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EARNINGS CALL TRANSCRIPT
EARNINGS CALL TRANSCRIPT 2020 - Q4
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Operator

Ladies and gentlemen, thank you for standing by and welcome to Adaptimmune Conference Call. With that I will turn the call over to Juli Miller. Ma'am you may begin..

Juli Miller Vice President of Corporate Affairs & Investor Relations

Good morning and welcome to Adaptimmune's conference call to discuss our full year and fourth quarter 2020 financial results and business update. I would ask you to please review the full text of our forward-looking statements from this morning's press release.

We anticipate making projections during this call and actual results could differ materially due to a number of factors, including those outlined in our latest filings with the SEC..

Adrian Rawcliffe Chief Executive Officer, Principal Accounting Officer & Director

Thanks Juli and thank you everyone, for joining us. Three months ago during our investor day I laid out plans to deliver transformative value for patients and for investors over the course of the next five years, our 2-2-5-2 plan.

In concrete terms this means two products on the market targeting MAGE-A4, two additional BLAs from our clinical pipeline as well as five autologous and two other generic products entering the clinic in the next five years.

All this is based on an integrated cell therapy company with the intent and capabilities to discover, develop and deliver products that are both curative and mainstream. At the JP Morgan conference last month we outlined the key catalyst for 2021 and beyond which will be the mile markers on the road to our 2-2-5-2 ambitions.

And I'm absolutely delighted every time I say this we aim to launch our first product next year.

As you know not many biotechs get to this stage and it is hugely motivating for our research and development teams to know that ADP-A2M4 the treatment they discovered and developed through clinical trials may soon be delivered to transform the lives of people with sarcoma. The launch is our first building block of our 2-2-5-2 plan.

The next key dates when we aim to release data at ASCO and CTOS and these data will be used to support the registration and approval of ADP-A2M4.

In 2021 beyond our BLA and launch readiness we will also focus on firstly initiating a phase 2 trial with our next generation MAGE-A4 targeted product for people with either esophageal or esophagogastric junction cancers in the first half of this year.

Secondly, treating patients in the ongoing phase one SURPASS trial that also uses our next generation MAGE-A4 targeted product.

We're focused on indications where we've seen signs of efficacy with our MAGE-A4 program namely lung, head and neck, gastroesophageal and bladder cancers and we aim to report updated data from the SURPASS trial at ESMO this year. Thirdly, treating patients in our phase 1 ADP-A2AFP trial with plans to report data at ILCA.

We will also determine the next steps for this product and lastly continuing our research work to bring new products to the clinic including HLA independent TCRs, next generation TILs and next generation spear SPEAR T-cells targeting additional HLAs..

Operator

Thank you. Our first question comes from the line of Tony Butler with ROTH Capital. Your line is open. Please go ahead..

Tony Butler

Good morning. Thank you very much for taking the question. Elliot, Adrian I wanted to actually touch on commercial readiness given that you were moving forward in with SPEARHEAD 1 and then I have one follow-up on the clinical program. Thanks a lot..

Elliot Norry Chief Medical Officer

Okay. Thanks Tony. Thanks for the question.

As we're preparing to be able to launch ADP-A2M4 for synovial sarcoma on approval which we anticipate to be next year and clearly we've been in the process of planning for that for some time and 2021 is the year where we are committing to both the BLA filing which will happen in 2022 and starting to build the commercial presence and I think I have said before this is a perfectly sized opportunity for a company like Adaptimmune because of the very concentrated nature of the patient and physician for treating footprint here and we are obviously talking to many of those centers and sites as part of the clinical development.

So it's important that we build something that is focused on delivering for the synovial sarcoma community but also critically scalable for the other indications that will be coming down the pipe in due course obviously starting with esophageal and gastroesophageal junction for which we're starting the phase 2 trial now.

