Earnings Call Transcript
Allogene Therapeutics, Inc. (ALLO)
Earnings Call Transcript - ALLO Q1 2021
Operator, Operator
Good afternoon, ladies and gentlemen, thank you for standing by, and welcome to the Allogene Therapeutics First Quarter 2021 Conference Call. After the speakers' presentation there will be a question-and-answer session. Please be aware that today's conference call is being recorded. I would now like to turn the call over to Christine Cassiano, Chief Communications Officer. Ms. Cassiano, please go ahead.
Christine Cassiano, Chief Communications Officer
Thank you, operator. And welcome to our first quarter 2021 conference call. After the market closed today, Allogene issued a press release that provides a corporate update and financial results for Q1 2021. This press release and today's webcast are both available on our website. Joining me on the call today are Dr. David Chang, President and Chief Executive Officer; Dr. Rafael Amado, Executive Vice President of Research and Development and Chief Medical Officer; and Dr. Eric Schmidt, Chief Financial Officer. During today's call, we will be making certain forward-looking statements. These may include statements regarding the success and timing of our ongoing and planned clinical trials, data presentations, regulatory filings, future research and development efforts, manufacturing capabilities and 2021 financial guidance among other things. These forward-looking statements are based on current information, assumptions and expectations that are subject to change. A description of potential risks can be found in our earnings press release and latest SEC disclosure documents. You are cautioned not to place undue reliance on these forward-looking statements and Allogene disclaims any obligation to update these statements. As a reminder for this call, we will continue to limit questions to one per person so we can do our best to answer all questions during the hour. I'll now turn the call over to David.
David Chang, President and CEO
Thank you, Christine and good afternoon. We are pleased to provide an update on our progress during the first quarter of 2021, which built on our exceptional performance in 2020. Just days ago we celebrated the third anniversary of Allogene. As I reflected on this milestone, I had many things to be proud of, most importantly each and every patient we had treated so far with our AlloCAR T candidate. From the first patients with relapsed/refractory non-Hodgkin's lymphoma treated with ALLO-501 in 2019 to the side of our first ALLO tumor with ALLO-316 earlier this year, we’re continuing to define, shape and advance the field of CAR T therapy. While the initial standard in this field was set by the groundbreaking of autologous cell therapy, we’re increasingly able to shine a spotlight on the inherent benefits of allogeneic cell therapies and our goal of improving outcomes for our broader patient population. Allogeneic CAR T therapies, of course, also come with inherent challenges. We believe our platform is capable of addressing these challenges and we’re proud to continue advancing the depth and breadth of our pipeline, our next-generation technologies and our state-of-the-art manufacturing capabilities. On the clinical front, we’re expanding our AlloCAR T trials to incorporate new targets, new cancer indications, and new technologies. As we indicated during our last quarterly call, we are targeting this year’s American Society of Clinical Oncology annual meeting for an update on our CD19 program. While Rafael will cover most of what to expect via ASCO during his remarks, I’d like to note that we recognize the importance of this most advanced allogeneic CAR T program in the field and we look forward to discussing not just the data we’ll present as part of ASCO, but also our broader vision for the program during our virtual CD19 forum on May 19. I think it is also important to note that while we’re still treating and collecting data from our ALPHA and ALPHA2 trials, prior to the next phase it remains our goal to advance ALLO-501A to our pivotal phase 2 trial by the end of 2021. We continue to build on the positive momentum from our presentation of the universal trial at last year’s American Society of Hematology annual meeting. Interim findings from this ongoing trial demonstrated for the first time that an allogeneic CAR T therapy directed at BCMA can achieve clinical responses in heavily pretreated patients with refractory multiple myeloma while eliminating both the need for bridging therapy and treatment delays associated with autologous CAR T manufacturing. Our recent Regenerative Medicine Advanced Therapy or RMAT designation for ALLO-715 was supported by our proof-of-concept data. We’ve continued to execute on our three-pronged BCMA strategy in multiple myeloma. Through our collaboration with SpringWorks Therapeutics, we’ve started dosing patients in the combination arm of the universal trial to evaluate ALLO-715 in conjunction with SpringWorks investigational gamma secretase inhibitor, Nirogacestat. In addition, we’ve received