Presenting for the event, and additionally, tomorrow there's an investment panel session featuring several specialists in the sector. I also just want to quickly thank Bioshares and highlight the Biotech Summit in Hobart on the 7th and 8th of August this year, which is an event well worth getting to for those involved in the sector. Lastly, a quick thank you to the Vertical Events team too, who run some of the best investor conferences across the year. To kick off this year, we have Imugene and Managing Director Leslie Chong. Imugene is a clinical stage immuno-oncology company developing a range of new and novel immunotherapies that seek to activate the immune system of cancer patients and to treat and eradicate tumors.
Just a reminder, three questions, please feel free to type them in using the Q&A function within Zoom, and we'll get through a few of those at the end, but I'll hand it over to Leslie for the presentation.
Thank you so much, Matt. It is my pleasure and honor to present to you Imugene. We are developing cancer immunotherapy specifically. We have three drug classes that we are developing, CAR T that I'll explain in just a second, and two oncolytic viruses that we have already in the clinic in cancer patients. Three prioritized platform technologies. One is called an allogeneic CAR T cellular therapy. Allogeneic just means off the shelf, and I'll go into that in detail in just a second. We also have CF33 oncolytic virus. This is the parental virus. Along with the parental virus, we have what we call onCARlytics. By the name, you could tell on CAR, so there's a CAR T component. It is the same backbone as CF33 oncolytic virus, and I'll explain that in just a second.
Our B-cell immunotherapies have an outlying opportunity, and we have three ongoing clinical studies in cancer patients. Over 200 patients already dosed on our several different programs and platforms. Our market cap is, as of 18th of March, AUD 261 million, and we have, as of December 31st of 2024, a pro forma of AUD 65.4 million. Our investment highlights are quite simple. We have novel platforms. We have products that are quite unlike any other cancer products out there. We have clinical data readouts in the next 12 months. We have extremely experienced cancer drug developers on the management team, and of course, we ring-fence all our patents with a broad portfolio. I will go into our allogeneic CAR T cellular therapy first. This is in blood cancer.
In order to explain allogeneic CAR Ts, I need to explain to you the importance and the revolutionary product called autologous CAR T, or auto-chimeric antigen receptor T-cell CAR Ts. Now, these products came on the scene because they offered blood cancer patients over 50% of response rates or clearance of their cancer. However, these are quite expensive and laborious. When a patient has failed off of chemo, sometimes they come on this auto-CAR T product. It takes anywhere between four to six weeks of wait time to receive their own re-engineered T-cells. Such as this bearded man is a patient on an auto-CAR T or auto-CAR T therapy. This patient comes in after having failing off of a couple of lines of either chemotherapy or stem cell transplant.
The patient waits four to six weeks after they've had their T-cells taken out. It's re-engineered and then placed back in the body.
Sometimes roughly about 20% of the patient population either progress while they're waiting for their therapy or they simply cannot take their own T-cells back. High manufacturing costs. These products are roughly anywhere between AUD 350,000-AUD 500,000, and there seems to be a variability of potency due to the health of the patient's own T-cells. What we're proposing is a new way of CAR T therapy, which is an allogeneic or off the shelf. No allogeneic CAR Ts are currently approved, and this may be one of the first. We take healthy T-cells and then healthy T-cells from a healthy donor. We genetically engineer those, and then when the patients are ready, they are infused with Azer-cel. In this case, it's a CD19-directed allogeneic CAR T. There is this bearded man who comes into auto-CAR T, maybe his third line of therapy, maybe a fourth line of therapy.
Once they fail, they can then qualify for our allogeneic CAR T. Simply put, this patient comes in directly to the hospital after failing many lines of various different therapies. This patient has diffuse large B-cell lymphoma, which is a rare type of blood cancer and a deadly type of that. The patient comes into the hospital, they're ready. Our frozen batched product is there waiting for them, and within three to five days, they can receive our auto-CAR T, our autologous, our allogeneic CAR T. Our allogeneic off-the-shelf CAR T has already been dosed with seven patients, and what we found is incredible. Out of the seven patients that receive this regimen with their regular standard routine lymphodepletion, which is a chemo regimen, Azer-cel, and then taken our interleukin-2, this is a very low-dose off-the-shelf product that provides energy and T-cell proliferation.
