Phase III

Moderna and BioNTech are getting all of the attention with their phase 3 clinical trials for lung cancer and melanoma.  But someone else is already further ahead.
 
French company Ose Immunotherapeutics has already done a phase 3 study for non small cell lung cancer, and if the final run of work confirms that data it will have the first cancer vaccine on the market in 2028.

And it's results like those emerging from Ose that are inspiring investors to start getting set for a cancer vaxxed future. 

In our final episode of VAXXED we feature OneVentures partner Dr. Jeannie Joughin and Ose Immunotherapeutics CEO Nicolas Poirier. 

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Produced by Rachel Williamson and Charis Palmer. Music and effect credits to Ziso, Inspector J, Seth Parson and Boom Library.

Cancer vaccines are an area that anyone who is anyone is getting into, but it's a field  led largely by academics, not-for–profits, and specialist researchers. So this week we go back to basics - science that is. 

Australia may not have many cancer vaccine biotechs but – as we pointed out in episode one with the godfather of cancer vaccines, professor Dr Ian Frazer – it has heft in its research. 

Dr Seth Cheetham from the University of Queensland's Base Facility, a specialist mRNA manufacturing lab, explains why they went from COVID19 to cancer. 

And Dr Shalin Naik from the Walter and Eliza Hall Institute of Medical Research explains why he's bringing back a spectre of the past, and why he believes it could be the winner of this biotechnology cage match. 

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Produced by Rachel Williamson and Charis Palmer. Music and effect credits to Ziso, Inspector J, Seth Parson and Boom Library.

In some ways, cancer vaccines are a history of hype and hope, over success. But that hasn't stopped people from trying. In 2024, biotech CEOs are hoping that this time, it's different.

Research houses are predicting significant market growth come 2030, mRNA vaccines are making it through to phase three clinical trials for the first time, and there are exciting new discoveries in technologies that have already been tried and tossed on the rubbish pile.

So we asked two life sciences analysts about what they think of this market and whether this time, it really will be different. With Phase III regular Chris Kallos and Pitt Street Research cofounder Stuart Roberts.

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Produced by Rachel Williamson and Charis Palmer. Music and effect credits to Ziso, Inspector J, Seth Parson and Boom Library.

Cancer vaccines are a very niche section of cancer treatments. But two companies in Australia – the only two so far to go public with their work in this arena –are working on an even niche area within this. And one says their work is not a vaccine. The other does. 

So what gives? Well it depends on what you want to focus on: the deadly infectious nature of an oncolytic virus that bursts tumour cells from the inside, or the resulting immune memory that can fight that cancer as well as others that look similar. 

We speak with Imugene CEO and managing director Leslie Chong and ImmVirX founder Dr Malcolm McColl about why they think that finally the time has come for this underloved field and what they plan to do with their science if they can prove it up. 

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Produced by Rachel Williamson and Charis Palmer. Music and effect credits to Ziso, Inspector J, Seth Parson and Boom Library.

Cancer vaccines started out as prevention. Think Gardasil for cervical and oral cancers caused by HPV, and the hepatitis B vaccine for liver cancer.

But today the science has moved on, to therapy vaccines. Vaccines that take immune cells and "rub their little noses in the antigen" - the substance that forces the body to sit up and take notice of a foreign invader or unusual activity.

Clinical trials abound, by some of the heavy hitters in mRNA and pharmaceuticals, but nothing yet has been commercialised. Wilsons Advisory senior equity analyst Dr Shane Storey reckons we're five years away from a vaccine from the most-likely candidate of mRNA.

In this episode we talk to the coinventor of the first smash hit in cancer vaccines, Gardasil, professor Dr Ian Frazer, and Shane about where the field has come from, and where it's going. 

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Produced by Rachel Williamson and Charis Palmer. Music and effect credits to Ziso, Inspector J, Seth Parson and Boom Library.

