Atara Biotherapeutics, Inc. (ATRA)
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Earnings Call: Q4 2019

Feb 27, 2020

Operator

Good morning, ladies and gentlemen, and welcome to the Atara Biotherapeutics Q4 and full- year 2019 financial results conference call. At this time, all participants are in a listen-only mode. Later, we will conduct a question- and- answer session, and instructions will follow at that time. If anyone should require assistance during the conference, please press star then zero on your touchtone telephone. I would now like to turn the conference over to your host, Dr. John Craighead, Vice President of Investor Relations and Corporate Communication of Atara Biotherapeutics. Please go ahead.

John Craighead
VP of Investor Relations and Corporate Communication, Atara Biotherapeutics

Thank you, operator. Good morning, everyone, and welcome to Atara's Q4 and full- year 2019 conference call. On today's call, we will provide an update of our clinical, operational, and strategic progress, as well as review our upcoming milestones and key objectives for 2020. Earlier this morning, we issued a press release providing an overview of the company's Q4 and full- year 2019 financial results. This press release and an updated investor presentation are available in the investor and media section at atarabio.com. Joining me on today's call are Dr. Pascal Touchon, President and Chief Executive Officer, Utpal Koppikar, Chief Financial Officer, and Joe Newell, Chief Operations Officer, and Dr. AJ Joshi, Chief Medical Officer. We begin with prepared comments from Pascal, and then open the call for your questions. We'd like to remind listeners that during the call, the company's management will be making forward-looking statements.

Actual results could differ materially from those stated or implied by our forward-looking statements due to risks and uncertainties associated with the company's business. These forward-looking statements are qualified in their entirety by the cautionary statements contained in today's press release and the company's SEC filings. These statements are made as of today's date, and the company undertakes no obligation to update these statements. Now, I'd like to turn the call over to Atara's President and Chief Executive Officer, Pascal Touchon.

Pascal Touchon
President and CEO, Atara Biotherapeutics

Thank you, John, and thanks to all of you for joining us this morning. 2019 was a year of strategic prioritization and significant advancement of our T-cell immunotherapy programs. I would like to highlight that we've made important progress on our four strategic priorities. We have also extended our cash position into Q2 2021, and we continue to leverage our tab-cel experience to advance our innovative off-the-shelf T-cell immunotherapy platform. Building on the significant progress and momentum, let me start by reviewing the recent highlights and anticipated milestones for tab-cel. We are currently conducting a phase III clinical trial with tab-cel in patients with Epstein-Barr virus or EBV associated post-transplant lymphoproliferative disease or PTLD, in a relapsed refractory setting. Atara remains on track to initiate a tab-cel BLA submission to the FDA in the H2 of 2020.

We currently have 38 sites in the United States and Australia actively enrolling patients and are preparing to open additional sites in the U.S., Canada, and Europe. Toward this end, we submitted clinical trial application or CTA to several European countries in November and December of 2019, which will allow us to open clinical site in Europe in 2020. We are excited as we recently received CTA approval in the U.K., Austria, and Spain. These additional sites are being added to support full enrollment of the phase III study. However, they are not necessary to meet the number of patients required for the planned phase III interim analysis. Indeed, as I just mentioned, we continue to be on track to initiate a tab-cel BLA submission for patients with EBV-positive PTLD in the H2 of 2020.

We plan to hold a pre-BLA meeting with the FDA prior to this submission, during which we will discuss the totality of tab-cel data we and our academic collaborators have generated, including the phase III HCT and SOT cohorts, Memorial Sloan Kettering phase II studies, and our Expanded Access Program. As a reminder, we most recently presented data from this EAP in December 2019 at ASH annual meeting. These data comprise long-term clinical results for 61 patients with diverse EBV-associated diseases, including efficacy and safety data for 26 patients with relapsed refractory EBV-positive PTLD, and safety findings for 35 patients with other EBV-associated disease. The data demonstrate that tab-cel was generally well-tolerated in all patients participating to this study.

