1 00:00:04,080 --> 00:00:06,660 Sean Aylmer: Welcome to the Fear and Greed Daily Interview. I'm Sean 2 00:00:06,660 --> 00:00:09,510 Sean Aylmer: Aylmer. It must be challenging at times to run a 3 00:00:09,510 --> 00:00:14,100 Sean Aylmer: biotech company. It's a very long, expensive, process developing new 4 00:00:14,100 --> 00:00:17,400 Sean Aylmer: products, testing them, and then seeking approval to use them. 5 00:00:17,700 --> 00:00:20,669 Sean Aylmer: And almost every country has different requirements and different hoops 6 00:00:20,670 --> 00:00:24,660 Sean Aylmer: to jump through. Starpharma is an interesting example listed here 7 00:00:24,660 --> 00:00:29,040 Sean Aylmer: in Australia. It's a biopharmaceutical company. And while it's antiviral 8 00:00:29,040 --> 00:00:31,680 Sean Aylmer: nasal spray is registered for sale in more than 30 9 00:00:31,680 --> 00:00:34,650 Sean Aylmer: countries around the world, it's still waiting on approval by the 10 00:00:34,650 --> 00:00:39,300 Sean Aylmer: TGA here in Australia. Dr. Jackie Fairley is the CEO of Starpharma. 11 00:00:39,330 --> 00:00:40,680 Sean Aylmer: Jackie, welcome to Fear and Greed. 12 00:00:40,860 --> 00:00:41,550 Jackie Fairley: Thank you very much. 13 00:00:42,810 --> 00:00:44,159 Sean Aylmer: You've been around for a while. I think you were 14 00:00:44,159 --> 00:00:48,930 Sean Aylmer: founded in 1996 and listed on the ASX in 2000. 15 00:00:49,650 --> 00:00:53,370 Sean Aylmer: There's been a big focus on antiviral products more recently 16 00:00:53,370 --> 00:00:58,740 Sean Aylmer: because of COVID. Now, your Viraleze nasal spray, that was in 17 00:00:58,740 --> 00:01:00,630 Sean Aylmer: development prior to the pandemic? 18 00:01:00,990 --> 00:01:03,720 Jackie Fairley: No, in fact, it was developed in response to the 19 00:01:03,720 --> 00:01:07,680 Jackie Fairley: pandemic. The ingredient in it, the antiviral ingredient in it, 20 00:01:07,680 --> 00:01:11,310 Jackie Fairley: which is an example of a highly branched kind of 21 00:01:11,310 --> 00:01:15,209 Jackie Fairley: polymer called a dendrimer, which is our specialty, that had already been 22 00:01:15,209 --> 00:01:17,760 Jackie Fairley: developed. And we knew that it was potent against a 23 00:01:17,760 --> 00:01:21,390 Jackie Fairley: bunch of other viruses, but we developed Viraleze, the nasal 24 00:01:21,390 --> 00:01:24,961 Jackie Fairley: spray formulation, in response to the COVID pandemic. 25 00:01:24,960 --> 00:01:29,190 Sean Aylmer: Okay, so in layman's terms, how does it work? 26 00:01:30,150 --> 00:01:33,510 Jackie Fairley: It's got a specific ingredient in it, which is called 27 00:01:33,540 --> 00:01:39,419 Jackie Fairley: SPL7013, which is a highly branched polymer molecule, or a dendrimer. And 28 00:01:39,420 --> 00:01:44,790 Jackie Fairley: essentially, it binds to the spike proteins on both the 29 00:01:45,060 --> 00:01:49,500 Jackie Fairley: coronavirus that causes COVID, but also the influenza virus and 30 00:01:49,500 --> 00:01:53,130 Jackie Fairley: all sorts of other viruses. It binds to those proteins 31 00:01:53,130 --> 00:01:57,360 Jackie Fairley: and it renders the virus incapable of binding to and 32 00:01:57,360 --> 00:02:02,730 Jackie Fairley: attaching to human cells. So, it essentially creates a physical 33 00:02:02,730 --> 00:02:08,070 Jackie Fairley: barrier between the virus and the mucosa of your nose, 34 00:02:08,070 --> 00:02:13,530 Jackie Fairley: for instance for COVID or other mucosal surfaces for other viral infections. 35 00:02:13,740 --> 00:02:16,919 Jackie Fairley: So, the molecule had already been developed. We knew it 36 00:02:16,919 --> 00:02:21,810 Jackie Fairley: was active against HIV and other sexually transmitted viruses, but 37 00:02:21,810 --> 00:02:25,620 Jackie Fairley: we reformulated it into a nasal spray for use in 38 00:02:25,620 --> 00:02:29,639 Jackie Fairley: respiratory infections, and we've shown it to be highly effective 39 00:02:29,730 --> 00:02:34,380 Jackie Fairley: in inactivating all of the variants of the SARS- coV- 2, 40 00:02:34,380 --> 00:02:35,580 Jackie Fairley: or coronavirus. 