Q1 2022 Adaptimmune Therapeutics PLC Earnings Call
Yeah.
Operator: Good morning, and thank you for standing by. Welcome to the first quarter 2022 Adaptive Immune Earnings conference call. At this time, all participants are in a listen-only mode.
Good morning, and thank you for standing by welcome to the first quarter 2020 to adapt immune earnings conference call. At this time all participants are in a listen only mode. After the speaker's presentation. There will be a question and answer session to ask a question. During this session you will need to press star one on your telephone please be advised that today's conference.
Operator: After the speaker's presentation, there will be a question and answer session. To ask a question during this session, you'll need to press star 1 on your telephone. Please be advised that today's conference is being recorded. I would now like to hand the conference over to your speaker today, Juli Miller, Head of Investor Relations.
Is being recorded I would now like to hand, the conference over to your speaker today Juli Miller head of Investor Relations. Please go ahead.
Juli Miller: Good morning, and welcome to Adapt Immune's conference call to discuss our first quarter 2022 financial results and business updates. I would ask you to 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 several factors, including those outlined in our latest filings with the SEC.
Good morning, and welcome to adapt Indians conference call to discuss our first quarter 2022 financial results and business update I would ask you to 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 several factors.
Including those outlined in our latest filings with the SEC Adrian <unk>, our Chief Executive Officer, and Gavin Wood, our Chief Financial Officer are here with me for the prepared portion of the call and other members of our management team will be available for Q&A with that I'll turn the call over to Adrian Barclays' App.
Juli Miller: Adrian Rawcliffe, our Chief Executive Officer, and Gavin Wood, our Chief Financial Officer, are here with me today to work with me for the prepared portion of the call. Other members of our management team will be available for Q&A. With that, I'll turn the call over to Adrian Rawcliffe. Thank you, Juli. And thank you, everyone, for joining us.
Thank you Julie and.
Thank you everyone for joining us.
Adrian Rawcliffe: Adaptimmune's ambition is to transform the lives of people with cancer by discovering, developing, and delivering cell therapy. This is clearly a long-term goal, but in the short and medium term, we are focused on the delivery of our 2252 strategy. And this year, our focus is specifically on four clear areas. Buy all the BLA for a Famasel, and continue building our Mayday 4 franchise.
But that to me in some patient is to transform the lives of people with cancer by discovering developing and delivering cell therapies.
This is clearly a long term ambition, but in the short to medium term. We are focused on the delivery about 2252 strategy.
And this year I'll focus specifically on four clear areas.
File the BLA for <unk> myself.
Continue building, our MAGE a full franchise.
Adrian Rawcliffe: Gailer for manufacturing capability and progress our allogeneic products towards the clinic. In the first quarter, we have executed well across all four areas. We are making good progress towards the submission of our BLA for our first product, Afamisal, for the treatment of synovial sarcoma. At ASCO next month, we will present pooled analysis from patients with synovial sarcoma from across our trials with the family, with a full update on the Spearhead 1 trial planned for CTOS later this year.
Scale up our manufacturing capabilities and.
I am Progresso allogeneic products towards the clinic.
In the first quarter, we have executed well across all four areas.
We are making good progress towards the submission of our BLA for our first product by myself for the treatments of synovial sarcoma.
I ask go next month, we will present pooled analysis from patients with synovial sarcoma from across our trials with a pharmacy with a full update on the spearhead one trial planned for seats off later this year.
Okay.
Adrian Rawcliffe: Secondly, our May J4 franchise is expanding with a surpassed family of clinical trials using our next generation SPIR T-cells targeting May J4. We have continued to recruit steadily in the Phase 1 surpassed trial, and we are planning a data update at ESMO this year. As a reminder, this is a Phase 1 trial that has shown responses across a broad range of solid tumors, and we aim to convert these early signals into registrable products. There have been two tumor types identified so far for further progression, esophageal and EGJ as well as ovarian cancer.
Secondly, our MAGE a full franchise is expanding with the supposed family of clinical trials using our next generation spear T cells targeting MAGE a pool.
We have continued to recruit steadily in the phase one so pulse trial and we are planning a data update at ESMO This year.
As a reminder, this is a phase one trial that has shown responses across a broad range of solid tumors and.
And we aim to convert these early signals into registered products.
There have been two tumor types identified so Paul for further progression.
The soft gel in the DJ as well as ovarian cancers.
Adrian Rawcliffe: For esophageal and EGJ cancers, we are recruiting in our Phase 2 Surpass 2 trial. And for ovarian cancer, we are planning to initiate an additional Phase 2 trial to pass three this year. We are also initiating a combination arm with Nivolumab in the Phase 1 Surpass trial. Thirdly, as the only cell therapy company with late-stage autologous programs as well as advanced capabilities in the allo space, we are making progress towards filing an IND for our first wholly-owned allogeneic product, targeting May J4 next year, as well as progressing our collaborations with Genentech and with Estella.