Importantly, in a subgroup of 22 patients with EBV-positive PTLD who would have likely met eligibility criteria for the ongoing tab-cel phase III study, the overall response rate for the HCT cohort was 55%, with a two-year estimated overall survival of 79%. For the SOT cohort, overall response rate was 82%, and two-year estimated overall survival was 81%. We also engage in multiple activities designed to expand access to tab-cel for patients in Europe. Atara recently submitted a pediatric investigation plan, or PIP, to EMA. Following EMA approval of the PIP, Atara plans to submit the tab-cel EU marketing authorization applications for patients with EBV-positive PTLD in 2021. The clinical data generated to date with our EAP and SPU programs also support the potential of tab-cel as a transformative therapy in several other EBV-associated diseases.

In the H2 of 2020, we expect to initiate enrollment of a tab-cel phase II clinical study, including up to six additional ultra-rare EBV-positive disease. In addition, we have enrolled the final planned patients in a phase I-B portion of a phase I-B/II clinical study of tab-cel in combination with anti-PD-1 therapy in patients with platinum-resistant or recurrent EBV associated nasopharyngeal carcinoma NPC. Prior to starting the phase II portion of the study, we will evaluate the initial results of this phase I-B, as well as a relapsed/refractory NPC clinical landscape. I will now turn to ATA188, or allogeneic T-cell immunotherapy for the treatment of patients with progressive multiple sclerosis. Recall that at ECTRIMS 2019, we reported encouraging early data from a phase I-A multi-center open label dose escalation study evaluating the safety and efficacy of ATA188 in patients with progressive form of MS.

Safety results showed that across the four dose cohorts, ATA188 was well-tolerated in patients with progressive MS. We reported at six months follow-up in the lowest dose cohort, one of six patients with clinical improvement using the criteria we define at ECTRIMS. This improvement was also maintained at 12 months. In cohort 2, two out of six patients reached clinical improvement at six months. We recently selected the cohort 3 dose to initiate the randomized double-blind placebo-controlled phase I-B part of this study. Our decision to initiate the phase I-B was based on achieving in cohort 3 of predetermined criteria of an acceptable safety profile and three out of six patients achieving clinical improvement at six months for more than one clinical study site.

Looking ahead, we expect to present updated clinical data at appropriate forums, including six months follow-up for all cohorts in Q2 2020, and 12 months follow-up for all cohorts in the H2 of 2020. Additionally, we recently retreated the first patients in the open label extension portion of the phase I-A study, which is designed to allow patients who complete one year in a dose escalation portion of the study to be retreated annually using the cohort three dose for up to four years. We are also on track to initiate enrollment of a randomized placebo-controlled phase I-B ATA188 study in the Q2 or Q3 of 2020. Site activation for this study is in process, and we are expecting an increased number of leading MS centers to participate in the U.S. and Australia.

In addition, Atara and leading experts recently published a review article in Trends in Molecular Medicine regarding the mechanistic connection between EBV infection and MS. Now, let's discuss our EBV CAR-T platforms. At the 2020 Transplantation and Cellular Therapy meeting last week, an academic team presented a clinical study in patients with relapsed/refractory B-cell malignancies treated with an off-the-shelf allogeneic CD19 CAR-T made from primary donor or partially HLA-matched third-party donor EBV-T cells. In this first human study with these EBV CD19 CAR-T cells, investigators observed durable complete responses for five out of six patients who received partially HLA-matched EBV CD19 CAR-T cells manufactured from third-party donors. No cytokine release syndromes or neurotoxicity above Grade 2, and no dose-limiting toxicities were observed post-infusion with multiple EBV CD19 CAR-T doses. Also, no confirmed GvHD was observed in patients who received third-party donor EBV CD19 CAR-T cells.