Drone-deliveries of radioactive medicines and diagnostics to Australia's far-flung towns. Radiopharmaceuticals matched with genetic information to tailor precisely the right dose and isotope to a person's cancer. Pan-cancer drugs that fix many tumours, not just one. Miniature particle accelerators. 

These are the hopes, dreams and expectations we canvas in our last episode on radiopharmaceutical 'theranostics', the old-now-new cancer technology that is sweeping the globe and capturing imaginations in the world of biotech. 

In the final episode of our series NUKED, we speak with Novartis Australia and New Zealand country manager Matt Zeller, Wilsons Advisory equity analyst Dr Melissa Benson, and Cyclotek partnerships and innovation manager Sam Graf about what is happening now to advance this modality into the coming years, and what the distant future might hold.

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Produced by Rachel Williamson and Charis Palmer. Music and effect credits to Ziso, Inspector J, Seth Parson and Boom Library.

The rule of thumb in biotech is that it costs around $1 billion to bring a new therapy from lab to market. Protecting that investment is the patent system. But what if part of your product is not made by your contract manufacturer, but by the people who are giving it to patients? Ie, their doctors.

We explore an example in Australia where this push-pull when the years and money required to develop a groundbreaking new therapy goes up against medical professionals' desire to help their patients.

And we also take a look at what the future might hold, based on what people are protecting today.

In episode 5 of NUKED we speak with FB Rice patent attorneys, senior associates Brittany Ashton and David Herman about what they're seeing in the tea leaves of patent application filings.

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Produced by Rachel Williamson and Charis Palmer. Music and effect credits to Ziso, Inspector J, Seth Parson and Boom Library.

Can Australia create a mine to lab to bedside production line for radiopharmaceutical medicine? It has the reactor, biotechs and the hospitals to do that last two, and even has a growing pool of expertise to run these. 

What it doesn't have, yet, is many advanced manufacturers to do the first bits, the critical parts such as sifting through old mine tailings for precursor materials and making nuclear isotopes for industry use, such as clinical trials. 

In episode 4 of NUKED we speak with entX managing director Bryn Jones and Cyclowest head of production Dr Jacquie Cawthray about whether Australia has the 'it' factor to go it alone. 

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Produced by Rachel Williamson and Charis Palmer. Music and effect credits to Ziso, Inspector J, Seth Parson and Boom Library.

The question we are dancing around in episode 3 of NUKED is whether locking down isotopes supply chains are really the only way to play the radiopharmaceutical game.

We ask Clarity Pharmaceutical executive chair Alan Taylor and Radiopharm Theranostics executive chair Paul Hopper how their companies are instead owning the IP, or banking a portfolio of IP licences, to create the kind of economic moat that others are pursuing via isotope supply chains. 

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Produced by Rachel Williamson and Charis Palmer. Music and effect credits to Ziso, Inspector J, Seth Parson and Boom Library.

In early 2023, one of the first two really big radiopharmaceutical drugs ran into a problem.  Novartis' prostate cancer therapy Pluvicto, released only the year before, was suddenly in short supply, snarling up just in time treatment schedules. 

In 2024 the supply chain problem is with the isotope Actinium 225, which *everyone* wants for clinical trials. RayzeBio has been a very famous victim, delaying a clinical trial because of the shortages. 

In episode 2 of NUKED we explore where the nukes come from, and how biotechs large and small get their hands on them. 

With GlyTherix CEO Dr Brad Walsh and Telix Pharmaceuticals CEO Dr Chris Behrenbruch, we look at a potential new front in the US-China tariff war, the Russia question, and how an early stage biotech and one with a product in the market organises its nuclear material supplies. 

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Produced by Rachel Williamson and Charis Palmer. Music and effect credits to Ziso, Inspector J, Seth Parson and Boom Library.