For a sofa Gilani T J, Kansas, we are recruiting in our phase II <unk> II trial.
And for ovarian cancer, we are planning to initiate two additional phase III trial <unk> three this year.
We are also initiating a combination arm with Napoleon map in the phase <unk> trial.
Thirdly is the only cell therapy company with late stage autologous program, so as well as advanced capabilities in the allo space, we are making progress towards filing an int for our first wholly owned allogeneic product targeting MAGE a for next year.
As well as progressing our collaborations with Genentech and with Astellas.
Adrian Rawcliffe: And lastly, we are scaling US manufacturing facilities to deliver cell therapies for our first commercial product and our ongoing and planned clinical trials, and we are nearing the completion of construction for our new dedicated allogeneic manufacturing facility in the UK.
And lastly, we are scaling U S manufacturing facilities to deliver cell therapies for our first commercial product and our ongoing and planned clinical trials.
And we are nearing the completion of construction for a new dedicated allogeneic manufacturing facility in the U K and we will begin the commissioning process in Q3.
Adrian Rawcliffe: And we'll begin the commissioning process in Q3. We are constantly developing as a company, building the capabilities required to be an integrated cell therapy company. And in our last call, I talked about the external additions to leadership, commercial, and quality. Last week, we announced that Joe Brewer has been appointed to the role of Chief Scientific Officer, effective May 4th.
We are constantly developing as a company building the capabilities required to be an integrated cell therapy company and in our last call I talked about the external additions to leadership in commercial and quality.
Adrian Rawcliffe: Joe is an exceptional scientific leader with a strong track record of building successful teams and driving innovation in cell therapy. She has a long history with Adaptimmune and its predecessor company, with more than 20 years of experience specifically in T cell receptors, TCRT cells, and cell therapy. She's worked on all of our clinical autologous programs, and most recently, she led our allogeneic efforts, building the allogeneic team from scratch, playing a key role in the partnerships with Estelas and with Genentech, and with her team taking allogeneic stem cell derived alpha beta T cells from an idea to clinical reality for us and our partners over the coming year. And with that, I'd like to hand over Gavin?
Last week, we announced that Jo Brewer, who has been appointed to the role of Chief Scientific Officer effective may the fourth.
Joe is an exceptional scientific leader with a strong track record of building successful teams and driving innovation in cell therapy.
She has a long history with <unk> and its predecessor companies with more than 20 years of experience specifically in T cell receptors, TCR T cells and cell therapies.
She has worked on all of our clinical autologous programs. Most recently has led our allogeneic efforts building the allogeneic team from scratch, playing a key role in our partnerships with Astellas and with Genentech and with her team taking allogeneic stem cell derived alpha beta T cells from an idea towards clinical reality.
And our partners over the coming years.
And with that I'd like to hand over to Kevin to provide a financial update Kevin.
Gavin Wood: Thanks Ed, with a robust balance and total liquidity at the end of Q1 of $304 million. And I can confirm that this provides a cash runway that extends into early 2024, enabling us to execute against the focus areas Ad has just laid out. We have invested significantly over the last few years to build an integrated cell therapy company with a full range of end-to-end capability, which is critical for the long-term success of Adaptive Care. Like you, we are acutely aware of the challenges presented by the biotech and wider financial markets. We have a strong management team who have weathered difficult markets in the past.
Thanks, Ed.
With a robust balance sheet with total liquidity at the end of Q1 of $304 million and I can confirm that this provides a cash runway to extend into early 2020 full enabling us to execute against the focus areas add its just laid out.
Significantly over the last few years to build an integrated cell therapy company with a full range of end to end capability as we still as we strongly believe that this is critical for the long term success of it that to me.
Lucky we are acutely aware of the challenges presented by the biotech and wanted to financial markets. We have a seasoned management team has weathered difficult markets in the past.
Operator: We believe that fundamentally good companies with products that are close to commercialization and with a proven platform will be well placed to achieve fair valuation as the markets rebalance. We have the people and the capabilities to position us well for long-term success in executing against our mission to transform the lives of people with cancer. So with that financial update, I'll turn over the call to the operator for Q&A. Thank you. Thank you. As a reminder, to ask a question, you'll need to press Star 1 on your telephone. To withdraw your question, press the pound key.
We believe that fundamentally good companies with products that are close to commercialization and with a proven platform will be well placed agee achieve fair valuation as the markets rebalance, we have to pay for them the capabilities to position us well for long term success to execute against our mission to transform the lives of people with cancer.
So with that financial update I'll turn over the call.
To the operator for Q&A.
Thank you.
Thank you as a reminder to ask a question you will need to press star one on your telephone to withdraw your question press the pound key.
Adrian Rawcliffe: We have a question from Marc Frahm with Cowen & Company. Your line is open. Thanks for taking my question. Maybe just to start off, you were getting to the next update from the A2M4 CD8 program at ESMO, give some color as to how many patients you expect to be there, and do you expect more tumor types to kind of reach that go-no-go decision that you've already gotten to with ovarian and esophageal? So, the short answer is, time out. Thanks for the question.
