Q4 2021 Adaptimmune Therapeutics PLC Earnings Call
Good day, Thank you for standing by welcome to the full year and fourth quarter of 2021 adapt immune earnings conference call. All lines have been placed on mute to prevent any background noise. After the speakers' remarks, there will be a question and answer session to ask a question you may need to be.
Operator: Good day. Thank you for standing by. Welcome to the full year and fourth quarter of 2021 Adaptimmune Earnings Conference Call. All devices have been placed when new to prevent any background noise.
Star one on your telephone.
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I would now like to turn the conference over to MS. Cheng. Please go ahead ma'am.
Juli Miller: After the speaker's remarks, there will be a question and answer session. To ask a question, you will need to press star 1 on your keyboard. Set in Jentan, the conference we need to reach an operator, Peace Press T0. I would now like to turn the conference over to Ms. Juli Miller. Please go ahead. Good morning, and welcome to Adapt Immune's conference call to discuss our full year and fourth quarter 2021 financial results and business updates.
Good morning, and welcome to adapt Indians conference call to discuss our full year and fourth quarter 2021 financial results and business update.
Juli Miller: I would ask you to please review the full text of our forward-looking statements in 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 filings with the SEC.
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 several factors, including those outlined in our filings with the SEC.
Juli Miller: Adrian Rawcliffe, our Chief Executive Officer, is here with me for the prepared portion of this call. Other members of our management team will be available for Q&A. With that, I'll turn the call over to Adrian.
Adrian <unk>, our Chief Executive Officer is here with me for the prepared portion of this call. Other members of our management team will be available for Q&A with that I'll turn the call over to Adrian walked with ads.
Adrian Rawcliffe: Add, Thanks, Juli. And thank you everyone for joining us. We filed a form 10k earlier today, and I'd like to recognize the team for their hard work enabling that to happen. Late in the process, we identified a material weakness in the operation and design of specific controls for the calculation of the valuation allowance against deferred taxation.
Thanks Julie.
And thank you everyone for joining us.
We filed our Form 10-K earlier today and I'd like to recognize and thank them for their hard work, enabling that to happen.
Late in the process, we identified a material weakness in the operation and design of specific controls for the calculation of the valuation allowance against deferred taxation.
This has no impact on our cash or cash runway we.
We have a plan in place to remediate this weakness and I refer you to the 10-K for further details.
Adrian Rawcliffe: This has no impact on our cash or cash flow. We have a plan in place to remediate this weakness, and I refer you to the 10K for further details. I'll begin the call today by laying out our focus for 2022, which ties into, and will ensure delivery of, the next stages of our 2252 strategic plan. This year, we are focused on four main areas. Firstly, we intend to file our BLA for Famousel for the treatment of synovial sarcoma in Q4 of this year.
I'll begin the call today by laying out our focus for 2022.
Which ties into and will ensure delivery of the next stages about 2252 strategic plan.
Adrian Rawcliffe: Secondly... We will continue building on our Major 4 franchise with the surpassed family of clinical trials. Thirdly... With our Allogeneic platform, we are making progress towards filing our IND for our first wholly owned Allogeneic product targeting MAI-J4 next year. And lastly, we are scaling up on manufacturing facilities to deliver cell therapies for our first commercial product and our ongoing and planned clinical trials, including this first-allegiate... I want to touch briefly on each of these and describe the progress we made last year and our plans for the coming year.
This year, we are focused on four main areas.
Firstly, we intend to file a BLA for <unk> for the treatment of synovial sarcoma in Q4 of this year.
Secondly.
We will continue building on our MAGE, a forefront jives with the support family of clinical trials.
Thirdly.
With our allogeneic platform, we are making progress towards filing a I N D for all first wholly owned allogeneic product targeting MAGE a for next year.
And lastly, we are scaling up our manufacturing facilities to deliver cell therapies for our first commercial product and the ongoing and planned clinical trials, including this first dollar generic product.