And I think that the scope for commercialization for a cell therapy is obviously quite broad and it covers all of the usual things that you would anticipate for a normal commercialization of a product patient and physician research and all of that's been ongoing for a while but it also covers I think the importance of patient services aspects from our supply chain organization and we think about how to develop those from the clinical state whether we've been operating to date including for the pivotal trial through to something that is fit for purpose for commercial and we'll have more to say about that and other aspects of it as we go through the year.

It's such a diverse type of stuff that you have to do, I mean from the large things that I have just mentioned but all the way through to relatively small things.

I mean just a couple of days ago we got the generic naming confirmed for ADP-A2M4 for synovial sarcoma which will be called and it's just accumulation of lots of activity and lots of small and large milestones along the way that's going to ensure that we're able to get there and I want to just say that I think our ability to do that will be largely based on the fact that we're specialized in this space, knowledgeable in this space and we've built the integrated capabilities to enable us to be able to do this..

Tony Butler

Thanks very much. I did want to follow up on two clinical, short clinical questions. Number one is our patients still being dosed with the AFP SPEAR T-cells? That's one.

And number two on the phase 2 SURPASS 2 study which starts the first half of this year and SURPASS 1 correct me if I'm wrong you already have 17 sites at least according to clinicaltrials.gov.

Are all those 17 sites going to then switch over to dose 4 SURPASS 2? How will those be split up or will there be new sites that have already been recruited for SURPASS 2? Thank you..

Adrian Rawcliffe Chief Executive Officer, Principal Accounting Officer & Director

Thanks Tony. I'm going to ask Elliott to answer both of those questions. Please Elliot..

Elliot Norry Chief Medical Officer

Yes. So the first question, thank you Tony. The first question was around whether we're still dosing patients in the ADP-A2FP liver cancer directed trial and the answer is yes.

We're dosing patients in the expansion phase of that trial and there's an intent to provide an update with respect to patients dosed and direction at the International Liver Cancer Association Conference in the third quarter.

With respect to SURPASS sites and SURPASS 2 many of the sites will that are in the SURPASS trial will be engaged in the SURPASS 2 trial as well but there will be differences as well. We will be, we're going to be adding new sites and also expanding geographies as well.

I don't think that we've got it specifically to the exact number but those will be specifically gastrointestinal focused sites while the SURPASS trial also includes sites that are focused on a broader range of tumor types.

But we're going to leverage our experience from phase 1 into phase 2 those centers that are enrolling well we certainly would want to have in phase 2 and we will have to make that transition for those tumor types from enrolling in the phase 1 trial into the phase 2 trial.

That will be the intention once that trial is open is to enroll the phase 2 trial..

Tony Butler

Elliott thank you. Adrian appreciate it..

Adrian Rawcliffe Chief Executive Officer, Principal Accounting Officer & Director

Thanks Tony..

Operator

Thank you. And our next question comes from the line of Kenneth Atkins with Cowen & Company. Your line is open. Please go ahead..

Kenneth Atkins

Hi guys. Thanks for taking my question.

Could you comment on the breakdown of the enrolled patients in SPEARHEAD 1 between synovial sarcoma and MRCLS and how many patients in each category do you think you would ultimately need to support licensure in each indication?.

Adrian Rawcliffe Chief Executive Officer, Principal Accounting Officer & Director

So I will say that just to say that we haven't guided us to patients in either in category and how that allocation split out other than to say that we believe that there will be significantly more synovial sarcoma patients than MRCLS patients..

Kenneth Atkins

Got it.

Okay and then assuming that ADP-A2M4 is successfully developed for refractory sarcoma, how much of a priority is moving that product into the frontline setting? Do you think ADP-A2M4 has the right profile or would you want to explore next gen product for frontline use?.

Adrian Rawcliffe Chief Executive Officer, Principal Accounting Officer & Director

Elliot do you want to comment on?.

