Allogene Therapeutics, Inc. (NASDAQ:ALLO) Q4 2023 Earnings Call Transcript

David Chang: I think that’s relatively simple to me. I mean, when you think about there are multiple different companies taking different assets into [indiscernible], yes, it is true. But when you think about number of potential patients that are out there, what — the current clinical studies are covering is not even a tip of an iceberg. I mean you are probably talking about fewer than 100 patients out of 20, 30, 100,000 potential patient population that we can go after. So our view is, we are less concerned about that as long as we maintain the differentiation. And frankly, if you can get rid of the lymphodepletion, I think the opportunity to do a quick development program, that just becomes a more real and something that we can easily do very quickly.

Operator: Thank you. Our next question comes from the line of Kelsey Goodwin of Guggenheim. Please go ahead, Kelsey.

Kelsey Goodwin: Hey. Good afternoon, and thanks for taking my question. Mine is on CLL. How do you think about the ideal placement for CAR T given kind of the age of this patient population and the durability that we see with BTKs and BCL2 inhibitors? Thank you.

Zachary Roberts: The question was around the durability that we can expect?

Kelsey Goodwin: More so the positioning and what kind of patients would you want to get on this given kind of the age at diagnosis and how durable the responses are with the inhibitors that are already approved.

Zachary Roberts: Yes, okay. Thank you. So, well, as a reminder, the study will enroll patients that have BTK inhibitors and BCL2. Now there is a non-covalent BCL –BTK inhibitor, pirtobrutinib that’s been approved. That has shown that in a similar patient population, there is some benefit to that drug. However, similar to the established modalities, this is non-curative. And so what we have seen from the autologous experience in CD19 for CLL is that some patients, significant fraction of these patients can actually have very meaningful, durable, complete remissions that go on for months or even years in a patient population that has failed these prior therapies. So, number one, I think that the modality is promising in this patient population.

Number two, I’ll point out that just looking at our experience from LBCL is that our toxicity profile is wholly consistent with a somewhat more frail population with very low rates of high-grade CRS and ICANNs and consistent with outpatient dosing, which we do have experience with. So while we are getting our feet wet with this Phase 1 study and getting ready to share data later on this year, we will be paying very close attention to how that toxicity profile plays out in this patient population, as well as being able to meet or even exceed the bar that has been established by the autologous players.

Operator: Thank you. Our next question comes from the line of Reni Benjamin of JMP Securities. Please go ahead, Reni.

Reni Benjamin: Thanks guys, thanks for taking the questions and congrats on the progress. Maybe just continuing with the thought of questions around CLL, what would you consider to be kind of the go, no-go results that you would like to see by the end of this year? I know there’s only going to be about 12 patients’ worth of data. How do you plan on kind of dissecting that? And I guess just as a second part of that, just given your experience with LBCL, do you think there might be an opportunity to move cema-cel to some type of a consolidation or more of a frontline treatment in combination with drugs that are already out there. I remember way back when, [indiscernible] were thinking about combination studies in a frontline setting, and just wanted to know how you guys were thinking about this. Thanks.

Zachary Roberts: Yeah. So as far as the bar for internal decision making, of course, we’ll watch the data as it rolls in. But I’ll again point out that the bar is not all that high here, and actually that’s one of the things that — why we believe that moving into CLL is exactly the right thing that we should be doing with cema-cel because the data that’s before the FDA right now suggests that an improvement of 50% ORR and a sub 20% CR rate is something that is probably – well, not probably, is attractive to the treating physicians and patients who are in this predicament of having failed the approved therapies. So we’ll be watching the FDA’s response to that dataset very carefully and as our data matures, being able to make a decision about whether to move that into a Phase 2 registrational study.

As far as the other question goes with respect to consolidation and/or combinations, I do think that that is an attractive avenue to pursue and in fact, our focus in consolidation in large B-cell with ALPHA3 is a testament to our belief that a consolidation strategy or treatment with CAR T cells when the diseases that are [relative mid-year] (ph) is a very interesting proposition and can be applied to other indications as well. Combination is a little bit more of a challenging idea, but it certainly has been floating around and I think there’s a strong biological rationale to do that. And so we’ll be looking at that carefully as the program matures as well.

Operator: Thank you. Our next question comes from the line of Kalpit Patel of B. Riley Securities. Please go ahead, Kalpit.

Kalpit Patel: Yeah, hey, thanks for taking the question. Maybe just one on ALLO-329. Can you discuss any thoughts on broader immunomodulatory effects beyond direct cytotoxicity such as any impact on regulatory T cells since you have targeting of CD70, and how might these effects influence outcomes for autoimmune disease patients?