Kazia Therapeutics is confident that a positive future is on the cards. Pic via Getty Images.
Health & Biotech
Kazia Therapeutics is approaching 2023 with renewed optimism, having successfully completed a cap raise, and with key trial results due this year.
Brain cancer- focused drug development company Kazia Therapeutics (ASX:KZA) said the company is expecting results of two key trials into brain cancer this year.
CEO Dr James Garner explained to Stockhead that, unfortunately, science has still not made significant progress on brain cancer. However, the company is hoping to “shift the needle”.
“If you’re diagnosed with brain cancer today, it’s still a similar prognosis to what it was at the turn of the century, so our core objective at Kazia is to advance treatment,” he said.
KZA completed a $4.5 million capital raise for institutional and sophisticated investors in January, while a share purchase plan (SPP) is now open for eligible existing shareholders to each purchase up to $30k worth of new, fully paid, ordinary shares.
“Kazia is still a pre-revenue company, with both our drugs – paxalisib and EVT801 – in human trials,” Garner said. “Our brain cancer drug paxalisib is in late stage and may start to make revenue before too long, but right now we depend on periodic injections of capital.”
While markets are looking more promising in 2023, Garner said 2022 was a tough year for biotech companies.
“Last year was probably one of the most challenging bear markets we’ve seen in biotech for quite some time,” he said.
With the company’s previous cap raise undertaken back in October 2020, Garner said the latest has been carefully calibrated to minimise share dilution for existing investors.
“We did this capital raise as a very tight round to existing shareholders with a specific objective to nicely position the company, and see it through the next phase of progress,” he said.
So, what is KZA focused on now? Garner said the company has eight clinical trials underway, investigating the potential of the drug in various forms of brain cancer, including glioblastoma, brain metastases, and childhood brain cancer.
Its most promising avenue is a pivotal Phase III trial of lead drug Paxalisib for glioblastoma, the most common and most aggressive form of brain cancer, which is due to read out final data in H2 CY23.
The average life expectancy from diagnosis with glioblastoma is about 15 months, and less than 5% of patients are still alive after five years.
In recent years, the disease has claimed the life of several high-profile Americans including Republican Senator John McCain, Democrats Senator Ted Kennedy and Beau Biden III, son of US President Joe Biden.
“It affects somewhere in ballpark terms around 2,000 Australians per year and 15,000 in the US so not as common as say breast or lung cancer but it’s far from a rare disease,” Garner said.
Garner said KZA is targeting patients primarily who are resistant to the only existent old school chemotherapy drug to treat glioblastoma, which works for one out of three patients.
“We are targeting the other two thirds of patients with the aim of extending their life and giving them more time, while opening a window for other treatments,” he said.
“It’s worth noting that the drug, at this stage, is unlikely to be a cure – something which is sadly the case for most cancer drugs, which are largely aimed at buying patients quality time.
“If you buy enough time, you effectively make cancer a chronic disease.”
Garner said the initial treatment for glioblastoma is surgical and after the surgery patients are relatively fit and well for a period.
“Senator McCain was diagnosed with glioblastoma and for some months afterwards was still going to work – and you wouldn’t have known he was a man with terminal brain cancer at the time,” he said.
“That’s not unusual in the early stage of the disease, so if we can keep patients at that stage for a bit longer, it makes a big difference,” Garner said, “because that is time they can spend with family, go on a holiday of a lifetime, see their kids graduate or another major milestone they may otherwise have missed.
“We are trying to keep patients as fit and well as possible, for as long as we possibly can.”
KZA has two clinical trials underway in childhood brain cancer and is targeting a particular form known as DIPG (diffuse intrinsic pontine glioma).
KZA is due to see some data on the Phase II international trial of paxalisib for DIPGin H1 FY23.
“DIPG affects around 800 kids per year in the US, so it is thankfully a rare disease,” Garner said. “But there are currently no approved drug treatments, and the disease is – sadly – 100% fatal.”
“We believe that it’s one of, if not the, largest study done into this disease.”
“At this stage, any signal it is working or moving the needle with these patients is something we will grab onto, but where it takes us will remain quite complex to map out,” he said.
He said for these rare childhood diseases, the regulatory pathway is bespoke for each individual drug.
“We’ll have to look at the data and talk to agencies like the US FDA and the TGA here in Australia – but they are generally open to having these discussions,” he said.
KZA is also expecting readouts on other trials it has underway this year.
“In some cases, it will just be a preliminary, initial read out,” Garner said. “But in other cases, it will be final data.”
“The business of drug development has a rhythm to it, in that you invest a lot of time and money in stepping up clinical trials – and then it’s only sometime later you see the data.”
Garner said the company has been carefully building a portfolio of clinical trials around the world over the last few years.
“This year is when most of them will be reading out data and so it’s a very exciting time for the company. It’s where we get the pay-off for the hard work we’ve been doing,” he said.
This article was developed in collaboration with Kazia Therapeutics, a Stockhead advertiser at the time of publishing.
This article does not constitute financial product advice. You should consider obtaining independent advice before making any financial decisions.
Health & Biotech
Health & Biotech
Health & Biotech
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