Hello, everyone. Good afternoon, and welcome to the Jefferies 2005 Global Healthcare Conference. It is my pleasure to introduce Martin Welschof, CEO of BioInvent International.
Thank you very much. I will start with a quick introduction to the company, and then later I will give you a more detailed update where we are with our clinical development and clinical development stage programs. BioInvent is a company listed in Sweden, and the company is based in Lund, which is southern Sweden. We are roughly 100 employees, and we are quite, at least for European standards, an integrated company. That means we do target discovery, so we identify new targets, as I will show you later. Antibody discovery, we do our own manufacturing up to 1,000 liter GMP. We do our own formulations, so one of the assets that I will discuss today is a subQ formulation that we have generated in-house.
That gives us actually a strong competitive advantage, and that means we can move quickly from preclinical into the clinical setting since we have all those capabilities under one roof. The pipeline that I will discuss today is focused on two first-in-class assets that have shown efficacy in liquid as well as in solid cancer and have an excellent safety profile, but more details later. You can see in the third column that the platform that I also will explain to you in a moment has been validated in a number of partnerships. You see the names there, so we have done deals with Pfizer, D&G, Bayer, Mitsubishi, Takeda, Genentech. Besides those R&D collaborations, we are also having strategic partnerships, and they are most importantly with Merck and AstraZeneca, where we have supply and collaboration agreements in place. We're listed in Stockholm, as I already said.
Even though we have a Swedish listing, we have a very strong international shareholder base, so our largest shareholder is Redmile. We have Omega from the US in voice, but then also blue-chip European investors such as Forbion, HBM, and Van Herk, who is also a quite active investor in Europe. Our current market cap is SEK 200 million, and we have a current year runway into Q1 2027. As I already mentioned on my previous slide, as you know, pharma and also large biotech, they're really focusing on a handful of targets, so the space is really getting crowded. We are an innovative company, so we really discover new targets, and I will show you on the next slide how we do this. We're currently focusing on two new targets. One is TNFR2.
The other one is FcγRIIB, and those are two new targets in the context of immuno-oncology. Currently, we are with the two compounds in phase two, and as I already mentioned, we have activity in liquid cancer that we have now very nice data that's coming up at ASH, plus also single-agent activity in solid cancers, and I will show you that in a moment in more detail. Very briefly on the platform, so the platform which is at the core of BioInvent is called FIRST, and this is a reverse phenotypic functional screening. I will try to explain it in simple words what we do. The platform allows us actually to screen directly on patient material.
We have a very close collaboration with a local hospital in Lund, where the company is based, such that we receive cancer patient material on a regular basis, which is fresh and high quality. We do not modify that material, so we do not take an end to culture, we do not transform it, so we use it as it is in our screens, and we screen directly against our highly combinatorial complex antibody library in a kind of small molecule compound fashion. In the first step, we just select for specificity. Once we have specific binders identified to the material of interest, we go into functional testing, first in vitro and then in a number of animal models in vivo. We would only focus on those antibodies that have shown strong therapeutic effects.
In our case, of course, it's cancer models in several animal models, and then we would identify the target. That's what I mean with reverse phenotypic functional screening. That allows us, as it's mentioned here on this slide, to identify novel IO targets, as we have done for TNFR2 and FcγRIIB, but also we are able to identify new unique epitopes on already validated targets. Those are the two things that we can do with this platform. With this platform, we have generated this portfolio, and this is just a quick summary that I wanted to give you. BI-1808 is our lead antibody against TNFR2, and we are currently developing this as a single agent as well as in combination with pembrolizumab in liquid as well as in solid cancers. We're currently in phase two.
The second program is BI-1206, which is a unique antibody very specific for FcγRIIB, and we are developing this in combination for non-Hodgkin lymphoma. We have soon the data set coming out at ASH and also in combination with pembrolizumab in solid cancer. You see a couple of names on this slide, so whenever we have combination development with pembrolizumab, this is under supply collaboration with Merck. We also have such an agreement with AstraZeneca because in the non-Hodgkin lymphoma we combine with their Acalabrutinib. We think this is an advantage because you get, of course, drug for free, but also you get input into the clinical design from very experienced companies because they are their assets, and you have potential partners already at the table in case data develops nicely.
With those two compounds, we have significant commercial opportunities, which I wanted to introduce quickly at the beginning. This is BI-1808, and we will focus first, as I will tell you, on CTCL, second line, which is a smaller size opportunity, but a quick-to-market opportunity, also relatively small trial, as I will show you. Then very quickly we can go into first line, which is then, of course, a larger opportunity, and the big money comes when we focus on ovarian cancer, first line platinum resistant. That is also something that we are approaching. Of course, once you have established this there, you can also go for other solid cancer indications since the mechanism that we have is very broad. It looks very similar for BI-1206, so we will also here start with the heme indication first because that goes quicker.
