My name is Øystein Soug. I represent Oncoinvent, where I am the CEO. Been here for two and a half years. This is a company that goes back a bit in time. We started our first phase I trial back in 2020. In the meantime, we have read out the phase I data. We have a U.S. Fast Track in ovarian cancer, and we are in the middle of a phase II and are starting to design our phase III in radiopharmaceuticals. Many companies, or many biotech companies in the Oslo area actually do engage in radiopharmaceuticals, and we are one of those companies. We are going after an area of extremely highly unmet need, which is cancer that has spread to the peritoneum, the abdominal cavity, or bukhålan in Swedish, where there's really no good treatment options for the patients.
The only thing that works for these patients is surgery. There's a very high unmet need. So far, we've done two trials, one in ovarian cancer, one in colorectal cancer, with good results, and I'll show you the data in a minute. But within radiopharmaceuticals, most importantly, we have a very strong safety profile, and that has to do with the mode of action that we have developed, where we are able to go after cancer in the abdominal cavity in a way that it does not spread to other parts of the body. That is a big problem in radiopharmaceuticals. Usually, you have systemic treatments, something that you deliver through blood, and lots of it get lost. In our case, we deliver it locally, and very little get lost, and most of the radioactivity goes towards the tumor. That is a unique mode of action.
Nobody's really trying to do the same. A part of the history here goes back to a biotech company 10 years ago called Algeta, which developed Xofigo, was bought by Bayer for $3 billion back in 2014. We do have the same founders. There's a good overlap in the team, and also on the board, there are many people who have this background from Algeta. Which, of course, is an important track record of taking an alpha radiopharmaceutical to data, to the market, and also to an exit. The problem that we are going after, the problem that we are solving is peritoneal metastases, and they can originate from many different tumors.
This is not really an indication per se, but it's a disease that results from many different types of cancer, like ovarian cancer, colorectal cancer, gastric cancer, and a long list of other cancers. What is important here is that systemic therapies, they work poorly, meaning anything that you send through blood doesn't really get to the cancers in the peritoneum. The reason for that is poor vascularization. Particularly the really small micrometastases, the small nodules, they're not really linked to the blood supply at all, which means that it's impossible to get to them. If you do go after the larger tumors with systemic approaches, you have to give extremely high doses, which will lead to toxicity. In effect, surgery is the only thing that works. But surgery, no matter how good it is, leaves behind micrometastases.
These are small residual lumps of cancer, small nodules of single cancer cells that live in the peritoneal fluid or on the peritoneal wall, and they will cause the cancer to return. In most cases, actually kill the patient. Our promise is with our radioactive treatment to kill off these micrometastases and thereby prolong the life of the patient. The way we do that is with a product called Radspherin. It uses the alpha emitter, the radioactive substance radium-224, on a calcium carbonate microparticle. It's essentially limestone, small limestone spheres that have radium-224 integrated in the salt of the surface. A typical dose will have maybe a billion of these. They're not nanoparticles, they are microparticles, meaning they are small enough to act like a fluid inside the peritoneum, but they are large enough not to escape.
You inject it into the abdominal cavity, and they stay there. The half-life is 3.6 days, which is very short. It's good. It means that 75% of the radioactivity is being released during the first week. It's a solid jolt of radiation. It's exactly what you want. This will have a meaningful radioactivity in the abdomen for about two or three weeks, which is good because this matches also the therapeutic window. These patients go through surgery. They have just been through surgery. After surgery, the peritoneum is an open sac that you can flood with our product. But if you wait for a month, then it will start close again. There will be adhesions, it will start get locked. It's not going to be an open sac anymore. It's going to be a much more closed part of the body.
We have this window, this therapeutic window right after surgery where we can flood the peritoneum, which matches the half-life very well. It's short half-life, but it has an eight-day shelf life, which means that we can produce this locally. Today, we produce it in Oslo, and we can ship around the world. Usually, we produce one week, ship over the weekend, and then it's being used the next week. It's long enough for that. As some of you may know, other radiopharmaceuticals, they have more complex logistics with the shorter half-lives. Also, we have a good raw material situation. We use thorium-228 as a raw material, which is easily available and not too expensive. The way it works is that the patient, in our case, ovarian cancer patients, they have been through surgery. They have been up to a week in hospital-
-recuperating after surgery. Usually on day two, we will then inject Radspherin in the form of a quarter of a liter of radioactive fluid through an indwelling catheter left by the surgeon during surgery. Then we essentially flood the peritoneum and let the radioactivity work there for a week or two. Essentially, every spot inside the abdominal cavity, any spot on the wall or in the fluid where there might be a micrometastasis or a single cancer cell, will be hit at least twice with an alpha particle, causing a double-stranded DNA break and killing the cancer. You might ask, if you're killing all the cancer in there, why aren't you hurting healthy tissue?
