And in fact, the patients that actually were transplanted certainly in the early findings, suggests that the patients unfortunately didn’t do any better. And so, that’s obviously also one of the key questions as well, is whether indeed it’s beneficial, because one of the things you do when you move a patient to transplant after CAR T therapy is that you also eliminate all the CAR T-cells prior to the transplant. So, that’s a tricky decision to make because if the CAR T-cells are still active, you actually may have taken away a substantial component of your opportunity for longer term success in the patient. And at the same time, there is obviously not insignificant amount of risk, particularly if it’s a second transplant, that you have complications related to the second transplant, including treatment-related mortality.
So, it’s a very – it’s a much more nuanced conversation. And I think as we have more data and longer-term follow up in the study, I think that’s certainly an area we’re going to look into whether or not patients that have received a second – or a second transplant have received a transplant after obe-cel, how they’re doing and whether they actually are doing better or worse than patients who did not receive it.
Kelly Shi: Super helpful, thank you. And I also have one quick one regarding the lupus trial. So, does the manufacturing process require additional steps to increase purity compared to oncology CAR T product? Thanks.
Dr. Christian Itin: That’s a really good question, Kelly. And the answer is actually, the lupus patients are a lot simpler to manufacture because you do not have the contamination by higher levels of leukemia cells floating in the blood. So, the starting material you collect from these patients is a much better starting material. And it’s also – because of that, we believe that also will allow us to actually shorten the manufacturing process for these patients because we need less cells and we actually have a much better – much more homogeneous starting material. So, it’s actually just the other way around. It is an easier material to work with than what we’ve done in ALL, which we believe is probably the single most challenging patient population from a production perspective.
Kelly Shi: Great. Thanks.
Operator: Thank you very much. Please stand by for our final question, and please remember that management will follow up with everyone directly who didn’t get to ask the questions. Our next question comes from Eric Joseph of J.P. Morgan. Your line is open.
Noah Burhance: Hi guys, this is Noah on for Eric. Thanks for taking our question. We were wondering regarding the SLE trial what clinical parameters will inform an optimal dose selection. Thanks.
Dr. Christian Itin: Hi, Noah, thanks for joining. Really good question. So, what you want to see is the two parameters that you’d like to see and that I think you can actually get out of this study. The first one is you want to see that therapy at the level you dose gives you a very profound B-cell aplasia removal of B-cells in these patients, and a rapid decline of autoreactive antibodies in that patient. And then you also want to see that the lupus-related composite scores actually track down, and you would expect most of those to actually go to baseline. At the same time, you want to see that that clinical activity can be induced without triggering any significant level of toxicity to the patient. So, it is both the safety that obviously will be important, as well as the pharmacodynamic parameters, as well as then the disease parameters that will be following that will inform the understanding of the dose and activity relationship.
Operator: Thank you very much. At this time, I would now like to turn the conference back over to Christian Itin for closing remarks.
Dr. Christian Itin: Well, thank you very much for joining today. Obviously, this was a full presentation. There’s a lot of updates that we had in this quarter. I think an exciting stage for the company. I think it’s fair to say we’re kind of moving flat out across the entire organization to deliver a BLA by the end of the year, which requires obviously the completion of the work on the manufacturing facility, and then also all the work that’s going on, on the clinical analysis – the analysis of the clinical data from the FELIX study. So, an exciting time, very intense, but also I think very rewarding because we’re feeling that we’re working with a product that has a very unusual profile, and I think that promise to really have a big impact on patients’ lives going forward. So, with that, I’d like to thank you all for joining today and looking forward to keeping you updated as we go through the second half of the year. Thank you.
Operator: Thank you. This concludes today’s conference call. Thank you for participating. You may now disconnect.
