Good afternoon. We're back here now with David Dodd, the CEO of GeoVax. David, thanks for coming.
Thank you for having me.
Well, let's get started by talking about the COVID-19 vaccine part of GeoVax. You know, BARDA, the big division of the HHS, they award contracts as part of the White House's Project NextGen initiative. Is GeoVax applying for these contracts, and will you receive such funding? You know, if so, when might that arrive, and how much might that be?
Sure. Excellent question, John. First of all, we remain in active discussions and negotiations with BARDA about being a participant in the Project NextGen. You do not know whether or not you receive an award until you receive an award letter. So all the discussions are progressing, we think, in a manner that would be supportive of receiving an award. But until we receive that letter, it's, you know, it doesn't make sense to speculate on it. In terms of the value of such an award, there are what we would refer to as probably biobucks. What is the full value of the award? Because it will more than likely be a combination of direct funding to GeoVax as well as pass-through funding for the CRO with whom we'd be working in terms of the clinical program.
I would suggest that based on what we've seen, the value of an award would be $300+ million, more than likely.
That's a chunk of change. So even I, as a virologist, you know, having had COVID a couple of years ago, 3 different vaccinations, I'm at the point of just rolling the dice. And so why do we really need a next-generation vaccine?
Well, the importance of a next-generation COVID-19 vaccine is to clarify, first of all, what it means to be a next generation. And as the federal government in their initial announcement about Project Next Gen defined it, they're looking for broader, more robust immune responses, so giving a greater breadth of protection as well as durability. As you may be aware of, the current vaccines that are out there are utilized in general about 2-4 months as the viewed durability. Currently, what we have in the clinic, we're seeing something close to 8-12 months, so significantly greater durability than what is currently out there. In terms of breadth of immune response or robustness, what is being looked at there are largely how does a vaccine respond to the continuous emergence of variants?
So what we have seen with the mRNA vaccine specifically is as new variants have continued to emerge, we see the need to reconfigure the vaccines to address the current variant of interest. So that could be the original. We started with Wuhan. We then went to Delta. We went to Omicron. We went to Omicron XBB.1.5. And the current sort of scourge of variants is the JN.1. What we've seen in clinical data, which was recently published on the GeoVax vaccine, is that we're showing protective immunity from the original Wuhan strain all the way through the Omicron XBB.1.5 without any reconfiguration. And we currently are prepping to evaluate against the JN.1. So we're seeing a much broader, more robust response, which is very important for patients out there, and then also the durability.
The critical importance, however, in our view of a next-generation COVID-19 vaccine are for those populations who have compromised immune systems. These are individuals who may have blood cancers. They may have kidney disease. They may have sickle cell anemia, a host of types of medical conditions that result in a patient's body's ability to be able to respond to an antibody stimulation, which is critical in vaccinations, but to not respond as they should. And so in the United States, we have almost 25 million people, about 250 million worldwide, whose bodies are depleted in their ability to respond. And that's where our vaccine comes in because it gives a much broader response by inducing not only antibodies but also T cells, and therefore providing a greater level of protective immunity than they would otherwise be receiving.
We think that sort of captures the importance of why, why a next generation. It's because we need a more robust, a broader types of, durability, and also to address populations for which the current vaccines are insufficient.
You want to elaborate any more on how your MVA technology gets there whereas the RNA viruses, vaccines don't?
Sure. Sure. It's a very good question. A vaccine platform, be it Modified Vaccinia Ankara or MVA, which we use, or the mRNA, which everybody's familiar with mRNA, it generally a platform is useless until you add an antigen into it to induce the type of immune response you'd like to induce given the target pathogen you're trying to address. What is important about our technology, MVA, is in and of itself, it's already a vaccine. And it provides a very strong immune response in and of itself. What's even more important is that the core basis of MVA allows a vaccine to be constructed that you can add additional antigens or components or proteins into that vaccine. Whereas with mRNA, you're generally restricted to only use one particular component of the virus.
So we have a dual antigen construct versus the single antigen construct the mRNA has. The net result is that we induce a very strong antibody response as well as T cell response. Whereas with the mRNA, you're inducing primarily the antibody response. And you're missing that opportunity to be able to provide greater protective immunity potential for people who have these compromised immune systems. And so they're not being served well. And that's a major point of differentiation between our technology and what you see with mRNA.