IND clearance for ALLO-605, our eagerly awaited first TurboCAR candidate and remain on track to initiate our phase 1 IGNITE trial in the coming month. We’re excited about the potential of each approach to deliver a meaningful result for these patients. I’ll let Rafael dive into the details of these innovative approaches designed to further advance the potential of AlloCAR-T therapy in myeloma. While our initial candidates target blood cancers and follow in the footsteps of autologous CAR-T therapies, we’ve begun to place new trials in solid tumors. We’re very excited to be dosing patients in the TRAVERSE trial with ALLO-316, which targets CD70 for the treatment of renal cell carcinoma. We believe demonstration of activity in this setting has the potential to accelerate the development of CAR-T therapy in solid tumors and significantly advance the trajectory of allogeneic CAR-T. We look forward to executing this study. From our first days in Allogene just three years ago, controlling our own manufacturing has been core to our vision of ensuring that our therapies are available and accessible to eligible patients within a matter of days. Under the skillful leadership of Dr. Alison Moore, our Chief Technical Officer, we’re well on our way to achieving that goal. We believe producing our AlloCAR-T therapies at Cell Forge 1, our state-of-the-art manufacturing facility in Newark, California will allow us to scale production, control costs, and equally importantly continually improve and enhance the quality of the product. We’ve begun engineering runs at our new facility and are on track to initiate GMP production later this year. As we execute towards a new vision for CAR-T therapy—one that allows us to embrace the inherent benefits afforded to an off-the-shelf therapy, including the ability to treat every eligible patient, the ease with which to consolidate therapy, and the potential to extend access into community settings—we’re excited about what is to come and the role we’re playing in redefining the future of this therapeutic modality. I’ll now turn the call over to Rafael for further updates on our research and development activities.
Rafael Amado, Executive Vice President of Research and Development and Chief Medical Officer
Thank you, David. Our research and clinical teams have been pursuing numerous projects all aimed at strengthening our current AlloCAR-T pipeline and platform and preparing to meet future challenges in extending the potential of allogeneic cell therapy. Last week, we were pleased to announce that we will be presenting updated data on the phase 1 ALLO-501 study together with initial results from our ALLO-501A study at ASCO. The update on ALLO-501 will include longer term follow-up from the 22 patients that were initially reported at ASCO 2020. In addition, we will provide information on additional patients treated subsequent to ASCO 2020 with a particular focus on CAR-T naïve patients. As part of this update, we’re doing our best to break down responses between follicular lymphoma and large B-cell lymphoma. Initial data from ALLO-501A also include those reported on the phase 1 dose escalation portion of this trial. Recall that the objective of the dose escalation phase was designed to quickly confirm that the findings in ALLO-501 translate into ALLO-501A prior to advancing this concept forward into a potential pivotal phase 2 study. For that reason, this trial focuses on a homogenous population with large B-cell lymphoma. Dose escalation was completed late last year and as such, the duration of follow-up will be limited in the ALPHA2 trial. More recently, we’ve begun treating patients in ALPHA and ALPHA2 under our consolidation dosing regimen. This regimen allows patients who have not progressed after an initial dose of therapy to receive a second scheduled administration of CAR-T cells with the goal of improving or extending the response. Our ASCO presentation will include results on the first few patients treated with consolidation therapy, although the duration of follow-up will, as a result, be shorter. ASCO will also feature a separate presentation on the safety and biomarker data on ALLO-647. As you’re aware, ALLO-647 is a key component of our platform and we believe that it enables a differentiated approach for including patients in our trial. We look forward to reporting data for our CD19 program later this month. Given that the ASCO meeting is just weeks away, we will not be discussing any further details between now and the presentation and do hope that you will join us at our CD19 forum on May 19. The structure of ASCO as a virtual meeting will allow us and a select group of clinical trial investigators to discuss the full set of clinical results being presented at the conference and provide the Allogene team with an opportunity to share our vision for the future of allogeneic CAR-T therapy. As David mentioned earlier, we’re pleased with the progress we’ve made across our multi-pronged BCMA strategy for relapsed/refractory multiple myeloma. An important program is ALLO-715, which received