Importantly, investigators also observed durable complete response CR with median follow-up of 26.9 months for five out of six patients who received partially HLA-matched EBV CD19 CAR-T cells manufactured from third-party donors, including four out of four responses in patients with NHL, one out of one response in patient with CLL, and 100% survival with NHL and CLL. Findings from this study provide initial clinical proof of principle that an EBV-T cell platform has the potential to generate off-the-shelf allogeneic CAR-T immunotherapies with high and durable responses, low risk of toxicity, and rapid delivery to patients. We continue to make progress in advancing our multiple CAR-T therapeutic candidates. We expect that our collaborators at MSK will submit an IND to the FDA in the Q2 or Q3 of 2020 for ATA2271 An autologous mesothelin-targeted CAR- T in patients with advanced mesothelioma.

This program incorporates next-generation technologies, including a novel co-stimulatory domain, 1XX, that may offer greater persistence and more physiologic T- cell signaling, as well as a PD-1 dominant negative receptor that is designed to provide intrinsic checkpoint inhibition and unlock the solid tumor microenvironment. Furthermore, we have started pre-clinical IND-enabling studies for ATA3271, an off-the-shelf allogeneic EBV mesothelin-targeted CAR-T with the same next gen CAR-T technologies as ATA2271. In addition, we have started pre-clinical IND-enabling studies for ATA3219, an EBV CD19 targeted CAR-T that incorporates 1XX. We believe Atara's off-the-shelf allogeneic EBV CAR-T platform is differentiated and has tremendous potential as an engine for continued innovation, leveraging favorable EBV T cell safety, expansion, trafficking, and persistence characteristics.

Our dedicated facility in Thousand Oaks has the flexibility to produce multiple T-cell and CAR-T immunotherapies and integrates pre-clinical and translational research, process science, quality control, and regulatory CMC capabilities under one roof. Such close integration enables a rapid development and scale-up of robust manufacturing processes to support our potential current and future clinical and commercial demand. The efficiency of our manufacturing platform capabilities has recently been demonstrated with significant improvement in our manufacturing yield with tab-cel. Our commercial stage process is now enabling us to make over 400 doses from a single donor leukapheresis. Over time, we believe our commercial manufacturing process will allow for cost of goods profile similar to those of Biologics. In addition, with our lead program already in phase III and T-cell manufacturing commercial validation activities progressing well, we are creating a significant competitive advantage for Atara in off-the-shelf allogeneic T-cell immunotherapies.

Not surprisingly, we are seeing a strong level of interest from potential partners to access our off-the-shelf T-cell platform. We also see opportunities for potential partnership with the current product portfolio. On the operational front, earlier this month, we are pleased to welcome Kristin Yarema as a new Chief Commercial Officer. Dr. Yarema brings extensive hematology, oncology, neuroscience, and autoimmune disease commercialization experience to Atara, which are very valuable as the company advances commercialization activities for tab-cel. We also created a Chief Operations Officer role to continue to drive operational excellence across the company program and platform, and have appointed Joe Newell, Atara current Chief Technical Operation Officer, to this new role. Turning to our financial positions, we extended our cash runway into the Q2 of 2021.

We ended 2019 with cash equivalents, and short-term investment totaling $259.1 million as compared to $282.9 million as of September 30, 2019. Of note, pro forma cash and investments as of December 31, 2019, including ATM and option exercise proceeds from January 2020, was $282.7 million. In closing, the progress we made in 2019 has positioned us well for tremendous success this year. Delivering on key milestones for tab-cel, our lead pipeline candidate, and further advancing other promising programs through the hard work of all Atara's employees. I'll now turn the call back to the operator to begin the Q&A portion of the call. Operator?

Operator

Ladies and gentlemen, if you have a question at this time, please press the star then the number one key on your touch-tone telephone. If your question has been answered or you wish to remove yourself from the queue, please press pound key. Your first question comes from the line of Phil Nadeau with Cowen and Company. You may ask your question.

Phil Nadeau
Analyst, Cowen and Company

Morning. Thanks for taking my questions, and congrats on the progress. Just a couple on tab-cel. First, since you're guiding to having a pre-BLA meeting in the H2 of this year and starting the filing even later in the H2 of this year, it would seem that you've sufficiently enrolled enough patients for the interim analysis. Is that accurate?

