Thank you very much, Philip. Thank you, Aktiespararna, for hosting me on this virtual presentation of ExpreS2ion Biotech at Digital Temadag. My name is Bent Frandsen. I am the CEO of ExpreS2ion Biotech, and I will carry you through a presentation introducing the company, our pipeline, and near-term expectations here. Having said that, there is a disclaimer here. Any forward-looking statements are under own risk in case of investment considerations. First, a brief of company overview. ExpreS2ion Biotech or ExpreS2ion Biotech Holding AB is the listed company on Nasdaq First North Growth Market since 2016. It is a holding company that 100% owns ExpreS2ion Biotechnologies ApS, which is the company residing in Denmark where all operations take place. This company was established in 2010. It holds the protein expression platform technology, our vaccine pipeline, and our CRO services business.
It is situated in DTU Science Park, just north of Copenhagen, and we are about 20 employees. Importantly, we own 34% of the company called AdaptVac, which is an important part of our history. This company we co-founded back in 2017 together with researchers from University of Copenhagen. AdaptVac holds a very important virus-like particle technology, which I will be talking more about. It is an important component of our lead asset. Our management team has combined experience of more than 100 years in making drugs. I myself come with a master's degree from Copenhagen Business School, have more than 25 years of experience, always working closely with scientists in the field of developing drugs. Our CFO, Keith Alexander, has a very strong banking background with more than two decades of experience in financing. 10 years from JP Morgan in New York. He is American.
Eight years in Danske Bank before he joined ExpreS2ion three years ago. Dr. Farshad Guirakhoo, our Chief Scientific Officer, joined ExpreS2ion a year ago, has four decades of experience in making vaccines, taking them all the way from the lab to a clinical and commercial setting. Holds a PhD in virology and has vast experience in making vaccines. Also, Dr. Max M. Søgaard, our Senior Vice President of R&D and Technology, two decades of experience in making the active component in vaccines. Very strong academic background, PhD in biochemistry, and has been in the company more than 10 years. We have a scientific advisory board, which is important to mention here as we go through the lead asset, the breast cancer vaccine asset here later in this presentation.
This is an oncology-focused scientific advisory board, which really holds key opinion leaders of very well, well-known and high scientific knowledge, having published scientific findings in hundreds of peer-reviewed papers and books and so forth. They help us and endorse what we do with our breast cancer vaccine asset. ExpreS2ion Biotech, we have a platform that we call ExpreS2. It is based on a proprietary insect cell system based on so-called Drosophila S2 cells. That is why we write the platform spelled like this, ExpreS2, and we call our company ExpreS2ion. It is because of the S2 cells, which are well-known in the scientific field. We have a proprietary improved method for making recombinant vaccines based on this, and it is really enabling two important things in making vaccines, the development of novel vaccines and the production of hard-to-express vaccines.
We've seen 14 years now of experience in working with these cells, also before the company was established, very strong advantages, especially in making vaccines. We have seen good advantages in terms of safety, immunogenicity, and versatility. We've seen that antigens made with our ExpreS2 system are easily combined in delivery vehicles, such as combining them with a virus-like particle. Furthermore, the system enables production of hard-to-express proteins. We've seen that with clients that we have supported for the first 10 years of the company's history and also across our pipeline activities. There's a nice speed in terms of production. We can produce gram per liter yields, which is important, and it's a very easy system to work with that makes homogeneous manufacturing batches. Very stable proteins, which is important. No need for cold chain requirements, as you've seen with mRNA vaccines.
These can be handled at room temperature. We have seen also functional modifications in terms of glyco modifications, which means certain super structures on the surface of the protein that allows for better vaccines even that we work with this system. We have proof of concepts with this system across a number of projects, and starting from the right here on this slide, I want to emphasize the COVID-19 vaccine that we were heavily engaged in during 2020 to last year, 2023. We got this COVID-19 vaccine validated in a phase III clinical trial that was sponsored by Bavarian Nordic, who had an exclusive license to the project. We are very, very pleased as a biotech company that we can actually say that we have a phase III validated technology platform. Furthermore, it's being applied in multiple malaria projects, which are all under development by Oxford University.
These are, in fact, sponsored by non-diluting funding. We are very, very pleased that Oxford University progresses with these important malaria vaccines and further clinically validate our ExpreS2-made antigens under these settings. Then we have a very important preclinical proof of concept with the HER2 breast cancer vaccine that I'm going to speak much more about in this presentation. A wholly owned asset by ExpreS2ion, and we are in a very important stage of being a clinical trial application-enabled phase. That means we have carried through the preclinical package, and we are approaching the first clinical trial. We also have earlier proofs of concepts in discovery and research. I'll just briefly highlight the pipeline assets where we are in control of all the assets here, the breast cancer vaccine asset, our oncology asset is, as I mentioned, in the clinical trial application-enabling phase.