Out of those seven patients, we saw four patients with complete response, meaning no residual tumors, and some of them have been able to maintain a durability, and that is without any cancer growth for over going on 11 months, nearing a year. That is our first patient that ever took the IL-2 and Azer-cel combo, basically, and have been living on a fifth-line patient more than 11 months and almost going on 12 months, and they're still ongoing, and there are several who are currently ongoing with their durability, living without cancer. What's interesting is that all seven patients had several different lines of therapy prior to, and it was their fifth line of therapy where they took Azer-cel.
This 47-year-old young patient came in, had gone through several lines of therapy, including autologous CAR T, the approved autologous CAR T, had progressed, came on our study as a fifth line, and even in day 28, we started seeing responses and have been going on more than 11 months without any tumor growth. I'm going to move on to our oncolytic virus, our CF33. Our oncolytic virus is made up of several different types of smallpox virus. It went into a vat, and the 33rd combination of the oncolytic virus had the most cancer-killing power. This is the one that we took into the clinic. In the simplest way, our virus loves to replicate and explode cancer cells. It only replicates in cancer cells and imparts that love onto other cancer cells.
We've seen this at the time of our data cut, and we have certainly dosed more than 40 at this point, but at the time of our data cut, 40 patients were looked at, and nearly half had stability of disease. These patients with solid tumors have gone through at least five lines of therapy prior to coming on to our study, and yet half of them had stability of disease, some going on more than 200 days with stabilization of their cancer growth or the cancer growth just not happening. We had two patients that had partial response, and then one patient who has a bile tract cancer who experienced a complete response, no residual tumors for more than going on two years and plus. We've already received fast track and orphan drug designation from the FDA. What is even more exciting about our oncolytic virus?
In our previous slide, I showed you that our oncolytic virus only loves to infiltrate into solid tumors and replicate there. OnCARlytics is a very novel and unique product where our oncolytic virus invades into solid tumor cancers, replicates, and then shuttles up a flag or covers a solid tumor with a CD19 flag. When you add a combination of CD19-directed targeted therapy, you then create a solid cancer situation where we can attack and kill the cancers. In two ways, our onCARlytics can kill cancer. One way is to lysis the cell or replicate and burst the cell. The other way is to upload the CD19 flag and then add a CD19-directed target, and in that combination, the killing occurs again and again. CD19 does not appear in solid tumor. It's only a blood cancer target.
To bring a blood cancer like 50% or more response rate to solid tumor is the holy grail, and it's something that we're looking forward to. We're currently in the clinic in cancer patients with onCARlytics as well as a combination with a CD19 bispecific product called BLINCYTO. This is marketed by Amgen. You can see 10% of cancer types are blood cancers and 90% is solid cancers. I just told you about CAR Ts and CD19-directed bispecifics and what have you give a level of response to only blood cancers for upwards of 50% or more. Solid tumors, unfortunately, do not get that level of response. They get approval with around 20%-30% response rate. This is a means to bring a higher level of response and a higher working therapeutic combination to solid tumors.
This is revolutionary, and we can't wait to see the data unfold. Over the next, we've had a pretty great 2024 with lots of data, especially around Azer-cel, with complete response or complete clearance of certain kinds of blood cancers. We will continue this into 2025 with a fast track designation, and that means a conversation with the FDA. We will continue to update the status on Azer-cel because four out of seven, that 57% response rate in the fifth-line DLBCL patient is quite compelling and promising in that field. VAXINIA and onCARlytics, as we move into dose escalation and get that optimal biological dose, as well as onCARlytics, currently in a very low-dose combination with BLINCYTO, where it's highly anticipatory of what we'll see in that particular program. I have an incredibly experienced team whom I have worked with before to bring a cancer drug product approved.
You see our running line of big pharma as well as biotech. We just added Darren Keamy to the group as our CFO, who also has a product that he's helped shepherd through the clinic and then approval to market. My investment highlights are quite clear. We have novel platforms producing that data, meaningful data in cancer patients, data across the next 12 months, an extremely experienced cancer team who actually have developed cancer medication, and we keep our robust and broad patent portfolio. Our stock code is on the ASX as IMU, and our market cap is currently at AUD 261 million. We have several top 15 shareholders, as you can see, and they have maintained that stability. That's the end of my presentation. I thank you for your time.