Elliot Norry Chief Medical Officer

Sure. So I think that it certainly could be used in a frontline setting either in sequence with chemotherapy or upfront. It will never be for every patient with sarcoma because of the HLA restriction and the patients need to express the target.

So even if in the frontline setting it won't be sort of across the board for all patients with the disease type would be those that qualify.

I don't think that we've made sort of a final decision as to, as we might pursue a first line setting whether that would be the first or the second generation product that I would, I think that we would have to sort of evaluate closer to the time of us really implementing the studies that would support that..

Kenneth Atkins

Got it. Okay. Thank you..

Adrian Rawcliffe Chief Executive Officer, Principal Accounting Officer & Director

Thanks Kenneth..

Operator

Thank you. And our next question comes from the line of Mohit Bansal with Citi Group. Your line is open. Please go ahead. .

Mohit Bansal

Great. Thanks for taking my question and congrats on the progress. One question I have is regarding the use of AKT inhibitor. You have talked about that on your R&D day.

Could you please help us understand the rationale there? What it does and how it actually improves the manufacturing aspect of the TCR manufacturing? And the other second part related to that is that you are using that in your CD8 the second generation program at this point.

Would we be able to see any comparative data and clinical setting that I mean use of AKT inhibitor is actually doing something to these patients either in terms of responses or durability? Any color there. Thank you..

Adrian Rawcliffe Chief Executive Officer, Principal Accounting Officer & Director

Sorry just coming off mute. So as you say we use the AKT inhibitor in the manufacturing process. I just want to be clear that the comparison then there is no AKT inhibitor in the final product that's administered to patients.

So I just want to make that clear and then I was wondering Helen do you want to talk about use of the AKT from a mechanistic perspective and what it does?.

Helen Tayton-Martin Co-Founder & Chief Business & Strategy Officer

Sure. Just coming off mute. Sorry about that.

I think that there are the use of kinase inhibitors and their impact on T-cells has sort of been known for some time and bluntly I think probably a number of dimensions to the mechanism but that sort of simplest said I think it increases the overall potency of the cells and that's probably a number of pathways involved in that but it's certainly something that that we and others have seen and are using and I think it's been a relatively straightforward adjustment to sort of making our process for a potential increase in the potency of the cell product that we make..

Mohit Bansal

Do you think it could help you from the patent point of view? Can you patent it this particular part of the manufacturing that you are using AKT inhibitors in there?.

Adrian Rawcliffe Chief Executive Officer, Principal Accounting Officer & Director

We haven't commented on our patenting strategy as regards our manufacturing process of this aspect of our manufacturing process..

Mohit Bansal

Got it. Thank you very much..

Adrian Rawcliffe Chief Executive Officer, Principal Accounting Officer & Director

Thank you. Thanks Mohit..

Operator

Thank you. And our next question comes from the line of Michael Smith with Guggenheim. Your line is open. Please go ahead..

Unidentified Analyst

Hey, this is Cassie on for Michael. Thanks for taking our questions..

Adrian Rawcliffe Chief Executive Officer, Principal Accounting Officer & Director

Hi Cassie.

Unidentified Analyst

Hey, how is it going? I guess first question in the SURPASS trial, what efficacy signal I guess would you need to see in order to kind of make that go no-go decision and how many patients in a given indication would you feel comfortable basing that on and then separately if I could maybe bigger picture, maybe could you just remind us of your strategy for developing HLA independent T-cell receptors and maybe to what extent that might broaden the opportunity for your platform kind of longer term? Thanks so much..

Adrian Rawcliffe Chief Executive Officer, Principal Accounting Officer & Director

Certainly. Thanks Cassie. So I'm going to ask Elliot to comment on the signals on SURPASS just to say that the other focus areas for SURPASS are obviously lung, bladder, head and neck and gastroesophageal.

That doesn't mean we'll only recruit patients in those settings, but that's what we're focusing the trial on and we plan on putting data out at ESMO on the first set of patients in the expansion cohort. Elliot do you want to comment on that and then we'll move to the other question on TILs..

