Good day, everyone. Thank you for joining the Medicenna presentation again. As you recall, Medicenna is a TSX-listed company, also listed on OTCQX. We are a company that's developing therapies for oncology, first and foremost, but generally immunotherapies. I did a presentation to you all in May this year, so this will be a quick update as to where we are since then. So, moving on, just to let you know that I will be making forward-looking statements today, so I recommend that you review our regulatory filings. Just as a background to those who are listening in for the first time, just to let you know that Medicenna is a clinical-stage immunotherapy company. We are focused on what we call evolved Superkines that we license, that program from Stanford University.
We are developing what we call revolutionary medicines to treat patients with unmet needs in oncology, first and foremost, but other unmet needs as well. Let's start with our lead program, MDNA11. This is the best-in-class IL-2 super-agonist, the only Superkine that's being developed that has been engineered in a manner to target cancer-fighting immune cells. To date, we've seen response rates in 30%-50% of the patients that have previously failed blockbuster drugs such as Keytruda and Opdivo. The second program, this is really exciting. It's not in the clinic, but the plan is to enter the clinic next year. This is a bispecific molecule that combines our IL-2 from our MDNA11 program with a blockbuster checkpoint inhibitor like Keytruda, so creating a bifunctional molecule.
The design or the intent here is to treat patients who are resistant to checkpoint inhibitors or immunotherapies. And then finally, the third program, this is the most advanced program, ready for Phase 3 clinical trials. This is a drug known as bizaxofusp. And the intent here is to really target these patients who have failed surgery, radiation, chemotherapy, and have no other option. And our Phase 2 clinical trial showed that we're able to double the survival from seven months to 14 months. And this is a program that I won't talk about today, but this is a program that we are actively looking to partner with a company that can take this program into Phase 3 registration trials and then commercialization.
So just as a background, also with respect to the Superkine platform that we have, the backbone of the program, as I say, comes from Stanford University using their directed evolution platform on the left-hand side. And what we do on the Medicenna front is really to create better versions of these Superkines so that we can use it either to attach some potent payloads, to extend the half-life so we don't have to treat patients on a regular basis, but instead once every two or three weeks. And then finally, to create these Bispecifics, which are really the next generation hot space in the biotech arena. So the pipeline is really clear here.
The first program at the top is MDNA11, which is the program I've talked to you about today briefly, where we are using MDNA11 either on its own or in combination with a clinical collaboration we have with Merck, combining with Merck's blockbuster Keytruda, and then MDNA113 is our next generation molecule, which is an anti-PD-1 IL-2, and then finally, bizaxofusp right at the bottom, which is a program that we have partnered, so let's first and foremost go to the molecule that we are focused on, MDNA11. This is a molecule that has been uniquely engineered so that first and foremost, it is safe to administer, unlike other IL-2s that have been tested in the marketplace where you see incredible toxicity with the IL-2 program. We've been able to abolish this particular aspect of the drug so that we have a much safer drug.
But second of all, what we've done is we've substantially enhanced the drug's activity so it's more potent. It selectively stimulates the cancer-fighting immune cells and therefore is very novel compared to other therapies out there. And then finally, in order to enhance the drug's ability in terms of reducing the frequency of administration, we've fused it to albumin. And this albumin allows us to localize the drug at the tumor site and second of all, also to extend the half-life, patients receive the drug every two weeks or three weeks. We've been conducting this study now, and we've treated nearly 100 patients so far. And the data looks really promising in terms of what we're seeing with respect to tumors where the drug is being used as a single agent in patients who have failed checkpoint inhibitors.
So here you see data from a dozen or more patients that have received the drug on its own or failed checkpoint inhibitors or other chemotherapies, radiation, etc. And what we're seeing is a good fraction of these patients responding to treatment. More specifically, we're seeing response rates anywhere from 30%-50% depending on the different tumor types. And this is with MDNA11 being administered on its own. So really encouraging data so far that we've seen. And then second of all, when we combine it with checkpoint inhibitors, we're seeing really promising results in tumor types that previously did not respond to checkpoint inhibitors or where checkpoint inhibitors have not been approved. So in a sense, we have an opportunity here.
The data shows that the tumor types that we have the best potential to get approval from a Phase 2 clinical trial are these three different patient populations. We have melanoma patients, these are skin cancer patients who have failed checkpoint inhibitors, and two other biomarker-driven patient populations, patients that have a biomarker known as MSI- high and a biomarker known as TMB- high. You can see that the market opportunity is large. Combined together, over 100,000 patients annually just in the U.S. would have failed checkpoint inhibitors with no other options to treat these patients. Seeing that we are observing response rates of 30%-50%, we think the potential here is not only for these three tumor types, but potentially for other tumors where Keytruda and checkpoint inhibitors have failed.
This is our near-term data readouts that we'll be sharing towards the end of this year. We'll share with you the data from melanoma, MSI- high, and TMB- high patients, either on its own or in combination with checkpoint inhibitor Keytruda to show that there is potential for us to enter into a Phase 2 registration trial if we show response rates of 20%-30% in these patients. We look forward to sharing that in the coming few months and definitely before the end of this year. The other program that has really become a hot topic is the bispecific space. These are anti-PD-1 bispecifics. As we all know, drugs such as Merck's Keytruda, Bristol Myers Opdivo are going off patent in 2028. We are creating bispecifics. This bispecific that we are focused on is really an IL-2 fused to anti-PD-1.
What we have done is also using a targeting approach. We are sort of targeting so that the anti-PD-1 IL-2 is delivered directly to the tumor. And this is done with our second Superkine called MDNA213. This is a molecule that targets the IL-13 receptor alpha 2. And as you can see here, this particular target is expressed in so many different tumors and affects about two million cancer patients here per year globally. It's a huge market opportunity for us. And this is particularly the case where checkpoint inhibitors currently do not benefit these patients. So overall, we have an approach here to really develop this next-generation bispecific such as MDNA113, where we have substantial benefits compared to our competitors, as you can see on this particular slide.
So what we expect in the coming quarters is really the data that we'll share with you with respect to our MDNA11. More specifically, before the end of this year, we'll have data readouts on MDNA11, both as a monotherapy but also in combination. And these top-line data we will be able to share with you before the end of this year. Also, we will be advancing our MDNA113 program, so we will have data in non-human primates to show that the drug is ready for IND-enabling studies, which will result in a Phase 1/2 clinical trial in the second half of next year. And then finally, we continue to partner bizaxofusp with potential partners, and that activity will be reported as we make advances there. So Medicenna, as I said, we are listed on the TSX and OTCQX. We are headquartered in Toronto.
Market cap is around CAD 80 million. We have CAD 21 million in cash, allowing us to have sufficient funds into Q3 next year, and we have insider ownership of about 22%. The company is currently covered by a number of analysts from Bloomberg, Jones Research, H.C. Wainwright, and Research Capital as well, and we look forward to providing you with more data in the coming next few months. Thank you very much, and hope to provide you with another update in the coming months as well. Take care and goodbye.