Kura Oncology, Inc. (NASDAQ:KURA) Q4 2022 Earnings Call Transcript

In terms of the second part of your question, Roger, around the Phase 2 design, the 85 patients is really driven by safety that’s our view on what’s needed to support a marketing application. Again, in the NPM1-mutant relapsed/refractory population, we haven’t disclosed the specifics of the statistical design, nor do we intend to. But, again, I’ll reiterate to you that we intend and we’ve built into our development strategy and our protocol, every opportunity to go more quickly if the data permits. So I’ll just leave it with that, don’t want to get too much more into the details. But we’re quite enthusiastic at the rate of enrollment, the rate of interest, and very much look to continue the trend that was becoming clear in the Phase 1b.

Roger Song: Great. Thanks for the comment. I appreciate it.

Troy Wilson: Sure.

Operator: Our next question is from Peter Lawson with Barclays. Please proceed with your question.

Peter Lawson: Thanks, Tony. I guess, on ziftomenib, 2 questions. When can we see the combination data like we see that by year end, and then just as we think about EU kind of has the strategy pen and out there? And do you think to be comfortable with DS? Thank you.

Troy Wilson: Peter, forgive me. Could you repeat the second part of the question? I want to make sure I understood it. The first part, I think was clear.

Peter Lawson: Oh, yeah. So as you think about kind of a global study, and you try it was in the EU?

Troy Wilson: Oh, EU. Got it.

Peter Lawson: How are you thinking about adding European sites, and if they’re comfortable with DS?

Troy Wilson: Yeah. Yeah. So let’s take that question first. As we alluded to in the prepared remarks, there’s strong precedent that of the ability to manage differentiation syndrome in combination with standards of care. That’s what we’re seeing with the IDH inhibitors. And if you look at the data, the DS was certainly mitigated. I think, in the discussions we’ve had with investigators, they’re very much of the mind that that should both allow us to mitigate the DS that we’ve seen in the Phase 1 and really unlock the full therapeutic value of ziftomenib. So there isn’t any real concern, the European sites, as you know, they just take longer to get up and running. It’s €“ not unusual for the some of the European sites to take 9 to 12 months.

So now going to kind of the first part of your question, we expect that we’ll have €“ we’re very much working toward initiation of the 007 trial here in the second quarter. And I’ll just remind everybody that in the Phase 1, we observed responses as a monotherapy at both the 100 milligram and 200 milligram doses were the starting dose in combination is at 200 milligrams. So, I think, we’re well within the window in terms of potential activity, I don’t want to guide, Peter, yet to disclosure €“ sort of timing of disclosure of data. I will say, we appreciate it’s a question on people’s mind. We’re confident in our ability to mitigate any DS through combination, and we’ll look for an opportunity, if possible to share that data later this year.

I think it’s premature to be more specific on venue or timing, but it’s something we definitely are €“ it’s one of our goals.

Peter Lawson: Great. Thanks so much.

Troy Wilson: My pleasure.

Operator: Our next question is from Li Watsek with Cantor Fitzgerald. Please proceed with your question.

Li Watsek: Okay. Thanks for taking my questions. I got a couple of questions on the combo study, I guess, you initiate the 007 study in, I guess, second quarter. Just wondering what are the gating steps here? And how should we think about the enrollments in these 2 cohorts, any chance that we can see the combo data in KMT2A cohort this year?