Elliot Norry Chief Medical Officer

Sure. So thank you. But with respect to what efficacy signal would we look to see to drive a go-no-go decision to a later stage development program. There is nuance here and it's not a specific. I can't quote you a specific cut off with a specific number of patients where we would say if we see this we will go and if we don't we will not.

There are several parameters and we like to think of it along the lines of when we see it we will know that we're seeing it and I think you could use the example of synovial sarcoma as a great example where we saw 44% response rate in the phase 1 study which is clearly advantageous as compared to the other treatments available for second-line treatment and we've typically used a threshold of a 30% response rate with a six month duration of response as a guidepost but not as a definitive marker and the reason that I say that is that there are other factors beyond just response rate.

And it really depends on each tumor type as well and you can use the gastroesophageal cancer example to look at that where these patients have very limited treatment options and very short time of survival even with after first-line treatment.

I think that with the data that was published at ESMO last year showed that even in the best circumstances the median overall survival was approximately 15 months in this patient population with first line treatment. So coming in a later line of treatment it's obviously going to be the expected survival is less than that.

So if you're determined that patient if we are able to show that there's 25% response rate with some of those are durable or that we really improve the quality of life in patients with prolonged stable disease.

Those are things that need to be factored in as well and you start to look at progression-free survival as well as just overall response rate to look at the benefit of a treatment.

So if you look at the gastroesophageal scenario we saw that three patients out of three with the first in the first 6, 3 out of the first six patients in the phase 2 SURPASS trial had esophageal gastric junction or esophageal cancer and all three demonstrated meaningful anti-tumor response.

Well, that was enough for us to say that we ought to be planning a phase 2 trial, especially when some of those patients have been treated with lower cell doses than we had seen previously. So I think that again it takes nuance.

We have some guideposts and that we're going to work around that but we're really looking for relatively clear indications of advantage over current treatments. You shouldn't have to squint at it to say maybe that's going to be advantageous, maybe it's not. You're going to need 500 patients to show a very narrow marginal difference.

It has to be visible..

Unidentified Analyst

Thanks Elliot and on the question, which was sort of how it works and how it works to expand the applicability of our platform maybe I'll ask Helen to touch on that..

Helen Tayton-Martin Co-Founder & Chief Business & Strategy Officer

Yes. I'm glad. We are very happy to talk about the HOA independent TCR platform, the HIT platform. It is exactly sort of what it says it is. It's actually a T-cell receptor that can find an epitope on a cell surface protein.

So the target protein the whole protein could be the same as a CAR or an antibody but the -- it's actually a TCR that's binding to a specific peptides or specific epitope on that cell surface protein. So there are two aspects of that. One is that there is no HLA restriction.

So we don't have to screen out for HLA for the treatment of patients with an HLA targeted T-cell therapy. So that obviously increases the number of patients by removing a specific criteria that segment of population with HLA restricted T-cell receptors.

The other aspect of this which is it's very exciting for our services visit the functional T-cell receptor is functions and behaves like our other optimized T-cell receptors.

And we also have the ability to test that for specificity and sensitivity, affinity really leveraging all of the capabilities we built up over many years to safely bring T-cell receptors through to the clinic.

So very excited that we've got a T-cell receptor platform that can broadly increase the number of patients that we can access with a T-cell receptor that combines to a cell surface protein and that broadens out the patient pool specific targets, and these are I think is a validated target now.

we're very excited about that program with a collaborator acceleration which we have co-developing and we also mentioned another one we started to bring through targeting TPC3 which is a hepatic cancer to specific target and obviously for us it'll be very important to continue to bring and validate this platform alongside the HLA in independent programs that we have like MAGE-A4, AFP to increase the numbers of targeted products that we can bring through.

I hope that is a useful overview of the platform and it's applicability..

Unidentified Analyst

Yeah, great. Thank you so much..