The answer to that has to do with the range of the alpha, because alpha particles, as opposed to gamma and beta particles, they are extremely potent, but they are also very, very short. They travel 0.1 millimeter or two to 10 cell diameters, which means that they do not penetrate into the organs. So the organs that are in this part of the body, they have a protective lining which is thicker than the range of the alpha, so you just bump into that protective lining and nothing really happens. I mentioned that it can be used in many different indications, and of course, this is a mechanistic mode of action. As long as the cancer is in the peritoneal space, Radspherin will kill it, no matter where it comes from. I mentioned we are now doing ovarian cancer. We have done colorectal cancer.
Gastric cancer is an obvious candidate to go after, but essentially all of these indications will metastasize to the peritoneum, and Radspherin can help these patients. But in our plan today, as a small biotech company, we are laser-sharp focused on ovarian cancer. Now, this is for illustration, the landscape of radiopharmaceuticals today, and it looks a bit messy, but also looks a bit strange in the sense that you will see that most of these projects, most of the trials that are being done here, are in prostate cancer and the neuroendocrine tumors, which are two indications out of hundreds. But this is where the action is happening, and the reason for that is that Novartis had a great success in prostate cancer and neuroendocrine tumors. So the two red boxes with Novartis, these are blockbusters.
I believe it is a quadruple blockbuster in prostate cancer, and also the Bayer drug, which is the one that we developed in Oslo 10 years ago, is also in prostate cancer. So this is where the action happens, and this is where the data is. This is where you can compare your data. These are validated targets, so a lot happens there. But of course, there is no point being number eight in prostate cancer, but you have to prove yourself there. So there is a lot of other action going on as well. Tendency towards lead and actinium these days, away from lutetium, where the action started. But the point here is that we are alone up in our corner with radium-224, and the reason for that is that radium doesn't chelate.
So at least so far, nobody has been able to link radium-224, which we think is a fantastic radioisotope, but nobody has been able to link it to a target-seeking molecule that you can use systemically. So it has to be used locally or without a target-seeking element. We are using it in the abdominal cavity. Alpha Tau, which is an Israeli company, they are using it on skin cancers, and of course, we are not competitors. In terms of peritoneal metastases, there are two companies up in the upper left-hand corners that are preclinical, and for various reasons, these companies are not really moving. So, as far as we can see, there is not much competition for us out there. But also, these radioligands, everybody else here, are quite complex.
I mean, these are complex structures, and we believe that with our mode of action, with our technology, we are simpler in a positive way. We are less complex, and we therefore also believe that we have a higher probability of succeeding with our approach. Another item which is important to note when it comes to these other radioligands, they are called targeted therapies, because they go after a target. They go after usually some sort of surface marker on the cancer cell. That is why they are called targeted. But quite normally, less than 1% of the radioactivity actually hits the cancer. Yes, they are targeted, but our approach, where we lock in the radioactivity with microparticles in a closed compartment, we actually have up to 85% of hit rate, let us put it that way, of the target.
Very little of our radioactivity escapes the peritoneum and is to be found in other organs. As I mentioned, we start in ovarian cancer, and the reason for that is that these patients, when they are diagnosed, they usually present with metastases. The reason for that is that women do not have nerves in that part of the body that send signals that something is wrong when the cancer starts growing. So usually, it has already metastasized out of the ovaries when they are being diagnosed. They are usually being sent pretty straight to surgery. After surgery, 85% relapse, so they get the cancer back, and they also get it in the peritoneum. So the relapse is in the peritoneum. Very little is in other organs, like liver and lung and brain. There is very little metastasization.
There is a little bit going into the lymph nodes, but cancer in the lymph nodes do not affect the expected survival of the patient very much. It is very easy to treat, and they do not spread. So it means, at first, this is a good place to start. It is a huge unmet need. We have Fast Track in this designation. The FDA agrees with this, because getting local control of the peritoneum is extremely important. The reason why that is important is when that cancer gets out of control in that part of the body, it will start penetrating into the small intestines and cause complications that will prevent the patient from absorbing food. So in many ways, this is a slow way of starving to death. As soon as you have real complications with peritoneal metastases, your life expectancy is being reduced to maybe days.
