Daina Graybosch: I wonder if you could talk about for autoimmunity, why start with FT819 rather than going to FT522, and how you think about both of those products and their potential ultimately in autoimmunity.
Scott Wolchko: Yes, I think FT819 obviously, and we’ve sort of alluded to this, has human clinical experience. To date has a highly differentiated what we consider to be safety profile. It’s readily available off-the-shelf and there’s certainly strong proof-of-concept for autologous CAR t-cell therapy. And as we have shown anti-tumor activity, including complete responses with 819. So I think there is a very strong rationale for off-the-shelf cell therapy in autoimmunity, and at least in the cancer setting, we’ve seen all the sort of safety and activity hallmarks that we believe can have a differentiated profile in autoimmunity. We’ve talked about 522 and potentially the benefits of an NK-cell, which again, has an exquisite safety profile in oncology.
I think with FT522, there is potentially a broader therapeutic appeal, including and especially if the ADR technology allows for reduction or elimination of conditioning chemotherapy, which I think is somewhat of a barrier, obviously, in autoimmunity is certainly more so than in oncology. And with FT522, as you know, we have the potential to combine with monoclonal antibody therapy. And I think with FT522, we are looking at, call it, sort of a broader array of potential autoimmune diseases that we could target giving the multiple mechanisms of action that will going to in FT522 beyond CD19 targeting. So whether that be, for instance, targeting CD20 with a monoclonal antibody, CD38 with a monoclonal antibody, or potentially be targeting auto reactive, 4-1BB expressing T-cells.
So I think the FT522 profile has — FT522 product candidate has potentially much broader reach than a CD19 targeted cell therapy.
Operator: Our next question comes from Mike Schmidt with Guggenheim.
Kelsey Goodwin : This is Kelsey on for Michael. Thanks for taking our question. I guess specifically for 825 in in HER2 solid tumors. I guess, what types of tumor should we expect in the Phase 1? And I guess, what kind of efficacy benchmark are you thinking about, as we kind of get those patients in? Thank you.
Scott Wolchko: I think the efficacy is going to be judged by the particular patients that were looked that, that we will ultimately enroll. There is a fairly broad enrollment or inclusion criteria in the study. It is not limited to, for instance, or to IHC 3. So we can certainly, enroll patients that are both high and low expressers of HER2 into that study.
Operator: Our next question comes from Peter Lawson with Barclays. Your line is open.
Peter Lawson: Great. Thanks for the update. Thanks for taking my questions. Just on the solid tumor program, so circling back on that. The learnings from your prior NK cells sales in solid tumor that kind of rolled over to the current program. So what were the learnings there? And then it is redirected T-cell. Where do you think that would fit in the treatment paradigm?
Scott Wolchko: Yes. I think, while we have shared some of the data that we have seen in NK cells with solid tumors, in the setting of solid tumors, including CAR NK cells, where with our most recent version of, in solid tumors with FT536, which was the CAR NK product candidate. We certainly saw activity, at a 100 million cells per dose. So I do think there is interesting activity that we have demonstrated in the past with off-the-shelf cell therapies. Think it would be premature for me to say, comment on, what do you know with respect to an NK cell versus T-cell. I think they are just very different sort of cellular vehicles, if you will. So I don’t necessarily think you can extrapolate what we have seen in a small number of patients with NK cells to the sort of the T-cell vehicle, if you will.
So, we don’t really do that sort of cross comparison between NK cells versus T-cell, especially in a solid tumor setting. And knowing quite honestly, all the incremental innovation that’s building A25.
Peter Lawson: And then I guess the follow-up question was just on, where you think this her two directed T-cell would be positioned in…
Scott Wolchko: Yes, I think it’s too early to comment on that. I think, as we look at the HER-2 landscape obviously, what’s being demonstrated with the ADCCs are pretty remarkable. But I think what we’re excited about at the same time is that, again, solid tumor settings, patients are relapsing for significant unmet need. And I think what we’re excited about as well is, there seems to be activity in HER-2 expressing tumors that cover a breadth of different types of solid tumors. So I think that we’re now seeing HER-2 starting to become validated, especially if you’re able to target her two low not in what you would think of just the traditional setting, for instance, of breast cancer. So, I think, the opportunity for safely targeting HER-2 in the solid tumor space is significantly expanding.
Operator: Our next question comes from Andrea Tan with Goldman Sachs.
Unidentified Analyst: This is Tani on for Andrea. Thank you for taking our questions. Firstly for FT819, would you mind just sharing a bit more about the rationale for choosing lupus as the initial autoimmune indication? And then secondly, if you could provide a bit more details around the clinical trial design for the Phase 1 study.
Scott Wolchko: Yes, I think, the rationale for starting lupus is there’s strong clinical precedent for CD-19 targeted therapy, and there’s significant enthusiasm from the lupus community in treating patients with cell therapy. So I think it’s a terrific place to start. The trial design, I alluded to on the call, it’s a pretty standard design with respect to a cell therapy that we’re seeing that others are exploring. It is a dose escalation study. We can treat at multiple escalating doses, stepping up at three times the previously cleared dose level, each dose level, each and every dose level that clears DLT is able to expand and enroll 10 patients in expansion. So you can explore multiple different dose levels and multiple different expansions assuming that, that dose level has clear DLT. We are able to enroll patients with lupus nephritis as well as patients with other organ involvement.