Operator

Thank you. And our next question comes from the line of Nick Abbott with Wells Fargo. Your line is open, please go ahead..

Nick Abbott

Good morning. And thank you for taking our questions.

Ad can you provide some additional guidance on when in 2022 you plan to file on the SPEARHEAD 1 data?.

Adrian Rawcliffe Chief Executive Officer, Principal Accounting Officer & Director

Short answer to that is no, we haven't provided additional guidance and we won't be as of moving parts as you can imagine that affects the timing of that and will update as we have more certainty as to the specific filing timeframe.

I would just mention we've got the arm at designation and therefore the opportunity to have rapid, more rapid approval on that..

Nick Abbott

Right.

The goal is to file and launch in 2022?.

Adrian Rawcliffe Chief Executive Officer, Principal Accounting Officer & Director

That is certainly our goal..

Nick Abbott

Yes. So in preparation for the filing obviously this would be the first TTR engineered product to be reviewed and clearly there's no established path.

So how confident are you have alignment of the agency on CMC given issues that have delayed filing or approval of other cell therapy products?.

Adrian Rawcliffe Chief Executive Officer, Principal Accounting Officer & Director

So I think the challenges that have been faced by people who have sought to bring cell therapies to the market are significant and nobody should ever think that this is easy because it's hard but I think we do have some advantages for us in thinking about this.

Number one, we have the advantage that others have taken not exactly the same products and not a TCR. But an autologous cell therapy. Autologous cell therapies in the hematological space.

And I think there were likely to be at least four of those approved by the time we get there, four or five of those approved by the time we get there and then secondly, I think there is the opportunity to learn from the experience in TILs and the first TIL product is likely to have been approved there.

So there are precedents for this and obviously in the interactions with the agencies, theyget to see that and we get the benefit of that in terms of understanding. They're evolving thinking over this in the space. The second thing that I'll point out is that we have arm act designation in the in the U.S.

and prime designation in the EU and that gives us I think the opportunity to have enhanced interactions with the regulators in both of those jurisdictions and to ensure that insofar it's possible there is alignment.

Now you will never find anybody at this company tell you what the regulator think that's going to be for them to speak to but at the same time we are having what we believe is constructive discussions with both of those and I think we are, we certainly are think believe that we understand what we need to do.

Then lastly I'd say that we are using from a CMC perspective the same facilities and the same process in the phase 2 that we will use for launch and I think our processes and our essays, etc.

are in and appropriate place relative to where we want to be for our BLA goals and I'd say we have not got some of the challenges that some other types of therapies have for example the potency assay as it relates to a TIL therapy which is obviously quite different to the discussions that we've had.

So this isn't easy and there's there are as I said, there are a number of moving parts. But because with some be focused on this because of the capabilities and the insight that we've built up over a long period of time and a lot of interactions with the regulators, I think we're confident that we've got the process and the requirements gripped..

Nick Abbott

All right. Thank you. And then you recently listed the phase 2 esophageal gastric trial which I believe you have, you consider as a potentially registration enabling and like they had one plan to roll 45 patients.

So can you explain how you got to that number and then also I know this is being studied in other tumors that are clearly perhaps unique concern here is for on target tumor toxicity.

What do you need to do to assure the regulator that this is not an issue? How many patients do you need really to treat in order to ensure the issue?.

Adrian Rawcliffe Chief Executive Officer, Principal Accounting Officer & Director

So Elliot do you want to speak to the thinking around the SURPASS 2 trial design a little bit and in terms of what we've said publicly and how we're thinking about the toxicity, the safety profile that will be required to register products in this place. Elliot I think you are on mute..

Elliot Norry Chief Medical Officer

Sorry about that. I will start over. I don't think that we’ve guided with respect to the powering and statistical methodology for the trial. I will say that it is designed very similarly to SPEARHEAD 1.

