Welcome to the Fear and Greed Business Interview. I'm Sean Almer. The pandemic reminded the world of the importance of vaccines and demonstrated the extraordinary ability of health professionals to innovate. The latest developments in medical technology are another giant leap forward. Needle free vaccines might sound a little bit like science fiction, but clinical trials have shown it's not just possible, but it can improve the effectiveness of a vaccine immune response. My guest today is David Howey, the President and CEO of Vaxis, the company behind this needle free technology. Vaxis works across the US and Australia, developing and commercializing its products in Brisbane. The Brisbane health sector is the fastest growing in Australia and in medical and pharmaceutical products. Growth in Brisbane has occurred seven times faster than the rest of Australia. Companies in this space are benefiting from commercial and research partnerships as well as the Medtech Accelerated Program, an initiative of the Brisbane Economic Development Agency, a great supporter of this podcast. As I mentioned, I'm joined today by David Howey, the President and CEO of Access David, Welcome to Fear and Greed.

Welcome to the Fear and Greed Business Interview. I'm Sean Almer. The pandemic reminded the world of the importance of vaccines and demonstrated the extraordinary ability of health professionals to innovate. The latest developments in medical technology are another giant leap forward. Needle free vaccines might sound a little bit like science fiction, but clinical trials have shown it's not just possible, but it can improve the effectiveness of a vaccine immune response. My guest today is David Howey, the President and CEO of Vaxis, the company behind this needle free technology. Vaxis works across the US and Australia, developing and commercializing its products in Brisbane. The Brisbane health sector is the fastest growing in Australia and in medical and pharmaceutical products. Growth in Brisbane has occurred seven times faster than the rest of Australia. Companies in this space are benefiting from commercial and research partnerships as well as the Medtech Accelerated Program, an initiative of the Brisbane Economic Development Agency, a great supporter of this podcast. As I mentioned, I'm joined today by David Howey, the President and CEO of Access David, Welcome to Fear and Greed.

Thank you, it's great to be here.

Thank you, it's great to be here.

Let's start at the very beginning. Tell me about the technology. How does it work?

Let's start at the very beginning. Tell me about the technology. How does it work?

So well? The technology has its origins at the University of Queensland at the Australian Institute for Biotechnology and now Engineering, and VA's has actually formed in twenty eleven licensing the technology out of the university, and so our path since then has been to transform the technology essentially from working in small models in mice through to scaling it to larger animal models and then into humans for clinical studies. So this you know in biotech. I say that when you're doing development and biotech you wish you were own information technology. Because we're about fourteen years into the process so far, and we've invested about a quarter of a billion dollars to get to the current point. But we've now done a whole series of in fact five completed phase one studies more than five hundred people. So we know the technology works and you know I can describe it to you in a nutshell if you're ready.

So well? The technology has its origins at the University of Queensland at the Australian Institute for Biotechnology and now Engineering, and VA's has actually formed in twenty eleven licensing the technology out of the university, and so our path since then has been to transform the technology essentially from working in small models in mice through to scaling it to larger animal models and then into humans for clinical studies. So this you know in biotech. I say that when you're doing development and biotech you wish you were own information technology. Because we're about fourteen years into the process so far, and we've invested about a quarter of a billion dollars to get to the current point. But we've now done a whole series of in fact five completed phase one studies more than five hundred people. So we know the technology works and you know I can describe it to you in a nutshell if you're ready.

Yp please please describe the technology in English, David, in English, in.

Yp please please describe the technology in English, David, in English, in.

English, in English, Well, it's well it's a fun space to work in, first of all, because you know, we're working in a field that really hasn't seen fundamental innovation for more than one hundred and seventy years. I mean, the needle and syringe is what we used to inject vaccines because we have a needle. What we know, based on modern immunology, is that the immune cells are actually not in the muscle. Most of the immune cells in your body are in fact in the surfaces, so in the skin, your cosal surfaces, where you have about ten thousand times in the density of immune cells. And so we've developed technology that instead of injecting vaccine into muscle, enables us to apply a small patch to the skin for about ten seconds and we deposit the vaccine just underneath the surface of the skin, basically into the arms of the weighting immune cells. And that way they are able to very efficiently pick up the vaccine and it's still processed, you know, immunologically in the same way by the lymph nodes, et cetera. But what it means is that we have a dramatically more efficient and effective way of getting a response to a vaccine, and that that's just the start of good things.