We have a question from Marc Frahm with Cowen <unk> Company. Your line is open.
Adrian Rawcliffe: The short answer is, no, we're not providing any guidance on the numbers of patients. We've said we've recruited steadily in that phase one trial, and we'll update on all of the patients that we have, that we have assessments for at the time that we do the data cut for Esmo. I think the answer to your second question is a bit more nuanced. Obviously, the entire purpose of the phase one trial is to deliver signals about that. And so, clearly, as time goes by, we anticipate that we will identify additional indications for development, and that's the purpose of the trial, and that's all I'm going to say on that. Okay, thanks. That's helpful.
Hi, Thanks for taking my questions.
Just to add your.
Turning to the next update from.
The ATM for CD eight program at ESMO.
Alright, Brian some colors to how many patients do you expect to be there and do you expect more tumor types have kind of reached that go no go decision that you've already gotten too with ovarian and esophageal.
So short answer is talking about thanks for the question short answer is no we're not providing any guidance on the numbers of patients who have said we recruited steadily in that phase one trial and we will update on all of the patients that we have.
But we have assessments for at the time, but we do the data cut for asthma.
I think the answer to your second question is a bit more nuanced.
Obviously, the entire purpose of the phase one trial is to deliver signals.
And that and so.
Clearly as time goes by we anticipate that we will identify additional indications for full development.
That's the purpose of the trial and that's all I'm Gonna Santa Mara.
Okay. Thanks, that's helpful and then.
Adrian Rawcliffe: Maybe on the BLA submission. Just on timelines there, I guess. Have you had your pre-BLA meeting yet? If not, what steps still need to be done before you can request that and get that part of the process?
Maybe on the BLA submission.
Just on timelines there I guess you had your pre BLA meeting and if not kind of.
So what steps still need to be done before you can request that in that part of the process scheduled.
Yeah.
Adrian Rawcliffe: So we haven't had the pre-BLA meeting. What I would say is that the list of things that we have yet to do is outlined on a slide that's in our corporate deck. We've got a range of things that we've completed, including the preclinical sections of the filing, the pediatric plans, et cetera. And then on the right-hand side of that slide, which I'll refer you all to, it's got the things that are in progress, many of which relate to the CMC section of the file.
So we haven't had the pre BLA meeting what I would say is that the the.
The list of things that we have yet to do with outlined on the on the slide.
In our corporate deck.
We've got a range of things that we've completed including the preclinical sections of the of the filing of the pediatric plans et cetera.
And then on the right hand side of that slide, which I'll refer you all to <unk>.
It's got the items that are in progress many of which relate to the CMC section of the file.
Adrian Rawcliffe: I think progress is good on all of those aspects, and we remain on track for the filing this year. Okay, and then the last one, ASGCT, you're presenting a new next-generation MAYJ4 product with IL-7 and CCL-19. Can you explain the rationale for that product and are there particular tumor types or tumor microenvironments that you think that it's particularly well suited for? So I'm going to ask Helen Tayton-Martin to take that. Helen said:
Progress is is is.
Good on all of those aspects.
We remain on track for the filing this year.
Okay.
And the last one.
S GTT, you're presenting on a new next generation major core product.
With iOS Southern CCL 19.
Can you explain the rationale on that product and yeah are there particular tumor types or tumor microenvironment that you think thats, particularly well suited for.
So I am going to ask Helen <unk> Martin to take that Helen.
Helen Tayton-Martin: Thanks, Marc. A good question. Thank you. Yes, so the next general construct you're referring to is a collaboration program, construct for a program with an oil immune, where there are two additional molecules in the construct alongside the same TCR. One of them is IL-7, which is there to increase proliferation and survival of T cells, and the other one is CCL-19, which increases, basically, trafficking to the tumor site of not just T cells but other immune cells as well.
Yes, thanks Mark.
Good question. Thank you, yes, so the nexgen.
You're referring to is a collaboration program construct with private quip program with knowing you mean.
Where there were two additional molecules in the coastwise alongside the same TCR what does it mean for <unk>, seven which is start to increase proliferation and survival of the T cells and the other one is CCL 19.
Which increases basically sticking to the.
To the team of site not just the T cells that broader immune cells as well.
Helen Tayton-Martin: Two slightly different mechanisms to the CD8 alpha, which is basically increasing the potency of CD4 cells. And in answer to your question about which tumor types, I think that we're taking a view that we're looking at both hot and cold tumors to see whether these two mechanisms together, you know, deliver the effect that we hope that they will. So more to come on that as we get closer to opening the study. Okay, thank you. Thanks, Mark. Our next question comes from Tony Butler with Roth Capital. Your line is open.
Two slightly different mechanisms to the Cta Alpha which is basically increasing potency of <unk> four cells.