Can you tell us a little bit about what was disclosed in a September publication you had relevant to this vaccine?
Sure. In September, around the middle of September, in Vaccines, which is a peer-reviewed journal that deals with the vaccine industry, obviously, we had a publication. It came out. It was published and authored by our colleagues at the City of Hope National Medical Center. That's the organization from whom we licensed this vaccine and have now expanded it into the clinic. And what they demonstrated in that article was they showed a much broader robustness in terms of the immune protection. One of the key takeaways from that was they demonstrated and provided the data that validated that our vaccine is showing protective immunity from the original Wuhan strain through Delta, through the Omicron XBB.1.5, which is pretty much unprecedented without having to do any reconfiguration.
It showed very strong responses, not only in antibodies versus the mRNA, but especially among T cells, as you would expect, since we're also inducing a very strong T cell. So the net of that publication was validation in a phase 2 setting of a very strong protective immune response, greater robustness as well as durability, and confirming what we're hoping to see and hope to continue to see out from the clinical data, which is a very strong response on both sides of the immune system, being able to then provide the coverage that's needed for people with compromised immune systems.
Okay. I mean, it certainly sounds like today, the data strongly argue for this product. But what must you show between today and the FDA saying, "Go ahead?"?
What is going to be most critical is to be able to reach agreement with the FDA on the T cell measures as measures of protective immunity. It's pretty well defined in the field of vaccines or vaccinology what to look at with antibodies. It is less clear and less agreed upon when one is looking at T cells. But as we have learned through working with BARDA and with others, that is at the top of the list of the current discussions within the FDA, which are what are the appropriate markers to be looking at from a T cell so that we can use that to show that the protective immunity is there. Now, we are part of those discussions because of our current involvement and active discussions with BARDA on that. And so we're at the table.
We're presenting all of our tables, data, sharing it all with BARDA and all, and also engaging with other experts in the field, looking at what should the markers be so that we can all, as an industry and as a public health group, sign off on the type of markers that'll be the basis for signing off on a vaccine such as our next-gen vaccine.
Okay. And so what's going on at City of Hope, a handful of other sites, and will you be adding more sites to that? Tell us about what's going on.
Sure. So we initially started this phase two program with our COVID-19 vaccine, just at the City of Hope National Medical Center in Duarte, California. What has happened is since then, we've expanded to four expansion sites. So the Fred Hutch Center in Seattle, University of Massachusetts in Worcester, Wake Forest, and also Eastern Carolina. And with what that's provided us is an opportunity to accelerate the pace of enrollment in the immunocompromised trial among blood cancer patients prepping for stem cell transplantation. And so we've got additional sites underway. We're looking at further additional sites right now. We have interest not only within the U.S., but within North America and also within the United Kingdom to participate in this.
So we expect to continue to expand incrementally, probably a few more sites, and then be able to have the basis to go forward and reach the certain, I'll call it, data milestone points in conjunction with ongoing discussions with the FDA as well as with BARDA.
You know, regarding safety, you know, this global, Global Vaccine Data Network and, you know, some other large looks at safety among COVID vaccines, what have you got to say about the safety of current vaccines that came out in reaction to this pandemic and where you might shake out comparatively?
Well, the latter is probably easier to address because I think most people agree we still are continuing to learn about, I'll say, safety parameters, not that there are unsafe parameters necessarily, but the safety issues that one would want to evaluate with mRNA as a technology because it's a relatively new technology. This is in contrast to MVA, which has been around since the 1960s and early 1970s. It's well documented of the safety of MVA in humans. It does not replicate in mammals, so it's exquisitely safe. In fact, we've been given an exemption by the FDA to not have to do the traditional animal tox studies because it is so well known of the safety of MVA. So our technology is not a new, unknown, unproven technology. It's recognized for its extreme safety.
In Europe alone, in Germany, in fact, alone, there were over 120,000 people who were evaluated over the early years of MVA, extremely safe from that perspective. It delivers the type of payload of being able to add additional antigens into it that enable you to get a very broad immune response that you might be seeking.