I want to touch briefly on each of these and describe the progress we made last year and our plans for the coming year.
Adrian Rawcliffe: The first focus area is filing the BLA for FAMAS, our first generation SPIR T-cell product targeting May J4. In less than two years, against the backdrop of a global pandemic, we have successfully completed enrollment and treatment in Cohort 1 of the Spearhead 1 Pivotal Trial, which will serve as the basis for the BLA. We've completed the efficacy analysis for cohort one, and as we shared during the JP Morgan Combe, the trial has met its primary end.
The first focus area is filing the BLA for <unk> myself.
First generation spear T cell product targeting MAGE a fool.
In less than two years against the backdrop of a global pandemic, we have successfully completed enrollment and treatment in cohort one of the spearhead one pivotal trial, which will serve as the basis for the BLA.
We've completed the efficacy analysis for cohort one and as we shared during the JP Morgan Conference. The trial has met its primary endpoint.
Adrian Rawcliffe: Further, at CTOS, we reported an overall response rate per independent review of 36% for patients in this heavily pre-treated synovial sarcoma patient population. However, at the time of this data cut, the median duration of response had not been reached, with 75% of the responders still in response. The non-clinical dossier for the BLA is complete, and the pediatric plans have been agreed with the regulatory A- Going forward, we are working on additional elements required for the BLA filing, including supply of Vector from Miltenny Biotech's new facility, and T-cell product characterization.
Further it suits us we reported an overall response rate per independent review of 36% for patients in this heavily pretreated. So I know, we all saw kind of a patient population.
At the time of this data cutoff. The median duration of response had not been reached with 75% of the respondents still in response.
The non clinical dossier for the BLA is complete and the pediatric class have been agreed with the regulatory agencies.
Going forward, we are working on additional elements required for the BLA filing including supply effector from milk Tenney biotechs new facility.
Vector and T cell product characterization.
<unk> validation for the lot release assays, including our potency assays.
Adrian Rawcliffe: Method validation for the lot release assays, including our potency assay, and completion of the clinical and CMC dossiers. We are confident in our capabilities to deliver against these remaining elements, and we will report progress throughout the year. We are planning to present data from Cohort 1 of the Spearhead 1 trial at ASCO, as well as combined data from Cohorts 1 and 2 at CETOS. The second focus area for 2022 is to continue building our MAGE A4 franchise with the surpassed family of trials using our next generation ADPA2M4 CD8 SPIR T cells targeting MAGE A4.
And completion of the clinical and CMC dossiers.
We are confident in our capabilities to deliver against these remaining elements.
We will report progress throughout the year.
We're planning to present data from cohort one of the spearhead one trial of <unk> as well as combined data from cohorts, one and two sito's.
The second focus area for 2022 is to continue building our MAGE a full franchise with the <unk> family of trials using our next generation ADP <unk> spear T cells targeting MAGE <unk>.
Adrian Rawcliffe: Last year, at ESMO, we presented data from our Phase 1 Surpass Trial in multiple solid tumor indications. We reported an overall response rate of 36% with a confirmed complete response in ovarian cancer and confirmed partial responses in ovarian, head and neck, esophagogastric junction, and bladder cancers as well as sonobial sarcoma. Based on these and earlier data, we initiated recruitment in a phase two trial, PASSED 2, for people with a suffigogastric junction or a suffigial cancer. And we'll initiate another Phase 2 trial, Surpass 3, for people with ovarian cancer this year. The SUPAS Phase 1 trial continues to enroll patients with gastroesophageal, head and neck, lung, bladder, and ovarian cancer.
At ESMO last year, we presented data from our phase <unk> trial in multiple solid tumor indications.
We reported an overall response rate of 36%.
With a confirmed complete responses in ovarian cancer and confirmed partial responses in ovarian head and neck, esophageal gastric junction and bladder cancers as well as synovial sarcoma.