In answer to your question.
In regard to which tumor types I think that we are taking a view that we're looking at both hot and cold team is to see whether these two mechanisms together.
You know how to deliver the effect that we had.
They will say more to come on that as we get closer to that in the study.
Okay. Thank you.
Thanks Mark.
Our next question comes from Tony Butler with Roth Capital. Your line is open.
Adrian Rawcliffe: Yes, good morning. Thanks very much. Two brief questions. One, I just want to again refer Adrian to slide 12, and really speak directly to the vector release from ML-TINI. I want to understand, If I'm correct, you're also building your own vector manufacturing, but you're going to continue to use Meltanin, vector, if that's correct. What are the steps that would strike me as being on the list, a much more, let's say, heavy-weighted item that needs to be checked off.
Yes. Good morning, Thanks, very much two brief questions one.
I just want again refer.
Adrian to slide 12.
Really speak directly to the.
<unk> released from <unk> I want to understand if.
If I if I'm correct, you're also building your own vector manufacturing, but youre going to continue to use mill trainees.
Vector if that's correct.
Adrian Rawcliffe: And I'm just curious if you could speak to the nuances there. The second question is around surpassing. And to what end is there a desire, perhaps, to consider, or is there a consideration for, a tumor agnostic indication for MAYJ4? Thanks very much. Okay, so I'm going to ask, I'm going to say something, and ask John to answer the first question, which is, I just point out that Miltenny Biotech is our supplier of Vector for FamaCell, and for all other products, we make our own Vector. John, do you want to comment on the deliveries around the BLA? Yeah, sure. Thanks, Tony. This is John.
What are the steps.
That would strike me as being.
The list is much more let's say heavy weighted.
Item that needs to be checked off and I'm. Just curious if you could speak to the nuances. There second question is around surpass and I guess to what and is there a desire perhaps.
To consider or is there a consideration for tumor agnostic indication for matrix for thanks very much.
Okay, So I'm going to ask.
Something I ask John to answer the first question, which is.
Just point out that <unk> biotech is our supplier for back to fall for <unk> and for all other products, we make our own Baxter John do you want to comment on the deliveries around the BLA.
Sure. Thanks, Toni this is John .
John Lunger: So, Lentogen is in their new commercial facility. Early days, actually, but they're quite advanced in the commissioning of that facility. So, we expect by Q3 to have material from that facility that we'll use for our own drug product PPQs in Q3. And you're also right that we have our own facility as well for Surpass and for future autologous products. We will use that for the viral Vector. Thanks again.
So <unk> is in their new commercial facility. There are early days early days actually they are quite advanced in the commissioning of that facility. So we expect by Q3 to have material from that facility that we'll use for our own drug product <unk> in Q3.
And you're also right on that we have our own facility as well for for surpass and for future autologous products, we will use that for the viral vector.
Okay.
Elliot Norry: With respect to the opportunity for a tumor agnostic indication arising out of the SPAS trial, I'm going to ask Elliot Norry, our Chief Medical Officer, to comment on that. Yeah, hi, thanks. I think that from the standpoint of a tumor-agnostic approach, it certainly makes sense. You know, our belief is that the basis for efficacy is the target, not the tumor type. That being said, and with...
Thanks, and then with respect to the.
Opportunity pool re tumor agnostic indication arising out of the Spa trial I'm going to ask Elliot Norry, our chief Medical officer coming from them.
Yeah, Hi, thanks.
I see.
Think that from the standpoint of a tumor agnostic approach it certainly makes sense.
Our belief is that the basis for efficacy is the target not the tumor type.
That being said.
And with that with.
Elliot Norry: In conversations with experts and regulatory advice, one needs to establish that the drug would generally be approvable in one or more tumor types, initially, and then can approach a more tumor-agnostic approach. So I think that we certainly have our eye on the ability to approach this from a tumor agnostic standpoint, Tony, but we're also simultaneously looking at how we demonstrate in each specific tumor type what would warrant an indication so that we can, you know, sort of..., move along those paths simultaneously. The trials that are designed to look individually at one tumor type and then another trial to look at another tumor type are not exclusive of a tumor agnostic indication. They can be pursued simultaneously.
In conversations with experts.
And regulatory advice, one needs to establish that.
The drug would generally be approvable in one or more tumor types. Initially and then can approach a more tumor agnostic approach.
So.
I think that we certainly have our eye on the.
The ability to approach this from a tumor agnostic standpoint, Tony but.
We're also simultaneously looking at how do we demonstrate in each specific tumor type.
What would warrant.
And indications so that we can sort of.
Move along those paths simultaneously.
The trials that are designed to look individually at one one tumor type and then another trial to look at another tumor type are not exclusive of of a tumor agnostic indication that can be pursued simultaneously.
