Analyst, [1]
Just a question regarding the administration of the virus. Of course, you can give it intravenously and have a systemic effect than an intratumor. I saw that the last deals that we made have been focused mostly on the intravenous administration. Can you comment on the advantage, disadvantage about the different way of giving the virus?
Magnus Jäderberg, Targovax ASA - Chief Medical Officer
Yes. Well, our – okay. So yes, I mean, I think you’re absolutely right. We all wish to be successful with an IV administration, and just because we haven’t started doesn’t mean that we don’t believe in it. But if you look historically and also what’s happening with data being released, there are some significant system challenges when you give a virus intravenously. So the first challenge is that you have in the liver a very effective organ that will metabolize viruses. So what you need to do if you’re going to give a virus intravenously, you have to give very high doses of the virus and sort of saturate the liver before you can actually get in the virus out to where you really want the virus to go, which is to find the tumors. There have been several published cases of life-threatening side effects giving viruses intravenously. So that’s sort of just – you can’t quite get around that.
Then the other – there is another challenge which is, depending what kind of virus you use, you have neutralizing antibodies. That can be a problem. So that’s the second thing. And then my third comment would probably be to say that if you look at the data that are available, there isn’t much convincing data so far that viruses given intravenously will work. But we hope they will because that clearly is going to be the way forward for us as well.
Our – the Targovax R&D and development strategy is to give the virus first where we know we want it to end up. And that’s why we give the virus straight into the tumor to show you and others, the scientific community, that this virus can actually do something when it ends up in the tumor. In other words, the data I showed you earlier on that you get appropriate immune activation. And that immune activation is correlated with an important clinical result.
And then we’ll take a step-by-step into different ways of administering the virus. So Øystein and Torbjørn mentioned that we have collaboration with AstraZeneca and Cancer Research Institute. In that trial, we’re not giving the virus into a tumor. We’re actually giving it intraperitoneally. So we’re diluting it with saline and then we give it through an indwelling catheter. So that’s sort of our first step in Targovax to test a slightly different way we’re administering the virus. So that’s sort of where we see things going. We’re pursuing intratumoral administration. We think that’s quite straightforward. We are starting to look at intraperitoneal cavity administration. We’re keeping an eye on the IV administration development and – to see how that’s going to pan out and when it’s time for us to get ourselves involved.
Øystein Soug, Targovax ASA - CEO
Okay. Let’s take a look at the questions from the web. And there’s one question here also to Magnus. Can you comment on your plans for mesothelioma if the readout of current data are positive?
Magnus Jäderberg, Targovax ASA - Chief Medical Officer
So as you’ve heard today and previous times, this is the indication that we classify as path to market. And that by definition means that if we produce good data, and we’re going to be able to share those data with you around the new year, we will, of course, pursue a subsequent trial. We are not sitting back and waiting for the data. We’ve already started to make some preparations. So we have, for example, conducted both European and U.S. investigator consultations. We have identified principal investigators both in the U.S. and Europe. In other words, already looking at sites. We’re talking to regulatory experts and statistical experts to try to get an idea of which way to go. I should also mention, but I can’t mention the name, we are talking to a major corporation who’s shown interest in working with us on that trial, which is, of course, very encouraging as a small biotech. What I can say is that it’s likely that the trial will be a first-line trial, but please don’t hold me to that. But that’s the thinking at the moment. That’s probably as far as I can go. As we are putting together more plans and as we’re getting closer to releasing the data for the ongoing trial, of course, we will share with you how we see this next program develop.
Øystein Soug, Targovax ASA - CEO
And then there’s a question about TG, which I will answer myself. Regarding the Parker trial, what is happening to that? And what’s happening to TG partnering in general?
With regards to Parker, as I mentioned before, we are discussing with Parker the possibilities for doing that trial. As you know, we are in a collaboration with Parker in order to do a trial in late-stage pancreatic cancer. What has changed since we went into that agreement is that we have decided not to actively invest in that trial. So currently, we are in discussion about how to enable that trial without us participating financially, but contributing the drug to the trial. So that’s – it is still not decided how that is going to be.
In terms of partnering in general, we’re not going to give detailed updates on exactly what we are doing, obviously, on the partnering front. But on TG, it is challenging and you should not expect major TG deals in the short term. The expectation on TG should be perhaps more in the direction of developing a RAS platform in other developments than resected pancreatic cancer, as we have done before. Of course, larger deals could happen, but the expectation should be more to see developing of RAS.
So there’s another question here. When do you expect a readout for the expanded melanoma trial? And Torbjørn, if you go back 1 slide, you will see here, second from the top, is that in the first half of 2020, we expect some data coming from that trial. Magnus already mentioned that this – that we had 6 patients in that trial already. The protocol dictates between 6 and 12 patients. So at some point, there’s going to be either interim data or full data set during 2020 from that trial.
Then there’s a question about the new viruses to you, Magnus. The question goes, “Maybe too early, but can you indicate what oncological indications could be more interesting for the new viruses?”
Magnus Jäderberg, Targovax ASA - Chief Medical Officer
Yes. It’s a little bit early. So let’s just go back one step maybe. What we’ve done, we have cloned the viruses. We have in-vitro tested them, and we’re now testing them in various animal models. As you know from previous presentations, we have ourselves developed a couple of pretty interesting models, one in mesothelioma and one in melanoma in combination with checkpoint inhibitors. So we’re right in the middle of that with our 3 viruses. They all have double transgenes.
As we’ve said on this slide, you can see a first preclinical data coming second half of '19 where we are – I guess you are saying we are now in second half of '19. What we hope to do before the end of the second half, in other words before Christmas, is to give you some more information from those preclinical trials and those data. And that, of course, will direct us into thinking about indications.
Clearly, the next step after the preclinical data would be to do – to select 1 virus and to go to Phase I. And what we are doing here, as you can imagine, we’re also testing these new viruses in – or rather, against ONCOS-102, our existing virus, to see what benefits we can see by changing the transgenes. So I haven’t given you an answer to your question, but just to say that as soon as we have some more information, we’ll let you know and we will speculate on indications.
Torbjørn Furuseth, Targovax ASA - CFO
Okay. Excellent. So unless there are any questions from the audience in the room, then we conclude the quarterly presentation. Thanks, everyone, for watching us and coming to the presentation.