I'm pleased to be back here at a BioStock event and present ExpreS2ion Biotech. My name is Bent Frandsen. I'm the CEO of ExpreS2ion Biotech, and we have a groundbreaking therapeutic breast cancer vaccine asset, which is approaching the first clinical trial as we speak, and I'm telling much more about that at this event. ExpreS2ion Biotech Holding AB is the public listed company at Nasdaq First North Growth Market, and it 100% owns ExpreS2ion Biotechnologies ApS, which is the Danish subsidiary where all operations take place and also where we have our vaccine pipeline, our technology platform, and we also have some services business there. We also own 34% of AdaptVac, which is a Danish biotech company that ExpreS2ion co-founded in 2017. It holds a very unique virus-like particle technology.
That platform is clinical phase III validated like ExpreS2ion's production technology platform and is a key component in the breast cancer vaccine asset I'm going to talk about. We have a leadership team and a board of directors, as depicted here. I'm the first one to admit that our leadership team is heavily biased towards males. However, our board of directors has a 50%/50% split between the genders. Very importantly actually is that combined, our leadership team and the board, we have 300 years of experience in taking vaccines all the way from the lab bench, all through clinical development, and even into the market. I'm going to address HER2 breast cancer. Unfortunately, it may affect one to eight women in their lifetime. There are some concerning statistics about this disease in terms of diagnosis and even deaths.
HER2 can, in 15%-30% of cases, be the factor for a very aggressive form of breast cancer. HER2 is a protein that we all carry, but when it overexpresses, it can lead to this potentially fatal disease, and that's the target of our therapeutic breast cancer vaccine. We call it ES2B-C001. We have designed it using our unique technology platforms. We make the antigen using our ExpreS2 system, and we couple the antigens on the surface of a virus-like particle using the technology from AdaptVac, which we own 34% of. This combination is already validated in clinical phase III because it was the same technologies that were used in a COVID-19 vaccine that Evotec took a license to and brought all the way through to clinical phase III. It met the primary endpoint, showing non-inferiority towards COMIRNATY from Pfizer-BioNTech.
As a biotech company, we're extremely proud with this clinical phase III validation, which is a blue stamp of our technology platform. The VLP concept is already used in commercially available vaccines. You probably have heard of HPV vaccines such as Cervarix and GARDASIL. They exactly, even to the antigen, they also made in insect cells, which is also the basis for our ExpreS2 technology platform and couple it to another VLP system. The concept is already out there. Our combination of antigens and VLP are very immunogenic, very safe, and can make a durable immune response, which is also important in this context because you want to show a long-term effect. We can combine it with the standard of care, which is out there, such as Herceptin and PERJETA.
We have a very compelling preclinical data package, and this is just a snapshot of what we've generated over the last couple of years. To the left, you see a mouse study where mice are being challenged with tumor cells, and they will get increased tumors over time. You can see the black curve is the control group with the development of the tumors, and the red curve is on the X-axis. There's no development in tumors at all giving our vaccine with an adjuvant. To the right, you see a survival model where you see these mice, they will actually die in the control group around 60 days into the study. We can see with our vaccine, as shown here in the red curve, that even over 600 days, none of these mice, they will die.
Very compelling data, and we're taking that into a clinical stage here as we speak. In terms of competition, we face competition against monoclonal antibodies, antibody-drug conjugates, tyrosine kinase inhibitors, as shown here in the first three columns, all having some safety issues, as shown in the first five rows here. Of course, we have been in a preclinical stage, but we can say we have not observed anything related to these safety aspects as known in the current treatments available. Standard of care resistance is an important factor, so up to 1/3 of patients will develop resistance to the therapy using, for example, monoclonal antibodies. We have actually, in an in vitro setting, demonstrated that we can break tolerance and not develop resistance to our therapy. The long-term effect is also what we will be able to generate.
