Joseph Thome: Great. Thank you. And then maybe just one quick follow-up on the ONC206 patient that had a response. I know it’s monotherapy, and they weren’t on any, sort of corticosteroids, which is great. Can you just comment a little bit? It’s refractory disease, so I’m assuming they had some sort of treatment prior to this. What was kind of their treatment journey? And are there other similarly treated patients in the study that have enrolled so far? Thank you very much.
Mike Sherman: Josh, I’ll let you address that one.
Josh Allen: Yes. With respect to treatment course, Joe, we know that this patient had following surgical resection and diagnosis of disease, went through the typical chemo radiation course in the fall of 2021, experienced disease progression following that standard , early year-end 2022 in initiated monotherapy ONC206 in April of last year. So, pretty typical treatment course following frontline therapy, and again, had a progressive disease prior to coming on study for this particular cohort. I think like Mike alluded to earlier on the call, we’ve had a couple of cohorts within that study where patients can initiate therapy on one of the cohorts following radiation, but prior to . That’s been useful for generating safety and PK information, but with respect to interpreting efficacy, we’ve really kept our eye on that dedicated cohort of recurrent disease like this patient fit to where response is more .
Joseph Thome: Perfect. Thank you very much.
Operator: Naureen Quibria with Capital One Securities. Your line is open.
Naureen Quibria: Hi, good morning and congrats on the updates. So, sort of piggybacking on the ONC206 questions. On the 18-year-old responder, do you know how quickly the patient response was relative to what you’ve seen with ONC201? And then just on possible data update, do you think it will be at ASCO or later on in the year at SNO?
Mike Sherman: Josh, do you want to take a first cut at that?
Josh Allen: Yes. Sure. Well, I mean, first of all, thanks for the question, Naureen. We want to be careful given that this is just a single response. Like Mike alluded to, we’ll keep our eye on the data sort of as it unfolds, but we thought it was important to report on this observation, particularly given that the patient lack the H3 K27M-mutation. It’s just a population where we’ve not seen 201 work as a monotherapy in that prior clinical experience for those patients. But with respect to this one observation, we did see the tumor, at least based on the investigator report, steadily, sort of trickled down. This wasn’t a case where the response just showed up in 10 months. It was a gradual regression that occurred. Whether or not those response kinetics will be more rapid with ONC206 than we saw with ONC201, that’s just something we’re going to have to keep our eye on as the data unfolds.
Mike Sherman: And I would not expect, given the submission time lines, that this would be an ASCO presentation. I think this would be an observation, the details on this patient, including potentially into images and so on would be something presented later and probably more likely at a neuro-oncology-focused conference.
Naureen Quibria: Okay. And Mike, on the ACTION study, are you able to provide a little more specifics on the sites of the ACTION study? Like how many are currently active? And how many do you expect mid-year? And possibly any specifics on enrollment numbers?
Mike Sherman: Yes. So, we won’t give enrollment numbers other than to say, you know we’ve got a plan to enroll, which would lead to the timelines we have for data in 2025. And so, as long as we stay on that plan, we’ll sort of acknowledge accordingly. The site activation, I think they’re actually only a few sites that show up on clintrials.gov as of today. There’s a little bit of lag in that. And so, we would expect to have this week, essentially five active sites, but then, in the coming weeks, you’re essentially activating that number of sites per week for a while, and then it accelerates from there. So, you typically €“ this is what you typically see with a few early sites €“ like a few sites can manage their internal review and IRB review process very quickly.