41 00:02:36,060 --> 00:02:39,269 Sean Aylmer: Okay. So, we have a product here developed in Australia. 42 00:02:39,270 --> 00:02:40,200 Sean Aylmer: Am I right in saying that? 43 00:02:40,410 --> 00:02:41,820 Jackie Fairley: Correct. Yep, absolutely. 44 00:02:42,300 --> 00:02:46,560 Sean Aylmer: Which is effective. It's registered in more than 30 countries, 45 00:02:46,560 --> 00:02:49,590 Sean Aylmer: including the United Kingdom, but it's not approved here yet. 46 00:02:49,650 --> 00:02:50,340 Sean Aylmer: Why is that? 47 00:02:50,730 --> 00:02:54,300 Jackie Fairley: The reality is that the approval in any given country 48 00:02:54,360 --> 00:02:57,510 Jackie Fairley: is very much at the control of the regulatory authority 49 00:02:57,510 --> 00:03:00,630 Jackie Fairley: in that country, so in Australia the TGA. As soon 50 00:03:00,630 --> 00:03:04,530 Jackie Fairley: as we completed the development of the product, we pursued, 51 00:03:04,710 --> 00:03:09,360 Jackie Fairley: obviously, its registration in the markets where we felt that 52 00:03:09,360 --> 00:03:12,270 Jackie Fairley: the product was most needed. So, we did actually go 53 00:03:12,270 --> 00:03:18,780 Jackie Fairley: to the European market first. We gained registration in Europe 54 00:03:18,870 --> 00:03:25,500 Jackie Fairley: in March, 2021. We then subsequently submitted to the TGA. 55 00:03:25,500 --> 00:03:30,060 Jackie Fairley: And the process with the TGA has simply been longer than 56 00:03:30,060 --> 00:03:33,840 Jackie Fairley: it has been in other markets. But that regulatory process, 57 00:03:34,110 --> 00:03:38,580 Jackie Fairley: they vary by country. And that's really something probably for 58 00:03:38,580 --> 00:03:40,920 Jackie Fairley: the TGA to comment on, not us. 59 00:03:41,250 --> 00:03:45,390 Sean Aylmer: I'm showing my ignorance here, but why don't countries rely 60 00:03:45,390 --> 00:03:46,080 Sean Aylmer: on each other? 61 00:03:47,490 --> 00:03:49,890 Jackie Fairley: Well, in fact, what you're referring to is a mutual 62 00:03:49,890 --> 00:03:51,900 Jackie Fairley: recognition process, which does occur. 63 00:03:51,900 --> 00:03:51,901 Sean Aylmer: Of course. 64 00:03:51,901 --> 00:03:51,961 Jackie Fairley: Yeah. 65 00:03:53,010 --> 00:03:53,790 Sean Aylmer: Much better put that way. 66 00:03:53,970 --> 00:04:00,270 Jackie Fairley: Yeah. It does occur in certain categories of healthcare products. 67 00:04:00,600 --> 00:04:04,200 Jackie Fairley: And there is a degree of reliance upon the review 68 00:04:04,200 --> 00:04:09,270 Jackie Fairley: by others. But there's also a local component to it. And 69 00:04:09,270 --> 00:04:13,020 Jackie Fairley: every regulator is different. And so, in Europe, for instance, 70 00:04:13,020 --> 00:04:16,860 Jackie Fairley: it's not reviewed in every single country, obviously. It's reviewed 71 00:04:17,580 --> 00:04:21,089 Jackie Fairley: centrally. And that makes it very efficient, obviously in terms 72 00:04:21,089 --> 00:04:25,140 Jackie Fairley: of accessing a large number of countries. But countries, like 73 00:04:25,140 --> 00:04:30,270 Jackie Fairley: Australia, and Canada, and others would do a degree of 74 00:04:30,270 --> 00:04:34,529 Jackie Fairley: their own review. But we have a lot of shareholders 75 00:04:34,529 --> 00:04:37,680 Jackie Fairley: in Australia. We have loads and loads of people approaching 76 00:04:37,680 --> 00:04:42,480 Jackie Fairley: us every single day, really wishing, desperately wanting to get 77 00:04:42,480 --> 00:04:45,479 Jackie Fairley: access to the product. And they include people who are 78 00:04:46,200 --> 00:04:50,370 Jackie Fairley: immunocompromised, because they've had kidney transplants and things like that. 79 00:04:50,820 --> 00:04:53,909 Jackie Fairley: And we certainly will make it available in Australia as 80 00:04:53,910 --> 00:04:57,270 Jackie Fairley: soon as we're able to do so. For the time 81 00:04:57,270 --> 00:05:02,250 Jackie Fairley: being, people would need to rely upon personal connections they 82 00:05:02,250 --> 00:05:03,600 Jackie Fairley: might have in other countries. 