Therapies and vaccines for life-threatening infectious diseases and solid tumors. David, please take it away and tell us about GeoVax.
Thank you, Vernon, and thank you, H.C. Wainwright, for this opportunity to present our story. We look forward to participating with everyone at the conference. Thank you. So indeed, we're a phase II clinical stage company focused on developing vaccines as well as cancer immunotherapies against a number of targets, as you might imagine. What we focus on as a company is to be reviewed or thought of as a company that clearly is focused on innovation, differentiation, acceleration, and collaboration. And what we mean by that is innovation, being we have a very strong IP portfolio and that supports and validates or demonstrates our innovative nature. We target populations that are either unserved or underserved by existing products or standard of care, and we will talk about some of those during this presentation.
We do in doing that, we're pursuing expedited registration pathways so that we can move our products through the pipeline into registration, commercialization, distribution, and most critically important is the administration of these products to improve people's lives worldwide. We are looking for worldwide distribution for our products. We anticipate doing that through business development activities, collaborations, whatever you want to call the form of it, but we have worldwide rights for all of our assets. We believe that in doing all this, we present a compelling investment opportunity for those who are interested in investing in biotechnology and in the companies that are growth oriented, that can provide a lot of opportunity, even though it's balanced with significant risk.
The priority programs that are advancing are, first of all, and we'll touch on each of these, is our GEO-CM04S1, our next generation COVID-19 vaccine, which was recently awarded a, an almost $400 million award funding in support of a phase IIb trial by BARDA, so we'll talk about that. We're also, with all the news and noise that's been circulating over the last week, it was one week ago that what we saw or what we received was the WHO declaring a global health emergency about mpox, formerly known as monkeypox. Now, driven primarily because of the extreme dire need within Africa, but we're already hearing reports about infections in Sweden. It's beginning to migrate in Europe, it's beginning to migrate in other parts of the world. North America is just a matter of time.
And then I'm going to touch on... And that's with GEO-MVA. And then finally, Gedeptin is our technology and the platform we have for which we address solid tumors, both either cancerous or benign, and we recently made a very important announcement about our plans to proceed with the phase II trial, a phase II program with that, based upon promising results, encouraging results that we've seen. Let's talk a little bit about COVID-19. It's clearly the pandemic is over. Most people sort of express, "I'm fatigued, I have COVID fatigue," etc.
What people are not aware of necessarily is that in the United States alone, there are an approximately 50 million adults who, because they have certain medical conditions that deplete their body's ability to respond adequately to antibody stimulation, that they are not protected and haven't been protected adequately by the first generation COVID-19 vaccines or even the monoclonal antibody therapies. These are individuals with certain diseases, blood cancer, certain immune deficiency types of diseases. They may have renal disease, etc. It goes on and on, and we'll touch on that. Where we differ is our approach of constructing our vaccine, and that is that we have the ability with our vaccine platform to incorporate or include within our vaccine multiple antigens or proteins of the SARS-CoV-2 virus.
And this is critically important because as this slide demonstrates, it was basically illustrated several years ago that you need to address both the humoral or the antibody side of the immune system, but also the T cell or the cellular side. All vaccines and typical vaccines are focused on inducing very strong antibody responses. But as this illustration demonstrates, antibodies are very important in the early stage of an infection. Make no doubt about it, they are those first soldiers, so to speak, that arise and provide a line of defense.
However, if you're only focused on antibodies in terms of stimulation, what you're missing out on is the extreme value and critical importance of what the cellular immunity or the T cells do, and that is that they are the ones that drive the reduction in severe infection, hospitalization, and the risk of death. That is critically important. We do that by incorporating not only the protein element of the virus, known as the spike protein, which all the existing first vaccines, first generation vaccines do, but we also include the nucleocapsid protein, and the nucleocapsid protein is recognized as being highly conserved across all coronavirus. Conservation means that it significantly reduces the ability of the virus to become evasive and evade what you're trying to do with the antibody side.
It's sort of a two-punch type strategy when you think about it, by doing both the spike protein and the nucleocapsid protein, and that's the basis and point of differentiation on our vaccine. The technology we use, I'm not going to go into a lot of it. It's called modified Vaccinia Ankara or MVA. That's an established vaccine. It was actually utilized initially as a vaccine to prevent smallpox, specifically among individuals who had had compromised immune systems or among pregnant women. That goes back to the early 1970s. That's why we were able to eradicate the world of smallpox. But as a carrier for other proteins to be as a vaccine platform, it has been demonstrated to have certain attributes that are very appealing. First of all, it does not replicate in mammalian cells, which means it's exquisitely safe for humans.