RMAT designation from the FDA following updated proof-of-concept data presented at the universal trial. We continue to enroll patients in this trial and, as we announced a few weeks ago, we’ve begun treating patients in the combination arm of the study, which is evaluating ALLO-715 in combination with Nirogacestat, an investigational gamma secretase inhibitor being developed by SpringWorks Therapeutics. Last month, we also announced progress in the third prong of our myeloma strategy with IND clearance for ALLO-605, our first TurboCAR candidate. We’re very excited about ALLO-605 as we prepare to launch the phase 1 IGNITE trial and learn more about how this proprietary next-generation technology performs in the clinic. As you may recall, TurboCARs are designed to provide selective programmable cytokine signaling into CAR-T cells in order to counter T cell exhaustion, inhibit T cell function and potentially reduce cell dose requirements. Should ALLO-605 demonstrate the benefit of this technology, we would look forward to the potential of applying it across our platform. We feel confident in the approach to maximize the benefit rates of allogeneic cell therapy and deliver a much-needed alternative to patients with multiple myeloma through progressive cell treatment. Lastly, but definitely not least, we’re excited to extend our AlloCAR-T platform into solid tumors. Earlier this year, we began dosing patients in our first solid tumor trial, ALLO-316, targeting CD70. This diverse trial is enrolling patients with advanced or metastatic renal cell carcinoma and is designed to explore various ALLO-316 trial doses. The endpoints will assess our safety, tolerability, depth and duration of lymphodepletion, cell expansion and antitumor activity. Given the high prevalence of RCC and the lack of new treatment modalities for patients with advanced disease who have failed standard therapy, we look forward to working closely with leading kidney cancer centers and cell therapy specialists to explore allogeneic cell therapy in patients with renal cell cancer as a potential meaningful treatment option. Beyond this trial, we’re leveraging internal innovation to expand the utility of our TurboCAR technology platform. The clinical data presented at the 2021 American Association for Cancer Research annual meeting demonstrates the ability to engineer inducible TurboCARs that confer cytokine signaling upon binding to PD-L1 and PD-L2 in the tumor microenvironment or when stimulated with an anti-PD-L1 antibody. In addition to supplying cytokine signaling, this TurboCAR is designed to enhance the therapeutic index of AlloCAR T cells within an immunosuppressive solid tumor microenvironment. As our clinical work proceeds, we remain committed to our deep pipeline and broad research to make allogeneic CAR T therapy the modality of the future. Now I’d like to turn the call over to Eric to review our financials.
Eric Schmidt, Chief Financial Officer
Thank you, Rafael and good afternoon everyone. During the first quarter, we made substantial progress in setting up our China joint venture Allogene Overland Biopharm by establishing governance and building corporate infrastructure. Financially, we recognized collaboration revenue of $38.3 million in the first quarter of 2021, reflecting the majority of the upfront payment we’ve received from the joint venture. We ended the quarter with $964 million in cash, cash equivalents and investments. In the first quarter of 2021, our research and development expenses were $55.2 million which includes $7.9 million of non-cash stock-based compensation expense. General and administrative expenses were $16.4 million for the first quarter of 2021, which includes $8.9 million of non-cash stock-based compensation expense. Our net loss for the first quarter of 2021 was $33 million or $0.25 per share, including non-cash stock-based compensation expense of $16.8 million. As mentioned last quarter, we expect to support five clinical trials during 2021, including the start of a potentially pivotal trial for ALLO-501A. We’re also looking forward to initial GMP production at our Newark manufacturing facility known as Cell Forge 1, which will require substantial incremental investment in R&D. We continue to expect full year GAAP operating expenses to be between $300 million and $330 million including estimated non-cash stock-based compensation expense of $80 million to $90 million and excluding any impact from potential new business development activities. With that, we’ll now open the call for your questions.
Operator, Operator
Our first question is from Salveen Richter with Goldman Sachs. Please go ahead with your question.
Salveen Richter, Analyst
Good afternoon, thanks for taking my question. As we look to this CD19 event around ASCO and you look at all the levers together, how do we think about whether there is enough information on consolidation and 501A to get a picture of what the go-forward is or do you think that will take more time to evolve, given the durability that you mentioned earlier on when these trials started?
