Q3 2021 Allogene Therapeutics Inc Earnings Call
And one financial guidance among other things. These forward looking statements are based on current information assumptions and the expectations that are subject to change the description of potential risks can be found on our earnings press release and latest S. E. C disclosure documents throw caution not to place undue reliance on these forward looking statements and allergy and display.
<unk> any obligation to update these statements I'll now turn the call over to David.
Thank you <unk> and good afternoon.
You know Cobra, we communicated that the F D. A I placed the clinical hold on I will Ala carte be critical programs.
Based on a coma fomo abnormality observed in one case in an Apple two trial.
Although we have been unable to treat patients while to hold it in place.
Colorado works cream said Alison continue.
Including preparation for a base two pivotal trial on Aloe five O one.
Advancement of our airports one manufacturing facility.
Oh I'll upgrade critical work on solid tumor target and next generation technologies.
On today's call, we will share of grief update on the critical hold and perhaps even more importantly, the ultimate reason that we remain committed to advancing our platform.
Our data and the potential impact the patients in need.
Let me first start with western copper mine.
Since we announced the clinical hold on October 7th we.
We have been actively engaged with the F D. A in discussions and we hope it will lead to a timely resolution.
We are extremely appreciative of the time and attention that the F. D. A has devoted to this matter.
Which we believe has implications not only for the buildup allergen aches out therapy, but also the broader field of cell therapy.
I'm also grateful to our team at our team, which I'm, making great progress in generating informational cloth and appealed to understand and properly address the chromosomal abnormalities observed patient.
Sonoma across five phase one study.
In the Alpha one trial alone we have treated over 60 lymphoma patients.
And we are excited to share updated data at the Ash conference in December.
I will now turn the call over to Rafael to preview our upcoming data presentations.
Thank you as David has noted I will focus my comments today on data updates from both our anti CD 19, and be CMA programs, which will be presented at next month's Ash conference. We believe the data disclosed in the onshore strikes for Allo 501, and Allo 501, a continued to validate our consolidation.
That strategy.
<unk> will feature an oral presentation or in our phase one all tied to the trial with Allo 501, eight in a poster presentation on an offload study with Allo 501.
Christine Cassiano: guidance, among other things. These forward-looking statements are based on current information, assumptions, and expectations that are subject to change. The description of potential risks can be found in our earnings press release and latest SEC disclosure documents. Please exercise caution not to place undue reliance on these forward-looking statements, and Allegine disclaims any obligation to update these statements. I'll now turn the call over to David.
Consistent with the data presented at <unk> earlier this year the updates in the ash abstract continued to support a favorable clinical profile for allo car T. In non Hodgkin's lymphoma, and demonstrate that consolidation dosing is well tolerated with the potential for enhanced efficacy compared to a single dose of cell.
David D. Chang: Thank you, Christine, and good afternoon. In October, we communicated that the FDA had placed a clinical hold on our Alilcarque Clinical Program based on a chromosomal abnormality observed in one patient in the Africa-2 trial. Although we have been unable to treat patients while the hold is in place, most of the work streams that I will continue, including preparation for a phase two pivotal trial on all 501A, advancement of our South 421 Manufacturing Facility, and all our preclinical work on solid tumor targets and next generation technology.
We chose to term consolidation to described our unique approach to re dosing, which goes beyond simple with treatment.
Reprised hiring needs for depletion strategy enables us to provide a second dose of cells. We tell the real administration of chemotherapy, allowing cells to persist from an initial dose remain active while newly administer south can work to consolidate our response to therapy.
David D. Chang: On today's call, we will share a brief update on the clinical trials and, perhaps even more importantly, the ultimate reason that we remain committed to advancing our platform, our data, and the potential impact on patients in need. Let me first start with what's top of mind.
While the data are early we believe these strategies wholesale vintages over older with treatment paradigms that are being studied.
As you May recall data presented from the Alpha study at <unk> earlier. This year included six Evaluable large b cell lymphoma patients treated with a single dose of Allo 501 a M.
The valuable large b cell lymphoma patients from the consolidation cohorts in this study.
David D. Chang: Since we announced the clinical hold on October 7th, we have been actively engaged with the FDA in discussions that we hope will lead to a timely approval. We are extremely grateful for the time and attention that the FDA has devoted to this matter, which we believe has implications not only for the field of allogenic cell therapy but also for the broader field of cell therapy. I'm also grateful to our team at Allergin, who are making great progress in generating information for us and the field to understand and properly address the chromosomal abnormalities observed in our patients. The FDA's state mission is to ensure the safety and efficacy of medical products, but the agency has also been mandated by Congress to expedite product development.
So tier Shasta data cutoff date in July 15 patients had received the allo 501, a fixing the single dose cohort and nine in the consolidation cohort with 12 patients six each evaluable for response at day 28.
In the consolidation cohort both the overall response rate and complete response rate were at 67% with all three partial responses converting to see ours following consolidation.
We look forward to presenting data on additional patients from the consolidation cohort that ash recognizing that a few in this group were not able to receive a second dose following the clinical hold.
The safety profile of <unk> continues to be manageable in both the single dose and consolidations cohort.
Events are interesting the single dose cohort, where previously reported at the 2021 ask one meeting.
David D. Chang: As FDA leadership has shared at recent public forums, they have identified the development of allogenic CARE drive from healthy donor cells as a potential way to increase access to the therapy and decrease manufacturing time and cost. We recognize the FDA's responsibility to ensure patient safety while supporting innovation. The FDA has continued its review of our end of phase one material submitted in anticipation of a potential alofybibyl-a, pivotal phase-to-trial. From Allegant's perspective, we understand our own responsibility that comes with being a pioneer in the field of cell therapy and look forward to doing everything necessary to facilitate a safe and timely resumption of our clinical studies.
In the consolidation cohort there was no cytokine release syndrome, no graft versus host disease, no icons no dose limiting toxicities, no dose reductions or grade III bloodstream infections and infusion reactions were great too.
Among all treated patients had opinions were the most common adverse event that occurred in the 72% of patients.
The patient with a plastic anemia, and the chromosomal abnormality treated in the Alpha trial, what's not referencing the asaf strike due to the timing of the data cutoff.
Meanwhile, we continue to prepare for the advancement of the Allo 501 program into a pivotal phase two study with the understanding that certain work streams are being delayed by the halls and subject to ongoing discussions with the FDA.
David D. Chang: During our interaction with FDA, we have remained in close contact with our investigators, including the clinician who is caring for a patient who subsequently received an allogenic stem cell transplant. We have heard from many of these investigators.
India has struck for the poster presentation of Allo 501 Alpha trial. The updated data continues to highlight that allogeneic car T therapy can be effectively and conveniently delivered to patients with relapsed refractory non hodgkin's lymphoma with responses observed across all cell doses in tumor histology.