83 00:05:03,750 --> 00:05:06,990 Sean Aylmer: Okay. Just before we leave Viraleze, I understand the idea 84 00:05:06,990 --> 00:05:10,830 Sean Aylmer: that it creates that barrier. Is it totally effective? 85 00:05:11,790 --> 00:05:18,870 Jackie Fairley: No preventative is ever totally effective, including vaccinations and other 86 00:05:18,870 --> 00:05:22,560 Jackie Fairley: methods of protection, masks, as we've all learned, air handling 87 00:05:22,560 --> 00:05:27,029 Jackie Fairley: and things. So, nothing is ever 100% effective. What we 88 00:05:27,029 --> 00:05:33,089 Jackie Fairley: do know is the antiviral ingredient in Viraleze is highly 89 00:05:33,089 --> 00:05:39,150 Jackie Fairley: effective at very rapidly inactivating all of the variants of SARS- coV- 90 00:05:39,150 --> 00:05:42,539 Jackie Fairley: 2 that we've tested, including Omicron, where we've shown very 91 00:05:42,540 --> 00:05:47,820 Jackie Fairley: high levels of efficacy. For instance, in a challenge study 92 00:05:48,150 --> 00:05:53,099 Jackie Fairley: that we ran in a special WHO identified strain of 93 00:05:53,100 --> 00:05:56,700 Jackie Fairley: mice, where you challenge them with large numbers of virus, 94 00:05:57,120 --> 00:06:02,490 Jackie Fairley: we showed more than 99. 9% protection against infection. Where 95 00:06:02,490 --> 00:06:06,539 Jackie Fairley: they were challenged with SARS- coV- 2 that was in one assay, and 96 00:06:06,540 --> 00:06:11,760 Jackie Fairley: a very similar, I think, it was 99.99 in Omicron. So, even 97 00:06:11,760 --> 00:06:16,080 Jackie Fairley: more efficacious against Omicron. And that's interesting, because what we 98 00:06:16,080 --> 00:06:20,789 Jackie Fairley: found is that for the viral variants, like Omicron, which 99 00:06:20,790 --> 00:06:24,600 Jackie Fairley: bind more tightly and that's how they become more infectious 100 00:06:24,600 --> 00:06:28,050 Jackie Fairley: than Delta and the other ones, actually the tighter they 101 00:06:28,050 --> 00:06:33,300 Jackie Fairley: bind the better our antiviral ingredient works, because that's actually 102 00:06:33,300 --> 00:06:34,200 Jackie Fairley: how it acts. 103 00:06:34,620 --> 00:06:36,750 Sean Aylmer: Stay with me, Jackie. We'll be back in a minute. 104 00:06:43,110 --> 00:06:46,380 Sean Aylmer: My guest this morning is Dr. Jackie Fairley, the CEO 105 00:06:46,380 --> 00:06:50,909 Sean Aylmer: of Starpharma. Okay, so away from Viraleze, you've signed major deals 106 00:06:50,910 --> 00:06:55,320 Sean Aylmer: with some of the big pharmaceutical companies, AstraZeneca, Merck. What 107 00:06:55,320 --> 00:06:57,120 Sean Aylmer: are you doing with them? What are you working on 108 00:06:57,120 --> 00:06:57,570 Sean Aylmer: with them? 109 00:06:57,660 --> 00:07:00,660 Jackie Fairley: Yeah, so we've recently signed a second one with Merck 110 00:07:00,660 --> 00:07:03,240 Jackie Fairley: and also with Genentech, and we have had a longstanding 111 00:07:03,240 --> 00:07:07,320 Jackie Fairley: collaboration with AstraZeneca. What we're doing in those collaborations, and 112 00:07:07,320 --> 00:07:10,230 Jackie Fairley: the AstraZeneca one is a multi- product license, so they've 113 00:07:10,230 --> 00:07:15,090 Jackie Fairley: secured commercial rights to our technology, and this dendrimer technology, 114 00:07:15,090 --> 00:07:19,590 Jackie Fairley: which is, as I mentioned earlier, these large, roughly spherical, 115 00:07:19,590 --> 00:07:25,980 Jackie Fairley: highly branched, polymer molecules, the dendrimer means