Syndax Pharmaceuticals, Inc. (NASDAQ:SNDX) Q4 2022 Earnings Call Transcript

Michael Metzger: Only that we’ve — yes, thanks for the follow-up. Only that we’ve guided to the second half of the year. Sometime in the second half of the year, we’ll be able to announce that we’ve enrolled to 64 and you’ll be able to figure out from there exactly when whereabouts we are with presenting .

Ashiq Mubarack: Okay. Got it. And maybe one more on axatilimab. For the frontline combo trial with ruxolitinib, which you’re starting later this quarter, how should we be thinking about maybe the combined ability of axatilimab with ruxolitinib, maybe in terms of the potential for overlapping toxicities maybe such as pneumonia or liver enzymes, for example. Is there any color you can share on combinability?

Michael Metzger: Thanks for the question, Ashiq. Maybe I’ll have Briggs address the overlapping toxicities. And just to point out, I think the trial — this is Incyte’s combination trial that they’ll be kicking off. And I think the guidance is, later this year, we didn’t specify the first quarter in particular, but I think it’s a trial we’re all looking forward to and maybe breaks, if you could address the overlapping target?

Dr. Briggs Morrison: Yes. Look, I think that was part of the keen interest of Incyte and wanting to partner with us on axatilimab because at least if you look at the monotherapy toxicities of each agent, they look like they would combine quite well. But that, of course, is the purpose of the initial phase of the combinations is to characterize that. But going into that trial, we would be quite optimistic that we can get full doses of both agents.

Operator: Our next question comes from Brad Canino with Stifel.

Brad Canino: This is Brad. It doesn’t sound like I can get more out of you on AUGMENT-101. So maybe I’ll ask about the status of the Phase I you’re doing around the multiple doses of Revu for the SIP inhibitor strength. Should we expect the data disclosure from that this year?

Michael Metzger: Brad, thanks for the question. As you, I think, pointed out in your question, these are supportive — these are supportive trials or this particular trial is a supportive piece of our filing, potential filing for Revumenib and that work is ongoing. I don’t think we’ve guided to when we would necessarily disclose data from that trial. I think we — related to certain pieces of this, there may be — there will be data that comes out in the ultimate filing when we disclose data. But I don’t think there’s any particular time line related to when we might disclose that particular study. But thanks for the question.

Brad Canino: Okay. And then maybe one on the safety data for the Beat AML because it’s exciting to get some combo data this year. I guess to set expectations for that, can you discuss the Revu dose being used there? Is it all the 163 mg on a strong SIP? Or is there any dose escalation of Revu taking part in that combo? And then for the ven/aza component, what is the schedule for then? Does it require continuous dosing? Or can physicians use the shortened schedule that’s often used in clinical practice now?

Michael Metzger: Yes, Brad, very good question. Maybe I’ll let Briggs address both of those.

Dr. Briggs Morrison: Yes. So starting is the standard Veneza-labeled regimen. Obviously, there are protocol-specified dose interruptions, if needed, but the request was to start with the labeled regimen. And then there is a dose escalation component to the revimenib. But everybody is on a strong inhibitor.

Operator: Next question comes from Peter Lawson with Barclays.

Peter Lawson: I guess just around NPM1, just any update around how enrollment is proceeding there? And then I’ve got a question on axatilimab.