Jonathan Miller: Hi, guys. Thanks for taking my question. I’m going to ask about the DLL-3, actually, as an entree to solid tumors more broadly. Can you walk us through the dose levels for the DLL-3 Phase 1 versus CARVYKTI? And maybe talk a little bit about how that relates to your expectations for dosing in solid tumors more broadly? And I have a follow-up. Thank you.
Ying Huang: Hey, Jonathan. Thanks for the question. This is Ying. So if you look at our disclosure on ClinicalTrials.gov, you will see that we’re planning to test four different doses ranging from 0.3 million cells per kilogram body weight up until 1 million to 2 million cells per kilogram body weight. So this is a weight-based dosing plan. And because this is a solid tumor, and we foresee that you may need a little bit bigger dose than in the hematology cancers. So if you look at our prior dose-ranging finding trials for the hematology, such as multiple myeloma indication, this is a little bit higher starting dose, given that we probably need a larger amount of T-cells. But on the other hand, we did put an armor, namely the dominant negative TGF-beta armor to help the expansion and penetration into the tumor setting. So that is the dose we’re looking at for DLL-3 in Phase 1.
Jonathan Miller: Thank you. And then on the CARTITUDE-4 label, can you remind us how big an impact that will have on out-of-spec rate when assuming it does get approved? And should we expect that out-of-spec rate change to happen immediately on approval or will there be a ramp period or some sort of recertification for that?
Ying Huang: Sure. So in part of our sBLA filing submitted to the FDA, we asked the agency to widen the release based on the clinical data from the Phase III randomized controlled trial in second-line beyond population, because we provide a significant amount of so-called sensitivity analysis through the agency trying to correlate the release spec with the clinical outcomes such as PFS and survival. So based on that data, we and our partner at J&J are very confident that we should be able to receive a wider release spec. And if we do receive such a wider release spec from an agency, then eventually we hope that the outer spec rate can decrease by additional 5 percentage to 10 percentage points from where it is today. That is our expectation, of course.
We have to wait until we see the label and also the FDA-approved release spec next April when the PDUFA date hits. But that is our hope. And to the second part of your question, let’s say, if we do receive a label and a wider release spec today, it is going to take a little bit time because once we start to roll out the second line in the market and then we start to see more uptake, you will gradually see that lower OS will take place in the manufacturing process.
Jonathan Miller: Just to clarify what you just said there, Ying, when you say you’ll take a little time to see that out-of-spec benefits come through, is that because you’re only going to see that out-of-spec benefit in the second line plus patients? Is it not going to also apply to manufacturing in later lines?
Ying Huang: You raise a very good question, Jon. Unfortunately, I don’t have answer to you, because we would have to wait and see what the agency gives us. It’s possible that we’ll get a uniform release spec from both the first indication and the second indication. But it’s also possible that the agency decides to give us two sets of release spec which haven’t before, I’m sure you’re aware, to one of the CD19 CAR-Ts in the market. So at this point, I actually don’t know the answer, but it’s a very good question. We’ll have to wait and see what the FDA says.
Jonathan Miller: Thanks so much.
Operator: Thank you. One moment for our next question. And our next question coming from the line of Ash Verma from UBS. Your line is open.
Ashwani Verma: Hey, guys. Thanks for taking my question. Good morning. I have two. So just in terms of your partnership with Novartis, could that eventually allow you to use their T-Charge program to, you know, further lower the CARVYKTI vein-to-vein time? And then second one, just wanted to see where you are on the CARTITUDE-2 study with the cohort E and F. I just wanted to get an idea. Is that something that we could see at the ASH abstracts late breaker tomorrow or is this more for ASCO next year? Thanks.
Guowei Fang: So for the T-Charge platform, it’s a unique manufacturer platform developed by Novartis and this is only applied for LB2102. Internally, we are also developing local manufacturing process and we are going to move internal development manufacturing process into other cell therapy products in the future. Thank you.
Ying Huang: Ash, this is Ying. I’ll take the second part of your question, which has to do with the CARTITUDE-2 cohort E and F. So I can tell you that at this point we have completed enrollment for both CARTITUDE-2 cohort E and F in the newly diagnosed patient cohort. But we’re not going to release data at this moment because, as you know, typically in the frontline setting, the PFS is relatively long. So we believe it will be more informative when we present data with a longer follow-up. So you should stay tuned when we present the cohort E and F in the future. Thank you.
Operator: Thank you. One moment for our next question. And our next question coming from the line of Kostas Biliouris from BMO Capital Markets. Your line is open.
Kostas Biliouris: Hello, everyone. Thanks for taking our question and congrats on the quarter. One question from us on the clinical ongoing trials. Can you comment on whether the enrollment in CARTITUDE-5 is completed? And given that the CARTITUDE-6 trial is slightly larger than CARTITUDE-5, should we expect any impact from this increase on the commercial slots or these two are somewhat independent now with the clinical manufacturing support from Novartis and the Ghent sites? Thank you.