Based on these and earlier data, we initiated recruitment in our phase II trial, so pulse to the people with the Suffolk gastric junction or suffer Geo Kansas.
And we will initiate another phase II trial surpassed three for people with ovarian cancer this year.
Okay.
This is a pause phase one trial continues to enroll focusing on patients with gastroesophageal head and neck lung bladder and ovarian cancers and.
Adrian Rawcliffe: And we'll add an arm to this trial to combine our spare T-cells with a checkpoint inhibitor. We plan to present data from the original protocol for the Phase 1 surpass trial at Esmo this year. The third focus is our allogeneic programme. We are the only company in our space with advanced autologous self-therapy trials, as well as a stem cell-derived allergenic T-cell platform. Autologous therapies are critical for near and medium-term value creation, and they provide learnings that will drive the long-term success of our allogeneic platform. We've demonstrated on our Allogeneic Platform that we can produce T-cells from stem cells that kill cancer cells in vitro, and do so in a serial fashion.
And we are adding on to this trial to combine our spear T cells with a checkpoint inhibitor.
We plan to present data from the original protocol of the phase <unk> trial at ESMO This year.
The third focus is our allogeneic program.
We are the only company in our space with advanced autologous cell therapy trials as well as a stem cell derived allogeneic T cell platform.
Autologous therapies are critical for near and medium term value creation and they provide learnings that will drive the long term success with our allogeneic platform.
We have demonstrated in our allogeneic platform that we can produce T cells from stem cells that kill cancer cells in vitro and do so in a serial fashion.
Adrian Rawcliffe: We plan to file an IND for our wholly-owned allogeneic cells targeting RAGE-A4 next year, and we've begun building a dedicated allogeneic manufacturing facility in the UK. Last year, we announced our strategic collaboration with Genentech to research, develop, and commercialize allergenic cell therapies. The collaboration covers the development of products but for five shared cancer targets, as well as a novel, allergenic, personalized self therapy plan. The collaboration has begun, and we received a $150 million upfront payment in Q4 last year, as reflected in our financials.
We plan to file an IND for our wholly owned allogeneic cells testing by Jay for next year.
Begun building a dedicated Ala generic manufacturing facility in the U K.
Last year, we announced a strategic collaboration with Genentech to research develop and commercialize allogeneic cell therapies.
This collaboration covers development of products for up to five shared cancer targets as well as a novel allogeneic personalized cell therapy platform.
The collaboration is initiated and we received $150 million upfront payment in Q4 last year as reflected in our financials.
Adrian Rawcliffe: The last focus area for 2022 is to add scale to our CMC capability. Our 2252 strategy is underpinned by our integrated cell therapy capability. I don't think it's controversial to say that to be successful as a cell therapy company, you need strength and depth across manufacturing and the supply chain, and we've been consistently, thoughtfully investing in our CMC capacity for more than seven years and have built an impressive set of capabilities.
The last focus area for 2022 is to add scale to our CMC capabilities.
Our 2252 strategy is underpinned by our integrated cell therapy capabilities I don't think it's controversial to say that to be successful as a cell therapy company need strength and depth across manufacturing and supply chain.
And we've been consistently thoughtfully investing in our CMC capacity for more than seven years and have built an impressive set of capabilities.
Adrian Rawcliffe: We've produced hundreds of batches of cell therapy for our autologous clinical trials with multiple products across a broad range of tumors. The GMP manufacturing capabilities at the Navy Yard are now being expanded to meet the needs of our first commercial product, as well as our ongoing and planned late-stage clinical trials. We've begun construction of an additional manufacturing facility in the UK for allogeneic therapy. And finally, our in-house vector manufacturing in the UK has been successfully running for about two years.
We've produced hundreds of batches of cell therapy for our autologous clinical trials with multiple products across a broad range of tumors.
The GMP manufacturing capabilities at the Navy yard and now being expanded to meet the needs of our first commercial product as well as our ongoing and planned late stage clinical trials.