David D. Chang: They look forward to reinitiation of our trials and view our Al-a-Carty product as an important therapeutic option for patients, calling out how many of their patients cannot wait for the delivery of Othalachit cells or don't want to risk manufacturing failure. Most importantly, we believe in the potential of our Alilcarcari products and have treated now more than 130 patients with lymphoma, multiple myeloma, and renaloma across five phase one studies. In the Alpha Line trial alone, we have treated over 60 lymphomas, And we are excited to share updated data at the Ash Conference in December. I will now turn the call over to Raphael to preview our upcoming data presentation. Thank you.
Raphael: As David has noted, I will focus my comments today on data updates from both our Anti-City19 and BCMA programs, which will be presented at next month's Ash Conference. We believe the data disclosed in the Ash abstract for Allo 501 and Allo 501A continue to validate our consolidation strategy. We will feature an oral presentation on our phase one alpha-2 trial with ALO 501A and a poster presentation on an alpha study with ALO-
Raphael: Consistent with the data presented at ASCO earlier this year, the updates in the ash abstract continued to support a favorable clinical profile for Alokar T in non-Huskins lymphoma and demonstrate that consolidation dosing is well tolerated with the potential for enhanced efficacy compared to a single dose of cells. We chose the term consolidation to describe our unique approach to redosing, which goes beyond simple retreat.
Is there something going on tiara 15 plus months.
Raphael: Our proprietary lymphodepletion strategy enables us to provide a second dose of cells without re-administration of chemotherapy, allowing cells that persist from an initial dose to remain active, while newly administered cells can work to consolidate a response to therapy. While the data are early, we believe this strategy holds advantages over other retribement paradigms that are being studied. As you may recall, data presented from the Alpha II study at ASCO earlier this year included six evaluable large-becile lymphoma patients treated with a single dose of all of 501A and five evaluable large-becile lymphoma patients from the consolidation cohort in this study.
I thought the data cut off the six month CR rates in Follicular lymphoma was 28%.
There were no cases of gvhd or Dlp's observe.
As noted previously one case of grade three items what's reported.
Greg wanted to Crs occur in 22% of patients with one case of grade three Crs.
All were managed with standard protocol set.
<unk> the most common adverse events had occurred in 83% of patients infection.
Infection rates remained similar to those observed in autologous car T trials.
There were no new treatment emergent deaths reported in their types right.
The oral presentation at ash from our multiple myeloma program with focus on a single administration of almost having one five at higher cell dose cohort sub.
Raphael: Associate Ashaashtra data cutoff date in July, 15 patients had received Alof 501A, 6 in the single dose cohort and 9 in the consolidation cohort, with 12 patients, or 6 each, available for response at day 28. In the consolidation cohort, both the overall response rate and complete response rate were 67%, with all three partial responses converting to CRs following consolidation. We look forward to presenting data on additional patients from the Consolidation Cohort.
Subject to the whole we continue to target 2022 for data from the combination of all of 715 with neuro Gotcha stat consolidation dosing with 71, 5% and our allo 605 to Volcker study.
Findings from Universal abstract indicated that an allogeneic car T cell therapy can be delivered rapidly and without the need for bridging therapy to patients with refractory multiple myeloma with a single dose of therapy capable of inducing deep responses.
Raphael: Ash, recognizing that a few in this group were not able to receive a second dose following the clinical hold, the safety profile of allof 501A continues to be manageable in both the single dose and consolidation cohort. Events of interest in the single dose cohort were previously reported at the 2021 ASCO Annual Neat. In the consolidation cohort, there was no cytokine release syndrome, no graph or so disease, no ICANs, no dose-limiting toxicity, no dose reductions or grade 3 plus infections, and infusion reactions were grade 2. Among all treated patients, had opinions were the most common adverse events that occurred in 72% of patients.
Raphael: The patient with aplastic anemia and the chromosomal abnormality treated in the Alpha II trial was not referencing the as-abstract to determine the timing of the data cutoff. Meanwhile, we continue to prepare for the advancement of the ALO 5018 program into a pivotal phase of study with the understanding that certain work streams are being delayed by the halls and subject to ongoing discussions with the FDA. In the abstract for the poster presentation of the Allofagio 1 alpha trial, the updated data continue to highlight that allogenic cardiotherapy can be effectively and conveniently delivered to patients with relapse refractory non-Hodgkin's lymphoma, with responses observed across all cell doses and tumor histology.
8383 months.
Of the 10 patients with the best response, a V. P. R. Plus eight were found to be in a negative.
No Gvhd was observed the most common Gracie plus adverse events include a side of opinions Trs what's reported in 52% of patience you know cases, great one and two except for one patient with great three one patient with great to Crs experienced grade one neurotoxicity that resolved.
Raphael: In data presented across 36 CART-C-NAIS patients, response rates continue to be similar to those seen in Autoboscarpi therapy trials, and the modified intent-to-trip population remains nearly identical to the intent-to-treat population, with 46 or 47 enrolled patients receiving therapy and an average time from enrollment to start of therapy of five days. As Sulfed July Ash Abstract Data Cut-Off, five additional patients were treated relative to the data related to the data previously reported at ASCO earlier this year.
Great three blessing fake infections occurred and 13% of patients, including two previously reported grade five of them.
We are pleased that the data from University showed that multiple myeloma patients treated with 715 can achieve and maintain meaningful response rate.
Raphael: Overall response rates and CR rates remain at 75% and 50%, respectively. In the 13 Cartin naive patients with large visa lymphoma, the overall response rate was 62%, and the CR rate was 46%. In the 23 CARC-C-NAIDS patients with follicular lymphoma, the overall response rate was 83%, and the CR rate was 52%.
We look forward to providing updated data across our lead pronto.
As in December.
We remain enthusiastic about a differentiate it a la carte T platform and what its potential may mean per patient.
Raphael: Four of the seven follicular lymphoma patients enrolled in the consolidation cohort were evaluable for assessment after consolidation dosing at the time of the data cut off, with an overall response rate and CR rate of 100% and 75%, respectively. As with Alpha II, we will report on additional patients treated in the consolidation cohort of Alpha at Asmita, with a few not able to receive a second dose following the clinical hall. The percentage of patients remaining in CR six months following a single infusion of all of 501 was 36% in large visa lymphoma, which is similar to six-month rates reported in the pivotal trials of autologous cartis cell therapies, with the longest ongoing CR at 15 plus months. As of the data cut off, the six months CR rate in follicular lymphoma was 28%. There were no cases of GVD or DLTs observed.
Ah like now to turn over the call to Eric for an update on our financial.
Thank you Raphael and good afternoon.
We ended the quarter in a strong financial position with $861.7 million in cash cash equivalents in investments in the third quarter of 2021, our research and development expenses were $58.7 million, which <unk>, which includes $10.1 million of non-cash stock based compensation expense.
General and administrative expenses were $19 million for the third quarter of 2021, which includes $10.8 million in non-cash stock based compensation expense or.
Net loss for the third quarter of 2021 was $78.2 million or 57 cents per share, including non-cash stock based compensation expense of $20.9 million.