English, in English, Well, it's well it's a fun space to work in, first of all, because you know, we're working in a field that really hasn't seen fundamental innovation for more than one hundred and seventy years. I mean, the needle and syringe is what we used to inject vaccines because we have a needle. What we know, based on modern immunology, is that the immune cells are actually not in the muscle. Most of the immune cells in your body are in fact in the surfaces, so in the skin, your cosal surfaces, where you have about ten thousand times in the density of immune cells. And so we've developed technology that instead of injecting vaccine into muscle, enables us to apply a small patch to the skin for about ten seconds and we deposit the vaccine just underneath the surface of the skin, basically into the arms of the weighting immune cells. And that way they are able to very efficiently pick up the vaccine and it's still processed, you know, immunologically in the same way by the lymph nodes, et cetera. But what it means is that we have a dramatically more efficient and effective way of getting a response to a vaccine, and that that's just the start of good things.

Is it applicable to all vaccines?

Is it applicable to all vaccines?

It is, so, you know, in the broader sense, you could say this is a potential replacement to needle and syringe for all vaccinations. Now, of course, for those of us who who like needles, I can ensure you've done the research, and it's a pretty small population, it doesn't make much difference. But there is actually in the field of vaccines, there is a lot of because vaccines are optional. I mean that when you're getting a therapeutic injection, you want it because you're sick. You're getting vaccines because you're healthy and when you're healthy, and that's so it's a choice. And you know, apprehension or anxiety around needles is actually one of the real barriers to it. So a technology like ours can lift that veil completely, and there are other advantages. The way we put the vaccine onto the of the patch, it's dry, so it can be stored outside of refrigeration, and that this means for things like our seasonal flu vaccine can be stable at forty degree centigrade for more than a year. I was opposed to having to have this kind of tightly controlled refrigeration distribution, so You know, we have two ways that we look at the world. You know, one, in the high income countries where we have the benefits of things like refrigeration and skilled administration, we take vaccines for branded. But most of the world's population we were with there's poor infrastructure and not much skilled administration healthcare. Where we can extend the reach of vaccines into places that are difficult or impossible to reach with vaccines, and that that can be a real game changer.

It is, so, you know, in the broader sense, you could say this is a potential replacement to needle and syringe for all vaccinations. Now, of course, for those of us who who like needles, I can ensure you've done the research, and it's a pretty small population, it doesn't make much difference. But there is actually in the field of vaccines, there is a lot of because vaccines are optional. I mean that when you're getting a therapeutic injection, you want it because you're sick. You're getting vaccines because you're healthy and when you're healthy, and that's so it's a choice. And you know, apprehension or anxiety around needles is actually one of the real barriers to it. So a technology like ours can lift that veil completely, and there are other advantages. The way we put the vaccine onto the of the patch, it's dry, so it can be stored outside of refrigeration, and that this means for things like our seasonal flu vaccine can be stable at forty degree centigrade for more than a year. I was opposed to having to have this kind of tightly controlled refrigeration distribution, so You know, we have two ways that we look at the world. You know, one, in the high income countries where we have the benefits of things like refrigeration and skilled administration, we take vaccines for branded. But most of the world's population we were with there's poor infrastructure and not much skilled administration healthcare. Where we can extend the reach of vaccines into places that are difficult or impossible to reach with vaccines, and that that can be a real game changer.

You talked about the trials, I mean, starting with mice and going through to humans. Again, one thing that amazes me when you read about these clinical trials, just like how it's discovered. You know, who came up with the idea, how do you actually migrate that to trialing it on mice to trialing it in humans? Right?