Pascal Touchon
President and CEO, Atara Biotherapeutics

Thank you, Phil, for your question. We are not making any comment on the enrollment at this stage. We confirming our guidance that we plan to initiate filing of the BLA in the H2 of 2020 following a pre-BLA meeting with the FDA, where we'll present the totality of data.

Phil Nadeau
Analyst, Cowen and Company

What's your most recent thinking on when you'd publicly release the data from the interim analysis? Is that likely to happen with the filing, or would it be sometime later?

Pascal Touchon
President and CEO, Atara Biotherapeutics

As we said, we plan to, of course, present this data on the study at an appropriate congress. We do not intend to do that before the filing, and we want to preserve the integrity of what is an open clinical study, where we will start to initiate the filing with an interim analysis of the data. We'll certainly discuss with the FDA during a pre-BLA meeting what is the best way to be able to communicate this data in due time. At the same time, the initiation of the BLA filing by itself is a material event, so we'll indeed communicate publicly that we have initiated the BLA filing.

Phil Nadeau
Analyst, Cowen and Company

Great. Last question from me is on the requirements for completing the filing and starting the PDUFA time clock. Do you think you'll be in a position to clarify what those requirements are at the time of the BLA filing, at the time of the initiation and filing? Will even more and subsequent discussions happen with the FDA once the initial filing is made as to exactly what will be necessary to get the PDUFA time clock started?

Pascal Touchon
President and CEO, Atara Biotherapeutics

When we will communicate about the initiation of the BLA filing, we will be, hopefully, able to give more details on that particular BLA filing and hence about what is the anticipated time of completion.

Phil Nadeau
Analyst, Cowen and Company

Got it. Perfect. Thanks for taking my questions.

Operator

Your next question comes from the line of John Newman with Canaccord. You may ask your question.

John Newman
Analyst, Canaccord

Hi, guys. Good morning. Thanks for taking my questions. Just curious, it sounds like you have been adding additional trial sites for tab-cel. Just wondering if you have a target number in mind for the total number of sites that you would like to have open and actively enrolling patients.

Pascal Touchon
President and CEO, Atara Biotherapeutics

Thank you, John, for your question. AJ, do you want to take that one?

AJ Joshi
CMO, Atara Biotherapeutics

Sure. I think, first- off, as you know, we have 38 sites open in the U.S. today. It's important to note that those 38 sites are the number that's necessary to achieve that interim analysis time point so that we can have the initiation of the BLA in the second half of 2020. In terms of Europe, Canada, and other sites, I can give you a general sense that in Europe, we'd enroll probably up to about 24 sites.

John Newman
Analyst, Canaccord

Okay, great. Then in terms of the data that are coming this year for ATA188 in MS, how should we be thinking about kind of the key points from that data? I know that you have sort of a different way of looking at the efficacy based on a composite. Just curious as to how we should be thinking about the efficacy when you give us data with the six and 12-month follow-up there.

AJ Joshi
CMO, Atara Biotherapeutics

Sure. In the H1 of 2020, we should expect six-month data on all four cohorts, and then also 12-month data on the first three cohorts. We've talked about the types of analyses that we do, and the way we describe the initial data was really meant for signal-seeking and making decisions about the trial. As you know, we've achieved our goal in the phase I study, which is safety and the decision to move forward with a cohort 3. We do expect to present some additional composite disability measures in that H1 2020 timeframe, as well as the second half.

John Newman
Analyst, Canaccord

Okay, great. Thank you.

Operator

Your next question comes from the line of Matt Phipps with William Blair. You may ask your question.

Matt Phipps
Analyst, William Blair

Good morning, yeah. Thanks for taking my questions. First, I guess, follow-up on Phil's question. Really the next kind of material disclosure we get on tab-cel then would be the initiation of the rolling submission. Is that correct? Or could there be a material update ahead of that?

Pascal Touchon
President and CEO, Atara Biotherapeutics

Our current plan is, as I say, to communicate what we believe will be a material update, i.e., the initiation of the BLA filing in the H2 of 2020.