So while the statistical considerations are not exactly the same, the study is powered to demonstrate benefit as compared to what would be the sort of historical control as it relates to the line of treatments. So I don't want to provide specific numbers around that at this juncture.

With respect to the off tumor on target toxicity it's important to remember that the T-cell receptor is the same as the first generation T-cell receptor and we have, it's not a huge amount of experience as compared to like a diabetes or cardiovascular trial but we have a pretty good accumulating experience of patients that we've treated with the MAGE-A4 directed T-cell receptor at this point and really have not seen any indication of off tumor expression of MAGE-A4 or off-target reactivity of the TCR against other tissues.

So look, I think that ultimately the benefit risk ratio is what will drive the day.

As we're able to further demonstrate the benefit of the T-cell receptor in this patient population or in others it'll have to come with a safety profile that is acceptable and the safety information that we put out along with the six patients that were reported at Fitzy showed that at least in early days that the safety profile for the second generation product is very similar to the first generation product.

Now you can't compare 6 patients to over 70 patients but that will come with time and at this point it's our anticipation that if the drug is more potent then we may see some of the more common toxicities associated with the potency of the product like cytokine release syndrome.

That has not been the case to-date but we'll have to see that over time but I think we're feeling reasonably confident around the specificity of the T-cell receptor in that we haven't seen off tumor or off target toxicity to-date with MAGE-A4..

Nick Abbott

Right. Thanks Elliot. That's very comprehensive and would you expect to communicate to us data from this trial as it's going along or only when it's complete..

Elliot Norry Chief Medical Officer

I wouldn't want to promise to provide data should we think of this as you said as potentially registrational. So if we're to make the decision that this trial would be a registrational trial then we would be unlikely to provide patient data along the way.

If it were to be determined to the contrary then we would reserve the right to provide interim data along the course of the trial if that were helpful from a communication standpoint. So I think in general for registrational trials we would not do that but if it turns out to not be a registrational trial then we certainly could..

Nick Abbott

Great. Thank you very much. .

Adrian Rawcliffe Chief Executive Officer, Principal Accounting Officer & Director

Thanks Nick..

Operator

Thank you. And our next question comes from the line of with Mizuho. Your line is open. Please go ahead..

Unidentified Analyst

Great. Thanks for taking the questions. I have two questions. The first just is on the SPEARHEAD 1 and can you just clarify for us the scope of what you anticipate for the preliminary update in June versus the full update later in the year? And then secondarily I'm just curious about the status of the TIL program.

It certainly appears within your pipeline chart advanced from pre-clinical perspective and I know it appears in your corporate deck almost as a crossover in the graphic that you have between the cure versus mainstream therapy.

So can you talk a little bit about what's going on in that program?.

Adrian Rawcliffe Chief Executive Officer, Principal Accounting Officer & Director

Certainly. Thanks so I'm going to ask Elliot to talk about the updates what's likely to be happening at ASCO and CETOS and then I'm going to ask Helen to talk about the IL-7 TIL program.

So Elliot do you want to touch on SPEARHEAD first?.

Elliot Norry Chief Medical Officer

Sure. So good question. First of all I want to just say that the update at ASCO is based on the information being accepted by ASCO and you raised I think the point of this being a registrational trial; how is it that we're presenting interim data.

The reason for we believe that being allowed is that all the patients will have been dosed by the time this information would come out. So it would have no effect on the recruitment and enrollment of the trial but it is ultimately up to ASCO as to whether they will allow the presentation of data in an interim fashion.

So if we were to present it it would be based on a data cut that will be ultimately approximately six months prior to the final data cut for the trial. So the level of durability of response across the whole population will be less robust than the final information.

We will also have to provide some interpretation along the lines of patients who have been treated but have not yet completed their series of assessments as to whether they represent responses or stable disease or there are some patients who have stable disease that at one juncture who then go on to have a response.