The radiopharmaceuticals sector is on a knife point. The scope of what nuclear medicine can do is exploding. But the radioisotopes that biotechs need to make those therapies are in very, very short supply. Major clinical trials are hitting pause because of shortages of critical nuclear isotopes, and the world's biggest pharmaceutical companies are buying up biotechs that have locked in both the science and the supply chain. 

There will be some very successful winners, and many, many losers as companies fight for the nuclear resources they so desperately need to make their therapies work.

In this series Nuked, we will walk you through this fascinating marriage between chemistry and physics, why is exciting both investors and clinicians, how biotechs are fighting to lock in supplies of nuclear material, and whether Australia has a shot at becoming a nuclear power.

In our first episode, we speak to Peter MacCallum Cancer Center chief radiopharmaceutical scientist Dr Mohammad Haskali and HB Biotechnology managing director Charlie Williams.

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Produced by Rachel Williamson and Charis Palmer. Music and effect credits to Ziso, Inspector J, Seth Parson and Boom Library.

Wearable kidneys. Organs on a chip. Xenotransplantation. The future is here.

But is that the future people in biotech are truly looking to? Because the future that Certa Therapeutics CEO Darren Kelly is looking to is much less 1980s sci-fi and more... Apple watch.

And in a future where the numbers point to a rise in lifestyle diseases thanks to diet and a lack of exercise, climate change is an added risk that few are yet factoring in. Professor Meg Jardine, the head of University of Sydney's Clinical Trials Centre, explains where the risks are.  

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Produced by Rachel Williamson and Charis Palmer. Music and effect credits to Ziso, Inspector J, Seth Parson and Boom Library.

We may have led you on a bit in the first two episodes... kidney disease is still a big problem despite the massive shifts forward in treating it. There is a long way to go to bring medical sectors -- and governments -- along as well. 

This episode features Breonny Robson, general manager of clinical and research at Kidney Health Australia and Richard Lipscombe, managing director of Proteomics International.

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Produced by Rachel Williamson and Charis Palmer. Music and effect credits to Ziso, Inspector J, Seth Parson and Boom Library.

We speak to Dimerix CEO Dr Nina Webster about why investors are thrilled with her company, as it nears the midway point for its Phase III clinical trial for the rare disease focal segmental glomerulosclerosis (FSGS).

And we talk to PYC Therapeutics CEO Dr Rohan Hockings about how his company's tech actually works to treat polycystic kidney disease.  

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Produced by Rachel Williamson and Charis Palmer. Music and effect credits to Ziso, Inspector J, Seth Parson and Boom Library.

Kidney disease is a silent killer, with only 10% of all people knowing they have it before damage has been done. 

But in the last five years there's been a surge of work that's resulted in the FDA approving some blockbuster drugs in the last 18 months. Billion-dollar takeovers are now on the table and the tiny number of Australian biotechs in this sector have a front row seat to the action.  

This series explains the mighty leaps that have already come, interviews the key biotech leaders in Australia working to treat and to cure kidney diseases, and joins the dots between what is happening today… and what could happen in the blue skies of the next 20 to 50 years. 

Episode 1 features Professor Meg Jardine, director of the NHMRC Clinical Trials Centre, a flagship research organisation at the University of Sydney, where she is head of the Kidney Health research program, and investment analyst Chris Kallos. They explain why kidney disease is so hot right now from a science perspective and for investors. 

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Produced by Rachel Williamson and Charis Palmer. Music and effect credits to Ziso, Inspector J, Seth Parson and Boom Library.

Life sciences more than anywhere else is the successful mashup of money and tech.  

I'm Rachel Williamson and this is Phase III, a weekly podcast diving deep into Australian life sciences. In each of our short series, we investigate, interrogate, and explore the most exciting companies and ideas in health science and the investment case for what they're doing. Join us as we explore the intersection between the breakthroughs and the money in life sciences.

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Produced by Rachel Williamson and Charis Palmer. Music and effect credits to Ziso, Inspector J, Seth Parson and Boom Library.