Charles Duncan: Got it. That’s helpful. Thanks for taking my questions.
Andrei Floroiu: Thank you so much Charles.
Operator: Our next question is from Mayank Mamtani with B. Riley Securities. Please proceed.
Mayank Mamtani: Good afternoon team. Thanks for taking our questions and I also appreciate the timely pivot focus on norovirus. So, maybe just piggybacking on the prior comment. Andrei, could you talk a little bit more for the Challenge study, the rationale for expanded cohorts? And I think it would be helpful for investors to understand what levels of protection, be it asymptomatic efficacy or even transmission, you’re looking to target in this data set? And if you are able to go a bit deeper on the types of immune correlates you’re looking at, that also would be very helpful?
Andrei Floroiu: So James, do you want to take this question?
James Cummings: Sure. So Mayank, thanks for the question. In terms of the type of data to drill down into what we’re looking at for the challenge study, essentially we’re looking at protective efficacy, so looking at a reduction in symptomatic acute gastroenteritis secondary to norovirus. We’re also looking at the potential for a decrease in shedding, viral shedding of norovirus. We all know it doesn’t take a lot of norovirus to cause an infection. But if you can decrease shedding, you should decrease potential transmission. So those are two of the things we’re looking at. And then another facet of that study, in particular, is looking at a correlates of protection. We feel that a correlates of protection is it could be key in sizing up our Phase 3 endeavors and looking at the potential to decrease numbers and/or time lines, for a Phase 3 study looking at a correlates of protection.
This challenge is a G11 challenge. And our bivalent, I think, in that we’re calling the dose-ranging study has G11 and G24. So we’re keenly interested in what that correlates of protection may look like, and then sharing that with the FDA in discussions to get a read on how that might impact our Phase 3 study. Does that answer your question?
Mayank Mamtani: Yes, it does. And maybe if I ask €“ can I ask you to be a little more specific on the dose-ranging study for the bivalent. The dose levels that you’re looking at, are they — how do we compare against the monovalent work that you’ve done before? And what sort of answers that you’re looking from there that you think would be very helpful with the regulators? And if there is a need for you to do bivalent specific challenge study, also before you start a Phase 3, if you could clarify that? Thanks again for taking the question.
James Cummings: Sure. Thanks. So in terms of the dosage levels of that study, and it’s available on clinicaltrials.gov. We’re looking at a bivalent of G11 and G24 to 5:10 , which a total dose is 1:11 dose, right? In terms of the high dose, that’s G24 and G11, that’s a 1:11 per strain, for a total dose of 2:11. Now in our previous studies, we’ve had doses as high as 1:11. So this is a higher dose, and as I said, we’ll be looking to maintain what we’ve already seen across our doses in this other vaccines, which would be a clean safety profile. In terms of other diarrheal diseases or diarrheal disease presentation while performing studies until we go into our Phase 3, certainly, we would collect any data in a Phase 2 if someone were to have acute gastroenteritis, but that would be exploratory only.
These studies aren’t really geared for that. That’s where our Phase 3 study would come in. So I think the best way to look at this is leveraging what could be the benefit of our challenge study. As you know, in the adult populations, there’s not a consistent transmission annually. It’s more a selected by population. And so we would look forward to garnering a lot of knowledge from that challenge study in terms of potentially protective efficacy. Does that answer that question, Mayank?