treelike, those highly branched 116 00:07:25,980 --> 00:07:29,790 Jackie Fairley: molecules can be used in Viraleze, which is for the 117 00:07:29,790 --> 00:07:33,930 Jackie Fairley: antiviral effectiveness of a single version of that. But other 118 00:07:33,930 --> 00:07:38,760 Jackie Fairley: variants of the dendrimer molecule can be used to actually carry 119 00:07:38,910 --> 00:07:42,510 Jackie Fairley: drugs. So, you attach the drug to the polymer molecule, 120 00:07:42,900 --> 00:07:45,960 Jackie Fairley: and then this larger, what we call a nanoparticle, which 121 00:07:45,960 --> 00:07:49,860 Jackie Fairley: is the dendrimer plus the loaded drug onto it, that 122 00:07:49,860 --> 00:07:54,120 Jackie Fairley: modifies its distribution in the body. And it has the 123 00:07:54,120 --> 00:07:59,220 Jackie Fairley: ability to improve efficacy and to reduce toxicities. And that's 124 00:07:59,220 --> 00:08:03,150 Jackie Fairley: a function of changing the distribution of the molecules in 125 00:08:03,150 --> 00:08:06,030 Jackie Fairley: the body. I'm talking, at the moment, about the use 126 00:08:06,030 --> 00:08:12,090 Jackie Fairley: in oncology. So, Genentech, Merck, AstraZeneca are largely in the 127 00:08:12,090 --> 00:08:15,150 Jackie Fairley: oncology space. We can use it in other areas too, but 128 00:08:15,630 --> 00:08:19,800 Jackie Fairley: in those oncology settings you're often dealing with molecules which 129 00:08:19,800 --> 00:08:24,060 Jackie Fairley: are very effective as anti- cancer drugs, but they have 130 00:08:24,120 --> 00:08:28,830 Jackie Fairley: what we call off target toxicity. So, toxicities on your 131 00:08:28,830 --> 00:08:32,490 Jackie Fairley: gut, or your hair follicles, or your bone marrow, all 132 00:08:32,490 --> 00:08:36,360 Jackie Fairley: of which results in either illness or untoward side effects. 133 00:08:36,360 --> 00:08:42,600 Jackie Fairley: And so, the dendrimer technology enables us to target tumor 134 00:08:42,600 --> 00:08:45,449 Jackie Fairley: tissue more, so we get much more drug into the 135 00:08:45,630 --> 00:08:48,720 Jackie Fairley: tumor tissue than you do with drug alone, when it's 136 00:08:48,720 --> 00:08:53,100 Jackie Fairley: on dendrimer, on our DEP dendrimers. And so, in those deals, all of those 137 00:08:53,100 --> 00:08:56,550 Jackie Fairley: companies, and that's three of the top 10 pharmaceutical companies 138 00:08:56,550 --> 00:09:00,060 Jackie Fairley: in the world, they are all seeking to access our 139 00:09:00,090 --> 00:09:06,150 Jackie Fairley: delivery technology to improve the performance of their drugs. And 140 00:09:06,150 --> 00:09:09,900 Jackie Fairley: they could be drugs which are already marketed or they 141 00:09:09,900 --> 00:09:13,980 Jackie Fairley: could be drugs which are in the development stage still. 142 00:09:14,309 --> 00:09:17,849 Jackie Fairley: But they might be drugs which for instance are a 143 00:09:17,850 --> 00:09:20,340 Jackie Fairley: little bit too toxic. And so, they wouldn't be well 144 00:09:20,340 --> 00:09:25,709 Jackie Fairley: enough tolerated. And so, we're trying to optimize or improve 145 00:09:25,710 --> 00:09:29,640 Jackie Fairley: the way they perform. And we do so via allowing 146 00:09:29,640 --> 00:09:33,750 Jackie Fairley: them to access in creating these dendrimer versions of those drugs. 