So we'll have to interpret it with some clarity as it relates to who's been dosed, who's had the right number of assessments to make a determination around efficacy and then of course there will be safety information as well.

We will provide duration of response information as is available at the time of the data cut but just recognize that for example if the data cut is sometime in let's say March then a patient treated in February we won't be able to provide real meaningful duration of response information. So I hope that clarifies what we expect to present at ASCO.

Later in the year we would anticipate providing the data that would essentially be similar to what we would present to agencies for registration. The study is set to read out six months after the last patient is dosed provided that patient remains on study.

So if you go six months from we've said that we plan to finish in dosing in this study by the end of the first quarter. So that data cut would be around the end of the third quarter and then we would be able to provide information at the CTOS conference that uses that data.

So that will be a more complete look at the data that will also be shared with regulatory authorities for the purpose of registration..

Unidentified Analyst

Okay. Thank you. That's really helpful..

Adrian Rawcliffe Chief Executive Officer, Principal Accounting Officer & Director

Thanks Elliot.

And Helen?.

Helen Tayton-Martin Co-Founder & Chief Business & Strategy Officer

Yes. Sure. Great question. It's a pleasure to talk about the TIL program that we have on our pipeline. So we have executed a collaboration with cCIT in Denmark which is the center for cancer immunotherapy which is a leading center for TIL trials in Europe a group that we've known for some time. And there are two aspects to this.

I think the TIL strategy feeds into two things. It feeds into our integrated cell therapy capabilities which we believe really enable us to sort of read across and apply in a relatively straightforward way the same sorts of approaches from the science through to CMC optimization, execution of the clinical programs, regulatory interactions, etc.

as we do with our SPEAR T-cells we can apply an awful lot of those capabilities to TILs and we have a TIL IL-7 program.

It's currently pre-clinical but expecting to move quite quickly towards the clinical stage in collaboration with the CCIT where we're bringing in our own second generation capabilities and expertise and knowledge from the SPEAR T-cells into a second generation TIL product which we think will improve the proliferation and penetration of the TILs in other solid tumors because I think that there's great promise with TILs and we believe that there's more promise in other tumor indications to be had.

So TILs don't require HLA restriction testing. They don't require target testing. So it's another one of our strategies that enables us to reach more patients without segmenting for HLA type or target type and it adds and complements, I mean our in-house capabilities in cell therapy broadly in T-cell therapy broadly.

So hopefully that gives a bit more color to where the TIL IL-7 program fits within our overall strategy of bringing further products. It's in the five of our 2-2-5-2. So hopefully that helps..

Unidentified Analyst

And do you have a sense of which indications would be prioritized?.

Helen Tayton-Martin Co-Founder & Chief Business & Strategy Officer

We do but we're not commenting on that at this point I'm afraid..

Unidentified Analyst

Okay. Thank you. I appreciate it..

Helen Tayton-Martin Co-Founder & Chief Business & Strategy Officer

Yes..

Adrian Rawcliffe Chief Executive Officer, Principal Accounting Officer & Director

Thanks..

Operator

Thank you and our next question comes from the line of Jonathan Chang with SVB Leerink. Your line is open. Please go ahead..

Unidentified Analyst

Hi team this is on for Jonathan.

I’ve realize it's still early in the year but for the second gen MAGE-A4 program can you talk about the current status of the SURPASS study? Any color on the progress of that study since the last update in expectations for the at ASMO including any potential or hopeful number of patients or breakdown of what tumor type s you expect?.

Adrian Rawcliffe Chief Executive Officer, Principal Accounting Officer & Director

Thanks John. So you asked the color on the study. It’s a very colorful study. It was enrolling above the patients there was nine different tumor types as you know we focused it down onto four different tumor types.

I do just want to be really clear about that doesn't mean we are only going to have patients in those four tumor types which are lung, bladder, head and neck and gastro gastroesophageal cancer. But our recruitment we are focusing on those centers that are recruiting those patients. But we will have others. Recruitment is going well.

