendar year 2019 so it’s really exciting time for the company.

INN: Thank you. So aside from what we’ve mentioned so far, what is some other big news that caught investors’ attention in 2018?

JG: Well, we had orphan drug designation for our glioblastoma drug come through early in 2018 which was really exciting. It kind of recognizes the need for a new therapies in the disease and helps us out quite a bit over the regulatory path with the drugs so that was a really nice to tick off early in the year and then right at the other end of the year, back in about October we completed a small placement to sector specialist institutional investors mostly in Australia raised just about $4 million dollars which nicely sees us through our next few to read out so over the course of 2019 so two nice book-ins outside of the clinical programs that mark out 2018 for us.

INN: Thank you. Now, as you mentioned, both glioblastoma and ovarian cancer are very difficult to treat; however, there are also companies focusing on these cancers right now. So how does your company stand out?

JG: Well, if I can focus perhaps first on the glioblastoma side, a lot of companies have tried to work here but I think the key thing has been that most of these companies have been really trying to take drugs that have been developed for other forms of cancer and they’ve tried to apply them to brain cancer. So a lot of the trials we’ve seen over the last 10 years or so have really been a lung cancer drug or breast cancer or a drug for something else that people have tried to develop in glioblastoma. And unsurprisingly, most of those studies, sad to say, have not been successful and what’s unique about our drug, what’s unusual about our drug at the very least is that our drug has been developed from the ground up as a drug for brain cancer.

It was initially developed by Genentech in here in San Francisco, one of the world’s leading cancer drug developers and they really set out a blank sheet of paper exercise to say what you need for great brain cancer drug. Hence our drug has been tailored to fit those needs and one of the key things about is that it gets into the brain, it crosses the so-called blood-brain barrier which so few cancer drugs do. And that gives it as I say a unique, relevance to brain cancer. So, although this has been a very tough disease to treat, a lot of people have tried we really think we’ve got something new and different and unique to play with so that’s been great. Our ovarian cancer drug is a little bit different. It was developed out of some Australian research in collaboration with Yale University and the challenge we have in ovarian cancer is actually a lot of our first line treatments work pretty well, you know we have some good chemotherapy regimens and some good newer drugs for ovarian but the problem is resistance and recurrence and eventually almost all treatments for ovarian Cancer fail.

We think that part of the reason for that is that ovarian tumors contain these so-called cancer stem cells that cause the tumor to recur and our drug and the research done at Yale is showing really good activity against these cancer stem cells. Again, it hopefully means that we can really bring something new to the table here and provide the benefit to these patients.

INN: Financing throughout this conference has always been a big question coming up, so how is your company doing on that front?

JG: Well that the great news is that we managed to raise a little bit of money late in 2018 and so we feel that we’re pretty comfortable now through calendar 2019. Now depending on exactly where we go with the programs obviously we’ll be needing to look at that continuously, we are a NASDAQ listed company, our ticker is KZIA and so we have access to both the US and Australian markets as when we need to but I think the nice thing is, this is an area where there’s lot of opportunities for grant funding, there’s a lot of partnering interest right now on brain cancer so I think our priorities in the near term are to generate some data with the compound. Really see where we come out and then I think to evaluate on long term financing needs once we come out some of the upcoming data readouts.

INN: Thank you. And now the goal for these readouts, would that be at medical conferences or do you have any timeline for this?

JG: Well we’re expecting to see some initial data from our glioblastoma program hopefully in the first quarter. I want to say first quarter, it might be early second quarter. Always a margin of error in these things and we’ll probably kind of share that with investors as we’re going as the studies still underway. There will be initially, primarily safety data. We’ll get an efficacy read on that study later in the year and obviously exactly when we kind of put that in front of peoples and a little bit on time and relative to conference deadlines but one thing I would say is there is really so little progress that treatment that glioblastoma historically that I think people are really watching this trial, really interested in data.

We presented our you know a study design poster at the society for neuro-oncology back in November in New Orleans and the level of interest from clinicians and scientists and even investors in that meeting was fantastic. So I think once we start getting some results coming out of the study, this is going to be some real great anticipation information. So hard to say exactly where we’ll be in our position to take it up at this stage is going to depend a little bit on the exact timing of the study but somewhere over the course of the next kind of six or nine months, we’ll be seeing as I say, deep pretty impact for basically so that should be great to share with people.

INN: What about manufacturing for these trials and the drugs?