We have completed the tox and we are in the manufacturing stage and approaching the first clinical trial. A CMV vaccine project that we call ES2B-I002. This is an infectious disease project, which is undergoing lead optimization with our collaboration partner, Evaxion Biotech. This is another Nasdaq-listed biotech company with a very unique AI platform that we use to design the antigens that we then make in our ExpreS2 system. Under this collaboration agreement, ExpreS2ion has the right to select the lead candidate for further development. We also have exploratory projects using our vaccine and protein development capabilities. All in all, our activities in this pipeline setting address high market values, the breast cancer obviously being a EUR 10 billion market, in excess of that. In this busy slide, I just want to convey that we have achieved several milestones since we initiated the pipeline-focused strategy in 2020.
We have generated more than EUR 40 million of funding over these years, and importantly, the breast cancer vaccine asset, we have now completed the tox studies. We are in the GMP manufacturing stage, and we expect to file the clinical trial application this year and initiate the first clinical trial. The cytomegalovirus project, the ES2B-I002, as I mentioned, here we are on path in our research setting, aiming to select the lead candidate here in the year to come. I also want to emphasize the COVID-19 vaccine project here because it actually demonstrated long-term protection, 12 months durability in a clinical phase II setting. To our knowledge, we have the only technology platforms in the COVID-19 space making a protein-based vaccine that has demonstrated that duration of protection.
It has also shown non-inferiority towards a commercial mRNA vaccine in a phase III setting, so it met its primary endpoint. Altogether, the COVID-19 vaccine project was very supportive of the platform. However, Bavarian Nordic decided to discontinue this project due to commercial expectations. I'll dig further into the breast cancer vaccine asset that we call ES2B-C001. Breast cancer is unfortunately a very common cancer. One in eight women will be diagnosed with invasive breast cancer during their lifetime. In approximately 25% of tumors, HER2 protein that we all have will be overexpressed. Unfortunately, this overexpression leads into the aggressive cancer disease and high recurrence rate, and also high mortality. In fact, now more than 685,000 women die on an annual basis due to breast cancer. The market for treatments of breast cancer today are dominated by monoclonal antibodies and antibody-drug conjugates.
Monoclonal antibodies or mAbs, as we call them, are really the standard of care. ADCs, as we call antibody-drug conjugates, have emerged in the last couple of years. However, none of these treatments are able to hinder resistance, which is a common thing. In 25%-30% of patients, resistance will occur, and this is something our approach with the vaccine can overcome. It's also very cumbersome treatments with frequent hospital visits and very expensive. There are also certain toxicology perspectives that are drawbacks with these therapies. All of these we overcome. There have been other HER2 vaccines under development, such as epitope-based vaccines, protein-based vaccines like we do in other forms, DNA vaccines, genetic cells vaccines. Now, these come all with findings of poor immunogenicity, high production cost, and really also even some safety concerns.
What we see with our vaccine approach that we apply in the ES2B-C001 is that we can overcome these drawbacks. We are very thrilled with the breast cancer vaccine project we are working on at the moment. Our vaccine targets multiple epitopes of the extracellular domain. This is a very important feature because the dominant treatments today, like Herceptin and PERJETA, these monoclonal antibodies, they really target only one epitope, where there are actually four epitopes. With our approach, we target them all. This actually leads to a potent clonal response and provides with high advantages, high immunogenicity, good safety profile. We expect the same as we've seen with the COVID-19 project, applying the same technologies here that we can show longevity. It may be possible to combine it with standard of care and become an off-the-shelf scalable and cost-effective vaccine.
The notion of resistance is very important. Here you can see an in vitro assay in Petri dishes where in the top row you see trastuzumab-sensitive cancer cells. These are Herceptin sensitive. If left untreated, as you can see to the right, tumors will emerge, or tumor-like cells will emerge. If you apply Herceptin, also known as trastuzumab, you can hinder the growth of these tumor cells, and that's the same that we see with the ES2B-C001. So far so good. Importantly, if the cells are trastuzumab-resistant, you can see if left untreated, the tumor cells will grow. If you apply Herceptin and trastuzumab, as shown in the lower panel in the middle, cancer cells will also emerge. Whereas if you apply our vaccine, as shown to the lower right, you can actually hinder the growth of tumor cells.