David Chang, President and CEO
Good afternoon Salveen, David Chang here. Let me take that question and I may ask Rafael to chime in a bit. Certainly, the questions you’re asking are very important. On data hand we’re very close to May 19 when we are planning to have that day where we will detail all this information. Throughout the development of 501 and 501A, we have been carefully advancing the program asking many important questions including the cell dose and also trying to optimize the lymphodepletion which we believe is very important to allow allogeneic CAR T-cells to function. And given the uniqueness of allogeneic in terms of the benefit of re-dosing and others, we also investigate re-dosing including the consolidation which is the sort of delayed regimen of how we are investigating different levers. So, from all these aspects, the way that we are envisioning is that the 501 study, which has been going on for a longer period than the 501A, will generate the most informative dataset on the durability of the response. When it comes to 501A, the primary objective of the 501A study is to ensure that 501A behaves similarly to 501. Additionally, we layered additional questions about whether consolidation can deepen the response. There will be many different pieces of information included in our CD19 presentation. For that reason, we specifically arranged for the CD19 day where we can detail the complexity of the data that may not be so apparent in a traditional scientific presentation. So yes, Salveen, I know that I did not directly answer your question, but I feel confident that as we have done in our other presentations, we will provide a very informative set of data during our CD19 day.
Salveen Richter, Analyst
Thank you.
Operator, Operator
Thank you. Our next question comes from Marc Frahm with Cowen & Company. Your question, please.
Marc Frahm, Analyst
Oh yes, thanks for taking my question. David, as you just mentioned that one of the bigger unnoticed rates is that durability of the responses that we followed last year and in that ALLO-501 can generate. So, when we focus on the kind of higher dose of ALLO-647 going forward. I believe there are eight patients a year ago with that dose. Should we think about that in the bulk of determining that durability or is there really a large number of patients coming forward? And then, given we think about comparing it to autologous, should we really be looking at, they reported the potency of the cells with reported kind of durable response rates on can 10 to three basis that they tend to be reported on or do you think we need to look at it more holistically, kind of the overall treatment process?
David Chang, President and CEO
Yes. Thank you for asking both important questions. First of all, in terms of how to better assess the durability, I suggest that we wait till the CD19 day, but ultimately when it comes to durability, we will be presenting all the available data including the patients that were part of the Vascular 2020 presentation as well as additional patients that we have treated since. In ALLO-501, this has been a really great opportunity for us to learn so many different aspects of allogeneic cell therapy that we didn’t know. With the number of patients that we have treated, we have a lot of confidence about the dataset that we have generated. So, that’s about it. The second question regarding ITT versus mITT is very important. This has been part of an ongoing debate in the cell therapy field since 2016. I recall the AACR meeting when Chris Zomato asked a question about whether mITT is the right way to assess the benefits of CAR T therapy. Since then, we have come a long way. As we advance allogeneic CAR T therapy, we feel there is an opportunity to correct the incorrect use of mITT to assess the clinical benefit in favor of a more robust ITT assessment. This will be an important aspect and we will gradually address this at the CD19 day.
Marc Frahm, Analyst
Okay, thank you.
Operator, Operator
Thank you. Our next question comes from Kelly Shi with Jefferies. Your question, please.
Kelly Shi, Analyst
Hi, hello. Congrats on the progress and then thank you for taking my question. My question's also regarding the consolidation regimen in ALPHA trial. I want to confirm so far all the patients have been treated the way the two doses are at a 120 million cells. And also, do you have a plan to actually increase the dose, and are we going to have data on T-cell dynamics and the biomarker studies for the re-dosing cohort at ASCO? Thank you.
David Chang, President and CEO
Kelly, again you're asking all the right questions. In terms of the number of patients that we have dosed in the consolidation, I'm going to defer to the CD19 day. But let me ask Rafael to go through the design and the objective of consolidation and what we expect during the CD19 day. We are learning quite a bit from the consolidation regimen. Rafael?
Rafael Amado, Executive Vice President of Research and Development and Chief Medical Officer
Yes. The concept of consolidation is really to drive deep and durable antitumor response using a second dose that's scheduled with ALLO-501. As you know, when we take patients who achieve complete response or PR after the initial treatment, they will receive this second dose. We provide 120 million cells on Day 0 and again on Day 30 after the scan is done. We’re providing this second dose without chemotherapy and we will enumerate the number of patients that we've been able to treat through both follicular and large B-cell lymphoma during the CD19 day and provide you with some details regarding its performance, acknowledging that the follow-up is relatively short. I’ll emphasize that the reason we are pursuing this is to capitalize on the versatility of allogeneic cell therapy to see whether the 60+% of patients that benefit in this autonomous setting can be further reduced using allogeneic therapy. We will have initial data focusing on the biomarker as well, including expansion and trafficking, and we will drill down on some of these biomarkers. We link other patients on the consolidation with the second dose only if they meet certain hematologic parameters prior to dosing. So you will definitely see this status on May 19th.