Matt Phipps
Analyst, William Blair

Got it. Thanks. Then just two other questions on the pipeline, I guess. You mentioned the final patient was enrolled in the nasopharyngeal carcinoma study. Is it possible we see results later this year, or is that something for early 2021? Then I realize this is an investigator-sponsored study, but do you anticipate MSK providing an update on the first-gen mesothelin CAR at some point this year? I know they've been enrolling patients beyond mesothelioma as well. Just curious if you've had any discussions with them on their plans there.

Pascal Touchon
President and CEO, Atara Biotherapeutics

Okay. Thank you, Matt. First question, AJ.

AJ Joshi
CMO, Atara Biotherapeutics

Sure. Matt, regarding the NPC study, we've enrolled, as you indicated, we enrolled the final patient in the phase I-B portion of the study. Our anticipation is we're going to evaluate the results and actually the entire NPC landscape, because as you know, that whole treatment landscape has been evolving. As the results mature and we assess the landscape, we'll then make decisions as to the appropriate forum to present those assessments.

Pascal Touchon
President and CEO, Atara Biotherapeutics

Second question, regarding the first-generation mesothelin CAR- T, as you said, this is an investigator-initiated study. What we understand is that the investigator is continuing to follow up with patients and are also including additional patients in that study. We understand the intent of the investigator at the appropriate stage to communicate further results of that study in a congress. We cannot comment at this stage on which one or when exactly that will occur, but that's certainly the plan of the investigator.

Matt Phipps
Analyst, William Blair

Okay. Thanks for taking my questions.

Operator

Again, ladies and gentlemen, if you have a question at this time, please press the star then the number one key on your touch-tone telephone. If your question has been answered or wish to remove yourself from the queue, please press the pound key. Your next question comes from the line of Salim Syed with Mizuho Securities. You may ask your question.

Salim Syed
Analyst, Mizuho Securities

Hey, guys. Thanks so much for taking my questions, and thanks for all the color as usual. Just a few from me on the multiple sclerosis program. AJ, did I hear you correctly in saying that we're going to be getting 12 months data, either at AAN or EAN for the cohort 3?

AJ Joshi
CMO, Atara Biotherapeutics

In terms of 12-month data in the H1 of 2020, absolutely, we would be getting 12-month data through cohorts 1 through 3.

Salim Syed
Analyst, Mizuho Securities

Okay. For all six patients in that cohort?

AJ Joshi
CMO, Atara Biotherapeutics

Yes.

Salim Syed
Analyst, Mizuho Securities

Okay. When we're thinking about ATA188, because I know this was something that came up at ECTRIMS last year, are you guys still thinking here that we're going to need 12 months data for investors to really diligence the ATA188 efficacy profile? Or will six months data be enough when we're going into AAN and EAN, wherever you present the data, will that be enough of a time duration to diligence this data set?

AJ Joshi
CMO, Atara Biotherapeutics

I think when you take a look at, certainly in all MS studies, you like to see some duration of response. Like anything else, 12 months is better than six months. When we talk about the ultimate proof of concept, that certainly is going to come at the one-year endpoint of the phase I-B randomized portion. Certainly, the 12-month data off of this portion of the study would provide good additional support, I think.

Salim Syed
Analyst, Mizuho Securities

Okay. Lastly from me, on the redosing for multiple sclerosis, are you guys expecting upon redosing at the one-year time point and the two-year time point, further improvement in disability or some sort of plateauing?

AJ Joshi
CMO, Atara Biotherapeutics

We don't really have data to suggest one way or the other. Obviously, we'd love it if we have further improvement. I think the most important thing is whatever improvement we achieve, if you're able to maintain that is already a major win in progressive MS. That should be our baseline that we work off of.

Salim Syed
Analyst, Mizuho Securities

Okay, excellent. Thanks so much.

Operator

Your next question comes from the line of Ben Burnett with Stifel. You may ask your question.