Elliot Norry: Elliot, thanks very much. Thanks, Tony. We have a question from Jonathan Chang with SVB Securities. Your line is open. Hi guys, thank you for reading the question. This is Faisal Alam speaking for Jonathan. I just wanted to ask about the last three, just what steps need to take place between now and trial initiation, and if there's, you know, just any other details you can provide on that trial and the plan that you have. Elliot, do you want to take that? Sure. Hi Jonathan.
Hello, Thanks, very much I appreciate it.
Thanks, Tony.
We have a question from Jonathan Chang with SBB Securities. Your line is open.
Hi, guys. Thanks for taking the question. This is vessel on for Jonathan.
Ask on surpass three just what steps need to take place between now and trial initiation and if there is.
Any other detail you can provide on that trial and the plan there.
Elliot do you want to take that sure.
Hi, Jonathan.
Elliot Norry: For the SURPASS III trial, it's really no different than what it takes to get other trials up and running. We have learned over time that it really is worth our while to get the protocol and the questions that we're specifically answering with the study really hammered out up front. So the steps that are ongoing, really, not sort of remaining, but ongoing, are seeking KOL advice, finalizing the protocol, getting ready to submit the protocol to regulatory authorities and study sites, and we're on track to initiate that study this year.
For the surpass III trial, it's really no different than what it takes to get other trials up and running.
We have learned over time that it really is worth our while to get to protocol and the questions that were specifically answering with the study really hammered out upfront so.
The steps.
That our ongoing really not sort of remaining but ongoing.
Are seeking kols advice finalizing protocol getting ready to submit the protocol to regulatory authorities and study sites and where we are on track to initiate that study this year.
Yeah.
Elliot Norry: Great, thank you for the additional detail there. Then also, just curious if there's certain indications that you think might be more warranted for combination versus monotherapy. Yes, so the combination can be used with any of the indications in the SURPASS trial. So it's not being introduced for one or two specific indications. We actually think that the mechanism of action should be applicable to all of the tumor types, and it's really there to help the T cell. And we know that we bring both our own T-cells and other T-cells into the tumor based on translational studies, and that's across tumor types.
Great. Thank you for the additional detail. There then I also just wanted to ask as you're starting the checkpoint inhibitor combination for the.
<unk> strategy just curious if there are certain indications that you think might be.
You know, it's more warranted for combination versus monotherapy approach.
Yes, so the the.
Combination can be used with any of the indications and the surpass trial. So it's not being introduced for one or two specific indications, we actually think that.
The mechanism of action.
It should be applicable to all.
Of the tumor types.
Really there to help the T cells.
And we know that we bring both our own T cells and other T cells into the tumor based on translational studies and thats across tumor types.
Elliot Norry: So if that's the case, then the checkpoint inhibitors really should have a chance of working across tumor types. But, obviously, checkpoint inhibitors have had a range of efficacy in those tumor types. So it's possible that it behaves differently from tumor type to tumor type, but we think that there's reason to pursue it in all of that. Great, thank you. Thank you. Our next question comes from Michael Schmidt with Guggenheim. Your line is open. Good morning, this is Paul. I'm for Michael.
So if that's the case then the checkpoint inhibitors really should have a chance of working across tumor types, obviously checkpoint inhibitors have had.
A range of efficacy.
In those tumor types so.
It's possible that it behaves differently from tumor types of tumor type, but we think that there is reason to pursue it and all of them.
Okay. Thank you.
Thank you. Our next question comes from Michael Schmidt with Guggenheim. Your line is open.
Operator: Thanks for taking our question. Just one more from us on the DLA filing. You previously mentioned the method validation for potency assays as part of the work in progress, which has caused some issues for other therapies during the process. So maybe just your thoughts on similarities or differences from others on potency assays and your confidence in aligning with the FDA. So, I'll ask John to, uh... cover that one, John.
Hi, Good morning. This is Paul on for Michael Thanks for taking our question.
Just one more from us on the DLA filing.
You mentioned the method validation for potency assays as part of the work in process.
Which has caused some issues brought itself their therapies during the process, maybe just your thoughts on similarities or differences.
Others on potency assays and and your confidence in line with the FDA there.
So I'll ask I'll ask John to.
Couple that one John .
John Lunger: Yeah, so on the potency assay, we're validating the same potency assay for our drug product that we used in the clinic. So we feel pretty confident about being able to successfully complete that validation. You know, obviously, we have the MAI-J4 target to test against, which is a little different than what some of the other companies, particularly the Till companies, have had to face.
Yes, so on the potency assay, we are validating the same potency assay for our drug product that we used in the clinic. So we feel pretty confident about being able to successfully complete that validation.
Obviously, we have the major four target to test against.
Which is a little different than what some of the other companies, particularly the til companies have had to face. So for those two reasons I think we're in good shape from a potency assay perspective.
John Lunger: So for those two reasons, I think we're in good shape from a potency assay perspective. Okay, great, thanks. And then just secondly, really quickly on the ASCO data.
Okay, great. Thanks, and then just secondly, really quickly on the <unk> data.