Kelly Shi, Analyst
Thank you very much.
David Chang, President and CEO
I would also add that from our perspective, in any Phase 1 study, especially with consolidation, the consolidation portion is key. Early evaluations will also be important if there is anybody who only achieved partial or stable disease during the first cell therapy. Can they achieve complete responses with the second cell infusions? So, there are things that we can figure out pretty quickly, and we will present a number of patients as well as what we are observing with the consolidation regimen.
Kelly Shi, Analyst
Very informative, thank you David.
Operator, Operator
Thank you. Our next question comes from Michael Schmidt with Guggenheim. Your question, please.
Michael Schmidt, Analyst
Hi, guys. I actually had one question regarding the BCMA program. Perhaps if you could comment on how you're tracking in the universal study towards potentially identifying the recommended Phase 2 dose and protocol, and also if you could comment on how the consolidation treatment concept has been incorporated into that study. Thanks, so much.
David Chang, President and CEO
Michael, thanks for the question. As you know, BCMA is an important part of our development program. We are making an exceptional approach towards BCMA by advancing different approaches including combination therapies as well as moving forward with our next generation. In terms of 715, we're excited about the RMAT designation based on the data presented at ASH last year. In terms of the questions, I’m going to ask Rafael, who has spent a lot of time on the BCMA program, to answer.
Rafael Amado, Executive Vice President of Research and Development and Chief Medical Officer
Sure. My goal is to continue to treat patients in the 715 program. We are producing more than one lot and evaluating different doses of 615 and T-cell dosages. This program is very vibrant and, frankly, the investigators are appreciating the reduced patient wait time and no bridging. As David mentioned, we presented updated data from March to submit for RMAT. We're excited that the agency recognized the potential benefit of this therapy. We are executing on this and also very excited to initiate 605. The consolidation has been incorporated as an amendment in the 715 study and we expect to be enrolling on that arm quickly. It’s a comprehensive program that spans CAR, combination treatment with neuro-gas and use of TurboCAR technology. We look forward to presenting updated data by Q4 on all aspects as they accumulate.
Michael Schmidt, Analyst
Thank you.
Operator, Operator
Thank you. Our next question comes from John Newman with Canaccord. Your question, please.
John Newman, Analyst
Hi, guys. Congrats on all the progress. Thank you for taking my question. The question is also regarding the universal program. I'm curious about, as I think you mentioned just a moment ago, Rafael that you are looking at some different dose levels for 647. I wondered regarding Nirogacestat, if you're also planning on looking at different dose levels or potentially different dose schedules? I'm just curious if we might explore perhaps giving another dose of Nirogacestat for patients that undergo consolidation. Just curious about it, thanks.
David Chang, President and CEO
Rafael?
Rafael Amado, Executive Vice President of Research and Development and Chief Medical Officer
Yes. We haven’t disclosed the doses we are using for Nirogacestat. Over 100 patients have been treated with our product in interim studies. There’s a solid understanding of safety parameters at various doses. We are working with SpringWorks to determine the dosage and schedule while ensuring treatment durability. Beyond that, we think we have covered the timing that's important for BCMA expression to be as high as possible.
John Newman, Analyst
Great, thank you.
Operator, Operator
Our next question comes from Cory Kasimov with J.P. Morgan. Your question, please.
Cory Kasimov, Analyst
Hey, good afternoon, guys. Thanks for taking the question. I wanted to ask about your solid tumor program, ALLO-316. So, I know that you're just getting off the ground. But as we think ahead to future updates and data releases here, how should we be thinking about the program and preliminary results relative to what you've been able to show in hematologic indications given this is a little more uncharted territory with presumably a different bar for proof-of-concept? I'm wondering if there's any aspects of the data that will guide you to push ahead with what you have or requires tweaking the approach. Thanks a lot.