While the clinical hold his detracted from our ability to enroll patients into our five clinical studies, we continue to support multiple research and operational initiatives, including preparation for a potential pivotal phase two study on L. O five O one a and deployment of C. G. M. P production at Ourself, which one manufacturing facility.
Raphael: As noted previously, one case of Grays 3 icons was reported. Grade 1, 2 CRS occurred in 22% of patients with one case of grade 3 CRS. All were managed with standard protocols.
Raphael: Sartopinias were the most common adverse events and occurred in 83% of patients. Infection rates remain similar to those observed in a total of a scartee trial. There were no new treatment emerging deaths reported in this event.
Raphael: The oral presentation at Ash from our multiple myeloma program will focus on a single administration of ALO715 at higher cell doses co-homed. On the whole, we continue to target 2022 for data from the combination of ALO 715 with Nirogasostat, consolidation dosing with ALO 715, and our ALO605 turbo carcin. Findings from the universal abstract indicate that allergen-ac-cartic cell therapy can be delivered rapidly and without the need for bridging therapy to patients with refractory multiple myeloma, with a single dose of therapy capable of inducing deep research.
Raphael: The ASHAstract contains data as of June, with 42 patients treated at escalating doses of ALO 715 and doses of ALO 647 ranging from 39 milligrams to 90 milligrams. As we see in alpha trials, the median time from enrollment to lymphodepletion was five days. Patients were in an advanced stage of disease with a median of five prior lines of therapy, and 43% of patients were bent, or arefracted. The trials did not permit bridging therapy.
Raphael: When the initial universal data set was presented at Ash 2020, we reported on 26 available patients across all those; the efficacy analysis for this ASS presentation, however, will focus on those patients treated at the highest two dose levels of 320 million and 480 million car positive cells. At the time of the abstract, 26 patients were treated at the highest two cell dose levels, along with Cludarabine, Cyclophosomide, analog 647, and lymphodeep The overall response rate was 62%, with a very good partial response or better, or VGPR plus rate of 38.5%.
With a single case.
Chromosomal abnormality is whether it just says any clinical relevance.
Raphael: The median follow-up for these patients was 7.4 months, with a median duration of response of 8.3 months. Of the 10 patients with the best response of VGPR plus, 8 were found to be MRD negative. No GDHD was observed.
Also whether there is any evidence of culinary expansion.
And also whether there is a relation between.
The chromosomal abnormalities and gene editing and each of these areas. Our team is has made a tremendous progress in commerce hub.
Raphael: The most common grade C++ adverse events included side opinions. CRS was reported in 52% of patients. In all cases, grades 1 and 2, except for one patient with grade 3. One patient with grade 2 CRS experienced grade 1 neurotoxicity that resolved. Grades 3 plus infections occurred in 13% of patients, including two previously reported grade 5 events.
May.
Aching up path.
Towards addressing each areas of their concerns so.
That's about at this point.
What we are willing to share and while the investigations are ongoing.
And.
This matter is still under FDA review.
Raphael: We are pleased that the data from Universal show that multiple myeloma patients treated with ALO715 can achieve and maintain meaningful response rates. We look forward to providing updated data across our lead product can. It's due in December.
We will not really we cannot really talk too much into the details.
Thank you.
Your next question comes from the line of Michael <unk> from Jefferies. Your line is now open.
Hi, This is <unk> on for Mike Thanks for taking the questions.
You outlined a few possible hypotheses on the last call or regarding the chromosomal abnormality, whether it's from Palin searches from T cell expansion has any of those change given the additional work that you've done.
Eric: We remain enthusiastic about our differentiated Alokartee platform and what its potential may mean per page. I'd like now to turn over the call to Eric for an update on our. Thank you, Raphael, and good afternoon. We ended the quarter in a strong financial position with $861.7 million in cash, cash equivalents, and investments. In the third quarter of 2021, our research and development expenses were $58.7 million, which included $10.1 million of non-cash stock-based compensation expense.
And then number two can you. Please lay out some of the timelines over the next few months in terms of your interactions with the FDA.
Eric: General and administrative expenses were $19 million for the third quarter of 2021, which included $10.8 million in non-cash stock-based compensation expense. Our net loss for the third quarter of 2021 was $78.2 million, or 57 cents per share, including non-cash stock-based compensation of $20.9 million.
How much back and forth do you expect just just because investors.
The timeline on when this could be resolved. Thank you.
Yes.
In terms of FDA interaction and I would say that this is a very active and collaborative interaction.
We have had in our soybean formal discussion as well as ongoing dialogue as we are preparing to respond to the clinical hold letter.
So.
To that extent.
This is very positive.
With respect to.
How this may happen.
In the previous conference call, we laid down.
Eric: While the clinical hold detracts from our ability to enroll patients into our five clinical studies, we continue to support multiple research and operational initiatives, including preparation for a potential pivotal phase two study on Allo 501A and deployment of CGMP production at our Self-Forge One manufacturing facility. As a result, we continue to expect our full year 2021 operational expenses to be between $300 and $330 million. This includes estimated non-cast stock-based compensation expense of $80 million to $90 million and excludes any impact from development activities.
A different hypothesis.
Sleep with.
Given all the published literature about.
Potential gene editing nuclease, two coast chromosomal structure deletion, so abnormalities, we have to take that into a possibility.
We also highlighted that the kind of chromosomal abnormality that we have detected in this basin is also known to happen in healthy T cells as they go on the expansion. So those two in a possible explanation. So that is the basis of our ongoing investigation.
Operator: With that, we will now open the call to your questions. Thank you. At this time, to ask a question, you will need to press 1 on your telephone.
Your next question comes from the line of Michael Schmidt from Guggenheim client is now open.
Operator: Again, then I will start once as a question. To withdraw your question, just press the pan. Please stand back while we compile your Q&A roster. The first question comes from the line of Tyler Van Buren from Cowan. Your lines are now open.
Hey, guys two questions just another regulatory question last one is around the end of phase one.
Materials that have been submitted to the FDA.
Just wanted to understand I guess, what but.
Tyler Martin Van Buren: Hey guys, good afternoon. Thanks very much for taking the time to answer the question. So in the release, you state that there are ongoing discussions with the FDA; I have to ask, is there anything more you could say with respect to these discussions or the nature of them? And if the FDA has formally requested any data and what that might look like. If not, perhaps you could talk about your ongoing internal investigation to generate the data that would make the FDA comfortable, whether that's testing samples from the manufacturing batch that produced a patient sample or other things that Hi Tyler, good afternoon. This is Dave Chang.
What needs to be checked off here in order to go to get the go ahead for the Phase III study, which you said I think it's a parallel process.
Our side by side to that cohort investigation.
Rafael has been leading the end of phase II discussions with FDA and I'll ask him to respond to your question.
Yes, I mean, obviously our main focus has been.
Two.
On the whole of activities and we obviously are fully dedicated to that and as David said.
