Good afternoon. Welcome to the Jefferies Global Healthcare Conference in New York. My name is Ella Rosenb latt, and I'm with the Jefferies Healthcare Team. It is my pleasure to introduce Jared Kelly, CEO of Oncolytics Biotech.
Thanks very much. I've been the CEO here for a year. This is a company that's been around for almost 30 years developing this drug. It's had over CAD 300 million worth of R&D put into the drug. The drug's called pelareorep, right there. It's an intravenously delivered oncolytic virus. It's unique because most oncolytic viruses are intratumorally delivered. People have tried to do intravenous delivery for, I don't know, 20, 30 years already, and the body neutralizes the virus. When it's in the plasma, it's basically wiped out, just like the flu virus would be if you get infected with the flu virus, eventually your body determines a way to kill it. Similar to these other oncolytic viruses that have been tested intravenously. Now, we have a systemically delivered oncolytic virus.
The way it works is it sort of masks itself, and evades neutralization by associating with other immune cells and sort of is carried to cells, healthy cells, and tumor cells. The difference is once it gets to a cell, this double-stranded RNA is not allowed to replicate in a healthy cell. Once it's in a tumor cell, and it could be any mutation from a RAS mutation or a BRAF mutation, et cetera, once it's inside the cell, pela then encodes its double-stranded RNA, replicates sort of endlessly, causes this inflammatory immunoresponse. We say it selectively replicates because it is capable of replicating in other cells that aren't cancer cells, but it's not able to replicate in healthy cells because of just a normal cell function that wipes the virus out from the normal cell. We're delivering a systemic immunotherapy.
We're doing it in a safe way where we're not infecting healthy tissue and normal cells. We're really doing this cold tumor to hot tumor thing. We should actually change this to inactive tumor to active tumor, which is really what we're trying to call it. We're turning the immune system on to the tumor. We're infecting the tumor with a virus, telling the body's immune system to attack the virus within the tumor. That's the first unique part of it. We're an intravenously delivered oncolytic virus. You don't see that being developed right now. It's a naturally occurring reovirus, so we don't have to genetically modify the virus. Special handling, special manufacturing doesn't apply to us.
We have the ability to scale in a large way commercially and to run very large trials. COGS actually are embarrassingly low, something like CAD 200 a vial to produce this. We don't have the sort of challenges that you would expect from other oncolytic viruses. We're focusing on combination approaches, which is where we've seen our best data. These are the three tumor types that we're currently focusing our clinical development strategy on. These are all GI tumors. We have large market opportunities. GI is the largest unmet need in oncology, and in my opinion, it's a CAD 20-plus billion market. Second line standard of cares across these three tumor types are not great, except obviously pancreatic cancer is getting a lot better now in second line with recent developments, which we're happy to see that.
These first two are the ones we're focusing on clinically, with the top one, the second-line metastatic colorectal cancer is our lead indication. Standard of care in the second-line has been the same for 10-15 years. Here's sort of top-line summary against the current benchmark. When I joined the company, I was coming out of Ambrx, and we had just sold an ADC platform to J&J. The idea was, let's find another undervalued technology that's sort of, my old CEO used to say it's an overnight success story, 20 years in the making. A similar concept applies here. This company's been around for 20-plus years. It's sort of been overlooked because it never really produced the clean, controlled data set that people need to believe that the drug works.
Now we are looking at all the data that we have. I come in with a fresh set of eyes, and focus in on these three tumor types, all GI based, all immunotherapy, places where immunotherapy hasn't worked traditionally. This is the data that we've seen. In the top line here, second line metastatic colorectal cancer, we're isolating the RAS mutated tumors, about 45% of the market, and we're going after a microsatellite stable disease, which immunotherapy just doesn't work there. The current standard of care is FOLFIRI and Avastin. Those are the numbers you'll get. We ran a study. It was a single-arm study with about 20 patients. Those are the numbers we got.
