Unidentified Analyst: A couple questions from us. So I know your last update was fairly recently. And you mentioned that you get the sites up and running with 300 mg dose. Do you by chance happen to have a sense of enrollment speed yet, or maybe how long it would take you to reach your end of 20?
Jim Dentzer: Yes, we really don’t yet. Obviously we just heard from the FDA and while we’re excited about it, now we have to go back to the sites and we have to get back through their IRBs and then it’s a lot of blocking and tackling at the clinical site to get enrollment up and running. So it’s a little early to be able to say that they’re all off and running again. I think we’re trying to do two things simultaneously from an operational perspective. The first one is we want to increase the number of sites. As you may remember, we had nine sites at the beginning of the year. We’d love to end the year with double that. So we’re working with new sites, identifying new KOLs and trying to see if we can expand our network of clinical sites period.
With all sites, we’re trying to get them up and running as fast as possible, identify the patients, screen them, and then enroll them into the study. My hope is that by the end of Q3, we’ll have a pretty good sense of where our enrollment rate is going and where our process of getting new sites up and running is going. So we can be a little more granular on which of the medical conferences makes the most sense for a data update. At this point in time, we’re obviously very confident it would be sometime in 2024, but we can’t really get more granular until we have a better sense of what – where enrollment’s headed.
Unidentified Analyst: Sure, sure. Thank you. So built upon what the data you already have at the RP2D. Can you remind us about the bar for success for both FLT3 mutant and spliceosome mutated patients? And I don’t know if this changes with the recent approval of crizotinib in first-line?
Jim Dentzer: Yes, so I would say first, our most recent data is in our corporate presentation on our website. So for you and for everybody else that’s on the call, I would encourage you to go to curis.com and if you scroll down, you’ll see our corporate presentation deck. You can open it up and we have the most recent data there, and I think it’s pretty compelling. We’ve got data on 84 patients, which includes all-comers, all dose levels, but we also show the rifle shot of, now that we know our patient populations, that’s AML patients with spliceosome mutation and AML patients with FLT3 mutation, that’s going to be the population we go after with monotherapy. And we know our dose, we know it’s 300 milligrams. We’ve highlighted on in that deck on a slide exactly how many patients have had that combination and what they look like.
So what we’re looking to do right now is we’ve got three patients at 300 milligrams, one to two prior lines, which is the group we’re looking for with a spliceosome mutation and three in with a FLT3 mutation. Of the three with a spliceosome mutation, two of the three have a CR or CRH. And of the FLT3 patients, two of the three have a CR. Now, I’m not suggesting that we’re going to get a 66% CR rate. That would be outrageous that that’s not what they get frontline. What I am suggesting is that our goal in each of these population groups is N equals 20. What you really need in order to have a good discussion with FDA, that you’ve got a single agent that shows compelling activity is we probably need four or five CRs, CRHs in those groups to have a nice discussion.
