Emily Bodnar: Got it. Very helpful. Thank you.
Khursheed Anwer: Thank you.
Operator: Our next question comes from James Molloy of Alliance Global Partners. Please go ahead.
James Molloy: Hey, guys, thank you for taking my questions. I just want to get your thoughts on the OVATION 2 data come out in mid-next year. Can you walk through what the potential Phase III, not much of how the data looks — what are potential Phase III or Phase II B trial design or next steps on trial design might be from that? And then on the AVASTIN trial, the Phase I/II AVASTIN trial, the interim data coming up here, what will be anticipating here in the second quarter for that, in the interim look?
Corinne Le Goff: Thanks, James. So as I mentioned, for the OVATION 2 program, we’ll be discussing with the FDA on the potential regulatory pathway. We not only would be very interested in breakthrough designation that could shorten considerably the development timelines, so that’s something that we are working on. And you can imagine that what we have in mind is we could continue in enrolling in the current Phase II. As we mentioned, the Phase II program is only exploratory. So with 110 patients, so we would need to increase the number of patients included in the trial, and certainly we would look at the separation of treated with PARP inhibitors. So that’s what we have in mind right now, but unless we speak with the regulators, we have — we don’t have — until we speak with the regulators, we have not confirmed any development plan at this stage. And, Khursheed, do you want to comment on the on this point before I address the MRD study?
Khursheed Anwer: No, I think you’ve covered it. I think that’s exactly we’re still in formulating our strategy and perhaps how firm agency feedback will be important.
Corinne Le Goff: And on the MRD study, right, so which we expect is like a year from enrollment, we would have already some interesting data. So maybe Khursheed, do you want to comment on this and what to expect from this study, which also has, in the product design, a number of translational data accounted for that, I think would be super informational for us. Do you want to comment on the MRD study, please, Khursheed?
Khursheed Anwer: Of course, of course. Thank you. James, yeah, so as you said, maybe in second quarter next year, what kind of information is anticipated from MRD study. So the MRD study, this is the first time we will be testing IMNN-001 with AVASTIN in humans, we have never done that before. So AVASTIN is now in new adjuvant setting, it’s been approved. So I think the first lead Phase I part of the study is to really look at the safety with AVASTIN. And so that’s, I think we want to get that out the way. We don’t anticipate any issue. So, that’s something I guess it will be to move on from the safe combination, and then open up the study into that population. Now, what to anticipate is certainly more enrollment by that time, second quarter, but down the road, as Corinne said, this study is really important because when patients get — had a detective surgery, after two cycles of chemo, tumor burden is surgically removed and then you get another three cycles of chemo and then nothing happens to maintenance therapy.
But now we’ve been looking at the peritoneum again after the surgery and one month after, and we anticipate that by IMNN-001, AVASTIN where we have pretty critical data which should benefit would reduce the burden of the residual disease, and lower the residual disease will be anticipated with longer survival. So we expect to see maybe some patients — I can’t promise in second quarter we’ll have that, like I said, safety part has to complete, but what you anticipate down the road will be the second look across KP, how many patients have seen those residuals disease versus what’s known, which is about 70% of patients at the residual disease minimal versus we’re trying to get it down to about 35%. So we might do some of that data coming in but also we are collecting a lot of translational research, understand that tumor biology that this probably will be done when all the patients have — sort of all the samples have been collected.
So I think safety plus some maybe update on minimal residual disease, and obviously, PFS data, zero data, secondary endpoints. As with OVATION 2, we have been updating the community over the years, or different time periods. So we’ll probably do some of that but clearly this study will have a lot of translational component to it, to understand the combination.
James Molloy: Great. Thank you for that. And I see also you guys have signed a cooperative R&D agreement with NIAID, you are talking about it here in the third quarter the Lassa virus. Does Lassa virus, is that potential [Indiscernible] down the road?
Corinne Le Goff: Yeah. Thank you, James. That’s a good question. So, as I mentioned, with the development of the PlaCCine modality we would look at partnerships to develop vaccine candidates and if NIAID is interested, why not. But maybe Khursheed, do you want to do to elaborate on this agreement that we have with NIAID?
Khursheed Anwer: Yes, of course. So, James, initially, of course, I mean, the PlaCCine is a new platform, as you know, the history suggests that we have a couple years we have kind of embarked on that. So our goal has been to demonstrate proof of concept or application in as many indication and opportunities we can. So we has a facility like biosafety level for some viruses, there you will need some collaborations. NIAID is looking at Lassa. They have looked at Lassa with different approaches in the past. They have ground force in West Africa, including Mali, where they have done some clinical trials. So as commercial potential for the company, as Corinne said, may not be as today, doesn’t look very huge but it’s increasing.