Ben Burnett
Analyst, Stifel

Oh, hi. Thanks for taking my question. This is a question regarding CAR-T. How has the Memorial Sloan Kettering study impacted your thinking on lymphodepletion and whether or not this needs to be done, and to what extent you think this could be done in the outpatient setting?

Pascal Touchon
President and CEO, Atara Biotherapeutics

Thank you for your question. I think as you know, this study that was presented last week is an academic study in 10 patients. That study has gone for some time with different type of lymphodepleting regimen used in these patients. We do not think we can draw a conclusion right now on what will be possible, if any, lymphodepletion regimen for ATA3219. This is something that we plan to study in our first human study. However, what we're going to do is to work with MSK on this particular set of data that they have, and more particularly on samples that they have of blood marrow and blood, to be able to better understand the expansionist persistence of the EBV CAR- T CD19 T- cells in these patients and see whether there is any relationship whatsoever with the lymphodepleting regimen that they've had.

That will be informative for us as we design the protocol of our first human study with ATA3219.

Ben Burnett
Analyst, Stifel

Okay, perfect. Just one more question on ATA2271. What's gating for the mesothelioma IND submission? Are there any plans to develop this in addition in solid tumors outside of mesothelioma?

Pascal Touchon
President and CEO, Atara Biotherapeutics

Thank you. There is no particular gating. It's just the time needed to put together all the data. Things are on track, progressing well, and of course, there will be the time then to submit that IND. As we said, it will be done by our collaborators at MSK in the Q2 or Q3 of 2020. The first in human with this very innovative construct of CAR- T is going to be in advanced mesothelioma, but we are already discussing with investigators about the possibility to use this construct, this new CAR- T, in other type of solid tumors that are overexpressing mesothelin, and particularly so ovarian cancer and pancreatic cancer.

Ben Burnett
Analyst, Stifel

Okay, perfect. Those are all my questions. Thank you.

Operator

Your next question comes from the line of Anupam Rama with J.P. Morgan. You may ask your question.

Tessa Romero
Analyst, J.P. Morgan

Hi guys. Good morning. This is Tessa Romero on the call today for Anupam Rama. Thank you for taking our questions here. Perhaps I could ask about your most up-to-date thoughts on the market size for the initial EBV positive relapsed/refractory PTLD indication in the U.S., and then maybe ex-U.S. as well in key geographies. Then how are you thinking about sort of the size and scope of sales infrastructure to sort of address the patients globally? Thanks so much.

Pascal Touchon
President and CEO, Atara Biotherapeutics

Thank you very much for your question. As we already indicated, we believe that in the U.S., the setting of our studies that could lead to a potential indication in relapsed/refractory PTLD is an ultra-rare disease, which means that we believe there are several hundred patients in the U.S. that could benefit potentially from tab-cel. We believe also that a similar number exists in Europe, and also a similar type of number exists in the rest of the world beyond the United States and Europe. This is an ultra-rare indication. This is our first indication for tab-cel that we hope will be followed by several other indications.

As we confirm today, we're going to start in the H2 of 2020 enrolling the multi-cohort study with up to six types of ultra-rare disease that could lead to up to six additional indications there that are going to increase the size, we believe, by at least a factor of four of the population that could be treated efficiently by that cell. In terms of the commercial organization that is needed there, this being an ultra-rare disease and having no other treatment approved today for that disease, we believe that the commercial organization that will be needed to make sure that patients can access that cell is of limited size. It will be typical of an ultra-rare disease type of commercial organization.

Tessa Romero
Analyst, J.P. Morgan

Okay, great. Thank you so much for taking our question.

Operator

Your next question comes from the line of Maury Raycroft with Jefferies. You may ask your question.

Farzin Haque
Analyst, Jefferies

Hi. Good morning. This is Farzin on for Maury. The MSK data looked quite promising, especially on the overall survival aspects. How confident are you that the non-standard conditioning lymphodepletion contributed to the survival benefit?