Last year we had a recruitment driven off the COVID pandemic increase in cases and decrease in people being recruited in early stage oncology and cell therapeutic trials in the second and third quarter but we established and we built the pipeline as we talked about in the fourth quarter last year.

And I think the recruitment in dosing of those patients is going well as we are headed into 2021. We have no explicitly not commented on number of patients. But all of these patients are being recruited in the expansion cohort of that trial and we will update at ASMO on all of the patients that we have dosed and have access to.

I think the objective of that is to be able to gather a sufficient cohort of patients to say meaningful things about the development of that therapy going forward beyond that we aren't commenting onto ..

Unidentified Analyst

Got it. Makes sense.

And quickly on SPEARHEAD 2, could you talk about the current stage of that study and just conceptually is this still viewed as a learning type of study that you might have eventually moved forward with the second gen? And what is the for success for that trial?.

Adrian Rawcliffe Chief Executive Officer, Principal Accounting Officer & Director

Elliot do you want to talk to those points?.

Elliot Norry Chief Medical Officer

Yes. So thank you. We haven't really guided as to sort of numbers of patients screened enrolled, dosed etc.

The study is open and enrolling and we do still look at it as a I mean every study should be looked as a learning opportunity but this one in particular is the first scenario in which we would be combining the MAGE-A4 corrected TCR program with PD1 inhibitor.

So based on sort of the natural potential synergies of those products we certainly would be paying attention.

I don't want to say that we wouldn't take the combination of those two products inherited next cancer forward if we were to see the right kind of responses and again I would comment on I will go back on the go-no-go comment that I made before.

But I also do think that this is the learning here is really more about the potential of this type of combination across programs. And the benefits we will certainly see how the patients do from the response and toxicity standpoint.

That will be really important but there will also be important translation information about what happens to up regulation or down regulation of certain genes that control cancer growth, T-cell exhaustion, tumor micro environment etc. So I think that it is a learning trial as you indicated.

But it does have the potential to really demonstrate the advantage of this combination with T-cell therapy for solid tumors.

I want to add that the way that we organize and design the trial also is an example of how cell therapy could fit into a first line sequence with approved therapy that is that one leukapheresis and obtained cells prior to treatment.

So no impact of the treatment on the bone marrow that would be, that would produce the cells that we would use to manufacture.

The patients get the first line treatment while the manufacture is ongoing sort of the product is ready at the time that they are no longer either seeing continued benefit or additional benefit from the first line treatment and then it provides an opportunity to use cell therapy right in sequence with another treatment and that's a paradigm that it's not simple to organize from the patient standpoint but we feel this is again our first toe in the water as it relate to that as well..

Unidentified Analyst

That's very helpful. Thank you..

Adrian Rawcliffe Chief Executive Officer, Principal Accounting Officer & Director

Thanks..

Operator

Thank you. And this dose conclude today's question-and-answer session and I would like to turn the conference back over to Adrian Rawcliffe for any further remarks..

Adrian Rawcliffe Chief Executive Officer, Principal Accounting Officer & Director

Thanks everyone for joining us.

I want to before we close the call acknowledge the incredibly hard work and commitment of everybody here at Adaptimmune who despite the challenges of the COVID-19 pandemic over the last year remained focused on our mission and our vision and delivery of the results that we just put out the press release and everything that we have accomplished last year.

I also want to thank our investors who continue to have confidence in the opportunity presented by Adaptimmune.

I think we are all here looking forward to 2021 and I am looking forward to being able to update you all on the key mile markers on the road to delivering that 2-2-5-2 strategy that I talked about in the beginning of this call and ultimately the opportunity to create significant value for people with cancer and for the company.

And with that thank you and speak to you soon..

Operator

Ladies and gentlemen thank you for participating in today's conference. This does conclude program and you may all disconnect. Everyone have a great day..

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