Okay. So pretty much you almost don't care. And the more they find wrong with the others, in some respect, the happier you are.
Exactly. And the other parameter is MVA is recognized for its ability to be lyophilized or freeze-dried. It does not have to be stored at -80 degrees Fahrenheit as you have to do with, with items such as mRNA. So there are other parameters about MVA that are beyond the safety, beyond the performance from an immune response, you know, induction type thing that, that make it a very nice, platform for developing infectious disease vaccines.
Do you think you make most of yours available as a lyophilized powder or as a, like, a refrigerated liquid?
Initially, refrigerated liquid, very, very at modest temperatures, but we'll move because in certain parts of the world, it is absolutely critical to not only be able to have developed a vaccine, but be able to administer it locally. And that means in certain parts of the world, for instance, in the Southern Hemisphere, that we need to be able to deliver something that could be delivered as a freeze-dried or lyophilized material, reconstituted in the particular locations, and then administered as necessary.
I mean, do you feel like you're getting your point across to investors or are some just COVID fatigued that no matter what you say and what your technology is, they're just done with it?
I think there is an extreme amount of COVID fatigue in all parties. And I think that's a challenge for all of us. We deal with it every day as we talk to investors, as we're at conferences such as the ROTH Conference. And we're always asked, "Why do you need another COVID-19 vaccine? Isn't everybody already vaccinated?" By and large, you could say, "Well, you're not too far off." But when you focus on those populations for whom the current vaccines are inadequate because of their medical conditions and all, and usually people can relate to that, they'll know someone who's had a blood cancer, someone who's dealing with diabetes, someone who's got kidney disease. So when you start sort of crafting that profile, that picture of someone, and someone says, "You know, I have a relative. I have a friend.
I have a colleague that deals with that type of condition," or they may actually know someone who continues to be sequestered in their homes because of their medical condition and the risk they're at with COVID. When we're able to paint that picture of that individual, I think it begins to resonate why it's very important to be working on next-generation COVID-19 vaccines.
Well, that sounds like a pretty natural stopping point for that. Can we talk about Gedeptin and, you know, how it works and why you picked head and neck cancer to start off with?
Sure. Sure. Well, Gedeptin is a very exciting. I'd call it platform or technology. It's not unique to a particular type of cancer other than a solid tumor. It allows us, as long as a tumor is needle accessible, which in today's technology, most solid tumors are needle accessible. So that becomes very important. And it works rather simply, I think, because I can explain it even, is that it's the delivery of a particular enzyme injected into a targeted tumor, then followed with an infusion of an existing hematologic chemotherapeutic agent called fludarabine phosphate or Fludara. And those two combine creating a prodrug activity, which then creates a new compound that is called 2-fluoroadenine, which is highly destructive to solid tumors.
If the Fludara is injected or infused into a tumor, into an individual, for those tumors that have not been treated with the enzyme, it does nothing. So what's exquisitely safe is what the phase 1 and the current phase 1/2 study have shown and all. So it provides us an opportunity to go after solid tumors, with a very acceptable manner and all. The current clinical trial, which we closed the enrollment at the end of December, we should be seeing the results of that trial, in the first half of this year. So we're looking at it. The initial indications for advanced head and neck cancer, these are patients, for instance, in the United States, there are approximately 16,000 individuals who die every year from head and neck cancer. That's our target population.
The reason why is they're on palliative care. There's nothing for them. They've failed on everything. So the question that was asked of us by the FDA was, "Can you demonstrate that by treating certain targeted tumors in these, you know, in these people who are at the last leg of their lives, quite frankly, can you improve by either stabilizing or reducing a tumor so that they might have a better end stage of life? They might be able to swallow better. They might be able to speak better." We're not trying to rescue strategy here because it's so late in their disease state, so their cancer state and all. But if we can provide something that can improve on there, then one, it'll validate the technology. It'll improve for these individuals their lives.
Then also, we can then begin to look at earlier stage head and neck cancer or earlier stage other solid tumors and all. That's what we're focused on right now. We're, we're excited right now because in the first half of this year, we'll be releasing and announcing the results of the trial that, that we announced at the end of the year last year, at the end of December, that we had halted or closed the enrollment on. We're looking forward to that. Statisticians are doing whatever they do right now to go through and analyze the data. We expect to be, making some announcements over the next couple of months.
