Christian Itin: Yeah, really good question. So, in terms of the data update, obviously, as I indicated, we’re looking, in particular, at different risk groups within the data set, so that’s going to be a key focus. And I think we’re going to be — obviously, the general update will be likely across the entire study because from a physicians’ perspective, that outlook is actually what’s really relevant because that reflects the patients that you would actually see in actual practice. And so, we’re probably going to report on that as a reference point referencing back to the ASH data. The bridging itself, obviously, is relevant in the sense that the analysis that you can run is sort of in two different ways and different agencies take different positions on it.
You have to look at the analysis based on the tumor burden that’s screening, which is basically, frankly, at the time point where any physician can look at the patients and you focus on the patients that have more than 5% tumor burden. Those are the morphological patients that’s the intent to treat. That’s certainly the position or the primary focus you’ll see with the European agency as of the primary view, which is to the physician’s view. This is when the physician can make a decision, okay, this is the patient that gets included, what is the outcome related to that. And then, when you look at the review process for Blincyto as well as for Tecartus, the focus the FDA has is more on the patients that actually have 5% tumor burden at the time point of dosing.
And so that would be 5% at lymphodepletion, and it would be that category of patient, which is the primary group for assessment. So, the difference is and some different views that are taken in terms of analyzing data, and it really depends on the agency. But that’s the fundamental difference on what we’re seeing based on prior review history in the space.
Yanan Zhu: Great. Appreciate the color. Thank you.
Christian Itin: Thanks a lot. All right. If we have no more — oh, sorry. Please go ahead.
Operator: Thank you. Our next question comes from Kelly Shi with Jefferies. Your line is open.
Unidentified Analyst: Hi. This is Dev on for Kelly. I have a couple of questions. One is you did analysis on obe-cel and German product, which is similar. Can you talk about what kind of patient baseline you’re thinking about enrolling in your study? And for data presentation, are you thinking of presenting at that medical conference?
Christian Itin: Yeah. So, when we look at the patients that we’re enrolling in the study, we’re rolling patients that have obviously our lupus patients that have or do not have the kidney involvement. So both manifestations, we do see. We do have patients as that’s done in the Erlangen study that will have at least one organ involvement in these patients. So, it’s very much track alongside what you have seen and read about in the publications from the Erlangen team. So, it’s a very comparable patient population that we’re enrolling in terms of inclusion/exclusion criteria. The plan would be for us to see that we can have our first data at one of the medical conferences at the end of the year. So that would be the plan.
Unidentified Analyst: Great. Thank you.
Christian Itin: Thank you very much.
Operator: Thank you. Our next question comes from Jacob Mekhael with KBC Securities. Your line is open.
Jacob Mekhael: Hi there, and thanks for taking my question. I have a few if that’s okay. First, I have a question on the option agreement with BioNTech on AUTO1/22 and AUTO6NG. What do you need to show or reach with those programs to trigger and opt-in from BioNTech? That’s my first question. And then perhaps more, a very broad question on autoimmunity here. Given the larger patient population we’re talking about, from your point of view, what needs to happen in the CAR T ecosystem to ensure that if approved, those treatments — or there is enough capacity in the ecosystem to ensure that those patients have access to those treatments? Thank you.
Christian Itin: Thanks, Jacob. I think two very good questions. So first of all, with regards to the option agreements on AUTO1/22 and AUTO6NG with BioNTech, the option really is structured such that the options have to be exercised before we start our pivotal studies with those programs. So, it’s actually triggered by progression, it’s not defined by a defined outcome or a defined certain level of activity. It’s the actual decision to move forward into pivotal study. So that’s the latest time point for the exercise. It could happen before, but that’s the latest time point. So that’s the sort of the option exercise question. In terms of the breadth with regards to autoimmune indications, I think the first observation is that we expect that the initial application for CAR T will really be in what you — often refer to as the more refractory type of population in those indications.
So that’s intrinsically a small — a relatively small part of the overall autoimmune indication that you’d be looking at. So, you have the overall lupus population, you may look at a few hundred thousand patients, but actually will be expect to go in and to sort of be amenable for a CAR T approach that may be in the few thousands. So, it is a smaller subset. And we expect that to be true also with some of the other indications. So from that perspective and moving into this disease setting, we would expect that capacity actually and the ability to serve is doable and will be there. One of the questions will be ultimately with some of the other indications is, how overall you would actually be able to go into these indications and have an adequate value proposition for these patients.
