Good morning, everybody. It's a real pleasure to be here, even with the emergency outside. Thank you very much to the conference organizers for the invitation. For those of you that are new to enGene, enGene's a unique company. It's a unique company in that it's focused in a technology that delivers non-viral gene therapy to various diseases. As you'd expect, I'm going to make a few forward-looking statements. Let me begin by summarizing enGene. We start with our lead asset, which is a product called detalimogene voraplasmid. We're developing that for non-muscle invasive bladder cancer. It is a product that's really designed with the community urologists in mind. I'll get into that in greater detail in a moment. As I said before, this is a novel class, a novel platform, novel gene therapy, and it's non-viral gene therapy.
What we've seen with detalimogene voraplasmid already is some really interesting efficacy, some terrific tolerability, and the handling and ease of use is something that I think that both community and academic urologists are going to like. You're catching us at a pretty exciting time for the organization. A lot is going on. We've planned a data update in the second half of next year. We plan for a filing to regulatory authorities in the second half of next year with the potential approval in 2027. What gets us very excited about detalimogene voraplasmid is not just detalimogene voraplasmid itself, but the market. This market is projected to grow to over $20 billion. Why? Up to this point, it's been an incident-based market, and it's moving into being a more prevalent-based disease. I talked about the non-viral aspect of what we're doing.
When you think about gene therapies and viral gene therapies, what is the challenge with these therapies? Number one, not that much genetic payload. You're limited by size. Number two, you can't redose. Number three, very expensive to make, very expensive to handle. By taking a non-viral approach, we solve all of these problems. So detalimogene is made up of three large genes. We redose, and we have very competitive cost of goods. When you think about non-muscle invasive bladder cancer, what is it exactly? How common is it? First of all, in the U.S., we estimate there are about 730,000 cases of NMIBC, about 65,000 every year. The key thing about NMIBC, it's an early form of bladder cancer. If things go untreated, you go on to muscle invasive and metastatic disease, which is obviously terrible. NMIBC itself presents itself really in three-ish different ways.
The first, NMIBC with just cysts, carcinoma in situ. Think about this as like plaques all over the bladder. Or you can have it with growth, Ta growths, or T1 growths, which you see go deeper into the lamina propria. The two on the right represent papillary tumors. As you get farther to the right, that becomes a bit more serious for the patients. All of it is relatively serious. That being said, you've got to think about NMIBC different than metastatic diseases. First of all, disease progresses about 20% over a 10-year time frame. It's slow. Serious, but slow. Your treatment choices are different. You have to think about the journey for the patients. However, it is a big, big cancer. It's the sixth biggest in the US, and it costs the system billions and billions of dollars. Currently, how are things managed?
A patient is diagnosed. They're given a product called BCG. As you know, BCG is a product that has been in chronic back order, about a decade of back order. It's not still the easiest product to take. It's a long dwell time. It burns. It's effective. It's inexpensive, but it's tough to get at. The doctors have these choices of some novel therapies, or they just use chemotherapies. Again, efficacy so-so with these products. Ultimately, patients get to radical cystectomy, which is removal of their bladder. These patients are generally mid-70s gentlemen. First of all, it has a high risk to it, a high mortality, but morbidity is terrible. You'll end up with an ostomy, so you have a stoma bag. You lose sexual functions because they remove your prostate generally. Not that great of an option.
Now, because of that, the FDA issued in 2018 draft guidance to say, "Look, if you did 100 patients open label, you can get an approval." You see there's been a number of other agents that have been approved. Despite these agents being approved, the FDA reissued draft guidance in the summer of last year, suggesting the unmet need is still very significant. It is particularly significant for where the patients are. When you think about NMIBC, you need to think about that the patients are in the community. They're not sitting in academic centers. Two-thirds of urologists are in the community. Their treatment considerations are different. If you're in an academic center, it is, "Look, I really want to remove your bladder. That's the best way of reducing your risk," 100% reduction of cyst risk.
In the community, over a 10-year journey, patients are looking for products that have good tolerability, that obviously have efficacy. Some of the logistical things you see on this slide here, freezer, cost of treatment, ease of administration, if you stack those all together, they become very important things for the community to consider. When you consider what the pressures on these community urologists is, first of all, there are not many urologists available. It's tough to get qualified nursing. Many of these practices in the US are increasingly owned by private equity. There is a lot of pressure on revenue. In fact, the sources of revenue before used to be surgery, used to be in-office procedures. These have become lower and lower in reimbursement. The concept of buy-and-bill is really growing with the community urologists.