David Chang, President and CEO
Hi, Cory, that’s a great question. For the past 2.5 years, we have focused so much on hematologic cancers, but I believe solid tumors offer the greatest opportunity with any innovative therapy, as the unmet need is high despite advances, and cure is rare. A one-time treatment or a few treatments of cell therapy could significantly change that trajectory. ALLO-316, which is our CD70 directed CAR T program, was prioritized largely based on the safety margin regarding the target, as CD70 expression in normal tissue other than some hematopoietic cells is extremely rare. Hence, we believe this can be safely administered. We must validate this through clinical trials. Ultimately, we want to determine if it works alone or in combination with I-O regimens for solid tumors. Before assessing tumor reduction, many important questions must be addressed, including how CAR T-cells expand in patients with solid tumors and whether engineered cell therapies can penetrate into the tumor and elicit the expected pharmacodynamic response. These layers of questions will be addressed by our translational research team. We are excited about advancing this program, and while we are initially targeting renal cell carcinoma, this target could have utility in many solid tumor indications as well as hematologic malignancies. We just started the study and hopefully by early next year, we will be able to update you and the rest of the field on how our CAR T program is performing within tumors. We plan to put more emphasis on solid tumors moving forward, as we see great opportunity.
Cory Kasimov, Analyst
Great. Thanks David, very helpful.
Operator, Operator
Thank you. Our next question comes from Luca Issi with RBC Capital. Please go ahead.
Luca Issi, Analyst
Hello, thanks very much. Congrats on the progress here. Maybe you want to circle back on Marc's question earlier. I think the last time I checked, Zoom reported a six-month response rate of 33% on an ITT basis and 36% on a modified intent-to-treat population. I know the right benchmark we should have in the back of our mind is we will see this data. And maybe it will lead you to it. Should the data be a bit shy of this number, do you think that some doctors will still be willing to compromise the rate of efficacy for all the benefits associated with Allogene? Maybe for those patients who are autologous and this is simply not an option. Any color there will be great, thanks so much.
David Chang, President and CEO
Luca, I have to say we are asking the same questions and are beginning to discuss them with physicians. Let me ask Eric to provide more context.
Eric Schmidt, Chief Financial Officer
Yes, thanks Luca. I appreciate the question and your interest in our views here. I think our May 19 CD19 Forum is expected to clarify this question in context with the actual data and how we size things up relative to the autologous products. You will have a lot more clarity there. I do think the ITT and mITT analyses and numbers you provided are in the right ballpark, as we see things quite consistently. However, in terms of outlining our strategy and where we're heading, particularly in maximizing the benefits of off-the-shelf characteristics of an allogeneic product, we feel we have unique leverage.
Rafael Amado, Executive Vice President of Research and Development and Chief Medical Officer
Additionally, we are trying to achieve with allogeneic cell therapy is the ability to treat every eligible patient—a facet that autologous CAR T therapy hasn’t been able to do. By treating every eligible patient, we inherently enhance the data from ITT analyses rather than simply compromising the efficacy analyses using modified intent to treat.
Luca Issi, Analyst
Got it. Thanks so much, very helpful.
Operator, Operator
Thank you. Our next question comes from Mark Breidenbach with Oppenheimer. Your question, please.
Mark Breidenbach, Analyst
Hey, thanks for taking my question. I certainly appreciated Rafael's earlier comment that you'll be breaking down response analysis in the ALPHA study by histology. I'm just wondering if patients who are enrolled into the ALPHA study more recently were enriched in any way for large B-cell lymphomas? Or will the proportion of patients with indolent versus more aggressive NHL remain similar to what we saw last year at ASCO?
David Chang, President and CEO
Rafael, could you respond?
Rafael Amado, Executive Vice President of Research and Development and Chief Medical Officer
Yes, I would say that we will have a sizable population of both histologies. Unlike ASCO 2020, we actually have more patients this time around, allowing us to draw meaningful conclusions. We will be able to separate the data to analyze by histology, and you should expect to see this at the upcoming May 19 meeting. The 501 study allows both histologies, whereas 501A is tailored primarily for large B-cell lymphoma, as that’s the product we intend to commercialize. We follow specific algorithms for patient distribution across studies, and we now have more patients that will help illustrate the trends.
Mark Breidenbach, Analyst
Okay, fair enough. Looking forward to the 19th.
Operator, Operator
Thank you. Our next question comes from Ben Burnett with Stifel. Your question please.