Adrian Rawcliffe: So will this update be for families that'll primarily be updated analyses in patients for whom we've already seen data, or will there be any new patients from Cohort 1 in the update at ASCO? Thanks. Yeah, so what will be different about the ASCO evaluation presentation will be that we're combining data from the phase one study and the phase two study in patients with sarcoma. So it'll be a larger data set, which will allow us to look at contributing factors to efficacy in a more robust fashion. But specifically to your point, there aren't any new patients. In fact, there aren't any significant new patients in that data set. Yeah, significant numbers. I mean, it's a pooled data set, which makes it larger.
Well this update for van itself, primarily be updated analyses in patients for whom we've already seen data or whether there'll be any new patients from cohort one.
And the updated scope.
So the what will be different about the <unk> evaluation.
<unk> will be that we're combining data from.
The phase one study and the phase II study in patients with sarcoma, so it'll be a larger dataset.
Which will allow us to look at contributing factors to efficacy and a more robust fashion.
But specifically to your point, there arent any new patients.
<unk> new patients in that dataset.
<unk>.
It's a pooled data set which makes it larger yes.
Got it thank you.
Adrian Rawcliffe: Yeah. Got it. Thank you. Thank you. We have a question from Nick Abbott with Wells Fargo. Your line is open.
Thank you we have a question from Nick Abbott with Wells Fargo. Your line is your line is open.
Operator: Oh, good morning. I have a question on the IL-7-TIL and that is, obviously, using the NFAT promoter to control IL-7. Makes sense. My question is, what are the levels of IL-7 that you expect to reproduce and are these sufficient to support other T cell populations, you know, on the hopeful assumption that the TIL-induced antigen is spreading?
Oh good morning, a quick question on the.
I also am til.
And that is obviously you see in fact promote to control all of sudden it.
It makes sense.
<unk>.
What are the levels of IL seven.
You expect to reproduce the sufficient to support other T cell populations.
On the hopeful assumption that the <unk> antigen spreading and then I have a follow up thank you.
Adrian Rawcliffe: Okay, so we'll get back to you on the levels of IL-7 produced, and we have a presentation at ASGCT that I think will deal with that. What's your follow-up? Well, it's kind of another one from the ASTCC, that's right, but it's, you know, do you think you'll be able to measure the level of IL-7 in patients and could it correlate to till quality, for a better term, as, you know, you would interpret the data from till as reflective of varying levels of T cells able to effectively target the tumors, so hopefully, better till quality products might produce Yeah, so Tony, I'm sorry. Sorry, Nick.
Okay. So we will get back to you on the levels of.
IL seven produced.
And we have a presentation at <unk>, but I think we'll we'll deal with that.
Sure.
What's your follow up.
Well is it.
Kind of another one from the CCD that's correct.
Do you think youll be able to measure the level of idle seven in patients and could it correlate to til quality for want of a better term is.
You could interpret the data from til is reflective of varying levels of T cells able to effectively target the chinas hopefully better til.
Quality products might produce smaller IL seven, but I don't know if you expect to be able to measure that in patients.
Adrian Rawcliffe: Sorry. I wanted to, let me just try and address that. First of all, we can measure IL-7 in patients, but what's really important is the IL-7 in the tumor. The way that the construct is made is that it's...
Yes, so Tony.
I'm sorry.
Sorry, Nick.
Alright.
<unk>.
Just wanted to let me just try and address that first of all we can measure IL seven in patients, but what's really important is the IL <unk> in the tumor.
And at the.
The way that the construct is is is made is that it's.
Adrian Rawcliffe: The IL-7 production is actually triggered by T-cell activity, so the action will actually be inside the tumor. And there are ways that we can assess that with post-treatment tumor biopsies, and systemic measurements of IL-7 will be part of it. And there will be other translational ways to look at the activation of T-cells and other markers that we'll use to assess the impact of IL-7. In addition to the efficacy itself,
The IL seven production is actually triggered by T cell activity.
The action will actually be inside the tumor and there are ways that we can assess that with post treatment tumor biopsies and systemic measurements of IL seven will be a part of it.
And there'll be other translational ways to look at activation of T cells and other other markers that we'll use to to.
To assess the impact of IL seven.
In addition to the efficacy itself.
Adrian Rawcliffe: Fair enough, thank you. Thank you. And we have a question from Peter Lawson with Barclays. Your line is open.
Fair enough. Thank you.
Thanks, Nick.
Operator: Good morning, this is Jiayuan on behalf of Peter Lawson. Thanks for taking the question. Just briefly, on the pre-BLA meeting, I believe you mentioned you hadn't set up a date for that. But could we expect an update when you have it, particularly around the manufacturing and release testing? And is there any sense of timing for when that might happen over the next few months here?
Thank you and we have a question from Peter Lawson with Barclays. Your line is open.
Good morning. This is Dan on for Peter Lawson, Thanks for taking the question.
Just briefly on the pre.