It used to be about 5% of revenue in OA. You see in 2025, it's estimated to be 15%-20%. After oncologists, urologists are probably the largest users of buy-and-bill. It really is a growth area. They're looking for medicines where they can generate revenue, but where also the costs of administering those medicines are as low as possible. That's where detalimogene comes in. It really is the perfect product for these community urologists. In that, it's demonstrated very good efficacy. It's very easy to administer. I'll go into that in greater detail. I'll show you some data to show that the adverse event profile is really compelling. Because it's a non-viral medicine, there's no special handling, no special storage. It really fits into the flow of a community urologist. What is detalimogene?
What's interesting about detalimogene is it's really three products in one. Remember I said earlier that we're not limited by genetic load. We have two RIG-I agonists and IL-12. What does that do? It stimulates both the innate and the adaptive immune systems. You see here the product is administered intravesically. It sort of bathes the bladder. It is our technology, our secret sauce, which I'll show in the next slide, that helps this genetic material get through the bladder lumen. What is detalimogene? It's really made up of a very simple plasmid, a DNA plasmid, where we stick those three genetic cargoes. The secret sauce is a proprietary sugar. They're mixed together very carefully. That creates a nanoparticle where we throw PEG on it, and there's the drug product. It's a non-viral product. How is this different from other products?
First of all, this is not an LMP. There is not the cost associated with that. We make this product in any regular plant. There is no special handling, no special liquids that are needed. It is air and water. We are already manufacturing at scale. Because it is four simple ingredients, the cost of goods of this product is quite competitive. We are well on our way through the manufacturing process. In that, we are almost through our FDA validation batches. I think you know in this category, there have been some issues in regards to manufacturing. We see this as being a real competitive advantage for detalimogene voraplasmid. Where are we studying detalimogene voraplasmid? We are pretty excited that detalimogene voraplasmid is right now in a pivotal program in NMIBC patients with CIS who are unresponsive to BCG. We fully enrolled that pivotal program.
In fact, over-enrolled it with 125 patients. We're also generating additional data in some other patient types. Patients who had never had BCG, patients who may have had partial doses of BCG, and patients who just have the papillary disease where just they have the growth. You see there that we've made some good progress in enrolling patients on that. It does not stop there. We are the inventors of this D DX platform. From that platform, we have some really interesting products that we're bubbling around that could be really interesting in the GU space. Because we are the inventors of this platform, we have very good IP. In fact, we have IP that gets us past 2040, as you see here. You saw on the previous slide that detalimogene is in the LEGEND trial. What is that?
That is for these BCG-unresponsive high-risk NMIBC patients. This is a study that we conducted around the world at multiple sites. Individuals get detalimogene in week one and two, week five and six, rinse-repeat three times that year. Then weeks one and two the following years in maintenance. We recently spoke to the FDA to agree on a new primary endpoint. That's anytime complete response rate. As I said, I'm delighted that we were able to fully enroll the study. Overall, we have 125 patients. This will be the largest cohort of patients being studied in this disease. We're proud of that. Last year, we announced, though, that as we'd enrolled some patients, we made some protocol changes. You see the split here. Thirty-one patients will be in the old protocol. Ninety-four will be in the new protocol.
Even that 94 would be as large as some of the other companies' filed number of patients. We provided a data update very recently on 62 of the 94 patients and 31 patients on the right. I will share some of that data with you. The first thing to note is in the pre-protocol change and the post-protocol changes, there is not much difference in baseline characteristics. Generally, older individuals, generally male, a lot of exposure to BCG. The one thing I will note for you is that our patient population is a very experienced population. They have had other medicines. 33% of them had other medicines for their disease. 42% had CIS plus a papillary disease. That is relative to some of the other programs, probably a more experienced patient population. What did we show very recently?
First of all, we're delighted to show that our six-month CR rate is 62%. You'll see later on that compares very favorably to some of the approved agents and agents in development. Anytime of 63. What we are very excited about is we had four patients who were at the three-month point, were not responders, but with reinduction became responders at the six-month point, speaking to immunotherapy and the time it takes. Now, we do not have much in the way of long-term data for this patient population as yet because they just haven't progressed that far. For the five patients that have made it to the nine-month mark, all five were responders. We're pretty excited as we wait for the rest of the patients to work their way through the system. Your obvious question is, how does this compare to the pre-protocol patients?
