Joe Pantginis: Hey, everybody. Good morning. Thanks for taking the question and nice to see the early data. Congrats as well. So maybe Taylor, wanted to see if we could get or do some scenario analysis here, maybe start with the AML/MDS study? What do you – obviously the expansion cohorts need to read out, but could you envision a, say more targeted path for initial approval, say targeting TP53 or other focused mutation? And then also, can you provide any color with regard to the kinetics of the responses that you’re starting to see in the AML/MDS study?
Taylor Schreiber: Sure, thanks for the question, Joe, and good morning. So as you know, one of the expansion cohorts is already specific to TP53 mutant AML patients where even in the frontline setting, there is a very high unmet medical need. And there certainly would be an opportunity for an accelerated path there if we were to first hit the CR rate in excess of 40% or so. I think that would be interesting and be a good indicator of what that could translate into in terms of duration of response, where we’ll be looking to exceed something in the six-, seven-month range as a benchmark. And those are readouts that we expect to come in the first half of next year, having fully enrolled that TP53 mutant AML cohort during the third quarter and would be the basis for discussion with regulators about first, an incremental expansion of that study to confirm that data and subsequently, what the registration directed path could be there.
But I do agree that there is a potential accelerated opportunity. In terms of the kinetics of response, I can comment on a couple of data points that we have and will certainly add to this soon. The – first of all, the relapsed refractory AML patient that is disclosed in the ASH abstract as a monotherapy responder, as Lini outlined, this was a tough patient. They’ve failed 7+3, they’ve failed FLAG, they’ve failed VEN-AZA. And then they came on to study and had a response within the first cycle of SL-172154 monotherapy. That’s unusual for a patient like this, but it’s consistent with the kinetics of response that we had observed with the pre-clinical equivalent of SL-172154 in various models. I can also say that the confirmed responder in PROC, that response started at the very first eight-week scan.
And that’s also the case with the two unconfirmed responders in PROC where that first eight-week scan, they met that PR criteria. So it appears that the kinetics of response to SL-172154 are rapid. And that’s helpful, especially when looking at initial data sets and trying to forecast how that might translate.
Joe Pantginis: Great. Thanks, Taylor.
Taylor Schreiber: Thanks Joe.
Operator: Your next question comes from the line of Marc Frahm of TD Cowen. Your line is open.
Marc Frahm: Hey, thanks for taking my questions and congrats on the early response data today. Maybe you start it off with when – can you just explain the gap from the 16 who have seen drug and the 11, how many of those five are still on trial awaiting the first scan versus you having maybe discontinued for other reasons? And then are you seeing any – to the point of about half the patients who have had PARP expansion [ph] and half have not. I know its small numbers, but any sense that maybe efficacy is in one of those populations more than the other?
Taylor Schreiber: Great. Good morning, Marc. Thanks for the question. Lini, why don’t you go ahead and take those. Lini, you might be on mute.
Lini Pandite: Sorry. Marc, can you repeat the first question? I lost the connection.
Marc Frahm: Oh sorry. Yes, the safety database has 16 patients in it today and 11 are efficacy evaluable. Can you just explain the kind of five patient cap there? How many of them are waiting for their first scan versus maybe discontinued for others?
Lini Pandite: Yes. All five are still on study. They are waiting for their first scan.
Marc Frahm: Okay. And then of the responses you’re seeing, any sense that maybe this efficacy is more or less in the PARP experienced versus non-PARP eligible type of patient?