It's been demonstrated, and it's approved throughout the world as the vaccine to prevent both smallpox as well as mpox. And so it's exquisitely safe. It does not require the extreme refrigeration that many people are aware of with the first-generation vaccines. It actually can be freeze-dried and delivered, and then reconstituted. So it has some real benefits in it from that perspective. We use MVA as the basis for all of our infectious disease vaccines, not just the COVID-19. Well, we announced in June, we were thrilled to announce that we had received from the U.S. federal government an award valued at approximately $400 million from BARDA to conduct a phase IIb study evaluating our vaccine, a COVID-19 vaccine, against a registered mRNA vaccine. And to us, that's a catalytic event that could rocket us forward as a company.
Project NextGen was announced in April of 2023, $5 billion program. To date, they have funded 5 vaccine candidates, 3 of which are candidates that will hopefully be able to demonstrate through alternative delivery, an oral delivery, an intranasal-type delivery, et cetera. But our vaccine was selected specifically because of the potential we've been demonstrating in our existing phase II trials of showing more robust and more durable protective immunity. Now, what does robustness mean? Well, it's defined as looking at cross-variant protection. In other words, as we have heard about new variants emerging related to the virus, what we've seen is the first-generation vaccines have to continuously be reconfigured.
Our data thus far out of clinical data has demonstrated that our vaccine protects not only against the ancestral Wuhan strain, but all the way through Delta and through Omicron XBB.1.5, meaning that it has a much greater robustness potential than what we've seen in first-generation vaccine. Durability is simply long-lasting, and that's important because the dual antigen approach that we utilize drives memory and is what enables our vaccine that right now our clinical data is demonstrating approximately eight to 12 months for durability. And that compares with what we're hearing and what we've been seeing through clinical data and real-world use of the first-generation vaccines, which are probably between two and six months. So we believe that we indeed we have the potential in this major trial, 10,000 patients, randomized 5,000 on our vaccine, 5,000 on an mRNA vaccine.
It'll last a year. It's a one-to-one comparison, that the goal is that we can demonstrate in the clinical setting of this large head-to-head study, that ours has greater robustness, meaning broader protection against emerging variants, and that we also last longer. That would reduce this continuous need for reconfiguration and for boosters that we're seeing. The activation of the trial is anticipated to be in the first half of next year, and we're delighted to be able to inform you that already, with the announcement being made on June the eighteenth, that here we are now in early September at the H.C. Wainwright Conference, that we already can inform you that we have over 80 of the sites. There'll be approximately 100 sites in each of these studies. Over 80 of them are already confirmed.
So this is going at a very fast pace, and we're delighted, and we look forward to providing continuous updates on our Project NextGen program. As a company, where we're differentiating in terms of the patient targeting is that population that are composed of individuals who have compromised immune systems as a result of certain medical conditions they have. But we're not saying that the first-generation vaccines are don't work or that they're bad vaccines. They're terrific vaccines. They saved the world, frankly, from this pandemic, and that was by the quick formulation, the technology, and getting it out there. However, in the U.S. alone, there are over 50 million individuals estimated who are still at risk because the medical conditions they have present their bodies with the inability to respond successfully.
We're seeing, though, that the T cell configuration incorporated in our vaccine makes up for that, and that's the potential we're hoping to demonstrate and to be able to follow with an expedited registration pathway. There's over 400 million such individuals worldwide. We believe that the vaccine we have at GeoVax gives us the ability to go after that marketplace, not having to do a direct competitive interaction against the very large players who are out there. We also believe that our vaccine, under the Project NextGen program, may well demonstrate that our vaccine as a booster to the first generation vaccines will result in an overall regimen of vaccination that will give you the need for fewer boosters, because we'll be delivering a, again, a much more robust protection that lasts longer. That's what we're all about in this regard.
We have three trials already underway. Two of these, there are scheduled, anticipated milestone data milestones that are coming out yet this year. We have one that is an immunocompromised patient population among chronic lymphocytic leukemia patients. The built-in interim review will be we'll see the data in September, and we believe we'll be able to announce it either by the end of Q3 or in early Q4, early October. Then we also have a trial that 63 patients, look, healthy individuals, who all received a mRNA vaccine, and then they received as their booster, our vaccine. And those results, so the final results of that, will be coming out in Q4 of this year also. We have a lot coming on. We plan to continue, obviously, to develop this product.
We believe it can be a differentiated product and capture the leadership position among immunocompromised patients on a global basis, and we think it has the opportunity to be the preferred booster regimen in conjunction with first-generation vaccine. And again, we have worldwide rights, and we're currently in discussion with potential partners, and we'll continue to keep people updated as those discussions may proceed. Let's talk about the news of the day, it seems, and of the moment. Over the last week, we've seen that, and we've heard all about mpox. On August the fourteenth, the World Health Organization declared a global health emergency declaration. There's only one supplier worldwide which has insufficient capacity to meet the needs. Africa alone is in need of ten million doses, and what we're seeing right now, they have access to two hundred thousand.