David D. Chang: Let me take that question. In terms of whether we have received a communication related to the clinical hold, yes, we have received the clinical hold letter that details FDA's concerns as well as the data requirements. And also, we have met informally with FDA to discuss some of the details. So, to that extent, we can talk about it, but, you know, in terms of the details, other than what we have previously communicated, which is that the agency is concerned around the single case of chromosomal abnormality is whether this has any clinical relevance. Also, whether there is any evidence of coronary expansion, and also whether there is a relation between the chromosomal abnormalities and gene editing.
Acting productively with FDA.
But in spite of that FDA has to remain engaged with us on the phase one.
Starting to phase two.
Our trial for <unk>.
Those discussions are also being very productive.
David D. Chang: And each of these areas, our team has made tremendous progress in terms of making a path towards addressing each area of the concerns. So, you know, that's about, you know, at this point, what we are willing to share. And while the investigations are ongoing, and, you know, this matter is still under FDA review, you know, you know, we will not really, we cannot really talk too much about the details. Thank you.
Operator: Your next question comes from the line of Michael E from Jeffreys. In your lines, Hi, this is Dennis on for Mike. Thanks for taking the questions. You outlined a few possible hypotheses on the last call regarding the chromosomal abnormality, whether it's from Palin's or just from T-cell expansion. Has any of that changed given the additional work that you've done?
Michael Jonathan Yee: And then, number two, can you please lay out some of the timelines over the next few months in terms of your interactions with the FDA? How much back and forth do you expect? And, you know, just good investors.
Stupid.
David D. Chang: a sense of the timelines on when this could be resolved. Thank you. Yeah, in terms of FDA interaction, I would say that this is a very active and collaborative interaction. We have had, you know, sort of informal discussion as well as ongoing dialogue as we are preparing to respond to the clinical hold letter. So, to that extent, I think, you know, this is very positive.
Study for five O one.
Just curious generally speaking if you would say that.
Given the additional data that will be seen at ash.
Do you believe that the.
Optimal way forward will be.
Consolidation dosing and whether that consolidation dosing would apply to.
Both patients with stable disease after the initial boats as well as.
A response.
David D. Chang: You know, with respect to, you know, how this may happen, yes, in the previous conference call, you know, we laid down a couple of different hypotheses. Obviously, with, you know, given all the published literature about the potential of gene editing in the nucleus to cause chromosomal structural deletions or abnormalities, we have to take that into consideration as a possibility. But we also found that the kind of chromosomal abnormality that we have detected in this patient is also known to happen in healthy T cells as they go on extension.
[noise], Yes, hi, this week Rafael.
I think what.
I would say to that is that we are encouraged above.
The consolidation data.
Is still.
Early for us to say.
This is going to be definitive dosing.
But.
You've heard it.
Bear remark.
Operator: So those two, you know, plausible explanations, you know, still form the basis of our ongoing investigation. The next question comes from the line of Michael Schmidt from Guggenheim. Hey guys, I have two questions, just another regulatory question. This one is around the end of phase one, you know, materials that have been submitted to the FDA. And I just wanted to understand, I guess, what needs to be checked off here in order to get the go-ahead for the phase two study, which you said is a parallel process, you know, side by side to the clinical trials. Yeah, Mike. Rafael has been leading the end of phase one discussions with FDA, and I'll ask him to respond to your question.
Operator: Yeah, I mean, obviously, our main focus has been on the whole activities, and we obviously are fully dedicated to that, and as David said, interacting productively with FDA. But in spite of that, FDA has remained engaged with us on the phase one, sorry, the phase two, pivotal trial for 501A, and those discussions have also been very, very good.
Michael Schmidt: productive; we don't get into the details of regulatory discussions just as a matter of policy, but I can tell you that all the discussions, which included not just clinical discussions and the nature of the clinical trial but also extensive discussions on manufacturing, which, as you know, in this field are quite important, have taken place both for the cell product as well as six four seven, which is, as you know, this development, type, sort of development. So, you know, further than that, I think it would be premature to comment, but with being doubly busy, I would say, with the hold as well as the registration, Great.
Especially FTA has reviewed the data.
When the data that shows.
Significant improvement over what could be considered as a as a standard of care. So I think there are many ways that you can sort of review the different regulatory precedence and our position still stands that in terms of the efficacy of demonstration of our our Aloe Card-key program.
Michael Schmidt: And then a question on Ato-715. I might have missed it, but I'm curious how much additional data you'll be able to share at Ash on the Multimiloma study and whether that will or will not include patients that have received consolidation. In multiple myeloma, we will not include consolidation.
We believe that can be done from a from control single I'm study.
And look on Christopher in the competition, obviously, it's really not are in place to comment on other parties data. We welcome competition. We think competition makes it feel stronger certainly there's plenty of unmet medical need to to support multiple potential entrants allogeneic cell therapy space obviously.
Raphael: That started later, and that will report next year. We will share data with you about a few additional patients or some more patients that have been accumulated since the cut-off that was in June, as well as longer follow-up, both in terms of responses, durability, and MRD-type data. Okay, thank you. The next question comes from the line of John Newman from Mechanic. Hi guys.
Our focus is just on continuing to execute try and leave this field and optimize our first in class products.
Got it thanks, so much.
Your next question comes from the line of solving Richter from Goldman Sachs Airlines melting.
John Lawrence Newman: Thanks for taking the question. I also had a question about the...study in the face, Pivotal Study for 501. Curious, generally speaking, if you would say that, Given the additional data that will be seen at Ash, you believe that the optimal way forward would be consolidation dosing and whether that consolidation dosing would apply to both patients with stable disease after the initial dose, as well as Yeah, hi, this is Rafael.
Good afternoon, Thanks for taking my question.
The investigation I don't know if you can comment whether you've been able to rule anything out at this point and then secondly under multiple myeloma data.
Raphael: I think what I would say to that is that we are encouraged about the consolidation data. It's still early for us to say that, you know, this is going to be a definitive dose. But, you know, as you've heard in the prepared remarks, the data is pretty encouraging with conversions from PR to CRs and VR, as is part of your question, treating patients that have stable disease as well.
Raphael: And so we look forward to updating that at Ash with, you know, additional patients and additional follow-up. Thank you. Next question comes to the line from Lucca EC from RBC Capital. Your line: Oh, great. Thanks so much for taking my question.
Luca Issi: I'll try not to ask questions from the clinical hold. So maybe on the pivotal trial, can you just remind us why you believe that the pivotal trial could be single-arm. It looks like GenMab has started a pivotal trial for CD3, CD20, by a specific antibody head-to-head versus dealer's choice chemotherapy in similar settings. So I'm wondering why that's not the right comparison for us to think about it.
David D. Chang: And then maybe in competition, obviously, we seem to have done that with CRISPR a couple weeks back. I know their data will not be at Ash, but wondering if you have any comment on what your take is on their data set. Thanks so much.