147 00:09:33,840 --> 00:09:35,790 Sean Aylmer: Isn't that one of the holy grails of medicine though, 148 00:09:35,850 --> 00:09:37,829 Sean Aylmer: the fact that you can actually get a drug to 149 00:09:37,830 --> 00:09:42,030 Sean Aylmer: the spot that it's needed without having huge ramifications for 150 00:09:42,030 --> 00:09:42,750 Sean Aylmer: the rest of the body? 151 00:09:43,440 --> 00:09:48,390 Jackie Fairley: Absolutely. And particularly in cancer, because cancer drugs traditionally are 152 00:09:48,390 --> 00:09:52,260 Jackie Fairley: pretty nasty, because they have nasty side effects. And so, 153 00:09:53,760 --> 00:09:56,730 Jackie Fairley: this is a technology that enables you to target tumor 154 00:09:56,730 --> 00:10:02,070 Jackie Fairley: tissue and to significantly improve the window between the amount 155 00:10:02,070 --> 00:10:04,470 Jackie Fairley: of drug where you start to get efficacy and the 156 00:10:04,470 --> 00:10:07,050 Jackie Fairley: amount of drug where you start to get toxicity, which 157 00:10:07,050 --> 00:10:10,830 Jackie Fairley: is called the therapeutic index. And so, in the case of, 158 00:10:10,830 --> 00:10:13,949 Jackie Fairley: for instance, one of the AstraZeneca drugs, which is currently in 159 00:10:13,950 --> 00:10:17,939 Jackie Fairley: human clinical trials, we were able to widen that window 160 00:10:17,940 --> 00:10:20,250 Jackie Fairley: by 25 fold. 161 00:10:20,550 --> 00:10:25,559 Sean Aylmer: Wow, that's impressive. I mean, that's a real advancement in 162 00:10:25,559 --> 00:10:29,250 Sean Aylmer: a sense, which, beyond finding a drug that works, it's 163 00:10:29,250 --> 00:10:32,069 Sean Aylmer: actually how you... It's like the infrastructure. I'm trying to 164 00:10:32,070 --> 00:10:33,630 Sean Aylmer: get my head around to how this works, but it's 165 00:10:33,840 --> 00:10:36,900 Sean Aylmer: like the rail line or the infrastructure that the drug 166 00:10:36,900 --> 00:10:42,959 Sean Aylmer: works via to actually help the patient but minimize the harm. 167 00:10:43,470 --> 00:10:47,220 Jackie Fairley: Absolutely. Well, that's the whole objective of a drug delivery 168 00:10:47,220 --> 00:10:52,200 Jackie Fairley: technology, like our DEP technology, is to optimize the efficacy 169 00:10:52,620 --> 00:10:57,600 Jackie Fairley: whilst you are using the technology to reduce and modify 170 00:10:57,600 --> 00:11:02,760 Jackie Fairley: the toxicities. And the reality is that the dendrimer delivery 171 00:11:02,760 --> 00:11:07,199 Jackie Fairley: technology can allow you to not only improve existing drugs, 172 00:11:07,200 --> 00:11:09,780 Jackie Fairley: so you might be able to, as we've done, we've 173 00:11:09,780 --> 00:11:11,850 Jackie Fairley: got some products of our own where we've been able 174 00:11:11,850 --> 00:11:16,530 Jackie Fairley: to take out some nasty, toxic, excipients or detergents in 175 00:11:16,530 --> 00:11:21,090 Jackie Fairley: formulations by using the dendrimer and also target the cancer 176 00:11:21,090 --> 00:11:24,150 Jackie Fairley: tissue, but also, in the case of some of the 177 00:11:24,150 --> 00:11:26,069 Jackie Fairley: other drugs that we are working on with some of 178 00:11:26,070 --> 00:11:30,300 Jackie Fairley: our partners, those products would not actually be able to 179 00:11:30,300 --> 00:11:34,620 Jackie Fairley: complete their development without the benefit of a delivery technology. 180 00:11:34,620 --> 00:11:38,910 Jackie Fairley: Because, they need some of those characteristics to enable them 181 00:11:38,910 --> 00:11:43,110 Jackie Fairley: to perform well enough and to have a therapeutic window 182 00:11:43,110 --> 00:11:44,280 Jackie Fairley: which is wide enough. 183 00:11:45,030 --> 00:11:48,090 Sean Aylmer: Jackie, I've been given a lesson this morning, which I 184 00:11:48,090 --> 00:11:50,190 Sean Aylmer: appreciate. Thank you very much for talking to us here 185 00:11:50,190 --> 00:11:51,030 Sean Aylmer: on Fear and Greed. 186 00:11:51,270 --> 00:11:53,040 Jackie Fairley: Very welcome. Thank you very much. Bye. 187 00:11:53,220 --> 00:11:56,790 Sean Aylmer: That was Dr. Jackie Fairley, the CEO of Starpharma. This 188 00:11:56,790 --> 00:11:59,160 Sean Aylmer: is a Fear and Greed Daily Interview. Join us every morning 189 00:11:59,160 --> 00:12:01,319 Sean Aylmer: for the full episode of Fear and Greed, Australia's most 190 00:12:01,320 --> 00:12:04,980 Sean Aylmer: popular business podcast. I'm Sean Aylmer. Enjoy your day.