That is why the local control in the peritoneum is extremely important, which is a problem that we are trying to solve. The market potential here is large. What I am looking at here is the funnel of patients in ovarian cancer alone in the United States, plus EU top five. Here we have done some research in the U.S., talking to payers, with the result that we can get the same pricing as Lutathera if we reach the market, which is a pretty high price. The pricing in the U.S.A. is very high, so around $200,000 for this treatment is what could be expected, which means that just for the U.S. and the top five countries in Europe, this is a blockbuster potential in ovarian cancer alone. Of course, there are many possible ways of expanding within ovarian cancer.
We can, for example, go after the second time that they have surgery, or we can go to early stage, also, which will increase the market substantially. Colorectal cancer is a bigger indication, but fewer of these patients will get metastasization to the abdominal cavity. Nevertheless, when all is said and done, this is also $650 million as we look at the peak sales in U.S. and EU five. If you add on other indications and you add on other geographies, you probably get up to a peak sale, somewhere between $3 billion and $4 billion for this company, for this drug, if everything goes well. Clinical development. So far, as I mentioned, we have done two trials. It is a phase I trial in ovarian cancer and a phase I/IIa in colorectal cancer. The results there have been good. I will show them soon.
They have led us to start a phase II in ovarian cancer. That trial has been recruiting well lately. We have been able to enroll two-thirds of the patients for full recruitment in this trial. So we are looking at the possibility of seeing data from this trial. So it is a randomized phase II trial with more than 100 patients. Before Christmas, we will take an interim look at the patients that we recruited so far, so it is 70 to 80 patients, on safety alone. So we unblinded for safety purposes. Then in April 2027, we will have an interim look at efficacy, and that is also going to be approximately when the trial is fully recruited. Nine months after that, we will have a second interim look, which is pretty much the ultimate, if not final data of this trial.
Given that we have good results in this interim results, we will start a phase III, maybe as early as next year, with a submission target of 2030. If we look at the phase I trial in ovarian cancer, it is a classical phase I trial, single-arm dose escalation, up to 10 patients in the top cohort. We recruited this in four sites across Europe. What you must remember here is that the patients that entered this trial, they are after surgery, the cancer is removed, so the only way of measuring success here is to wait for the cancer to come back. Of course, our aim is to prevent the cancer to come back, but the cancer will come back in many cases, nevertheless. We do not have tumors that we can look at.
There are no tumors to look at, so we cannot measure the shrinkage of a tumor. There are also no biomarkers that give us any sensible information here. So it is really a waiting game for the cancer to return. According to literature in this patient population, after two years, you would expect 55%-60% of the patients to have recurrence. In our trial, we saw that 30% had recurrence. So this is a small trial, but it is a positive result. Actually, these are 10 patients, so two of these three patients that had recurrence had two lymph node recurrences, meaning that they were actually in another place of the body than we are treating. There was only one of the patients that had recurrence in the peritoneum, what we are actually trying to do something about. So we think that it is a very encouraging result.
We did a similar trial in colorectal cancer. It was bigger. These patients are easier to find, so that's the main reason why this trial is bigger. We got 36 patients on the top dose because they were easy to recruit in Oslo and in Uppsala. Also here, we got similar results. This is after 18 months, 15% of the patients had peritoneal recurrence, versus 28 of the ones that had Radspherin on top. Again, it's a meaningful result. It's a fairly small trial, but there are two trials that point in the same direction, so we believe that they corroborate each other, and we are quite encouraged by these results. I mentioned that safety is maybe even as important in radiopharmaceuticals. That is a huge limiting factor for developing these drugs. But this drug was designed to be safe.
In the first 68 patients, the ones that were in the phase I program, we saw no dose-limiting toxicity anywhere. Adverse events, these are things like nausea, abdominal pain, constipation, vomiting, are the things that you see in most cancer patients. So there's nothing here that is worrying. This is what is normal for these patients without Radspherin. There were only three serious adverse events possibly related to Radspherin. They happened long after treatment, so we are also quite confident that this is not a feature of the drug. Then I say three here, one was also actually a catheter falling out. So it's related, but not really related. This is alpha therapy, which means that, as I said, it travels very short. The gamma component is very small.
This is not like Lutathera and PLUVICTO, the blockbusters I just mentioned, where the patient has to be shielded in hospital for a couple of days after treatment. But with alpha therapy, the patient can hug her family and loved ones right afterwards, and there's no need for shielding at the hospital at all. We also see very little signs of radioactivity in urine and blood. So this is as good as it can be. Going forward, in the phase III trial, we are planning to expand the patient population. So in the phase II, we're going after a quite narrow patient population, very few patients, in order to have a large probability of success. So, we require that they go through chemo before surgery. We also require that they are HRD-negative, meaning that they don't respond to PARP inhibitors.