Ben Burnett, Analyst
Hey, thank you very much for taking our question. You guys are holding the ALLO-501 company event on the day that ASCO abstracts are released. I think this is clearly something that we're all looking forward to. This just seems a bit different from how you held these events in the past, where they were typically aligned with the presentations at the medical meeting. I guess I'm curious as to why you're choosing to hold this event early ahead of the ASCO meeting?
David Chang, President and CEO
Ben, thanks for that question. Times are different, with virtual meetings becoming the norm, and we are learning as we prepare for each meeting. This is something we consider in advance of making this decision, but let me ask Christine, our Chief Communications Officer, to respond to your question.
Christine Cassiano, Chief Communications Officer
I'm actually really happy that you've asked this question because it has been posed often. While you're in person, this aspect is quite different; the embargo lifts when the abstracts come out. Companies have the option to focus just on the abstracts or to release all data. We decided to take this opportunity to stay out of the rush of full conference activities and host our event on the 19th, allowing us to dedicate substantial time to provide an update on the program.
Ben Burnett, Analyst
Okay, I appreciate your thought process there. Thank you.
Operator, Operator
Thank you. Our next question comes from Dane Leone from Raymond James. Your question, please.
Dane Leone, Analyst
Hi, thank you for taking my questions, and congratulations on all the progress. I want to ask a question about the TurboCAR program, which may not have received as much attention but you are moving into clinical studies, which is exciting for 605. The question is, we don't have a one-to-one comparison, but we do have some idea about utilization of the CAR-T and the CD19 space with PDL1 via the Zuma-6 study and a few others. I wanted to get your thoughts in understanding how your team designed the program, considering the safety components. Generally, it seems like the sequencing or actual overlap of using PDL1, at least in the ALLO-CD19 CAR-T setting, has been acceptable but there have been some events. I'm curious about your thoughts on the safety components of that design.
David Chang, President and CEO
Thanks for asking this important question. Safety, in the context of Turbo, involves various unknowns. We are managing this in a carefully orchestrated manner. The first program, ALLO-605, is a relatively straightforward approach where we provide programmable cytokine stimulation to the cells. This is intended to enhance the cell's fitness by providing signal three during the activation process. Preclinical results indicate these cells are much less prone to exhaustion and in xenograft studies, we have not only achieved tumor size reduction but complete eradication, which is rare in the CAR-T therapy setting. At AACR, we discussed a newer version we are designing, leveraging TurboCAR technology to potentially convert negative signals like PDL1 and TGF Beta into positive stimuli for the cells. This dual approach helps CAR-T cells function better in solid tumor environments by providing cytokine signaling while neutralizing negative signals. We will initially find data from 605, with more to come through this innovative platform. Stay tuned.
Dane Leone, Analyst
Thank you.
Operator, Operator
Thank you. Our next question comes from Randy Benjamin with JMP Securities. Your question please.
Randy Benjamin, Analyst
Hey, good afternoon everyone. Thanks for taking the questions. I guess I'd love to get a little more color or an idea of the biomarkers that you were focusing on for ALLLO-647. Is this primarily concerning patient selection or why is that a central focus as part of that poster presentation? And at the risk of the answer being 'let's wait until May 19', if I could follow that with a totally separate question. Regarding consolidation, have you thought about maintenance therapy? Given that the second dose of consolidation doesn’t involve chemotherapy? Any thoughts regarding maintenance therapy going forward?
David Chang, President and CEO
Well, I think I'd hire you to be part of our research and development team. You're asking all the right questions. Rafael, please answer.
Rafael Amado, Executive Vice President of Research and Development and Chief Medical Officer
Yes, those are two really good questions. With regards to 647, we have data suggesting that we can assess the ability of 647 to deplete CAR-T cells through C62, which isn't normally present on hematopoietic precursors except for T cell precursors. We have noted that the deeper and longer T cell depletion correlates with lower rejection of cells while also allowing for needed expansion. Knowing this correlation informs how we tune these cells. We also examine markers on expansion and persistence, which hinge on successful outcomes. We correlate these PK/PD markers to overall clinical responses, completing this basic biomarker array during the ongoing trial. Regarding chronic or maintenance therapy, we haven't ventured deeply into that yet. We're still focused on consolidation and will see what findings emerge before deciding on optimal doses and schedules for Phase 2.
David Chang, President and CEO
I will add that we've made a focused decision around the consolidation portion by utilizing ALLO-647 without chemotherapy. This decision derives from the PK/PD analysis we've gathered. Regarding how we're moving towards patient selection, it feels too early. The goal of this analysis is to best utilize 647 safely for its intended purpose of lymphodepletion.
