It's a great privilege to be here today to present Cantargia as a newly appointed CEO. And I'll walk you through a little bit of the operational and strategic strides we've made as a company. So I'll push the next slides. Forward-looking statements. So, as a global leader in IL-1RAP antibody development, we have, as you see, quite a lot of things going on. And our lead asset, Nadunolimab, has already shown a strong clinical effect in, it's a long word, pancreatic ductal adenocarcinoma, or we call it PDAC, and non-small cell lung cancer. More than 300 patients have been treated with Nadunolimab, and we have a development ongoing, which I'll come back to, for a prognostic marker in this patient population.
This prognostic marker has also been validated by the FDA in the sense that we got a fast-track designation in metastatic PDAC with patients that have high IL-1RAP expression levels. We've also now decided to invest even more into our antibody platform, the IL-1 CANxx platform. I'll walk you through a little bit of what we're doing there. Both sort of our focus on Nadunolimab and CANxx has been enabled by the transformative deal that we had with Otsuka. It was announced in July. To us, this means that we've validated the target as a druggable target. It also validates the technology and gives us financial flexibility as a company to start a lot more activities. This is the pipeline. I won't spend too much time. I'll dive into this later on, but we have a Phase IIb/III, Phase III ready product in Nadunolimab for PDAC.
We are in discovery phase with two different platform activities, one in the bispecific and one ADC, and then we have a strategic partnership with Otsuka after finishing our Phase I. Such an exciting, pivotal time to join Cantargia, and I have to say I'm privileged to serve together with such a strong management team with proven and relevant experience, and they have a comprehensive industry insight. Nadunolimab, our lead asset. IL-1RAP binds together with interleukin receptor 1 as a dimer and interacts with interleukin- 1 α and 1ß , which starts a cascade into IL-1 α/ß cytokine production. By blocking the IL-1RAP receptor, you can also block this cytokine production, and these cytokines uphold the tumor environment and activate quite a lot of tumor activations.
Nadunolimab also targets directly and labels tumor cells, so making it accessible for our own body's destruction by, for example, natural killer cells. Now, the foundation of Cantargia was based on the fact that IL-1RAP is expressed on a large number of tumors. And as you can see here, there's a lot of expression in breast, pancreatic, and small cell lung cancers. What is interesting is also that the stroma, the microenvironment around the tumor. Every tumor has expression of IL-1RAP. So, with one high IL-1RAP, why is that interesting to see the difference between high and low? Well, there's been two new datasets that have been published on RNA data, showing that patients with high expression of IL-1RAP have a very poor prognosis with regards to survival.
And in two independent datasets confirms this, and also we have performed an artificial intelligence study which confirms the exact data. Now, patients with high IL-1RAP, when we target those patients, we see the opposite. We see that the patient with high IL-1RAP expression treated with Nadunolimab has a better prognosis. And we divided our patients in low and high, and as you can see, the high group has an overall mean overall survival of 14 months, while low had 10.4. And the historic data has an overall survival of 9. So that's a five-month difference between historic data and the high IL-1RAP. We also saw a nice reduction in tumor size, where 11 of our patients had a 50% reduction in tumor size.
What is our hypothesis and what we believe is that by targeting the patients that need IL-1RAP targeting the most, we will have a higher probability of success. This is the diagnostic tree where in the eight major markets and advanced metastatic PDAC patients, we see a diagnosed incidence case of around 230,000 as estimated by GlobalData. Of those, patients with advanced or metastatic disease will constitute around 140,000. 60% of our patients, and also confirmed by other datasets, have high IL-1RAP. That would be our target population and the ones that we believe will benefit the most from Nadunolimab. How can we then move forward by selecting for high IL-1RAP? You need a diagnostic prognostic marker, which we have spent the last year now in development, and it's now done with the feasibility. We are in the validation phase.
After we validate our test, we can then interact with the regulatory bodies and get their approval of our regulatory plan. We expect to go towards an advancement of Nadunolimab, and our proposed clinical study design will then consist of metastatic PDAC patients selected for high IL-1 expression and will treat naive patients in combination with gemcitabine and paclitaxel. It will be a randomized controlled study, and the primary readout will be overall survival. We also had in July a readout from our triple negative breast cancer study, TRIFOUR, and we saw there a similar overall response rate in both arms, where both arms had somewhat higher overall survival than the historic benchmark. Subgroup analyses are ongoing, and we still are waiting for overall survival data, so it is difficult for us to conclude the exact effect in this study.
However, the safety data that we have now generated in this study will add to our global safety database, and we saw no clear added signs of toxicity when we added Nadunolimab to chemotherapy. Now, with regards to our exciting platform, oh, you're already there. Okay, I'll be quick. We are developing a bispecific, as mentioned, with target IL-1RAP and undisclosed second target and an ADC, and we'll update you all when we get more data on that. I'm sure you all saw our deal with Otsuka, a landmark deal for the company where there will be development, regulatory, and commercial milestones, and we had an upfront of $33 million. And then, as a conclusion, to us, CAN10 outsourcing to Otsuka was a transformative deal and has provided us with the financial flexibility we need as a company.
We'll use that financial flexibility to further develop Nadunolimab and also continue our investment in our unique IL-1RAP platform. With that, I'll open up for questions.
Thank you, Hilde. You had to rush through the Otsuka slide a little bit there, but you're lucky because, of course, there's a question about that, and someone's asked if you can just give an overview of the expected milestones from the Otsuka deal and how the deal is structured.
We have communicated that we got a good upfront. We'll have later development milestones and regulatory milestones, and in addition, we'll have milestones based on sales. On top of that, we'll also get single digit, no, yeah, high single- digit, low double digit royalties.
You, of course, talked about the TRIFOUR results here, and I understand you can't say too much about that because they're still being looked at. Do you know roughly a timeline for when the ongoing analysis will be done?
End of the year.
End of the year.
Yep.
And then you will make further decisions based on that.
Yes.
I understand. And then some questions about you, actually, as the new CEO, what your immediate priorities are, let's say over your first year. What is it that's the most important thing for you?
I think that for us, we recognize Nadunolimab as a true asset. We really want to develop the full potential of the product. Now, whether we do that in different strides or if we go full in with a pivotal trial, we will have to wait and see, but Nadunolimab will have a strong focus for us.
There's also a question about how you're working with public relations, for example, equity research and so on to increase interest. Is this something that Cantargia is actively working with?
We are, but we'll always try to do more. But yes, we are quite active in both investor relations and public relations.
You have previously secured some quite significant deals, a $480 million deal with Novo Nordisk and had been in charge of huge financing rounds at NorthSea Therapeutics. How do you think, how will you bring that experience to benefit Cantargia?
I think, as has been mentioned here today, it's not easy, and we have to work hard every day to secure that. Now, I think for me particularly, I have a broad network, so by calling, at least we can get meetings and we can present the company. That is helpful. I think I know how hard it is, so I'm not naive going into this. I know that we need to work very hard, but I am very optimistic that we'll be able to fund the company going forward.
On that positive note, thank you so much.