But in the phase III trial, we will open up for everybody that has had a complete resection. So the market potential here is bigger, and the recruitment of the phase III will be much, much quicker than the phase II. Normally, you would be worried about that when you develop drugs to expand the population to a large degree between phase II and phase III. But in our case, it's a mechanistic mode of action. There's absolutely no reason why this should not work in other patient populations that have the same disease, no matter what their biological status is, so to speak. The only thing is that we might have to wait a little bit longer before we see the results, but that's to be expected. And what we want is a broad label when we launch this drug.
In terms of IP, we were an early mover, so we have a pretty deep and broad patent protection. We have all the composition of matter and use patents that you would expect, and also the formulation of the product itself, and also the dosing of alpha in the peritoneum is something that we are trying to get the patent on. We also have a patent in combination with PARP inhibitors. This is good and will run into the 2040s. One thing which is special about this company, and I alluded to that in the beginning, is the fact that we have our own production. This goes back to the founders that started this company. They were willing to make large investments into a pilot plant even before we had the drug.
It may seem like putting the cart in front of the horse in many ways, but the 800 sq m lab or pilot plant that we have has been very beneficial for us when we have been developing this drug and producing for phase I and producing for phase II. Now we also plan to do part of the European production for the phase III in our lab or pilot plant in Oslo. I mentioned that safety is a stumbling block for many companies developing radiopharmaceuticals. Manufacturing is the second. That is because the CDMOs that provide these services, they are not yet too experienced. It is very complex, but of course, if you just can go down in the basement and do the job yourself, it is actually much, much easier to get to the target. We actually do everything here ourselves.
We elute radium-224 out of thorium-228 through generators. This is a pretty straightforward technology. It is like milking the thorium-228 into radium-224. It will constantly produce radium-224. We just have to purify it every once in a while. We also produce the microparticles on site, and we also label it as we combine the two together here as well. I mentioned that it is a radiopharmaceutical hub in Oslo that we can take advantage of in the sense that Bayer is producing Xofigo down the road, and they have a vast global supply network that we are piggybacking on and using when we are shipping our Radspherin to the clinical sites, that we have 11 of at the moment on both sides of the Atlantic. That sums it up. It is a high unmet medical need. Patients really need this drug. There is nothing for them today other than surgery.
So far, we have encouraging signs of efficacy that we are hoping is going to be translated into phase II, with a strong safety profile and an experienced team that has a track record of taking radiopharmaceuticals to data, to the market, and to an exit. Thank you.
Thank you very much, Øystein. We have a question from the audience. If you have a recurrence in the peritoneum with a patient, can you do a second treatment of that patient?
What you can do, at least in theory, is that the second time the patient gets surgery, you can treat the patient again. In the colorectal trial, we did two doses, or we split the dose right after the first surgery, but we didn't really see that that gave any benefit. As I mentioned, the peritoneum starts to close the first month after surgery, so you will not have the distribution that you need in order to kill everything unless you treat the patient right after surgery.
I see. Just a question, to be a very basic question, but when you talk about extensions, for instance, into colorectal cancer and so on, is it a prerequisite that you only treat metastases in the abdominal area?
Yes. This is a drug that is designed for a cavity. In our case, it's the abdominal cavity, but it's thinkable to use this or similar technologies in maybe the pleura or in the surgical cavities. The technology can be expanded, but right now, our goal is to develop this for the abdominal cavity in many indications.
I see. Also, a small clarification. You have your own production and your own GMP facility, which is a little bit unusual and very interesting. Is it large enough to accommodate commercial quantities? Like, if you reach your targets, can you ramp it up, or will you then have to turn to maybe a CDMO or?
Yeah. We will use a CDMO in the U.S. also for the phase III, for the sake of capacity, but also for duplicating the sources. It's hard to rely on one site.
Yeah.
As soon as possible, we want a site on the other side of the Atlantic.
Great. One final question. Speaking of the other side of the Atlantic, there has been a lot of discussion at Turmal about the U.S. market pricing, how most favored nation agreements and so on for the big pharmaceutical companies. With this indication, you seem to be, you're alone in your space, so do you think that perhaps you're a bit shielded from price pressure that we see in broader indications or larger therapies?
It also depends on our efficacy, right? We haven't really seen any signs of randomized efficacy yet. If we can provide the benefit to patients that we hope and assume, then I also think that the pricing will solve itself.
Great. Thank you very much for your presentation, Øystein.
Thank you.
Good luck with your future work.
Thank you.
For all of you who are watching, it is time for a break.