JG: We do all our manufacturing through contract manufacturing organizations we’re very much of virtue company so we don’t spend a lot of our money on building plants and equipment we outsource that work and just do it as we need to. We work with some really great manufacturers in the United States and Canada in fact to do that work and we’ve been thrilled with that regard. As part of our initial transaction with Genentech around with the GDC-0084 program we actually receive about 48 kilos of drug substance which is super stable, so that save us a ton of time and money getting the studies out, we’ve just manufacturing that into capsules as we need to. So it’s been pretty good shape there and it’s something we’ve got a great colleague in Australia and manages that program and it works out pretty well for us.

INN: That’s great. Now you mentioned before about the research collaborations and a play right now for the clinical trials, but are there any other collaborations or any licensing deals on the front that could be explored with commercialization later down the line?

JG: For sure, our strategy as a company it’s not really to seek to become a commercial pharmaceutical company, we sort of figure that’s a different kind of business, and that one, that’s better left to other people. So ultimately our vision for both of these candidates is to see them partnered to somebody who can bring them to market effectively. Now when and how we do that, I think we’re pretty open minded you know, we’ve certainly have a lot of interest even here this week at Biotech Showcase, now I think we wanna do so. Whatever we get there we wanna do some way that kind of represents good value to our shareholders and you know make sure the drug is in the best hand.

So there’s no rush around that and equally I think a lot of ways that could play out. But ultimately that’s the aspiration for both of these drugs and I think, you know just as I say given the challenge that there’s been historically with glioblastoma it really doesn’t take a lot of positive data to really activate interest and we’ve seen even just this week with things like Lilly’s acquisition of Loxo for US$8 billion at how much one good data readout can transform a story. So we’re very attentive to that and we’ve invested a lot of time kinda trying to build those relationships and that awareness so that when the time is right we can have the conversation.

INN: So on that point, do you believe that there might be some interest as well in acquiring or licensing the new drug for your pipeline?

JG: Yeah, look in a general sense of today just kinda speaking across the board it’s been interesting to see that is probably been a little bit of a shift in the last kind of 18 months to years from more licensing driven deals to more out right out acquisitions, and you know there’s some respect information and some easier transaction to be put together for a pharma company was a certain kind of simplicity and just buy a company for. I think all these things here for any company of our size and said all these things remain possible I think you know our over writing concern on that regard as always to be attended to value money for ourselves I think if we have the opportunity that we thought what’s great for our shareholders then we would be happy to discuss it but at the meantime I think we are really happy just taking programs for ourselves, making sure we get great data that maximizes that value.

INN: Thank you. And now, we talked about the data read out, lots of information coming in 2019. Is there any other information that you want investors to know about for this or the next few years?

JG: Yeah I think one thing that has been very interesting is so our focus is been on glioblastoma with the GDC-0084 heading program and we feel very strongly that the best fastest most sensible past the market for the drug. But we’ve have some great interest from clinicians and other centers to talk about other forms of brain cancer and we’ve been very excited of the last kind of six months to be able to put in place two really exciting collaboration which are investigating let that we are hands off but with fantastic sense didn’t work and other forms of brain cancer one of those is with Dana-Farber Cancer Institute in Boston and they are looking at a drug in breast cancer that the spread to the brain and we know that you know if we treat breast cancer really well these days but unfortunately we know that when it’s best for the brain it becomes terribly difficult to treat and that’s a lot of good signs and reason the GDC-0084 could really help out there so it’s great to be working with the team there to see if we can see if we can get some insight.

The others center that we have been really privileged to work with is St. Jude Children’s Research Hospital in Memphis, Tennessee. And we’re looking at our drug there in a rare full of childhood brain cancer and frankly speaking this is not millions of patients thank goodness, but it’s the very very definition of our unmet medical need and so, you know the St. Jude team is an incredible sense and you know we are absolutely thrilled to be able to work with them and see if our drug can help out with those kids. It was great to be able to look at some of these other opportunities for drug to bring benefit and this could be really exciting to see what kind of data those read out off for the next probably year or two

INN: Is there anything else you want to add?

JG: I think it’s been great talking and as I said it’s really exciting year ahead of the company I think we’ve got some great work ongoing, four clinical trials now at least as many data read out course of the years so I think it’s going to be an exciting 2019.

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Securities Disclosure: I, Gabrielle Lakusta, hold no direct investment interest in any company mentioned in this article.

Editorial Disclosure: The Investing News Network does not guarantee the accuracy or thoroughness of the information reported in the interviews it conducts. The opinions expressed in these interviews do not reflect the opinions of the Investing News Network and do not constitute investment advice. All readers are encouraged to perform their own due diligence.