Luca Issi: Okay, Luca, thanks for not asking a question about the FDA clinical trial halls, but your question about the clinical study design and our approach as we prepare for the end of phase one meeting and, you know, in preparation for the pivotal phase two study. You know, we don't want to, you know, go too far ahead of the FDA discussion and make sure that we communicate once we finalize the study design. So there are many aspects.
Luca Issi: I mean, certainly the question around whether we're going to approach it as a single dose or consolidation, I know that it's an outstanding question, and we've been sort of dodging the question. And it's not that we're not dodging because we don't have a position.
And of course.
<unk>.
The clinical hold letter to the FDA.
How long do you anticipate.
David D. Chang: We have a position, but I think it's a little bit ahead of the game for us to talk and communicate about the exact study design and your question around, you know, given the evolving environment in the other heart cancer lymphoma. You know, the question around the single arm versus a control study is a great one, but I think there are enough precedents in terms of how regulatory agencies, especially FDA, have reviewed the data when the data set shows significant improvement over what could be considered a standard of care. So I think there are many ways that you can sort of review the different regulatory precedents.
They're processing that and when you could restart the trials I guess just want to better understand.
When the pivotal trial initiation could could could start following that.
Following response to the FDA.
Yes.
Yes, let me take that question I mean, the questions that you're asking a very important questions.
We are working hard too.
Come to a resolution to the issues related to our clinical hold I mean.
Some of the question at this point.
We don't believe that were going to have to change what we do in the clinical setting.
That months and for that matter.
David D. Chang: And our position still stands that in terms of the efficacy demonstration of our LL, you know, CARCII program, we believe that can be done from an uncontrolled single-arm study. And looking at CRISPR and the competition, obviously, it's really not our place to comment on other parties' data. You know, we welcome competition. We think competition makes the field stronger.
Much of the focus is just generating some additional data too.
Include in our clinical response letter. So that's why we are doing and in terms of the second question about how long it's going to take I mean, I don't want to speak for the FDA. So let's just.
Deferred that to when that happens, but I am just going to add by saying that FDA has been very engaged in this discussion with us.
Luca Issi: Certainly, there's plenty of unmet medical need to support multiple potential entrances into the allergenic cell therapy space. Obviously, our focus is just on continuing to execute, try and lead this field, and optimize our first and class. Got it. Thanks so much.
Thank you.
Your next question comes from the line of Corey CASM of from Jpmorgan. Your line is now open.
Hey, good afternoon, guys. Thanks for taking the questions two from me as well. So first one is with your update today on the Alpha study, saying, 4% to seven patients and consolidation cohort, who about who are evaluable for response or all follicular lymphoma.
Salveen Jaswal Richter: The next question comes from the line of Salveen Richter from Goldman Sachs. Good afternoon. Thanks for taking my question. With regard to the investigation, I don't know if you can comment on whether you've been able to rule anything out at this point. And then secondly, on the multiple myeloma data, are you hitting a plateau here in terms of dose response, just, you know, with regard to dose level four versus dose level three? Any thoughts there would be helpful. Yes, Savin. This is David.
David D. Chang: Let me take the first question, and I'll pass the second question to Rafael. I mean, our investigation has been very active and very productive. We know quite a bit, but we want to follow due process. Our main audience for the investigation is FDA, and until we complete the response letter and come out of the clinical hold, I think it is premature to detail about, you know, what has been done and, you know, where our position is.
David D. Chang: I mean, you know, from our perspective, the path towards lifting the clinical hold is straightforward. I mean, there are some data generation that we have to do, but we see a clear path forward. With regard to multiple malomas, first, we will present data on 320 million and 480 million.
Well two singled out was treatment I kind of what you can learn from that why some will be better with single versus the consolidation is this a marketplace. We think eventually everyone just goes to get consolidation therapy.
Raphael: We don't have any intention of continuing to dose escalate. Whether we've reached a plateau or not, I think, is still premature to tell. You know, with more cells, particularly at the medium doses of aloe 6-7, we see slightly higher.
Yeah. It is true that some patients may new well with single dose.
And we have reported extensively on that on the Alpha study and we will provide an update of those patients.
Raphael: responses with 480, but the numbers are still very small to be able to tell. So I think, you know, the overall answer is that we will probably stop at 480 and analyze the data and then make a final decision as to what the recommended phase two does. Question comes to the line of Jason Gerberi from Bank. Hey, this is Perry on the line for Jason. Thanks for taking our question. I guess just an additional question on the kind of assuming resolution of the clinical holds.
Just belief that the.
The second dose come provide.
An increase in response state right, hopefully durability as well as well.
Show.
More data as I need.
It's really that Delta that we're looking forward in terms of being able to improve of beyond by the scene with the taller with therapy.
So.
Once we make a decision every.
Every patient will be treated uniformly in the fuel cell trial.
Raphael: Do you anticipate any updates to, I guess, screening protocols for this type of, you know, chromosomal abnormality that could happen? Second question, you know, in terms of once you respond to the clinical, the, the, uh, clinical hold letter to the FDA? How long do you anticipate them kind of processing that and when you could restart the trials? I guess just want to better understand when the, you know, pivotal trial initiation could start following that, following response to the FDA? Yeah, Perry, let me take the question.
Thank you.
Your next question comes from the land for Jew Brassard from William their Alliance open.
Thanks for the question I wanted to get your thoughts on two separate topics first.
Kind of piggyback on the last question on consolidation therapy, and Universal trial or.
Sorry, and the GSI and Turbo car.
These are you thinking about consolidation therapy, there or using GSI twice.
And then also wanted to get your thoughts on kind of a transforming during the seven data and how that may pertain to come second line transplant illogical usage, when you get to that level for.
<unk>. Thanks.
Yeah. So the.
Dsi's study.
Perry Ezra Mayo: I mean, you know, the questions that you are asking are very important questions. And, you know, we are working hard to come to a resolution to the issues related to our clinical halls. I mean, some of the questions at this point, we don't believe that we're going to have to change what we do in the clinical setting that much. And for that matter, I think much of the focus is just, you know, generating some additional data to include in our clinical response letter.
Perry Ezra Mayo: So, you know, that's what we are doing. And in terms of the second question about how long it's going to take, I mean, I don't want to speak for the FDA. So let's just, you know, defer that until when that happens. But I'm just going to add by saying that FDA has been very engaged in this discussion with us. Thank you. The question comes to the line from Corey Kazimov from JP.
David D. Chang: Hey, good afternoon, guys. Thanks for taking the questions, too, for me as well. So, first one is, with your update today on the Alpha Study, saying that four of the seven patients and the consolidation cohort who are available for response, we're all fully.
Corey Kazimov: Follicular lymphoma
Raphael: I'm curious in terms of not having valuable LBCL patients yet; is this a function of limited follow-up or Bayfine disease or something else? And then, second question, there are obviously some patients who respond very well to a single-dose treatment. So are there learnings you can take from the initial data as to why that might be or how to determine what patients get consolidation? Or is this eventually a market where you think everybody goes on to get consolidation?