Pre BLA meeting I believe you mentioned you had set up a day could we expect an update and when you have it particularly around the manufacturing and release testing and and is there any sense of timing for when that Manhattan.
And then secondly, if you could talk a little bit about how you're thinking about prepping for the launch now.
Eileen them what the next steps are there and then just sorry, just briefly as well on the needle cohort.
Are you expecting on this phase one or are you already planning Shea incorporate this into your phase two surpassed surpass three.
What's that look like that thank you.
Adrian Rawcliffe: And then secondly, if you could talk a little bit about how you're thinking about prepping for the launch now ahead of that filing and what the next steps are there. And then, just third, just briefly as well, on the NEBO cohort, are you expecting to just have this in Phase 1? Or are you already planning to incorporate this into your Phase 2, Surpass 2, and Surpass 3, and what might that look like there? Thank you. So, the first question concerns the pre-BLA meeting, so typically that will happen a few months ahead of the file, so we anticipate that later this year.
So.
First question first question around the.
The pre BLA meeting so typically that will happen three months ahead of the file. So we anticipate that later this year, we will update on the.
Adrian Rawcliffe: We will update you on the progress on that and on all of the milestones that we've outlined between now and the BLA. With respect to, well, your second question was with respect to the launch. What was the question there? Yes, correct, the launch. And when might you expect to do that, the release in 2023? Okay, so I'll ask Cintia Piccina.
Progress on that and on all of the.
Milestones that we've outlined between now and the.
Allied.
With respect to your second question was with respect to launch.
Christian left yes.
Yes, correct the launch and when might you expect to do that and they are released in 2023 okay.
I'll ask Cindy.
Gina.
Cintia Piccina: Chief Commercial Officer to just touch on that, Cintia. Thank you, Adrian. So we're planning to submit by the end of the year, and hopefully be able to launch by the end of next year. The launch preparation is going great.
Chief commercial officer to just touch on that Cynthia.
Thank you Adrian so yeah, we're planning system, the ear and so hopefully be able to launch by the end of next year.
The launch preparation is going great. We are leveraging a lot of the expertise that you already have the sites.
Cintia Piccina: We're leveraging a lot of the expertise that we already have with the sites from a clinical perspective, from a clinical operations perspective, and putting the team together to really have a launch that will be very focused on the centers of excellence. This is an ultra-rare disease, and we have the opportunity to also be extremely customer-centered as we are very focused on cell therapies alone. So, really, very agile and focused on leveraging our expertise for the launch.
From a clinical perspective from a clinical operations perspective.
And putting the teams together to really have launched and it will be very focused on the centers of excellence.
Is an ultra rare disease, and we have the opportunity to also be extremely customer centered as we are very focused on til therapies, along so it's very agile and focused and leveraging our expertise and a launch.
Cintia Piccina: And with respect to nivolumab in the Phase 1 trial and its potential use outside of that Phase 1 trial, I'll ask Elliot to comment on that. Yeah, so, um... The use of nivolumab is really based on the fact that it's given every four weeks, which fits very well with the way that the current trial is organized. We plan to test it in phase one. I mean, I think that that's really the nature of the first arm of this trial.
And with respect to the volume up.
In the phase one trial.
And its potential use outside of that phase one trial I'll ask Elliot to comment on that.
Yeah. So.
The use of <unk> is really based on the fact that it's given every four weeks.
Which fits very well with the way that the current trial is organized.
And.
Yeah.
We plan to test it in phase one I mean, I think that that's that's really the.
The nature of the arm of this trial, if we see that there are important efficacy advantages to it then we certainly could advance that into later stage trial, just like we look for other signals.
But we think that this is an important combination to explore.
Thank you.
Elliot Norry: If we see that there are important efficacy advantages to it, then we certainly could advance that into a later stage trial, just like we look for other signals. But we think that this is an important combination to explore. Thank you. Thank you.
Thank you we have a question from Mara Goldstein with Mizuho. Your line is open.
Operator: Great. Thanks so much for taking the questions. First, I'm wondering if you can maybe outline for us sort of where you are in terms of target identification with the Genentech program and how we should think about that for 2022 and 2023. And the second question is on the surpass two and three programs. And, you know, what should we think about in terms of what would be considered, you know, sort of the bar for signals for those programs?
Great. Thanks, so much for taking my question.
Firstly.
I'm wondering if you can maybe outline for us sort of where you are in terms of target identification.
Tech program and how we should think about that for 2020, Karen <unk> 'twenty 'twenty three and if I can just.
And then surpass two and three programs in.
What should we think about in terms of.
What would be considered.
The bar for signal for those programs.
Adrian Rawcliffe: So I'll ask Helen Tayton-Martin to talk about the status of the Genentech program, and then I'll come back and touch on the BAFTA record, if I can touch on the BAFTA record. Thank you.
So I'll ask.
Helen <unk> Martin to talk about the.
Status of the Genentech programmer, then I'll come back and touch on the ball for us I could touch on the bottom.
