David Chang: Thanks Jack. So as far as EXPAND goes we are still making progress there. We will intend to bring on Australia in the coming weeks there. So we are still working to expand the footprint there. And even within the countries in Europe we’re still adding sites. So we’re still in execution mode for both ALPHA2 and EXPAND and bringing on new sites to grow that footprint to support enrollment. And then the Earlier Line Study, so I will say again we’re not quite ready to share the details there on what we’re thinking. But suffice to say we are making good progress internally on the study concept, and we are pretty excited about the way that this is taking shape and how it’s mirroring the developing practice patterns for diffuse large B-cell lymphoma. So we’re still on track, I think, to share details around the time that we’ve guided to. So stay tuned.
Operator: Thank you. And one moment as we move to our next question. And our next question is going to come from the line of Kelsey Goodwin with Guggenheim Securities. Your line is open. Please go ahead.
Kelsey Goodwin: Oh, hey, good afternoon. Thanks for taking my question. I guess first regarding the BCMA program. I guess can you provide any kind of updates there and maybe any learnings from the assessment that you guys have been doing regarding the manufacturing process? And then maybe secondly specific to the Notch partnership, I guess, is there any kind of qualitative update you could give or maybe some sort of timing as you kind of work with them on the iPSC strategy? Thank you.
Zachary Roberts: Yes. So thanks Kelsey for the question. Maybe I’ll take the first one and then you can take – and David will take the Notch question. So as far as the BCMA program goes, we are still those programs, we’re not enrolling patients into the BCMA. Currently, we are still sort of examining the manufacturing process. What I can say, obviously, I won’t go into specifics there. But we are learning as I think every CAR T company is that there are elements to the manufacturing process that are ripe for optimization. And I do think that what we are learning across our portfolio on the manufacturing side is that many times what we learn in one program can be translated into another. So we are sort of overall quite excited about the progress that we’re making on understanding that manufacturing within the context of BCMA and our other clinical programs.
David Chang: So, Kelsey, on the second question, this is David Chang. Notch Therapeutics is our partner in the iPSC area. And we’ve been working with them now for about four years. They have made a tremendous progress in differentiating the iPSC into the CD34 positive stem cells, and subsequently after that, but differentiating into the CD18 cells. So the progress is being made, and we are working to – continue to work very closely with my team to incorporate that technology into what we are doing. But given all the things that we are handling now, I think, it’s going to stay the research stage for a little bit longer.
Operator: Thank you. And one moment as we move on to our next question. And our next question is going to come from the line of John Newman with Canaccord Genuity. Your line is open. Please go ahead.
John Newman: Hi, there. And thank you for taking my question. I just wondered for the ALPHA2 trial, you’re allowing, excuse me, outpatient treatment at the investigator’s discretion. I’m wondering if you expect a substantial number of patients to be treated this way. I also have a question on the enrollment, the clinical sites for the trial. I’m wondering if you’ve been able to open clinical sites in the EU, Canada, and Australia, where autologous CD19 CAR Ts are not as widely available or used versus the U.S. to help with enrollment? Thanks.
Zachary Roberts: Thanks, John. So maybe I’ll answer the second question first. So that has long been part of our strategy for enrollment is to EXPAND into geographies, countries, and indeed clinical sites where autologous product is not as widely used, and that can be for many reasons, reimbursement related or access related, or we’re sort of encountering all kinds of different reasons why those patients are not getting access to this lifesaving therapy. So in those cases having access to a clinical trial such as ALPHA2 or EXPAND really is welcomed quite heartily by the patients and by the physicians. And sorry, John, I’m blanking on your first question.
David Chang: Outpatient.
Zachary Roberts: Oh, outpatient. That’s right. Thank you, David. So we are seeing actually a fair number of patients being managed fully outpatient, and that means both the lymphodepletion as well as the CAR T infusion. And it has been I would say very encouraging so far and many of the centers that have met with some success in their first few patients continue to have that either default position. Of course, if a patient needs to come in for one or more reasons, that’s no problem at all if patients can be admitted. But there seems to be a high level of enthusiasm around managing these patients outpatient. And in fact, some of the centers are actually, we’re having them talk to other centers to try to teach them how they’re managing this. So there does seem to be quite a high level of interest to handle this outpatient.
Operator: Thank you. And one moment as we move on to our next question. Our next question is going to come from the line of Kalpit Patel with B. Riley. Your line is open. Please go ahead.
Andy Fleszar: Good afternoon. This is Andy Fleszar on for Kalpit. Thank you for taking the questions. One of your ASH abstracts revealed the impact of recipient alloreactive CD8+ T cells in allogeneic CAR T rejection. Can you please elaborate on ways that this could potentially be addressed?
Zachary Roberts: Sure. Good question. So we’ve known as a – I think the field is known and certainly other allogeneic CAR T developers have known that when you take an HLA unmatched product from donor into a patient, that the risk of allorejection is there. And so I think everybody is crafting these strategies around how to mitigate this host versus graft response. What I think Allogene has got that’s quite exciting actually, is a robust and targeted selected lymphodepletion strategy that the ALLO-647 component and in when used paired with our CD52 negative CAR T cells that is how we have so far, I think rather successfully managed this host versus graft reaction. What that abstract is really showing is that this is something that we can further refine both from an LV strategy, but also we’re taking those learnings and folding them into our new product development and looking for ways to through gene engineering or other strategies help to prevent or mitigate that host versus graft and not relying entirely on LV.
However, I would say that just what we’ve done so far around lymphodepletion as our clinical data will show is we’ve managed to create a great window of persistence for ourselves where we can see high levels of expansion and persistence, and that corresponds to durable complete remission. So I think Allogene is on the right track. But the point of that abstract is really that there’s probably more that we can learn and we’re taking that forward into our new product development.
Operator: Thank you. And one moment as we move on to our next question. And our next question is going to come from the line of Sami Corwin with William Blair. Your line is open. Please go ahead.
Sami Corwin: Hi. Thanks for taking my question. I noticed in the 10-Q that it was reported that there was some cases of a immune effector cell not lymphohistiocytosis like syndrome. I was wondering if you guys could elaborate on that a little bit. And if you think it’s related to the Dagger Technology at all, and if that’s what changed the guidance for data on the trial?
Zachary Roberts: Thanks, Sami for the question. And nice job with that mouthful of a new entity. So the way that we’re thinking about ICHS [ph] it is likely probably an umbrella term that has described an inflammatory process that is likely seen across CAR T products. And in fact, it’s been described in both heme programs, not our heme programs, but others as well as, other solid tumor programs. And so I think when we see sort of an inflammatory response we have begun to call that ICHS as opposed to HLH or CRS or ICAN, that sometimes this different description is a little bit more straightforward to use. So when it comes to the 316 program, we just want to reiterate just how careful we want to be as we are moving through this dose escalation.