Importantly, in duration of response within those 33% responders, we saw about 19 months of duration of response versus four to six months is what you'd expect with the current standard of care. Very encouraging signal. I won't go into the other ones right now because we're focusing on our colorectal cancer program. This is data that we'll have within seven to eight months. It's a controlled study. Hopefully, I can go back to that, but we'll figure that out. It's a controlled study. It's called REO 033. We launched it just about a month and a half ago. It's taking the current standard of care, adding our drug pela to the standard of care in 1:1 randomization. It's in second-line RAS mutated microsatellite stable. Only one prior line of treatment, and it's FOLFOX is what people get in the first line generally now.
We're four or five sites open right now, expecting another 10- 14 sites in the next six weeks to be open. We expect to have the interim data around December, January timeline. Very excited to see a controlled study that proves out pela's ability to treat a very difficult tumor, but also a tumor that is a large market indication and currently underserved. If you're aware of colorectal cancer right now, you'll know that first line is a lot of development happening, third line and later, a lot of development happening. Second line is a little niche indication that for us, you don't find these often in cancer where you have a CAD 3 to 5 billion niche indication. Not a lot of development going.
Last time we checked, only four or five studies that were registration-enabled in the second line, and they're all going after specific RAS mutations or other small subsets of the colorectal cancer market, where we're going after about half of it with the RAS mutated microsatellite stable. Let's see if I can go back. This is data from our REO 022 study, which is the same study as REO 033, the one we're running now. Just it was single arm. This is what we saw out of it. On the far left there, that's REO 022. This is the data that we got, and you're seeing the same benchmarks, just really blowing these benchmarks away. This disease is very difficult to treat. It's not for lack of people trying. There's a lack of people trying now, but it was because nothing's worked for 10-15 years.
The standard of care has been the same. This is our near-term catalyst. This is what we're going after. We're going to have controlled data by the end of the year and something that we're really excited about. I'm going to go back, I think. We're a clinical company. We've dosed 1,300 patients. Been around for 28 years, like you said. Our combinations historically have been with chemotherapy and checkpoints, and as a biotech, you have to try to look into the future a little bit. You can't go on what's happening right now and what you know in the past only. You have to think about where things are going, how can I become part of the treatment landscape. Mentioned Revolution Medicines' pancreatic cancer data, fantastic data, obviously. We have good data there as well, but taking on that mechanism on its own is foolhardy.
Our drug showed really great control data in breast cancer seven years ago, there was another drug called ENHERTU coming up at the time, and the company tried to take that head on, and obviously, we know what happened there. For us, we're looking at how can we add to the RAS inhibitor's efficacy. How can we delay the time to resistance and allow a company like Revolution Medicines to dose at maybe slightly lower dosing rates because then you can stay on treatment longer. You can keep toxicity down. What we have going right now is, for probably the large part of a decade, the company ignored the R&D function because it was already clinical stage, and it started to have all this good data that was generating with chemotherapy and checkpoints.
Now we're starting preclinical work to combine with new mechanisms, and this is probably the second most exciting thing that's going on right now. We talked about some of our RAS preclinical data earlier this week, but there's more to come. By the end of the year, we'll have, again, some time to resistance data that is going to be, we hope, very interesting to talk about. I'm going to skip ahead to. Look, my background is, I was a lawyer at Kirkland & Ellis, and I worked on transactions. When I went into Ambrx in-house as the head of legal and strategy, I was really brought in for one purpose: position the company to sell it.
I used sort of my background and my skill set of doing diligence on biotechs for large pharma and being on the other side of large pharma's diligence requests. I come at this from a unique angle. I'm not a scientist by training, so the science I can talk about as much as I just did about the science, right? I have a chief medical officer and PhDs all around me to talk more about that. What I do know how to do, and what I consider myself an expert in, is selling biotech companies. There's really four pillars that you need to check, four boxes that you need to check when you sell a biotech.