If you look on the bottom, the six-month rate for the pre-protocol patients was 41% by implementing a number of very important protocol amendments. These protocol amendments were amendments that brought our study to standard of care. They were not that fancy. They were just things that we should have been doing in the beginning. That boosted that efficacy to 62%. What about tolerability? Here you see that tolerability is really terrific with detalimogene, mostly grade 1 or 2 AEs, 42%. Most of the AEs are associated with the catheterization. I would draw your attention to the two numbers on the bottom. Dose interruptions of 1.6% and dose discontinuations of 0.8%. What does that say? Patients take their product on time and stay on that product. That is pretty important to have the best efficacy. You want to have the best compliance.
I'll come back to that a little bit later on why that's important. The other thing that's terrific about detalimogene is it really is designed for these community urologists. It's really good for the patients and good for the practice. For the patients relative to BCG, where you have to come in six times and if it doesn't work, another six times. As I said, it is four installations with a nice break in between. Right now in the clinical trial, it's one hour of chair time. Quite frankly, we're hopeful that if detalimogene is approved, it's really a five-minute installation and the patient can go home and void it at home. No urine bleaching, nothing else for patients to do before or after. For the practice itself, they literally can reach in the fridge or freezer for detalimogene.
You don't need any special nurses. You don't need a virus nurse or the like. There's no risk of contamination for the practice at all. You don't need to bleach anything. How do we look from a competitive perspective? You might recall that 62% number that I shared with you earlier, six-month time frame. For other products in this category that have been studied, you see the BCG product at 63%, the recently approved Johnson & Johnson product at 59%, and a real range there. You would see that our efficacy profile is emerging to be a very competitive efficacy profile. From a tolerability perspective, you might recall that 42%. You see that 42% compares to other products that range from 60%-80%. Very competitive from that perspective.
I'll draw your attention to the dose interruption rate of 1.6%, where these other products range from 20%-41%. Very competitive efficacy, very competitive tolerability. From an ease of use perspective, other products, you need to have drop shipping or you need a minus 80 fridge. Other products require multiple pre-washes and advanced pre-medications. Other products will require you to decontaminate the room. You'll need patients to bleach their urine. May need some staff to administer the product or may need an infusion chair. Detalimogene requires none of these things. Really, it is reach in the fridge, instill the product, send the patient home. In terms of logistics and simplicity of use, really is best in class. Here's what we're very excited about, though. I've talked about some of the other products.
All of those products will likely be used over time. In the past, for NMIBC patients, they would effectively be diagnosed, be given BCG, and it was sort of a combination of chemo or clinical trials before they took out their bladder. That really is terrible treatment for those patients. I'm pretty excited in the future. You're probably going to see the community urologists use two or three lines of therapy in sequencing patients and the academic centers doing something similar. What we anticipate is that BCG will continue to be the mainstay. When you think about a non-viral approach like detalimogene, because of good efficacy, good tolerability, ease of use, and low burden on the practice and on patients, it is relatively easy to use.
A referral to the academic centers where you'll get the more complicated viral therapies or checkpoint inhibitors and if they need removal of their bladder. To me, that's where when we talk about this market, it's not a winner-take-all market. It really is an all-boats rise market. All of these agents are going to be used in the interest of doing the best for patients. Now, we're a team that I'm very proud of. We put together a team that has a lot of experience in this NMIBC space and in this area of commercializing products. We're a team that puts our plans together but actually delivers on our commitments on a regular basis. Let me close before I take questions by just sort of summarizing where we are as a company. I'll start on the bottom. It says, first of all, we're well capitalized.
We have run away into 2027. Last week, we had the pleasure of doing a nice fundraising where a number of new investors came into the company. We raised well over $100 million. We were also supported by our existing investors. We are very well capitalized as an organization. What does that get us to? It gets us through this transformational opportunity where we see the market actually growing. Right now, the NMIBC market, the bladder cancer market, is about $2 billion. We anticipate that growing to over $2 billion. When you think about detalimogene, here is a product that is actually going to slide into the community urologist practices without really changing what they are doing. It is actually going to be easier than what they currently use.
It's really designed to give efficacy to have a very, very light experience for the patients, low adverse events, low number of instillations. As I said, you're catching us at a very exciting time. We think that we have a product here that we hope will get to the market in 2027. We plan to submit to the FDA in the second half of next year. We'll provide a data update as this new cohort of patients matures. I really thank you for your interest in enGene and your attention today. I'm happy to take any questions.