Pascal Touchon
President and CEO, Atara Biotherapeutics

Again, this study is, we believe, a clinical proof of principle that the EBV-based CD19 CAR- T allogeneic off-the-shelf, as the six patients where the cells were coming from third-party donors are demonstrating, is feasible, is safe, and is effective. There are a limited number of patients, we recognize that, as well as different type of disease. Altogether, the comprehensive nature of this data are a clear clinical proof of principle that allogeneic off-the-shelf CD19 EBV CAR- T are, again, safe and effective. We are particularly encouraged by the long-term durability of the response. If you think about five out of six patients with CR and pCR being durable with, in fact, survival following the follow-up of 26.9 months, survival of 100% in the patient with NHL and CLL, these are very encouraging data about the effect of this allogeneic off-the-shelf EBV CD19 CAR- T.

Farzin Haque
Analyst, Jefferies

I see. Thank you. Have you considered what conditioning regimen and variables you are going to do in your Atara-run study, and which ones you should focus on?

Pascal Touchon
President and CEO, Atara Biotherapeutics

First of all, what we're going to bring to the clinic is a different product. This is ATA3219, which is also based on EBV T- cells, but using Atara own process and especially using a new costimulatory domain, 1XX, which is there to bring potentially increased persistence of the cells and less exhaustion of the T- cells. That's a different product. Of course, we'll be informed in our first human study protocol and follow-up by the experience that this academic team has obtained with this construct, which is again, a different product from ATA3219. That's why we say that this is a clinical proof of principle, but ATA3219 is really the product we are supporting the development of.

We have started, as we said, preclinical IND-enabling studies for that product to bring it to the clinic as soon as possible, and to be able to prove the concept of our EBV T cell CAR T platform, and the ability to treat patients safely, effectively, with an off-the-shelf treatment that could be available within days to patients.

Farzin Haque
Analyst, Jefferies

Thank you.

Operator

Your next question comes from the line of Tony Butler with ROTH Capital. You may ask your question.

Tosh Dowling
Analyst, ROTH Capital

Hey, good morning. This is Tosh Dowling for Tony here. Just a quick question on 3219 in continuation of your latest comment.

Based on the learnings from the TCT Congress data, do you have any specific plan as to what kind of population that you'll be targeting with, say, CLL/NHL versus ALL?

Pascal Touchon
President and CEO, Atara Biotherapeutics

We are not communicating at this stage what will be the protocol and the type of patient we'll address in our first in human, but we'll do so at the appropriate time. Clearly, we believe that there is a medical need today that still exists in the population of NHL patients, CLL patients, ALL patients. We will allow ourselves to decide at the time we enter the clinic where we want to focus, but we believe that ATA3219 has the potential to bring significant benefit to patients.

Tosh Dowling
Analyst, ROTH Capital

Thank you. That helps.

Operator

Your next question comes from the line of Yigal Nochomovitz with Citi. You may ask your question.

Samantha Semenkow
Analyst, Citi

Hi, this is Samantha on for Yigal. Thanks for taking our question. I wanted to sort of build on a prior question on the EBV CAR- T study presented at TCT. Can you talk about any other differences outside of the 1XX stimulatory domain that ATA3219 will have versus the CAR T used in that study? With these differences between the two products, what should we think about the read-through in terms of the data that was presented there and the differences you think might show up in your clinical program?

Pascal Touchon
President and CEO, Atara Biotherapeutics

A few things. First of all, what we're doing with ATA3219 is to develop a product through a proper manufacturing process and development phase. This will not be an academic type of study. It will be Atara's study developing that particular product. The differences that we anticipate at this time is mainly the difference in the costimulatory domain, as well as in the manufacturing process to have a product that not only allows us to prove in a clinic, potentially safety, efficacy, and persistence and durability there, but also this is helping to build a platform of allo CAR- T. You know, ATA3219 is just one of the allogeneic EBV-based CAR- T that we are developing and advancing that through pre-IND enabling studies. IND first in human is going to help us to continue to progress with our platform.