You know, head and neck as a foray definitely sounds logical. I mean, it's not just accessible. It's unfortunately visible. But where else might you go in the needle-accessible tumor world?
Exactly. I think, first of all, we would look at earlier stage head and neck cancer. I think we value our advisors. In fact, we have an upcoming oncology advisory meeting. Our advisors will be looking at triple-negative breast cancer. We may even look at benign tumors in the breast as an alternative there because we believe that, at least from our clinical advice we're receiving, that would be an area of high interest and all. We're also looking at evaluating this and moving into the clinic and combining Gedeptin in conjunction with immune checkpoint inhibitors. We've been supporting preclinical studies that have shown that combining the two intends to improve the performance of the immune checkpoint inhibitor. So we're not at the clinic yet with that type of approach, but we're getting close to there.
Part of what we're looking at during 2024 is to lay out what would be the basis for an IND to go into the clinic with that.
Okay. Can you tell us, you know, what kind of milestones investors can expect in the next year regarding Gedeptin, head and neck, and maybe even outside of that if you're that far along?
Sure. Sure. I think what we will see is, first of all, in the nearer term for Gedeptin, we'll be announcing the final results of the current Phase 1/2 trial that we closed the enrollment on at the end of December. So we'll be doing that. We also expect to announce what our plans are for going forward in an expanded Phase 2 for advanced head and neck cancer, as well as looking at earlier stage head and neck cancer and also the degree to which we'll be proceeding forward in a slightly longer period, but let's say over the next 12-18 months, in combination therapy, combining Gedeptin with an immune checkpoint inhibitor.
Okay. So that sounds like it wraps up, that program fairly succinctly. How about GeoMVA vaccine in pox, monkeypox, smallpox?
So one of the challenges we've had is that right now, there is only one company worldwide that supplies the vaccine that is authorized against monkeypox and smallpox. And that is a vaccine which is MVA, which is we've been talking about as the basis for our COVID-19 vaccine as well as a standalone vaccine. We acquired the rights from the U.S. NIH to be able to bring forward their MVA as a vaccine that we would develop, manufacture, get it registered, and be able to sell as an alternative to the current single source supplier worldwide. We're in discussions and negotiations right now with regulatory authorities about the explicit pathway that'll be required as the basis for that. We're already in the manufacturing process of MVA or GeoMVA, as we refer to it, to go forward with that.
As a milestone, we expect to be clarifying yet this year what the plans are that we've reached an agreement with regulatory authorities will be the basis for being able to go forward.
Okay. So with these three programs just individually, what kind of addressable markets do you see?
Yeah, it's.
You think you're addressing?
It's quite exciting because if you look at immunocompromised patients for COVID-19, and you look at the number of patients, there's an estimated 23 million in the United States. There's an estimated 250 million worldwide, but let's just focus on the US. The potential revenue opportunity on an annual basis is over $7.4 billion in that alone. So keep in mind, that's not having to go up against the Pfizer and the Moderna. It's addressing populations for whom their vaccines are inadequate. And it would provide us the opportunity to be the leader in that particular segment of the marketplace. So it's quite strong. If we look at Gedeptin in terms of the advanced head and neck, it's about $2.7 billion, almost $3 billion on an annual opportunity.
But if you look at earlier stage head and neck, now you're adding another $11+ billion there. And if you look at the monkeypox opportunity and take into account what is kept in the target amount for the Strategic National Stockpile, plus the inclusion of patients who are candidates because of certain lifestyle activities in which they may engage, you've got, again, a $7.4 billion annual opportunity. So there's significant opportunity in these product areas. So the COVID-19 next-generation vaccine, the Gedeptin specifically just for head and neck cancer, combining both the advanced head and neck as well as earlier stage, and then also looking at the GeoMVA as a vaccine that would be utilized against monkeypox, but also relative to the stockpiling for smallpox.
Well, David, I think that does it. Thank you very much.
Thank you. Appreciate it. Thank you for your time.