I think it’s very encouraging because overall, it looks like they were able to replicate the data from the airline and team. I think that’s great news. I think for the active, for the approaches, that we’re working on, and particularly also for the approach we’re working on. In terms of the dose, the dose is relatively low, and that is actually, I think, quite consistent with our own experience where we have been able to obviously show in adult patients, we can go as low as 10 million cells, and we get high degrees of activity and responses. So we know that the cells are active at that level, and they’re operating at a somewhat lower level that was used to the airline. But again, it’s a different product that they’re using. So there’s going to be some differences.
And it may also be guided and to some extent from needing sub-safety data at the respective dose levels. So I think overall, I think, very encouraging and I think good news because we start to get, I think, a clear view that the data can be replicated that the airline have generated, I think that’s frankly good news for everyone in the field.
Yanan Zhu: Great. Thanks. So on FELIX and the ASH update, I was wondering, is the data cutoff for the abstract which we are seeing now, would that be the same as the actual presentation? And also, I think we noted the median DOR is now stated as not reached. I think back at ASCO, there was a median DOR. So it feels like the curve has probably fluctuated around the median and was bumped up somewhat with newer patients and additional patients or longer follow-up. I was just wondering if that the right understanding? And also if you can comment on how much it was bumped up, that will be super helpful. Thank you for the question.
Christian Itin: Yes. So in terms of the data cut, obviously, the data cut that we’re going to have at the – for the ASH meeting will give us about the six months additional view on the patients. If any case that the median follow-up at ASH was nine months, we expect the median follow-up – at ASCO was nine months, we expect the median follow-up for ASH to be at around 15 months. So it’s essentially the data cut. And it’s also different from the abstract, the data cut that went through to the abstract. I think one of the things that we’re pointing out in the context of the ASCO data, in the ASCO presentation was the fact that the time-dependent measures clearly were not mature by any stretch of the imagination. We have most of the patients still in the very early part of the curves when we presented at ASCO, which means that there’s still a significant amount of variability that we had in the curve, and we’re seeing obviously some of that play out.
And usually, it’s one patient up or down that can move the curve, particularly if you’re focused on the median and that’s almost arbitrary. So you need to – clearly, we’re going to have more follow-ups, six additional months of follow-up that obviously will give us more stability into the curve. But clearly, compared to where we were at ASCO, was predominantly driven by the fact that most of the data were still very early.
Yanan Zhu: Great, very helpful. Thank you, Christian.
Christian Itin: All right, thank you very much.
Operator: One moment of our next question. Our next question comes from the line of Asthika Goonewardene of Truist. Your line is now open.
Karina Rabayeva: Hi, this is Karina for Asthika, congrats on the progress. I had a question on – a few questions on AUTO8. So what kind of data can we expect at ASH? Will this have like baseline characteristics and percentage of patients with EMD and other high-risk agnostic factors? And I think you said it’s going to be eight patients worth of data at ASH, can you just confirm that?
Christian Itin: So the data, obviously, this is a Phase 1 study. So yes, we’ll obviously, we’ll have a review of the patients that were included, the state they were in, condition they were in and we’ll also give a full characterization of those patients on the treatment. Overall, we think we’re probably going to be in the range of 10-plus patients as mentioned before, so this is still as indicated, a Phase 1 study.
Karina Rabayeva: Okay. And will there be enough follow-up for six months, nine month PFS?
Christian Itin: No, that’s – well, there is some follow-up, but I think we need more patients and more follow-up to sort of be firm around those types of information.
Karina Rabayeva: Okay, thank you.
Christian Itin: Thank you, Karina.
Operator: One moment for our next question. Our next question comes from the line of Simon Baker of Redburn Atlantic. Your line is now open.
Simon Baker: Thank you for taking my questions. Two, if I may, please. Firstly, on SLE. As you say, you have an advantage over most, if not all, competitors in the space in terms of the size of the safety database and the suitability of the manufacturing process. So I’m just wondering if you could give us some idea of how much in terms of time that advantage is or alternatively, and I suspect it probably won’t, but some more idea on when we should think about pivotal trial starting and potential commercialization, should it be successful? And then secondly, on the manufacturing capacity and the Nucleus, could you give us an idea of the validated capacity here and now of Nucleus. I know it’s a modular facility that can be expanded, but some idea of where – what the capacities at the moment will be very handy? Thanks so much.
Christian Itin: All right. Well, thanks, Simon. Thanks for joining. On the SLE side, the question was when do we expect a pivotal trial to be rerun, obviously, that’s slightly premature, but the basic notion is that we’re planning to, the dose confirmation during the course of next year. With that data, we’ll then approach the regulators, which would sort of point to the following year as the start point than the starting point for a pivotal study. I think it is too early to point to kind of what the duration of a trial, a pivotal trial will be in the absence of having an agreement on the trial design with the agency. So that’s probably too early. . With regards to the capacity question at the Nucleus. So the facility is – basically, it’s a modular setup, as indicated, it has, for the initial setup for ALL 3 clean rooms.