We've made significant progress about it, and we're going to leverage that progress. Two key differences will be 1XX and the manufacturing process, and we believe that in particular, 1XX is going to bring some significant potential advantage. In preclinical studies, this particular costimulatory domain has shown that is indeed inducing less exhaustion of the T- cells and more persistence. That's something that is certainly going to bring some potential benefit. At the same time, the fact that we built a robust manufacturing process allowing us not only to make allogeneic CD19 CAR- T based on EBV T cells, but other type of allogeneic CAR- T based on EBV T cells, will be something very important there. There were some particular details in the presentation of the academic team last week.

Just to give you an example, the level of CAR T-cell transduction that they had at 20.5% is something that we believe can and is to be improved by our manufacturing process, as well as the yield, the possibility to make significant number of doses from one leukopak. As you know, recently we've announced that with tab-cel, which is at the beginning the same type of process where we harvest cells from healthy donors, we select and activate these cells. We are now able to make 400 doses from one leukopak. This type of efficiency of our manufacturing process is what we want to see in the manufacturing of ATA3219.

The preclinical stage we are at right now is indicative that we are on the right track in terms of making, not only rapidly bringing the product to the clinic, but also manufacturing this product in a very efficient way.

Samantha Semenkow
Analyst, Citi

Got it. Thank you for all that detail. Very helpful. That sort of leads into my other question. When we think about your CAR-T pipeline long term, should we anticipate you using the EBV CAR-T platform that you mentioned you're building out here? You had a comment about partnering potential. Is it this platform that you're thinking about versus, say, like the partnership with MSK for the ATA2271?

Pascal Touchon
President and CEO, Atara Biotherapeutics

Thank you for your question. Our current pipeline in CAR- T in terms of strategic priorities is having two allogeneic CAR- T based on EBV T-cells, ATA3219, that is in preclinical IND-enabling studies, and ATA3271, the mesothelin-targeted allogeneic CAR T that is also in preclinical IND-enabling studies. These are the two that are the most advanced. We have also activities with our collaborators at Memorial Sloan Kettering, as well as at Moffitt Cancer Center in Tampa, where at the earlier stage, we have some exciting type of CAR T that are being developed, and these are developed first by these academic collaborators as autologous CAR T, and once we are moving into a full development, we're going to, as usual, develop an allogeneic version based on EBV T-cells.

What we've built is a true allogeneic CAR T platform based on these EBV T-cells, and this is an allogeneic CAR T platform that benefits from the work we've done on tab-cel as well as the work we're doing on ATA188. There is a clear correlation between these. We have the most advanced allogeneic T-cell immunotherapy with tab-cel, as it is now in phase III, and we don't know any other that is in phase III at this stage right now. We have a robust manufacturing process there. We're going to leverage that, and that's what we're doing every day, our team is doing every day in our manufacturing unit. Leveraging that experience to make a robust and efficient process for allogeneic CAR T based on EBV T-cells.

Getting your question on partnering, as we said, we have a very advanced platform for allogeneic CAR T, so that's why there is strong interest regarding the possibility to partner around this platform, to be able to create, develop, and make allogeneic CAR Ts. At the same time, we also open the discussion on partnering other assets of our pipeline.

Samantha Semenkow
Analyst, Citi

Got it. Thanks very much for taking the question.

Operator

I'm showing no further question at this time. I would now like to turn the conference back to Pascal Touchon.

Pascal Touchon
President and CEO, Atara Biotherapeutics

Thank you very much, operator. Thank you very much for being there today for our conference. Clearly, we are making significant progress. This is an exciting time for all of us at Atara, and I am very pleased to have had the opportunity to review our recent accomplishments and discuss our upcoming milestones for 2020. We have a great deal of momentum coming into 2020, and I look forward to updating you on our continued progress in the months ahead. We aim at transforming the lives of many patients in need across various serious diseases, and this is possible only for the contribution of many individuals to whom we are very thankful, including our shareholders, our committed employees, our clinical investigators, our academic collaborators, and of course, all the patients that are participating in our studies. Thank you very much.

Operator

Ladies and gentlemen, this concludes today's conference. Thank you for your participation, and have a wonderful day. You may all disconnect.