The following is excerpted from the question-and-answer section of the transcript.
(Questions from industry analysts are provided in full, but answers are omitted - download the transcript to see the full question-and-answer session)
Question: Maury Raycroft - Jefferies - Analyst
: Hey, good morning, everyone and congrats on the update and the rich dataset. Really impressive. And so, first question is for the enhanced
lymphodepletion data, you showed the mean AUC at 45X. Can you talk more about how this compares to your standard lymphodepletion regimen
and can you contextualize to what is observed with autologous approaches and how this factors into durability?
Question: Maury Raycroft - Jefferies - Analyst
: Yes, that's great perspective. And then, second question is just on the enhanced lymphodepletion regimen. I guess, can you parse out or quantify
how much the enhanced lymphodepletion regimen is contributing to activity or durability versus the CAR-Ts?
Question: Maury Raycroft - Jefferies - Analyst
: Got it. Very helpful. And last quick question just on the novel lymphodepletion regimens, can you talk more about how these are going to be
incorporated into the clinical study? And are these proprietary to Precision?
Question: Maury Raycroft - Jefferies - Analyst
: Got it. Thanks for taking my questions, and congrats again.
Question: Eric Joseph - J.P. Morgan - Analyst
: All right, guys. Thanks for taking the question and thanks for all of those very comprehensive update.
I'm just thinking about read-through here to the other CAR-T programs' leveraging CD20 and BCMA. In terms of cell expansion and persistency, is
there a reason to anticipate a different dynamic in terms of cell expansion and have the trials underway been adapted for the enhanced
lymphodepletion scheme? Thanks.
Question: Eric Joseph - J.P. Morgan - Analyst
: Thanks. And just a follow-up, if I could, you guys, have you looked at further modifications to the lymphodepletion scheme? You're, you know,
consistently or anticipating that you're going to stay away from - or avoid using a biologic. Can you just talk about sort of what complications
associated with, you know, [CD52] depleting regimen, your - you know, you want to avoid the downside risks associated with that and sort of what
the upper - I guess sort of the - the tolerability profile you, the tolerability profile you'd want to kind of stay away from as you look to modify the
lymphodepletion regimen going forward.
REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us
consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies.
Question: Eric Joseph - J.P. Morgan - Analyst
: Yes, that's very helpful.
Question: Gena Wang - Barclays PLC - Analyst
: Thank you for taking my question. So maybe just following the doctors' comments, I'm just curious because I don't disagree with you. I think that
[CD52] is - could be very toxic. So we did see initial data from Allergan, you know, the [DOD CO] part. We actually didn't see very severe infection.
And I'm just wondering, you know, compare that certainly to - in that as the background and the data where we see - so far, we did see one grade
5 sepsis. And I think that that could be related to the enhanced - the full site conditioning regimen. So just wondering, you know, any concerns
there down the road regarding the safety with this intense - the conditioning regimen. And then you did mention we try to avoid certain patient
population but also would there be any additional concern or cautions we need to take regarding this enhanced conditioning regimen?
Question: Gena Wang - Barclays PLC - Analyst
: Yes, yes, that's very helpful. I do see actually other trials include the patient with the transformation for the (inaudible). So my -
REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us
consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies.
Question: Gena Wang - Barclays PLC - Analyst
: I see. Okay. That makes sense. And my second question is regarding the durability of the cell expansion. I think that could be debatable and then
a few is still evolving. So just wondering, you know, when we look at the other competitors or the other - I mean not really competitor because this
is important for the whole field to understand the allogenic you have that, you know, for how we should pursue. So for, you know, the [CRISPR]
and allogenic data, when we look at the [SL] expansion, it seems, you know, extended a pretty long time, you know, certainly beyond 28 days. And
then when we look at the [SCR] rate, they actually extended also quite a lot of them extended three, four months and it continue, you know, active,
maintain [CR].
So just wondering from perspective, you know, now revisit the peak expansion versus the duration of expansion, you know, how important that
is that, you know, I think the autologous CAR-T data is not really fair comparison because they don't have a host T-cell coming back at week 3, 4 to
attack the foreign CAR-T cells. So just wondering, you know, from that perspective, you know, as a background, wanted to revisit the slide 27, the
Patient 1140-001.
So that patient had a split dosing. According to your data, the split dosing should not help much so - but, you know, we - why the patient showed
a continued response if you can give a little bit better understanding. I know you discussed on this slide 30. I think that was the patient who maybe,
for the key study, if you can discuss a little bit more why the patient can extend it now to 120. Well, we see all the other patients mostly already
progressed.
Question: Salveen Richter - Goldman Sachs - Analyst
: Good morning. Could you just comment on how you're going to incorporate the levers of optimized dosing and repeat dosing in novel LD regimens
with the new stealth cell candidate that's entering the clinic next year and what this means for the broader CAR-T program? Thank you.
Question: Salveen Richter - Goldman Sachs - Analyst
: Great, and then for the broader CAR-T program the other program that's going into the clinic and have volunteer clinics would you be moving
forward with the stealth cell candidates for those as well, or are you going to see what happens here in lymphoma?
Question: Salveen Richter - Goldman Sachs - Analyst
: Thanks.
Question: Tom Shrader - BTIG - Analyst
: Good morning and thank you for the presentation. It's as clean a datacenter that I have ever seen in this field so congratulations.
I had a question for Dr. Shah in his figure where he got excited in the bottom half of slide 27, if we take that profile of the cell, that face value which
is a quarter of the people who get a profound response, another half of the people, either half to be watched very closely for two months or routinely
retreated but everybody can be treated immediately, is that an attractive profile relative to other approaches already?
REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us
consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies.
Question: Tom Shrader - BTIG - Analyst
: Yes, great. Thank you very much for the plausible answer.
Question: Raju Prasad - William Blair - Analyst
: Thanks for taking the question. Just a quick two-parter, it seems like you had four patients that reproduced the (inaudible), there's obviously one
case study that you presented. I am just kind of wondering were these CD (inaudible) escape relapses or just kind of your thoughts around potential
for exit (inaudible) escape [oncologist] versus not.
And then just looking at the clinical activities kind of a way it seems like there's three buckets peak persistent in weekly dose. I'm just wondering
if you could maybe put that into context some of the clinical activities in those three buckets and maybe more of a priority list of based on the data
that we are seeing today and how you are thinking about which levers are the most important to kind of look at first, both in terms of 0 and 91 and
kind of a broader platform. Thanks.
Question: Raju Prasad - William Blair - Analyst
: Great, thanks.
Question: Ben Burnett - Stifel Financial Corp. - Analyst
: Great. Thanks so much for putting me in and congrats on the updates. I have just one question for either Dr. Heery or Dr. Shah. I guess can you just
provide some more color or your thoughts around the case study which you mentioned on slide 30 where I think the patient converted to a CR at
day 90. And just biologically it's assumed that all the CAR-T cells would have been rejected by that point. And I guess if so what would be driving
that increased tumor response.
Question: Ben Burnett - Stifel Financial Corp. - Analyst
: Okay, that's super interesting. And maybe...
Question: Ben Burnett - Stifel Financial Corp. - Analyst
: Okay, super interesting. Okay. And then, maybe, Chris, just one last one, you talked about potentially going to novel lymphodepletion regimen
that I understand that that's something that is going to be proprietary. But I would just ask about the strategy and is this strategy based on this
data, is the goal arrived at deeper level of lymphodepletion or is the goal more about creating a longer window of lymphodepletion? I guess how
do you think about that?
Question: Ben Burnett - Stifel Financial Corp. - Analyst
: Okay, very helpful. Thanks so much, guys, and congrats again.
|