Helen.
Helen Tayton-Martin: Hi Maurice, so in terms of the Genentech collaboration, the initial targets were already selected at the time of the deals, and they're not disclosed and unlikely to be disclosed in the near term. So targets have been nominated, and we're pleased with that. The collaboration is moving forward as planned. I think it's different from the autologous system because here you have a gene-edited stem cell line that we start with, so obviously the focus is there, and then constructs drop into that.
Hi, Mara so in terms of the Genentech collaboration.
This will target for the selected at the time of the deals and then not displaced and unlikely to be displaced in the near term.
Targets targets nominated and.
With that.
Collaboration is moving forward.
Pat.
The expected plan I think.
It's the autologous system, because you have a gene edited stem cell line that we start with so obviously the focus is there and then construct drop into that say.
Helen Tayton-Martin: So work is moving forward according to the plan. I think we're really pleased with the collaboration. I think there's more to come; milestones will probably be around the anniversary payments and also research payments that become due, and we'll update on those in due course.
Work is moving forward. According to the plan I think we know we're really pleased with the collaboration.
I think more to come milestones would really probably be around the university payments until say research payments become gave an update on <unk>.
Adrian Rawcliffe: Thank you. Thanks, Helen. And with respect to the level of signal, I think there's a general answer and a specific answer.
Alright. Thanks.
Thanks, Allen and with respect to the the level of signal I think there's a general answer the specific answer the general answer, which we've given quite a lot is with.
Adrian Rawcliffe: The general answer, which we've given quite a lot, is that, you know, you anticipate that at least three out of 10 patients will show significant efficacy in the response in order to identify that that's sufficient efficacy to be thinking about taking that forward. Obviously, with individual tumor types, as Elliot referred to earlier, there are specific patient populations that exist within specific treatment paradigms, and the bars for efficacy, maybe, will vary across the tumor types that we're studying, and that's one of the things that we're taking into consideration as we go into SURPASS-2 and SURPASS-3. But for SURPASS-1, in terms of signal, three out of 10 responses with reasonable durability in what is, you know, inherently a very late end-stage patient population. Okay. Thank you. Yep.
Do you anticipate that at least three out of 10 patients.
So cigna.
Significant efficacy.
Hey.
Our response.
In order to defy.
Thats sufficient efficacy to be thinking about taking that forward.
Honestly with individual.
Tumor types as Elliot referred to earlier there are specific type of patient populations that exists within specific treatment paradigms in the the baas for efficacy maybe will vary across the.
The tumor types that were studying in that that's one of the one of the things that we're taking into consideration as we go into <unk> in South Australia.
So Pos one in terms of signal.
Three out of 10 responses with reasonable durability in this team what is.
<unk>, a very late stage patient population.
Okay.
Thank you.
Adrian Rawcliffe: Bye. Bye. Bye. Bye. Thank you. And I'm showing no other questions in the queue.
Yes, sorry.
That's it.
Okay.
Adrian Rawcliffe: I'd like to turn the call back to Adrian Rawcliffe for any closing remarks. Thanks. As I conclude the call, I want to just refer back to our ambition to transform the lives of people with cancer by designing and delivering cell therapies, which, as I opened with, is not a short-term ambition, but we do have short-term deliverables against that. We have chosen to go after difficult-to-treat solid tumors, and we are about, in that context, we're about to submit the BLA for our first product.
Thank you and I'm showing no other questions in the queue I would like to turn the call back to Adrian <unk> for any closing remarks.
Thanks.
I conclude the call I want to just refer back to our ambition to transform the lives of people with cancer by designing and delivering cell therapies, which as I said.
Opened with is not a short term ambition, but we do have short term deliverable was the guidance that we.
We have chosen to go off the difficult to treat solid tumors.
And we are about in that come in that context, we are about to submit the BLA for our first products, but we have shown significant responses across multiple indications with our first next gen product and I look forward to updating that.
Adrian Rawcliffe: We have shown significant responses across multiple indications with our first next-gen product, and I look forward to updating that at ESMO. More broadly, we are developing the manufacturing capabilities to deliver the commercial product and products for our clinical trial, and we are well underway to finalize construction of our first allogeneic manufacturing facility. Overall, I believe we are in a strong position to deliver against this ambition both for people with cancer and for investors.
At ESMO.
More broadly we are developing the manufacturing capabilities to deliver the commercial product and products for our clinical trial, and we are well underway to finalize construction for our first outlet generic manufacturing facility.
Overall I believe we are in a strong position to deliver against the ambition both for people with cancer and for investors. Thank you for listening and with that we'll close the call.
Operator: Thank you for listening, and with that, we'll close the call. This concludes today's conference call. Thank you for participating. You may now disconnect. [music]
This concludes today's conference call. Thank you for participating you may now disconnect.
Okay.
[music].
Okay.
Yes.
Yes.
Okay.
Okay.
Yes.