Now, if you go to the triple combination, very similar studies have been performed by the National Cancer Institute in the triple combination. Again, showing that very strong correlation between induction of HPV16-specific T-cells and the clinical responses and also showing that this triple combination in addition to inducing strong tumor-specific multifunctional T-cells, also induces an inflammatory immunological profile, which is strongly believed to suppress the tumor stability to hide from the immune system, right? So now we are getting all the information that we — that helps us better understand how and why we are seeing the kinds of results we’ve seen today in these patients, even in the very difficult-to-treat patients. So now coming to your earlier question, which had to do with the design of the VERSATILE-003 trial.
Now we have not made details of the clinical design public yet, but I can give you some insight into how we are thinking about this. The delta today is quite significant when you look at the delta of what we’ve see at the two-year results versus what we see in the published data, we know that by far exceeds what we’ll have to achieve for approval, but as a risk mitigation strategy in terms of our statistical design, what we are also looking at is we are also saying, well, let’s assume PDS0101, the patients in our control arm taking KEYTRUDA, we’ll do much better than KEYNOTE-048. And so, in terms of our endpoints for the control arm, we are anticipating that they’ll be higher than KEYNOTE-048. Oncologists are getting more used to administering KEYTRUDA.
They’re getting better understanding of which patients may respond better. And so, we have to assume that those patients are going to do better than has been published today. What we are also assuming in that design is that our patients in the study at multiple sites all over the world will not do as well as we’ve seen in VERSATILE-002. So, we are also reducing that target, and that risk mitigation allows us to overpower the study based upon what we’ve seen today and mitigate the risk that we will not get to that clinical endpoint. So, we are taking those strategies into consideration just based upon the really large delta we’ve seen today, allows us to narrow that delta, but also be reasonable in terms of trial size and the power of the trial to successfully achieve those primary endpoints of overall survival.
Mayank, I hope that answered your question.
Mayank Mamtani: Yes, no, very comprehensive, very helpful. Lastly for Matt, just quickly on the strategic collaboration discussions, are you able to describe qualitatively interest from strategic on doublet versus triplet and how maybe recent Triplett data may have informed those discussions, and also, there’s a full data set from your double-edged expected in second quarter. Would they want to see that mature analysis before transacting or like kind of just lay out what sort of the variables are there that impact discussion like that? Thanks for digging the question.
Frank Bedu-Addo: So, Mayank, I’m not going to be able to go — I’m not going to be able to go into specific….
Matthew Hill: Do you want to take that one Frank?
Frank Bedu-Addo: Yes, I’ll take that one. Yes. So Mayank, I won’t be able to go into very specific details as to what we are discussing. However, the data that we have today has been very helpful in clarifying certain things. So, one of the key things that I mentioned over the last couple of earnings calls has been the fact that we are waiting to see the data from the VERSATILE-002 refractory arm. That data was very important because it was key in giving us insight into the specific role of PDS0101 or the contribution of PDS101 in extending life in head and neck cancer patients. And so, looking at that combination of PDS0101 in KEYTRUDA, in patients who have failed checkpoint inhibitors, the majority of which we know were on KEYTRUDA, and still being able to extend those patients’ lives significantly was very important for us to demonstrate and to get potential partners also comfortable that, okay, PDS0101 is actually biologically active in this population and even seeing this extension in even a much more difficult to treat population.
So that was key. It was also important for us in the triple combination trial, as I mentioned previously, for us to have that understanding of what PDS0101 is doing in that combination. Because a lot of the questions we receive, both from investors and prospective partners is well in the triple, how do we know which of these components is working and what is contributing to what, right? So now the role of PDS0101 becomes very clear, but with the data we have today, right? We also now see the critical role of PDS01 ADC. And so now both components, both drugs have very clearly shown their biological activity. And what was also very important is you look at VERSATILE-002 right refractory arm, no IL 12, 0% of confirmed objective response. If you add a low dose IL 12, 5% confirmed objective response, if you go to a high dose IL 12, 63% confirmed objective response, very clear in terms of what’s happening with the IL 12, right?
So, all this data that is now available provides not just PDS, but potential partners with confidence in the biological activity of our drugs, right? In terms of discussions, I’ll say there are no issues with the current protocol, right? As you know, we have alignment with the FDA on the path forward, but what’s happening with these discussions is not at all uncommon. And we believe that it is prudent to at least evaluate suggestions that the serious potential partner may have, even though there are no guarantees that the partnership will resolve when all is said and done right. But there are number of typical things that we’ll typically want to evaluate at this case, and we’ll not do this for every prospective partner or suggestion we receive, however.
So, I hope that gives you some flavor of what — the data we’ve seen today and how it’s impacting discussions that we’re having.
Mayank Mamtani: It does. Thank you for taking your questions and look forward to future updates. No problem. Thanks a lot.
Operator: Our next question comes from the line of Joe Pantginis with HC Wainwright. Please proceed with your question.