Raphael: Allergenaic therapy. Thank you.
Raphael: Genetic Therapy. Thank you.
Raphael: Yeah, and let me take that question, Corey. So the reason why in the Alpha study, the consolidation patients are in follicular lymphoma is because we've been preferentially channeling the large cell lymphoma patients towards 501A study Alpha II. So there, you know, we've reported the conversion of 3PRs to CRs and, you know, the 67% CR rate, and we will update those results at ARA. And then, can you repeat the second question, please? Yeah, in terms of having patients who respond well to single dose treatment, that kind of what you can learn from that, why some will be better with Singo versus the consolidation. Is this a marketplace? We think eventually everyone just goes to get consolidation.
Tears I'll also talking about consolidation is an approach and there is a lot of good rationale, including very exciting emerging data. So we are encouraged by it but.
Way that we will approach and Tom Clancy.
Consolidation in other programs that really have to depend on evidence based.
Especially with the Turbo car I mean that is a novel technology I mean.
What.
A single infusion October caught construct will do is our key questions. So stay tuned great questions, but.
We will do this step by step manner.
Raphael: consolidation therapy
Raphael: Yeah, it is true that some patients may do well with a single dose, and, you know, we've reported extensively on that in the Alpha study, and we will provide an update on those patients. We just believe that the second dose can provide an increase in response rate and, hopefully, durability as well, as we will show more data at Ash. And it's really the response rate, that delta that we're looking for in terms of being able to improve beyond the scene with autologous therapy.
Raphael: So, you know, once we make a decision, every patient will be treated uniformly in the people's trial. Thank you. Your next question comes on the line for Drew Brassad from William Blair. Are your lines open?
Drew Brassad: Thanks, thank you. I want to get your thoughts on two separate topics. I kind of piggyback on the last question on consolidation therapy. In the Universal trial, I'm sorry, in the GSI and TurboCar therapies, are you thinking about consolidation?
Raphael: therapy there or using GSI twice, and then also want to get your thoughts on the kind of Transform and Zoom to 70.
Raphael: and zoom in on the seven data and how that may pertain to kind of second line transplant eligible usage when you get to that level for L5-1A. Thanks.
Raphael: Yeah, so the GSI study has a period of time during which GSI is administered, so it's not a single dose. And, you know, that study is ongoing. We are accruing, we were accruing up to the whole, and we will resume once the whole is listed, obviously. And then we hope to report next year on that experience. 6.05 had already started. That's the turbo car.
Raphael: And, you know, we were making really good progress in that trial. And again, we will report on that study after we continue to put patients following the hole. So, essentially, you know, the point with GSI is there's a finite period of time where they receive it after receiving cells. And then your additional question, I just wanted to get your thoughts on that.
Any of the learnings that you that you kind of discover here or learned here can kind.
Automatically transfer it to to the China opportunity.
Yeah in terms of the first question I know that that is a central too.
Raphael: on the transform in Zuma 7 data and potential for, you know, CNAC and Allo in Clicking, Al-O in Clicking Lime, Transplant, Eligible patients. Yeah, so...
In a lot of People's mind.
We will not provide any timeline on the resolution of the <unk>.
Raphael: Yeah, so, I mean, obviously, the therapies in the autonomous setting are moving into earlier lines of therapy. This is not a surprise, and, you know, this is obviously great for patients. I think those results were fantastic, and they will have an influence on how we end up developing 501A. You know, we will follow a pathway of starting with relapse-refractory patients, but we have plans for full development of the product. As, you know, time goes on.
The clinical hold.
Right.
Be assured I mean, the teams working very productively for some additional data generation and I think we're in pretty good shape too.
Complete response to the clinical hold.
The question around how long does the FTAA take before they respond to that.
When company respond to the clinical hold letter.
<unk> o'clock for there is a 30 days I mean that is a window during which they would have to respond.
David D. Chang: And clearly, you know, the data, you know, from transform, you know, has been very encouraging for us to really move 501A as well into earlier lines of therapy when the time is right. Let me just add, you know, by saying that we and others, I mean, certainly after we started talking about consolidation, our peers are also talking about consolidation as an approach. And there's a lot of, you know, good rationale, including very exciting emerging data.
They will have to act based on response that the sponsor produces provides to the clinical hold letter.
David D. Chang: So we are encouraged by it. But, you know, the way that we will approach in terms of consolidation in other programs, you know, that, you know, really have to depend on evidence-based, especially with the turbo car.
Raphael: I mean, that is a novel technology. I mean, what, you know, a single infusion of turbo car, you know, construct will do is our key question. So, you know, stay tuned. You know, great questions, but, you know, we will do this step-by-step. Next question comes to the line from Mark Bright and Back from Oppenheimer. Hey, good afternoon.
Mark Bright: Thanks for taking the question. This is kind of related to one of the previous questions, but I guess I'm wondering if before the clinical holds were imposed, you were able to enroll enough patients in the universal neurogasostat combination cohort and the consolidation dosing cohort and even the Ignite study to potentially arrive at some sort of answer in 2022 as to which prong of your multi-prong strategy is working best in myeloma. or if you really think you'll have to enroll additional patients from what you already have in these studies before you'll be able to make any sort of conclusion one way or the other. Thank you. Mark, let me take the question. Obviously, clinical hold, you know, was a big win for us.
Hi, guys. Thanks for taking my questions I wanted to.
Due to as well just to follow up on Ryan's question.
What would you what do you plan on announcing in regarding to the ongoing process I'm wondering with you all announced when you formally submit a response to the Fda's letter.
David D. Chang: I mean, we had to stop enrollment in the clinical study. That will definitely impact, you know, some of the timelines that we have previously communicated. At this point, you know, we are not ready to really talk about, you know, the data flow.
Or any other particular part of the whole process, that's going to happen here and then maybe a.
An academic question, how do you figure out the right window in which to give the second consolidation dose and maintain adequate pressure on on the tumor we noticed you guys could address.
David D. Chang: Much of what you're talking about, including the data from the ignite, our solid tumor study, the turbocard study of ALO605, as well as the combination with GSA, they were all planned in, you know, for 2022. We will make our best attempt to keep the same timeline, but, as expected, the clinical hold is delaying enrollment. Obviously, we cannot enroll any patients and the data generation timeline.
Address that correctly, but there'll be CFO, but maybe the folks at CRISPR wait a little bit too long so as we think about.
We're always having to other tumor types, what's your approach to really figure that out.
<unk>.
Oscar It's Eric let me take the first question on our disclosure strategy.
We aren't intending to give a play by play of day to day activities that allergy and interactions with the FDA I don't honestly think that that suits anyone well, but of course, we're committed to providing updates in a timely fashion when we do something.
David D. Chang: Okay, fair enough. Thank you. Next question comes to the line from my friend, Benjamin. From JMP Security, Eastern Alliance Mobile.
Meaningful and relevant to report so stay tuned.