This is a very important feature that we have high expectations around. In mice models that we have done in collaboration with skilled scientists at the University of Bologna, headed by Pier, we have seen prevention of tumors. These are transgenic Delta16 mice. In the control group, basically, these mice will eventually die in about 20-26 weeks. If you apply our vaccine, as shown here in the green bar, you can see that they are tumor-free for a longer time. Even if you actually apply our vaccine with an adjuvant, you see complete tumor-free, no development of tumors having applied our vaccine. Very strong finding in this pre-clinical test. The same goes in a therapeutic vaccination test where we were able to completely inhibit the development of tumors in the test mice.
You can see here, the black curve shows the control where mice develop these tumors. Whereas if you apply our vaccine without an adjuvant, you see a lesser degree of tumor growth. With an adjuvant, you actually see no development of tumor growth whatsoever. The same we can see in a model survival test, where the black curve here shows that mice will pass away in about 50-60 days. Whereas if you apply our vaccine with an adjuvant, there's actually survival, which we have registered in more than 600 days now, which is basically like a functional cure, which is very promising. With respect to our breast cancer vaccine project, we are now rapidly approaching clinical readiness. We have the pre-clinical package ready now. In fact, yesterday we announced the completion of the final safety report, the final GLP safety report.
That has been completed, and that part is a very important component in the clinical trial application we will make later this year. Secondly, on the CMC, chemistry, manufacturing, and control, which is all revolving the manufacturing of the vaccine, we are progressing as we plan. And then, at the moment, we are in the setting of making the clinical trial design and getting the clinical design up and running so we can initiate the clinical trial here as soon as possible when we have registered the clinical trial application and received the approval of that. Hopefully, that should all take place also within the next year. We have business development activities going on now as we approach the clinical investigations because we want to alert what we are doing to potential partners, which is important for potential co-funding of this asset in a later stage.
Commercially, we're looking into a market of vast numbers. It's a more than $30 billion global market, and we see a serviceable, obtainable market for our vaccine of EUR 2.8 billion. This is certainly a blockbuster potential we're looking into here. If you look at our investment highlights, we are addressing a high unmet medical need with our breast cancer vaccine, addressing the most common cancer. The market size is significant, as I mentioned, definitely blockbuster potential. We have seen our platform technology is validated technologically, and we also apply it across earlier phase projects, and we are definitely an experienced team in taking this onwards, supported by our board of directors and a very strong scientific advisory board as well. I'm happy to take any questions.
Thank you, Bent. Very interesting indeed. I have a question because trastuzumab, Herceptin, is that also available for lung cancer patients? Do you see an opportunity for your candidate to have an effect on lung cancer as well?
I'm sorry, I'm not the expert in lung cancer. Definitely the breast cancer vaccine market leader has been for years. I cannot respond on the lung cancer application.
Have you said anything about the annual treatment cost per patient? I've seen a number at $75,000. Is that correct?
Yes, it can be even higher than that. Actually, patient costs above $100,000, so it's definitely a costly treatment. In terms of pricing, it's quite early to say at this stage, but we certainly believe we have a competitive advantage, both with the manufacturing setup that we have that allows us to make competitive pricing, and also the way we are making this as a vaccine approach.
Do you believe it will be a one-time vaccine, or do you have to refill after a couple of years?
That's a very good question because what we've seen in a preclinical setting when it comes to resistance is quite extraordinary. So, we hope that the patients will experience a long-term protection, which is also that what we have as indications in the COVID-19 project, as I mentioned, and we apply the same technologies on the breast cancer vaccine asset. So potentially there's not a need for a repeat dosing, but that, of course, remains to be explored. Bear in mind, I should, however, comment that this is a therapeutic vaccine, so you will have been diagnosed with breast cancer. It's not a preventive vaccine, not in the first instance, at least.
Do you believe the therapeutic vaccine will have a different effect when it comes to HER2-positive or HER2-low patients?
That's a very good question. We are actually discussing it at the moment with our scientific advisory board and those people who support us in the clinical investigations. From a safety perspective, we can also look into HER2 low patients for sure. Basically, because what we've seen within HER2, which is one of the antibody-drug conjugates that I alluded to addressing HER2 low, we believe that we can potentially also address that market as well.
A little bit about the COVID-19 vaccine. Was it ever launched, or how was it?
Well, when Bavarian Nordic in Q3 last year announced that they saw no commercial opportunity, unfortunately, despite having just met the primary endpoint in the clinical phase III. They have other priorities in their pipeline and in their commercial portfolio, so that was their decision. Basically, they put it on the shelf, unfortunately. However, there was a very important milestone payment, which has been triggered earlier this year. We announced that a phase III completion milestone payment was paid by Bavarian Nordic. It's a bit complicated, but that goes into AdaptVac, the company that we own 34% of. Of course, we also have access to part of that funding as well.
Thank you very much, Bent, for your presentation and for answering the questions, and good luck ahead.
Thank you very much.