You talked about the trials, I mean, starting with mice and going through to humans. Again, one thing that amazes me when you read about these clinical trials, just like how it's discovered. You know, who came up with the idea, how do you actually migrate that to trialing it on mice to trialing it in humans? Right?

That process, right, that's the kind of the seed of innovation. You're right, because folks have actually known for many decades that the immune cells are actually these classes of immune cells are in the skin. If you really want to put vaccine somewhere, that's the place to do it. There was a technique developed to use a needle, which requires the needle to be kind of put obliqually into the skin and in certainly the way that you really don't want to imagine getting vaccinated that way. And so it's really then taking the knowledge that you know that's where the immune cells are and then reducing to practice a device that can achieve that. And that's what the University of Queensland and it was Professor Mark Kendall at the AIBN who came up with that original innovation. Essentially a controlled way to place the vaccine right where those immune cells are. Now from going into a demonstrating you get a response. You know, in mice is one thing. When you want to take the technology into humans, it's a completely different thing. You have to work out how it's a medical device that we make that contains the patch that is coated with vaccine. So it is a product that needs to be made in a sterile environment and our facility at Holton Northshaw we have clean rooms and that we have highly skilled operators that enable us to tape the sterilized components of the device applied to vaccine in a sterile environment and seal it and then it's refused then in human clinical trials. And I said, we've become very skilled at this We've completed five really successful Phase one studies. Today we're just completing a very large study for the US government about two hundred and sixty people. I'm using actually a pre pandemic influenza vaccine from the US stockpile, and so we've become super skilled in how to produce great material for clinical studies and that's the stepping stone to the commercial market.

That process, right, that's the kind of the seed of innovation. You're right, because folks have actually known for many decades that the immune cells are actually these classes of immune cells are in the skin. If you really want to put vaccine somewhere, that's the place to do it. There was a technique developed to use a needle, which requires the needle to be kind of put obliqually into the skin and in certainly the way that you really don't want to imagine getting vaccinated that way. And so it's really then taking the knowledge that you know that's where the immune cells are and then reducing to practice a device that can achieve that. And that's what the University of Queensland and it was Professor Mark Kendall at the AIBN who came up with that original innovation. Essentially a controlled way to place the vaccine right where those immune cells are. Now from going into a demonstrating you get a response. You know, in mice is one thing. When you want to take the technology into humans, it's a completely different thing. You have to work out how it's a medical device that we make that contains the patch that is coated with vaccine. So it is a product that needs to be made in a sterile environment and our facility at Holton Northshaw we have clean rooms and that we have highly skilled operators that enable us to tape the sterilized components of the device applied to vaccine in a sterile environment and seal it and then it's refused then in human clinical trials. And I said, we've become very skilled at this We've completed five really successful Phase one studies. Today we're just completing a very large study for the US government about two hundred and sixty people. I'm using actually a pre pandemic influenza vaccine from the US stockpile, and so we've become super skilled in how to produce great material for clinical studies and that's the stepping stone to the commercial market.

Say with me, David. We'll be back in a minute. My guest this morning is David Howey, President and CEO of Vaxus. Before the break, you kind of gave us a rundown of how we got to where we are today. What's the size of the prize here, David?

Say with me, David. We'll be back in a minute. My guest this morning is David Howey, President and CEO of Vaxus. Before the break, you kind of gave us a rundown of how we got to where we are today. What's the size of the prize here, David?

The size of the pre is very large. The global vaccine market is about one hundred and thirty billion, and as we discussed earlier, the technology itself is you could think of it essentially as a replacement for needland syrenge. So there is not an existing vaccine or a vaccine in development. This is not applicable too. So we see ourselves as being able to enter many of the disease segments that are currently occupied by needle and syringe and simply garnering market share. Because we know we have very strong consumer preference, but there are also vaccines that are in development and that we can confer special properties if you like, to those vaccines. We tend to generate a faster and a higher immune response and that you know, a different flavor of immune response and called it a broader immune response to vaccines. So this can sort of be transformative over time. I like to think if we fast forward, you know, sort of twenty years from now, most vaccines will be given by patch administration because that's where the immune cells are, and that we hope that most of those patches are outs.

