Frank Bedu-Addo: Oh, the doublet study, okay.
Andrew Fleszar: If the agency is requiring any more data before initiating that trial. Yeah, correct.
Frank Bedu-Addo: No, no. We don’t we don’t require any more data before initiating that trial.
Andrew Fleszar: Do you have a sense of the timeline of when that protocol will be submitted?
Frank Bedu-Addo: Right now, we are in discussions with the EU and the regulatory agencies from the other countries in order to get their feedback that we would then put into the final design that would then go to the FDA. And so, we are anticipating that by the time we have all that information from those other countries that we’ll put into that protocol, so that’s currently ongoing. That will probably be late Q2 or early Q3. So we anticipate that the final amended IND will be filed in Q3. And then once we get the FDA feedback, we will then start activating the various investigational review boards, IRBs, for the various sites. We are hopeful that we will be able to convert a number of the sites, most of the sites we working with today, into the VERSATILE-003 sites.
And so, those processes typically will take anywhere from four to six months. With that timeline, what we’re working towards and hopeful is that we will be able to get this trial up and running by Q4, considering all these other activities. As I mentioned, the clinical manufacturing has been successfully completed already. So we are finalizing the later stage of the CMC section, right? So, all those activities are progressing really successfully to date. Right? So, that’s our timeline in terms of when we anticipate we’ll file the IND and when we’ll get the IRB approval, get the sites activated, and get the trial initiated by Q4.
Operator: Next question is coming from James Molloy from Alliance Global Partners.
James Molloy: I had a quick question on the amended IND and the Phase 3 VERSATILE-003 trial. Did you walk through the amendments to the IND, what exactly you’re amending on there? What sort of breakpoints should we anticipate? The trial is going to take a little bit of time to run. Can we anticipate some interim looks at some point? Any way to guide to where sort of the next catalyst to be looking for once the trial gets up and running of potential data coming out?
Frank Bedu-Addo: We called amended IND. But if you’re really updating your IND, the initial IND was filed for the Phase 2 trial, which was a single arm trial, and now we’re going into a controlled Phase 3 trial, right? So those updates have to be made. We have to update the manufacturing process. We’ve now selected our commercial manufacturer. We’ve transferred the process. We’re going to have to update the manufacturing process. As we update the manufacturing process for Phase 3 manufacture of the peptides, those have to be updated in the CMC, manufacture of the R-DOTAP, the raw material for Versamune, that’s also been scaled up to the Phase 3. All those updates have to be made to the IND. And so, that’s why we call it the amended ind.
Really look at it as an updated IND with all the new information, transitioning from the Phase 2 to the Phase 3, with a lot of those pertaining to what the commercial manufacturing and CMC package would look like. So, that’s really what we’re doing there.
James Molloy: Any thoughts on expectation for potential interim looks or data points here once the trial is up and running? What should we be thinking on timing and data coming out?
Frank Bedu-Addo: I think that’s when we’re looking at, for example, with PFS. So, I think one of the key things we mentioned is whatever interim data points you come up with, it would have to give some indication that you are prolonging overall survival. As I mentioned during the presentation, objective response rates, for example, haven’t really correlated with overall survival in most immunotherapies or many of the immunotherapies that the FDA has been evaluating recently. And so, one of the key reasons we are looking at the data for PFS and overall survival is that in VERSATILE-002 that we see an improvement in PFS as well as overall survival. And based upon that improvement, what’s the delta between what we’re seeing with our VERSATILE-002 versus what’s reported in KEYNOTE 048 with KEYTRUDA monotherapy.
And then based upon that delta for both the PFS and the overall survival, that will inform us in determining how we design the trial and what we could use as an interim data look. And so, that delta is really going to determine the statistics in terms of what’s the size of the patient population that we’re going to need before we see PFS, if we have seen an increase in PFS, but very importantly, we would also want that to be associated with an increase in overall survival, at least an indication that we improved on overall survival. And that’s why those numbers were very important and that’s why we have to wait to get some clarity to those numbers before being able to design the trial. We’re now waiting for the feedback from the various countries.
That may cause us to tweak things a little bit before we finalize that design. But we are absolutely looking to design this trial to get some early looks to be able to go and have discussions with the FDA rather than waiting to go through the entire trial to completion of the trial before having discussions with the FDA. So we’re looking specifically at that design in our design.