Our positioning there is second line follicular lymphoma, which is a $500,000,000 market opportunity. We will go, as I will show and explain to you, for a veal melanoma, and because we just started that actually first line, we will subsequently go into non-small cell lung cancer first line. This study actually has just started a couple of weeks ago. Of course, you can also apply this to other solid cancer indications, but this is basically how we want to build, and you can see that we always have the quick-to-market via the heme ONC, and then have the larger commercial potential with the solid cancer indications.
Starting then with TNFR2, and I think it was also important to know that TNFR2 can be exploited in the way we're exploiting it because it's on one side expressed on tumoral T cells, overexpressed actually, and then it's also overexpressed on T regulatory cells in the tumor microenvironment of solid cancers. That's why we can approach it in those two different ways. A little bit more details about the positioning, so CTCL, as I will show you also the data later, we have presented data at EHA, and now we have an update coming up at ASH. We have a very good safety and tolerability profile. That's also something that we're really looking after because when you look at the most recent cancer developments, you will see always good efficacy, but very often combined with quite heavy toxicity.
In our case, what I will show you today, we have good efficacy and no toxicity and also very benign safety profile, which is important because especially when you think about solid cancer, you will have to go for combination therapy at some time point in any case, and then safety is a very important factor. Going back to CTCL, I mentioned the very good safety profile that we have there. What we have seen so far is overall response more than 40% with a nice number of complete responses and partial responses. When we look at the data, currently it is actually better than what is currently the standard of care, and I will show you where we are positioned there.
Even though we would first go for second line, and this is for development strategy reasons, we believe that we can go firmly for first line single agent in CTCL. On the solid tumor side, we have shown single agent activity in ovarian cancer, cyst, and lung cancer. That is established, and that goes also very well hand in hand with the preclinical data that we already have established, where we saw strong single agent activity, but also strong synergies with NTPD1. Currently, we're running the NTPD1 work, and by the end of this year, hopefully we'll have an update also on that one, and then hopefully have an idea where we go from there, which of course is more difficult than with heme ONC, smaller studies, easier to position. Going back to CTCL, this is the landscape that we have currently.
You can see there are quite a number of drugs out there with better efficacy and better safety. The only program that has, at least here on this graph, a reasonable efficacy is the NT30 ADC from Takeda, but this is also only limited to CD30 positive CTCL. We are much broader, and of course, whatever is on the left-hand side is very toxic. You want to be on the right-hand side and up, and we are currently well positioned there. That is the data that we have shown at EHA, early data that will be updated now coming at ASH. 100% disease control, we saw complete response in Sézary syndrome, which is actually quite advanced CTCL indication, and then nice partial responses in MF, and then a couple of stable diseases, so really, really all in all a very nice data set.
We even had a partial response in stable disease in PTCL, which is even more difficult to treat. Based on our safety profile, we believe that we are not only limited to SS and MF, but probably also can go into earlier stages of the disease. That is at least our plan. To give you a couple of pictures, there you see a PTCL patient baseline and week nine, and what you have to focus on obviously are those areas which are completely gone on the right-hand side, and the same for CTCL patient. What we really actually see is not only that we deplete the tumoral T cells, but we also have CD8 positive cell infiltration into the skin lesion. We really see an immune response in the skin lesions of CTCL, which I think is important.
Those are our current plans, so we are currently finishing, or have finished actually, the phase two, part A. We have orphan drug designation, we have fast drug designation, and we are currently running a combo just to see how it looks with Pembrolizumab, and then at some time point at the end of this year, we will start with the dose optimization and then prepare next year for potential pivotal study in 2027. Very quickly also on the solid tumor data that we have achieved with BI-1808, and that we can do because, as I said, it is overexpressed on T regulatory cells in the tumor microenvironment, not in the periphery. I think that is very, very important. What we see there is that we deplete those T regulatory cells, but we also see a very strong CD8 positive cells infiltration in the tumor microenvironment.
Basically, we're changing the tumor microenvironment from a tumor positive into a very tumor hostile environment, with deep responses. Just to give you a couple of examples, this is an ovarian cancer patient who has had four previous lines of treatment, all the standard treatment that she should have gotten, and this turned into a complete response after a couple of weeks. You could very nicely see the depletion of the T regulatory cells, so very, very strong data. Another patient, this is now GIST, where you could see a very robust partial response. The lesions are going down very nicely. This example I brought you also because they can really nicely see the CD8 positive cells infiltration.
This is pre-dose, and this is after week five, and all the green dots that you see are CD8 positive cells that go into the tumor microenvironment, which I think is also very nice to see. The last example that I brought you today is from a lung cancer patient. There you also could see nicely the infiltration of the tumor microenvironment by CD8 positive cells. This patient actually had to be taken off the study because he developed unrelated prostate cancer lesion, and then they have to remove, unfortunately, because we had this very nice response in non-small cell lung cancer. The next data point here will be then the combination with pembrolizumab. This is all single agent, what I just have shown to you, and the combination data should be available by the end of this year.