The size of the pre is very large. The global vaccine market is about one hundred and thirty billion, and as we discussed earlier, the technology itself is you could think of it essentially as a replacement for needland syrenge. So there is not an existing vaccine or a vaccine in development. This is not applicable too. So we see ourselves as being able to enter many of the disease segments that are currently occupied by needle and syringe and simply garnering market share. Because we know we have very strong consumer preference, but there are also vaccines that are in development and that we can confer special properties if you like, to those vaccines. We tend to generate a faster and a higher immune response and that you know, a different flavor of immune response and called it a broader immune response to vaccines. So this can sort of be transformative over time. I like to think if we fast forward, you know, sort of twenty years from now, most vaccines will be given by patch administration because that's where the immune cells are, and that we hope that most of those patches are outs.

So for your sake, they are too where how close are we to roll it? Are you to rolling it out?

So for your sake, they are too where how close are we to roll it? Are you to rolling it out?

Very close? So the facility at Brisbane's North Shore, you know, it's a bespoke facility and fantastic. We're about to start producing material for our later stage studies, so phase two and phase three and then our first commercial products. We're somewhere between three and five years out, and if the trials go smoothly, maybe twenty twenty eight for registration of our first products, or a year or two after. But in the biotech landscape, that's incredibly close. So it's very exciting.

Very close? So the facility at Brisbane's North Shore, you know, it's a bespoke facility and fantastic. We're about to start producing material for our later stage studies, so phase two and phase three and then our first commercial products. We're somewhere between three and five years out, and if the trials go smoothly, maybe twenty twenty eight for registration of our first products, or a year or two after. But in the biotech landscape, that's incredibly close. So it's very exciting.

You mentioned Brisbane a few times. It seems to have be the place to be med take biotech take. I mean there's a few listed companies here Technology One for example, Brisbane based company that's that everyone loves Technology one at the moment, but it just seems to be the place at the moment.

You mentioned Brisbane a few times. It seems to have be the place to be med take biotech take. I mean there's a few listed companies here Technology One for example, Brisbane based company that's that everyone loves Technology one at the moment, but it just seems to be the place at the moment.

Yeah, it's a fantastic place you know, to first of all, you know, incubate and then in our case, if you take it from a concept to a company that in twenty eleven had six people and has since then raised one hundred million dollars or so in conventional venture finance and one hundred others hundred and eighty million in NONOLU funding for folks like the US government pharmaceutical companies. We're now about one hundred and seventy people, and that most of the investment, about a quarter of a billion so far is spent locally into the local economy. And so we're part of this growing biotech colonel an ecosystem that is fantastic because we've sort of ridden away with a lot of other companies. We've got the big ones of course that we look at and what to emulate. It's like cookpor Cochlear, et cetera. That are you know, already famous that we say, but we're part of our growing community and the more of us, the figure to be the snowball gets bigger, and you know it's it's fantastic too because institutions like the University of Queensland churn out highly skilled scientists and engineers that are our target hiring base and so we're a great recruitment tool keep those people local and continue to feedback into the system. And Brisbane is a great climate in more ways than one. Economically, literally to recruit people to come here, even from overseas is very very easy, and so we're super excited about what we've been able to achieve locally, but also what the ecosystem has given back to us.