Benjamin Jay Burnett: Hey, good afternoon, guys. Thanks for taking the questions. David, I know that you mentioned that you didn't want to comment on how long the FDA may take, but could you maybe provide some guidelines as to how long it might take for you guys to respond to the FDA? And I guess just, you know, maybe one for Eric: is there any impact of the clinical hold on the Overland Joint Venture, or do you think any of the learnings that you kind of discover here or learn here will kind of be automatically transferred? Yeah, in terms of the first question, I know that, you know, that is central to, you know, a lot of people's minds.
David D. Chang: You know, we will not provide any, you know, timeline on the resolution of the clinical hold. But, you know, be assured. I mean, the team's working very productively on some additional data generation, and I think we are in pretty good shape to complete the response to the clinical hole. Oh, you know, the question around how long does FTA take before they respond to the, you know, when companies respond to the clinical hold letter, the Purdue clock for there is 30 days. I mean, that is a window during which they would have to respond.
David D. Chang: You know, they will have to act based on the response that the sponsor produces provides to the clinical hold letter. And, Rand, thanks for the question on our Allergy and Overland Joint Venture in China. Obviously, we'll apply any learnings from our interactions with the FDA and our investigation of the chromosomal abnormality to, you know, everything we do going forward. But with regard to specific and direct impact on China and timelines, no, I don't think there is any.
Yeah.
In terms of you know wind.
Eric: That joint venture is proceeding quite well. Obviously, we're still in the phase of building out infrastructure, including a manufacturer's facility, so we can use the time to continue to lay that groundwork and hopefully be ready to conduct tech transfer in the future and as appropriate. Thanks for taking the question. Your next question comes from the line of Benjamin Burnett from Stifle. Yeah, good afternoon. This is Neil Carnahan on for Ben.
The chromosomal abnormality occurred.
That's an important question, but there is a.
We used in our hypothesis that we believe that it.
It is making I would say that this could be from the <unk>.
Gene editing nuclease that we employ for the manufacturing of our car T cells, but equally possible is that this is a more of a natural phenomenon that can occur at some frequency when T cells undergoing expansion. So let me just stop there.
Neil Carnahan: On Allo 501 and the protocol around consolidated dosing, can you remind us what triggers the second dose? Do patients need to achieve a minimum response in order to get a second dose? Yes, that's correct. So the patient has to have stable disease or better to get the second dose. And they also get, as you know, Allo 6 or 7 prior to the second dose if they meet some study criteria. If they progress after the first dose, then they don't go on to get on to get them. Great
Not giving going too much into the details of how much we know at this point.
Yes, and with regards to the trial design as David mentioned before.
These products have been approved based on single arm trials, including.
The most recent ones.
And both in pharma and the most recent one in multiple myeloma.
We believe that.
We will.
Has the same followed the same path, particularly given the fact that we're an off the shelf therapy with vintages. So it's like a wafer aces in their ability to treat every every patient and the differentiation with autologous products. So.
Raphael: Thank you. The next question comes from the line of Astica Guna Wardine from Truist Securities. Your lines now: Hi, guys, thanks for taking my questions. I'm going to do two as well.
At this point.
That is our expectation and our belief that this will be a single arm trial.
Asthika Sarith Goonewardene: Just to follow up on Rand's question, what will you, what do you plan on announcing regarding the ongoing process? I'm wondering what you'll announce when you formally submit a response to the FTS letter or any other particular part of the whole process that's going to happen here. And then maybe an academic question: how can we figure out the right window in which to give the second consolidation dose and maintain adequate pressure on the tumor?
Your next question comes from the line of Robert <unk> from H C. Wainwright. Your line is now open.
Hi, This is Mitchell on for Robert Thank you for taking our questions.
First question is can you comment on any change in development plans after the clinical hold is lifted.
Would there be potentially a faster route to approval with the post car T setting that you anticipate pursuing.
Okay. So in terms of.
Any changes in the clinical study design obviously.
Asthika Sarith Goonewardene: We noticed you guys did address that correctly with LBCL, but maybe the folks that Chris talks to wait a little bit too long. So as we think about rolling this out into other tumor types, what's your approach to really figure that out? Thank you.
We will not go into that kind of detail, but we.
Do a lot of careful thinking before we finalized clinical design and.
Eric: Asakai, it's Eric. Let me take the first question on our disclosure strategy. You know, we aren't intending to give a play-by-play of, you know, day-to-day activities at Allergene and interactions with the FDA. I don't honestly think that that suits anyone well.
We stand by in terms of how we are designing.
Studies to safeguard the patients as well as asking many questions that could advance the field of allogeneic car T therapy.
Raphael: But of course, we're committed to providing updates in a timely fashion when we do have something meaningful and relevant to report. And with respect to the second question, yes, it is a scientific question. For us, one of the key things that we are trying to do with consolidation is to give consolidation without having to give chemotherapy based on lymphodepletion. So if we wait too long and when the patient's cells do recover, I mean, you know, our belief is that you will need both 647, our anti-CD-52 antibody, as well as chemotherapy.
Okay, great. Thank you and then.
For fiber, one <unk> and the data that we could see at the actual ash presentation, what incremental data set can we expect there.
Versus what we have in the abstract.
I think it's.
Hard to sort of.
Speak to that ahead of the Congress I mean, we want to reserve the ability to present this on keep their confidentiality until.
The timing the timelines of the Congress, though.
I apologize for dodging the question, but stay tuned and you will see the you will see the downturn in <unk>.
It's only four weeks from now.
Yeah.
Raphael: I don't think we want to go that direction, which is why we are giving the consolidation right now, essentially between 28 and 35 days after the first cell infusion is given. And I think that really optimizes the cell expansion kinetics, as well as our ability to use only 647 for the second cell infusion. Great, thanks for taking my question, guys. The next question comes from the line of Dane Leon from Raymond James.
Great. Thank you very much.
Your next question comes from the line of <unk> <unk> from B Riley Your line is open.
Yes, hi, good afternoon, thanks for taking the question.
Maybe a little more color on the planned phase two for Allo 501.
I guess, if you were to implement both single and consolidation dosing into your protocol.
Or is it just simply be designed as two separate cohorts I'm just trying to understand if you may need a greater number of total patients or even a larger study.
And what was required if you were to add that extra cohort. Thanks for the question.
Raphael: Thank you for taking the questions, too, for me. Firstly, was the clone with the chromosomal abnormality found in the starting batch material ahead of infusion into the patient? And then the second question I'd like to ask is, do you have any updated clarity on discussions around the
Yes, as I said before I mean, we.
Without going into the details.
How we will define the design the trial and we plan to have us.
Greg women in this study.
So we don't plan to have a single dose and consolidation dose will be.
Dane Leon: on the design of a potential pivotal study for Allo 501A, and whether that study
A single regimen.
In single arm trials, so far.
For us we.
We can go with regards to the study design.