Everyone always says, clinical data is the most important, and I think it's actually the least important. If you're a public company, it means you had really good clinical data at some point in your life cycle, or else you wouldn't have made it this far. So we're all sort of sitting on good clinical data. It's everything else that gets you to a buyout. CAR- T programs for a long time had fantastic clinical data. They didn't get bought out. There's current oncolytic virus companies right now that have amazing clinical data, Candel Therapeutics, to name them, and there's been no buyout, right? You have to check a lot of other boxes to do a deal with pharma, to be on their radar. One of them, I think the most important one, is manufacturing.
If you can't scale your drug in a way that pharma believes it can take it and sell a lot of it, you're not going to be a buyout target for pharma. One of the things I always check for a year and a half, I assessed where my next step was going to be after Ambrx. The first thing I checked was manufacturing, because that's where I see deals fall apart the most, manufacturing. There's manufacturing issues, pharma will walk away despite good data. Our profile, I touched on it a little bit earlier. We're non-genetically modified. We're just a specific strain of a reovirus. It's built-in double-stranded RNA. We're not modifying that. You don't have to dose intratumorally. You just get an IV, just like you would with a checkpoint or just like you would with chemotherapy.
As a patient, you're sitting in the chair just like you would anyway, getting an IV delivery system. You don't have to take a needle and go into uncomfortable positions. Tech transfer, really important. I've seen deals fall apart because someone doesn't want to use the same CMC provider. They want to move it to their own thing. They want to move to someone else that they have a relationship with, and they can't because of IP issues within that. We have a very clean scale. Check the box for me on the manufacturing. On intellectual property, you look at this company and say, well, if it's as old as you're telling me, it must be out of IP room. That's true for some of this composition of matter, which is the most important patent. It's up in 2028.
There's nothing you can do about that. You have to attack it in a different way. You have to say, All right, how can we block people from manufacturing our drug? How can we block people from using the reovirus? There's all sorts of different strains. How can you block people from using that to treat cancer? What we did, I think we dumped, I don't know, 25% of our budget into extending our IP life. One of the most near-term catalysts we'll have is an update on our new patents. These are brand-new patents. These aren't extensions on existing patents. These are going to be brand-new manufacturing patents, brand-new method of use patents that protect us for another 20 years. A fresh start on an IP profile.
You need at least 10 years, or else They're going to have a big problem with buying you if you don't have at least 10 years of IP protection left. It doesn't have to be composition of matter. There's other ways to block generics and biosimilars from coming. No one's come after a pelareorep yet because it's not a commercial success, but you expect that one day people will come after it, right? Those are two things that I see kill deals the most. You get to the good clinical data, then you start doing real diligence, and these are where deals fall apart the most often. We check both of those boxes right now. The next one is regulatory strategy. This is the third out of the fourth one.
How can you get your drug approved, and is there a path to achieve approval with your drug candidate? This is something that was completely lacking from the company when I joined, and this is something now we have two registration paths in two different indications. We have the ability to combine with checkpoints in both pancreatic cancer and anal cancer and run registration trials right now. We won't do that because it's not capital-efficient for us to do it on our own. We will only do that with a checkpoint partner. If there's a checkpoint partner that emerges and wants to go into two indications where checkpoints are generally not approved, they can run those studies tomorrow if they want to. That was one thing that I focused on.
We meet with the FDA five times in a year, figuring out the regulatory strategy for this company and for our drug candidate. I saved the last because it's clinical data, and like I said, I think it's the least important of the bunch. If you have data that's as good as RevMed, it doesn't matter. I think people will turn their head and say, All right, fine. That's good enough. That's obviously not always the case, and that's a rare achievement. How are you going to stick out with data that's just, let's call it, good to great, not fantastic to unbelievable, right? These other three ways are the ways you have to convince people to enter into discussions, but complete transactions. That's sort of the angle I look at from coming into this company.
I'm working backwards from, I want to be able to transact the company because as a small biotech, you're just part of a chain of development, and you're usually the first ring of that chain. That's the way I see it, and that's the four things I'm trying to accomplish. Like I said, by the end of the year, we'll have that controlled data, the controlled clinical data in colorectal cancer, and that's the fourth box check for me. That's all I had today. I'll open to questions for the last 10 minutes.