Yeah, it's a fantastic place you know, to first of all, you know, incubate and then in our case, if you take it from a concept to a company that in twenty eleven had six people and has since then raised one hundred million dollars or so in conventional venture finance and one hundred others hundred and eighty million in NONOLU funding for folks like the US government pharmaceutical companies. We're now about one hundred and seventy people, and that most of the investment, about a quarter of a billion so far is spent locally into the local economy. And so we're part of this growing biotech colonel an ecosystem that is fantastic because we've sort of ridden away with a lot of other companies. We've got the big ones of course that we look at and what to emulate. It's like cookpor Cochlear, et cetera. That are you know, already famous that we say, but we're part of our growing community and the more of us, the figure to be the snowball gets bigger, and you know it's it's fantastic too because institutions like the University of Queensland churn out highly skilled scientists and engineers that are our target hiring base and so we're a great recruitment tool keep those people local and continue to feedback into the system. And Brisbane is a great climate in more ways than one. Economically, literally to recruit people to come here, even from overseas is very very easy, and so we're super excited about what we've been able to achieve locally, but also what the ecosystem has given back to us.

I mean, there is that sense of paying forward, like kind of fostering the next generation of healthcare startups because you guys do that, don't you.

I mean, there is that sense of paying forward, like kind of fostering the next generation of healthcare startups because you guys do that, don't you.

We do. We're actively involved in the mentoring programs that BEIDA organizes, one of the many activities that be to do to sort of foster you know, big biotech companies start as small biotech companies, which start as an idea, and that BEIDA have got sort of the from the from the kernel an idea through how do you nurture these companies that are a concept. We do mentoring with early stage companies. BEIDA also have active programs to introduce companies when they're coming into the stage when they need to raise their first capital, not just to the Australian community, but to international audiences, particularly you know in the US the big biotech conferences here at GP Morgan, etcetera. Bidda have done a phenomenal job. We by the way, participate in those programs so we benefit from them, but we also help other companies to participate across.

We do. We're actively involved in the mentoring programs that BEIDA organizes, one of the many activities that be to do to sort of foster you know, big biotech companies start as small biotech companies, which start as an idea, and that BEIDA have got sort of the from the from the kernel an idea through how do you nurture these companies that are a concept. We do mentoring with early stage companies. BEIDA also have active programs to introduce companies when they're coming into the stage when they need to raise their first capital, not just to the Australian community, but to international audiences, particularly you know in the US the big biotech conferences here at GP Morgan, etcetera. Bidda have done a phenomenal job. We by the way, participate in those programs so we benefit from them, but we also help other companies to participate across.

The rain tour round it off, David, what next for Vaxis? So what do we expect for the next five years?

The rain tour round it off, David, what next for Vaxis? So what do we expect for the next five years?

Five years? Oh boy, there's lots of things going on, you know. Well. Out at our facility at north Shore, we're installing our first rebute systems for manufacturing, which is a really exciting transition time. We're gearing up for our first midstage so phase two and phase three studies. We're engaging with lots of government entities, not just the US government and farmer so exciting. Our new vaccine programs no a heck of a lot going on, and of course, most importantly the launch of our first products really exciting.

Five years? Oh boy, there's lots of things going on, you know. Well. Out at our facility at north Shore, we're installing our first rebute systems for manufacturing, which is a really exciting transition time. We're gearing up for our first midstage so phase two and phase three studies. We're engaging with lots of government entities, not just the US government and farmer so exciting. Our new vaccine programs no a heck of a lot going on, and of course, most importantly the launch of our first products really exciting.

David, thank you for talking to Fear and Greed.

David, thank you for talking to Fear and Greed.

Great thanks very out Sean.

Great thanks very out Sean.

That is David Howey, President and CEO of Vaxis, which works with the Brisbane Economic Development Agency. David was talking about BETA. That's it Brisbane Economic Development. That agency a great supporter of this podcast. This is the Fear and Greed Business Interview. Join us every morning for the full episode of Fear and Greed at Business News. You can use I'm Sean Elmer. Enjoy your day.

That is David Howey, President and CEO of Vaxis, which works with the Brisbane Economic Development Agency. David was talking about BETA. That's it Brisbane Economic Development. That agency a great supporter of this podcast. This is the Fear and Greed Business Interview. Join us every morning for the full episode of Fear and Greed at Business News. You can use I'm Sean Elmer. Enjoy your day.