Raphael: whether that study would contain a control arm or would be a single-arm study. Thank you. Okay, Dan, let me take the first question, and I'll ask Rafael to respond to the second one. In terms of, you know, when the chromosomal abnormality occurred, that's an important question. But, you know, there is, you know, a reasonable hypothesis that we believe that, you know, is making us say that, you know, this could be from the gene editing nucleus that we employ for the manufacturing of alilcate cells. But equally possible is that, you know, this is more of a natural phenomenon that can occur at some frequency when T cells undergo expansion.
Your last question comes from the line of Stephen Dye from F&B see your line is open.
Hey, guys. Thanks for taking my questions.
Last question around the Allo 605, the turbo car T could you share with us some of the type of cytokine armory youre using to further improve the shelf.
The activity of the cells and also could you remind us for Europe.
We have a trial a houston consolidation therapy and also are you also combining with GSK for the Allo 605.
Yes.
Total cost study were extremely excited about that.
David D. Chang: So let me just stop, you know, there without giving away or going too much into the details of how much we know at this point. Yeah, and with regard to the trial design, as David mentioned before, these products have all been approved based on single-arm trials, including the most recent ones, both in lymphoma and the most recent one in multiple myeloma. You know, we believe that we will...follow the same path, particularly given the fact that we're an off-the-shelf therapy with the advantages of lack of aphoresis and the ability to treat every every patient and the differentiation with the autologous products, so at this point, that is our expectation, and I believe that this will be a single arm. Our next question comes from the line of Robert Burns from H.C. Wayne Hi, this is Mitchell on behalf of Robert.
The potential of <unk>.
These cars to actually expand the grease exhaustion and have greater anti tumor activity and potentially perhaps be able to use for yourself.
These are cytokine signaling that are generally gamma chain cytokines that are <unk>.
Hoping to T cells.
<unk>.
We haven't gone into the details of the specifics, but you can imagine that these are the kinds of side of guidance of one six to recover homeostasis after LIFO depletion.
We may decide to use GSI.
<unk> been made yet.
In terms of consolidation I think it's premature to tell whether or not we're going to need consolidation or not.
We will know it when we have a little bit more data once we resume the trial.
Okay. Thank you so much.
Thank you that concludes our question and answer session.
Raphael: Thank you for taking our questions. The first question is, can you comment on any change in development plans after the clinical hold is listed? Would there potentially be a faster route to approval with the post-car T setting that you anticipate pursuing?
I'd like to turn the conference back over to management for any additional comments.
Thank you again for joining the call today.
We are deeply committed to patient safety.
Excuse me.
We are deeply committed to patient safety and continuing our work with FDA to find not only the best resolution today, but the best way to move.
Mitchell: Okay, so in terms of, you know, any changes in the critical study design, obviously, we will not go into that kind of detail. But, you know, we do a lot of careful thinking before we finalize the clinical design. And we stand by in terms of how we are designing studies to safeguard the patients, as well as asking, you know, many questions that could advance the field of allergen-a-carcic therapy.
Our field forward tomorrow.
We lead the field in the development of Allogeneic car T products.
Helping novel Science into innovative therapies is not easy, but we are confident that we are the team to bring the first allogeneic car T therapies to patients. We are proud to take the lead to expand boundaries and to revolutionize the future of cancer immunotherapy.
Operator, you may now disconnect.
David D. Chang: Okay, great, thank you. And then for 501A and the data that we could see at the actual Ash presentation, what incremental data set can we expect there versus what we have in the abstract? Yeah, I think it's, you know, It's hard to sort of, you know, speak to that ahead of Congress.
Thank you ladies and gentlemen, thank you for your participation in today's conference call.
This does conclude the program and you even now log off and disconnect.
Okay.
Yes.
Okay.
Okay.
Yes.
[music].
Raphael: I mean, we want to reserve the ability to present this and keep the confidentiality until the time, the timelines of Congress. So, you know, apologies for dodging the question, but stay tuned. You'll see the, you'll see the... And actually, it's only four weeks from now.
Raphael: Great, thank you very much. Your next question comes from the line of Kelpett Patel from B. Riley. Your line is, "Yes, hi, good afternoon."
Okay.
[music].
Kalpit R. Patel: Thanks for taking the question. Maybe a little more color on planned phase two for L0501A. I guess if you were to implement both single and consolidation dosing into your protocol, would it simply be designed as two separate cohorts? I'm just trying to understand if you may need a greater number of total patients or even a larger study than what was required if you were to add that extra cohort.
Yes.
Okay.
Thank you.
Okay.
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Okay.
Yes.
Yes.
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Yes.
Okay.
Raphael: Thanks for the question. Yeah, as I said before, I mean, we, without going into the details of how we will define and design the trial, we plan to have a single regimen in the study. So, you know, we don't plan to have a single dose, and the consolidation dose would be a single regimen and single armed trials. So that's, as far as, you know, we can go with regards to studies. Your last question comes from David Die from SMBC. Reliance on him, nope.
Yes.
Okay.
Okay.
Okay.
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Sure.
Okay.
Okay.
Okay.
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Okay.
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Yes.
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David D. Chang: Hey, guys, thanks for taking my questions. My last question about the Auto 605, the TurboCartee, could you share with me some of the type of the cytokine armory you're using to further improve the cellotoxic activity of the cells? And also, could you remind us about your clinical trial? Are you using consolidation therapy and also combining with GSK for the Auto 605? Yes, so the TurboCard study. We're extremely excited about that.
Right.
[music] coming out.
David D. Chang: The potential of these cars to actually expand, increase exhaustion, and have greater anti-tumor activity and potentially perhaps be able to use fewer cells. You know, these are cytokines signaling that are generally gamma-chain, you know, tritokines that are, you know, tropic to T cells. You know, we haven't gone into the details of the specifics, but you can imagine that these are the kinds of cytokinists that one sees to recover homeostasis after a link for depletion.
Raphael: We may decide to use GSI. That is a decision that hasn't been made yet. And in terms of consolidation, I think it's premature to tell whether or not we're going to need consolidation or not. You know, we will know it when we have a little bit more data.
Raphael: Once we resume the trial, thank you so much. Thank you. That concludes our question and answer session. I would like to turn the conference back over to management for any additional comments. Thank you again for joining the call today. We are deeply committed to patient safety. Excuse me. We are deeply committed to patient safety and continuing our work with FDA to find not only the best resolution today but the best way to move our field forward tomorrow as we lead the field in the development of allergenic carcate products.
Raphael: Developing novel science into innovative therapies is not easy, but we are confident that we are the team to bring the first allogenic carty therapies to patients. We are proud to take the lead to expand boundaries and revolutionize the future of cancer immunotherapy. Operator, you may not disconnect. Thank you, ladies and gentlemen, for your participation in today's conference. This does conclude the program, and you now log off and disconnect. The Bres The
Operator: BF-WATCH TV 2021 Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. The President: Thank you.
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Operator: Thank you. Thank you. Thank you. Thank you. Thank you.
Operator: Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you.
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