Switching now to FcγRIIB, and again, this will be developed in heme ONC, which is non-Hodgkin lymphoma in this case, focusing on follicular lymphoma, marginal zone lymphoma, and mantle cell lymphoma, and in solid tumors. Again, here's kind of a similar situation as with TNFR2. FcγRIIB is overexpressed on tumoral B cells. That's why we can use it to directly target those cancer cells, and in the tumor microenvironment on dendritic cells. This is the only inhibitory receptor of the innate immune system, which is mainly dendritic cells, which are quite important actually in the tumor microenvironment. To our knowledge, we're the only company that has the only specific antibody because FcγRIIB is quite homologous to the activating Fc receptors as well. There's just a tiny difference, and we managed to really identify an antibody that's only interacting with FcγRIIB.
I mentioned already it's a sole inhibitory FcγRIIB. There's already quite some data around such that the clinical significance is established, and we have broad pathway synergies, as I will explain to you on the later slides. Here again, the positioning. In non-Hodgkin lymphoma, we positioned this in second line with a triplet combination. That means BI-1206 plus Rituximab plus Acalabrutinib. We're on track for overall response more than 75%, and you will see once the ASH data comes out, it really looks strong. This antibody is subq formulated, so it's very convenient to give. It's more than less than 4 ml volume, and this subq formulation has been done in-house.
Here again, we have a very good safety profile, so no cytokine release syndrome, no neurotoxicity, no increased risk of infections, which places us very nicely in the second line because competition, of course, is coming from the bispecifics and the CAR-Ts. They are third line, and they have all this, what I just mentioned, that we do not have: cytokine release syndrome, neurotoxicity plus, and that is actually the highest risk here, high risk of increased infection, which is, I think, not easy to manage. On the solid tumor side, what we have done there, we have focused on patients, and of course, I should mention on the non-Hodgkin lymphoma, we are focusing on patients that are not responding anymore to any CD20-based therapy. All the data that I will show you is in refractory patients.
We have done the same for solid tumors where we focus on patients that do not respond anymore to anti-PD-1 or anti-PD-L1 containing regimens. We saw also there nice responses, as I will show you, and with that data, we could convince Merck to go first line non-small cell lung cancer, uveal melanoma, which we basically just started. First, starting with the non-Hodgkin lymphoma, this is data in combination with Rituximab only. You can see also here very strong data, nice overall response rates, large number of complete responses, as you can see. I think one point that I really want to emphasize is long-lasting complete responses, high-quality complete responses. We have now a number of patients that are in complete response for three years actually after the end of treatment, which I think is very nice.
This is then the triplet combination where we have the update at ASH, and the main thing is here that we're really on track for the overall response higher than 75%, which I think is very good. Otherwise, also safety, no problem, so very benign such that we are really nicely fitting into this niche of second line chemotherapy-free regimen after Rituximab alone. I think if we can keep that data, then we have also a chance to go first line after all because we have this very good safety profile. Initially, we'll go second line. That is kind of the plan that we have for non-Hodgkin lymphoma. We're finishing, or we're currently in the phase two A signal seeking study.
We'll have that finished during the first half of next year, roughly 30 patients, and already preparing for a pivotal study that potentially could be started at the end of 2026. On the solid cancer side, I mentioned already what we're targeting, that we're patients that do not respond anymore to anti-PD-1 or anti-PD-L1. We saw nice data, so this is a case study. This is a 69-year-old female with a uveal melanoma having received multiple lines of ICIs and chemo and was progressing when she was entering the study. And we could really establish a nice, robust partial response, and this patient is still in treatment now for a number of years and still in this very strong partial response, which I think is super nice. We have seen also complete responses, so this is a case of complete response in cutaneous melanoma.
That was a person that has received three lines of previous ICI therapy with partial response as the best prior response, and then even the combination of ipilimumab and nivolumab and was not responding, and with the combination of 1206 and pembrolizumab, we got this nice complete response. As I already mentioned, I think we do not have that slide here, but basically what we have done is we discussed with Merck. They agreed that we do first line non-small cell lung cancer, uveal melanoma. We will have 30 patients in non-small cell lung cancer first line, 12 patients in uveal melanoma, and that study has been kicked off. We will have the data or the first readout by second half of next year. At the end, very briefly, the key catalysts, I think mainly I mentioned it already.
Obviously, ASH is coming up with BI-1206 in non-Hodgkin lymphoma and BI-1808 in T-cell lymphoma. By the end of the year, we will have phase 2a data with pembrolizumab and BI-1808 in solid cancers, and then mid next year, further CTCL data and further non-Hodgkin lymphoma data, and then by the end of next year, the first readout for the first-line non-small cell lung cancer and uveal melanoma. Thank you very much.