The single-source supplier has said that, if possible, they would work to try and produce an additional 2 million doses throughout 2025, which still is only one-fifth of what is needed in Africa alone, much less what will be needed in Europe as well as in North America. What we have done as a company, we've already produced, and the various stakeholders about mpox are well aware of this. We've been in touch with them on a daily basis. We produce a cGMP master seed virus of our vaccine, which is very similar to what is currently authorized. What that means is we have the ability to proceed in the process development, optimization into production.
Of course, you have to validate that and go through a process, but we are probably the closest company behind the existing supplier to be able to add additional mpox vaccine supply capacity on a global basis as well. We're in dialogue with all the various parties that you're reading about, from WHO to others, you know, and we also are involved in regulatory discussions about emergency use licensing pathways, some form of an expedited pathway to be able to move forward. So stay tuned when it comes to mpox and GeoVax, and we have an awful lot going on. Finally, I want to talk about Gadeptin. Gadeptin is a technology that is tumor agnostic, in that as long as you have accessibility to the tumor, this technology can be utilized to reduce or eliminate the targeted tumors.
We have made recently some announcements of our plans. The mechanism of action is relatively simple. You inject this PNP enzyme into a targeted tumor. It produces. The cells multiply. You then combine it with an infusion of Fludara, which is an established hematologic chemotherapeutic agent. It's safe. It does nothing to the tumor if it doesn't have the PMP enzyme in it. If the enzyme is in it, it converts into a highly cytotoxic compound called fluorouridine that destroys or significantly reduces the tumor, and otherwise, it's very safe for the patient. Over the last several years, Gadeptin has been in a phase I/II trial that was funded by the FDA under their orphan drug clinical trials program.
The data have been promising and encouraging in the sense that it showed tremendous safety, which is good. It also showed the desired effect of some reduction, if not elimination, towards related to the treated tumors. We recently convened an advisory committee to go through all the data, both preclinical as well as the phase one and the phase one/two trial that we have so that we could announce what our next plans are. On July the thirty-first, we announced our plans to proceed with the phase two program. That'll be implemented next year. We're in the planning stage now. We're spending the money in the CRO selection, in the protocol finalization, et cetera. But we expect to be initiating a phase two trial of approximately around thirty-six patients.
This will be finalized with the work that's going on now. That would be during the first half of next year. We hope to be able to make that. It may spill over a little bit into the third, you know, to the Q3 of next year, but we'll keep everybody updated on that. And it's going to be looking at first recurrence head and neck cancer patients being treated by a regimen of Gadeptin in conjunction with an immune checkpoint inhibitor, and we're very excited about those plans. Upcoming milestones and catalysts to be thinking about for the remainder of this year is obviously with the COVID-19 vaccine. It's all about the operational progress with the Project NextGen, as well as the updates on our existing phase II trials with our mpox vaccine candidates.
Again, we're in discussions about being able to add additional supply of mpox vaccine and the critical need that is right now. That means that we're in discussion with all the various, not only U.S., but global stakeholders, but also we're addressing what would be the regulatory and abridged regulatory pathways. Gadeptin, it's all about moving forward in the phase II, and we will keep everyone updated on our advanced manufacturing process, which we're in transition, which will result in being able to produce for our infectious disease vaccines, a much higher yield production process, faster, at a lower cost. We've been able to validate that process. Obviously, we're still in the process of the transition, so in the interim, we'll just keep everybody updated.
Bottom line, if you look at what we're working on right now, this is not a, this is not a revenue estimate, but is what is the potential market on a global basis. If you look at the markets in which we're competing and what we're going after that we've talked about today, we're talking about approximately $55 billion in market revenue potential in US dollars on a global basis. So there's tremendous opportunity, some of which these opportunities we hope to be the preferred vaccine, for instance, among immunocompromised patients. That represents about 10 million - 10 billion, I should say, of the 30 billion that I'm illustrating here. And then also, we've got, you know, for the Mpox, that's over $10 billion in value we think that we could go after in that. So none of this is we're ready to go for it now.
We have products in development, but significant opportunity to deliver value to our investors and our other stakeholders. So with that, I would just conclude by saying, again, we focus on being innovative, being a differentiated company with our product, accelerating our pathways into registration, which leads to distribution, especially administration, and then we expect to do this in multiple forms of collaboration. Again, I want to thank everybody for their interest in GeoVax, and especially thank H.C. Wainwright for the opportunity to be part of this exciting conference. Thank you.
That was great, David. Thank you for helping us to learn about GeoVax. Your presentation of the opportunities that GeoVax targets and MVA technology was very insightful. We look forward to updates on GEO-CM04S1, Gadeptin, and the mpox vaccine in the next coming months. To everyone attending online, thank you. We appreciate your time and hope you are gaining valuable insights and ideas into investment opportunities that we believe are represented by GeoVax and the five hundred plus companies participating at our conference this year. Have a good day, everyone.