Randy Benjamin, Analyst
Got it. Thank you very much.
Operator, Operator
Thank you. Our next question comes from Raju Prasad with William Blair, your question please.
Raju Prasad, Analyst
Thanks for the question, and congrats on the progress. I had a question on the RMAT designation for 715. Does that encompass the Nirogacestat arm and how are you planning to approach or leverage that designation in advancing that arm of the trial? And I have a regulatory-related follow-up question. How should we think about maybe applying for designation for ALLO-501A? Are you waiting for perhaps consolidation therapy and maybe moving into pivotal before applying for that? Thanks.
Rafael Amado, Executive Vice President of Research and Development and Chief Medical Officer
Sure. The RMAT designation for 715 primarily encompasses the data presented at ASH with some additional updates. We're pleased to see that the agency recognized this product's value, particularly the doses demonstrating significant efficacy including GPR and complete responses. Discussions that took place between the agency and our sponsors were productive, so we think we'll take advantage of this designation as we further develop the BCMA product. Regarding 501A, we initiated this program later. As such, we have more data on 501, but we don't intend for 501 to be the commercial product. Therefore, we are not seeking RMAT or other designations for 501. We will pursue it with 501A; however, we started the dose escalation later last year, and while we finished it, the follow-up time is limited. We plan to let the data mature before we decide whether to approach for designation. The sooner we do it, the better; however, it depends on data maturity.
Raju Prasad, Analyst
Great, thank you.
Operator, Operator
Thank you. Our next question comes from Asthika Goonewardene with Truist Securities. Please go ahead.
Asthika Goonewardene, Analyst
Hi guys, thanks for taking my question. I just want to get a quick sense check. Your data suggests that the upfront response may be a key driver of durability and log cell. Can you share where you think there's published data that suggests this is often the case in follicular lymphoma? Or is persistence more pivotal in this setting? Lastly, did I hear Rafael correctly that we will see MRD negative data at the CD19 deck? Thanks so much, guys.
David Chang, President and CEO
Regarding deep response, that aligns with basic cancer treatment principles. The more cancer cells killed increases the chance of potential eradication. The field has shifted perspectives from controlling progress to focusing on upfront treatment specifications, which are critical for maintenance therapy. While the behavior of large B-cell lymphoma may mirror follicular lymphoma, we ought to wait for the data to mature—especially with Kite's study which had a three-year follow-up timeline. As for MRD response, Rafael, would you like to comment?
Rafael Amado, Executive Vice President of Research and Development and Chief Medical Officer
Yes, we’ve been following MRD response in an ongoing manner in our lymphoma program. It isn't standard in a series for aspects like leukemia or myeloma, but we have gathered this data and will share our current status alongside the set of data presented at the upcoming conference.
Asthika Goonewardene, Analyst
Great. Thank you very much.
Operator, Operator
Thank you. Our last question is from Rob Burns with H.C. Wainwright. Your question, please.
Unidentified Analyst, Analyst
Hi, this is Mars speaking on behalf of Rob Burns. Thanks for taking my question. In anticipation of data from the universal trial assessing 715, I was wondering if you could provide any indication as to whether the higher dose 715 plus 647 cohort is showing an improvement in response versus your data presented in previous conferences?
David Chang, President and CEO
Yes, Rob, your question wasn’t crystal clear. But I think the inquiry pertains to whether the higher dose 715 with higher lymphodepletion presents better outcomes. We addressed this minimally during the ASH presentation last year, and certainly, we are conducting further investigations. We plan to offer updated data at the next opportunity which we project will arrive towards the end of the year.
Unidentified Analyst, Analyst
Thank you.
Operator, Operator
Thank you. And this concludes our Q&A session. I will pass it back to management for any final remarks.
David Chang, President and CEO
Alright, thanks. As we close out the call, I would like to thank everybody who joined us today as well as our teams at Allogene, and our many patients, investigators and collaborators. As we discussed throughout the call, please join us on May 19 for our Virtual CD19 Forum. We look forward to seeing you then. Operator, you may now disconnect.
Operator, Operator
Thank you. Ladies and gentlemen, thank you for your participation in today's conference. This concludes the program and you may now log off and disconnect.