Thank you very much for that, Leslie.
Just again, as a reminder to those in the audience, if you have a question you'd like to submit, please type it in using the Q&A function within Zoom, and we'll read a few of those out now. Leslie, first off, I can see you've just had an announcement go be lodged on the ASX in the last 15 minutes while you've been speaking. Can you just talk to that one for those in the audience and what it is and what it means?
It's interesting. Not everyone gets an FDA IND to conduct their study, but not everyone also gets Fast Track and Orphan Status and et cetera. This means initial conversations with the FDA.
These are not just easy gets, but the fact that we have fast tracked, the FDA will recognize from when we put in a registrational study that these will be looked upon as a priority because there's a big unmet need in that particular indication and in that disease. We get lots of benefits as well.
Great. I know it's a frequently asked question, but can you speak to the timeline for data readouts and what goes into deciding when this can occur?
With this particular unmet need population, which is diffuse large B-cell lymphoma who have failed off of autologous CAR T, it's important to note that these patients are quite rare, and by the time they get to fourth line or fifth line, they're quite sick. We don't want to have everyone on in the study.
This is still a scientific experiment so that we can move into a registrational study. The patients are highly selected, and they're actually fit enough to be in our study. The enrollment for this kind of DLBCL, diffuse large B-cell lymphoma, happens to be quite slow. We have just added some Australian sites to the game. We're quite emboldened by the Australian investigators who are quite excited to put their patients onto this study. We're hoping that the enrollment will pick up. Therefore, the patient data is exactly what we take to the FDA to convince them that this is worthy of a registrational study and that this could be marketed and is safe.
Thank you. At a high level, can you speak to how active yourself and the team have been in terms of potentially partnering some or one of your assets?
We keep our eye out on who is looking for what and then try to engage them in conversation at big conferences like JP Morgan, AACR, ASCO, those kinds of things. We are fortunate that we come from U.S. big pharma and biotech, so we keep those conversations and relationships alive. They are curious about what is happening with us as well. We keep them informed. We also look to go outside of sort of the U.S., Australia countries for other partnerships. We keep that very much alive and ongoing.
Thank you. Another common question I know you have had before is, given the high volume of shares on issue, is the company considering doing a consolidation?
The board and I consistently talk about this, and we have to look at what is the most benefit to our shareholders and the company.
Another question that's come through is, there's still a plan for NMIBC with VAXINIA?
That is still in the books. We want to triangulate as to exactly what indications that we want to focus on because we obviously can't go to all the indications because the MAST study or VAXINIA looks to be working in several different indications, but we need to look at the areas where we're going to reap the most benefit, and the most benefit to the product, to the company, to the shareholders would be if we looked at a registrational study. If we can find an indication that is most likely to take us into an FDA registrational situation is what we're looking at.
We're still trying to decide with the MAST as well as onCARlytics exactly which indication we want to really focus on and then have a registrational study around it.
Great. Thank you. Can you speak—final question, Leslie—is can you speak to some of the other corporate activity in the CAR T and oncology sector recently?
Yes. CAR Ts had been a little bit of a—last year, I think it was not going so well, to be honest, but we are—I want to distinguish ourselves because we are an allogeneic CAR T, and we actually work after autologous CAR T fails. A lot of patients who get on these very laborious, expensive, and meaningful products like auto CAR T, about 60%-70% tend to fail. To have that allogeneic CAR T off the shelf with manufacturing ease, we will be there for when auto CAR T fails.
I think the world is starting to look at allogeneic CAR T. I know that there was a recent deal with AstraZeneca and in another allogeneic company. We feel pretty confident that the allogeneic CAR Ts are coming back on the rise.
Very good. Thanks for your presentation today, Leslie, and for taking those questions. We'll look forward to hearing more soon.
Thank you, Matt.
Next up for the NWR Virtual Healthcare Conference, we'll have Radiopharm Theranostics, and that will kick off from 9:40 A.M. Eastern Time. Hopefully, you'll join us again then. Thank you.