Progression-free survival, c urrent treatments can give up to 19 months of progression-free survival. If you translate our vaccine into that setting, we actually have progression-free survival for more than seven years. Of course, we hope to translate that into a clinical setting. Our plan going forward, now we have spent a couple of years in a non-clinical setting, and we have all set there. We applied for the Clinical Trial Application in Q3, and we are awaiting the feedback from the authorities. We are going to start the clinical phase I. We set it will be in Q1 2025, and that's still the plan, and we will conduct a trial in Austria. After that, we aim to go into a clinical phase II to generate the clinical proof of concept down the road and generate the real value.
We also have potentials to expand on the indication beyond breast cancer, because HER2 is also prevalent in gastric cancer as well. We have cash. We have actually just had a rights issue here earlier this year, and at the end of Q3, we had 76 million SEK at our bank account. That's actually higher than our market value these days. That's how market values look for a lot of biotech companies these days. But it's fine for phase I planning. We have some important milestones coming up. The CTA approval, obviously, it's right around the corner. We're very comfortable in getting that, and we can start the first in-human trial and get some interim results during 2025 before it concludes in early 2026. We have a warrant exercise window, which just started yesterday.
The rights issue we did earlier this year included two warrant schemes, the TO 10s, which are running now and through to 4th of December , and the TO 11, which is running next year in September and October. Just to wrap up, actually, this is a groundbreaking novel breast cancer vaccine that we are looking into. It is a EUR 27 billion market with a high growth rate over the coming five years.
We have demonstrated tumor growth inhibition and 100% survival of treated animals, and we can see that it can break tolerance and overcome resistance as is known with monoclonal antibodies. We have just filed the Clinical Trial Application and aim to start the first clinical trial just around the corner. We are committed to get this into a clinical phase II setting so we can demonstrate a clinical proof of concept and get the most value out of this important asset. All right. I am happy to take questions, Sonja.
Thank you, Bent. You can join me here. What biomarkers do you use in your clinical trials?
It is a HER2-focused vaccine, so HER2 plays a role there, obviously.
Mm-hmm. Short and sweet answer there. How do you intend to position your main candidate within the breast cancer treatment field?
It's a novel vaccine concept, and I mentioned some of the competitive advantages, which are all going to play a role in our competition and positioning of this asset. The resistance aspect is very important. It is, as I mentioned, up to 30% of cases, patients can develop resistance with the known therapies there. If we can avoid resistance, that's obviously a great place to position our asset.
That is sort of the push you will do, that this could be an option for those who won't develop that then or have. Someone writes, you are looking for early licensing of your main candidate. Why is that? One could argue for a larger upside further along.
Yeah. Well, actually, as I alluded to in this setting, we're committed to bring this to a clinical proof of concept, which is after conclusion of a clinical phase II trial, which is probably three or four years down the road. But getting us there is, of course, a challenge with a company and valuation as we are. That's why we have recently started being more active at partnering conventions like BIO-Europe, for example, just to present what we have. That's interesting, because we get some nice feedback. That doesn't mean we necessarily strike a licensing deal just around the corner. Some of the more important players want to see clinical data, but we're getting there.
Mm-hmm. Speaking of, you have entered a non-binding agreement with Serum Institute of India. What would a definite agreement mean for you if they would give it to you?
What would, sorry?
What a definite agreement, I mean, if it is now it is a non-binding agreement. If this person have understand his research correctly, I think a colleague of mine. If they would enter into a binding agreement and a definitive agreement, what would that mean for you?
Of course. That particular negotiation is revolving Serum Institute of India, which is the world's largest vaccine manufacturer. They've taken a strong interest in malaria assets that University of Oxford have been developed over the last couple of years using ExpreS2's production platform, and the term sheet revolves two of the four malaria vaccine asset that's going on. A definitive agreement will obviously be a further blue stamp of what we do from the world's largest vaccine manufacturer. I'm thrilled about the process, and it's going in the right direction, so it's good.
Okay, thank you so much, Bent, for your presentation.
Thank you.