With both gung construction of an additional manufacturing facility in the UK, the allogeneic therapies and.
And finally, our in house vector manufacturing in the UK has been successfully running for about two years now.
Adrian Rawcliffe: At Adaptimmune, we are motivated by a shared mission and vision to transform the lives of people with cancer by designing and delivering cell therapy. As part of that commitment, we've bolstered our internal team. We appointed Cintia Piccina as Chief Commercial Officer in January.
And adapt to me we are motivated by a shared mission and vision.
Transform the lives of people with cancer, designing and delivering cell therapies.
As part of that commitment with bolstered our internal teams.
We appointed Cynthia Pacino as Chief commercial officer in January <unk>.
Adrian Rawcliffe: Cintia has deep experience in oncology and, in particular, cell therapy. She'll be a great champion of our products, and the BLA this year is only the beginning of our ambition. We have also hired Irving Ford as our head of quality.
<unk> has deep experience in oncology and in particular with cell therapy.
She'll be a great champion of our products and the BLA. This year is only the beginning of our ambitions here.
We also hired Irving Ford as our head of quality, who previously worked on delivering marked its cell therapy products that both novartis and BMS.
In conclusion.
We have seen the power of T cells to treat cancer.
Shown in our own engineered TCR T cells, and also qualities tills and checkpoint inhibitors.
We've taken an ambitious path to develop cell therapies for difficult to treat solid tumors and it is extremely gratifying and motivating to hear about the impact of our cell therapies have in conversations with our investigators and the people they trade.
Adrian Rawcliffe: We are leading the way in engineered TCR T-cell therapies for cancer, and we are on the verge of filing our first BLA, which, if approved, will be the first engineered TCR T-cell therapy on the market, and we're well funded into early 2024 to deliver on our objective. Operator?
We are leading the way in engineered TCR T cell therapies for cancer, and we own the verge of filing our first BLA, which if approved will be the first engineered TCR T cell therapy on the market.
We're well funded into early 2024 to deliver on our objectives with that I'd like to open up for questions operator.
Operator: Thank you. As a reminder, to ask a question, you'll need to press star 1 on your telephone. To read the royal question, press the panel key.
Thank you as a reminder to ask a question we need to press star one on your telephone to withdraw your question press to pound key again Thats Star then the number one to ask a question.
Operator: Again, that's the star, then the number 1 to ask a question. The first question comes from the line of Marc Frahm with Colin. Your line is, Thanks for taking my questions. Maybe to start off, Adrian, you listen to a handful of different elements for the GMC dossier that you need to complete over the next couple of quarters to get the VLA submitted in Q4. Which of those can you view as the rate limit step to the CMC dossier, or are they all kind of on the same path? So I'm going to ask Dennis.
Our first question comes from the line of Marc Frahm with Cowen Your line is open.
Hi, Thanks for taking my questions maybe.
Maybe just start off with Adrian you will see a handful of different elements of the CMC dossier that.
You need to be completed over the next couple of quarters two to.
Get the BLA submitted in Q4.
Which of those you can view as the rate limiting step to the CMC dossier or are they all kind of on the same path.
So I'm going to ask.
Dennis.
Adrian Rawcliffe: Williams, who leads our late-stage development of a farmer cell, to comment on that. Thanks, Mark. Dennis?
Williams, Who's leading who leads our late stage development of our pharma sell to comment on that thanks a lot.
Dennis Williams: Yes, sure. Thanks, Mark. So I think... Some of those activities for T-cell process performance qualifications need prerequisites to be complete, meaning things like assay methodality.
Sure. Thanks, Mark So I think.
Some of those activities for T cell process performance qualification need prerequisite to be complete meaning things like assay method validation you need to have.
Dennis Williams: [inaudible] You need to have your commercial vector in hand, so I wouldn't necessarily categorize one versus another as being significantly limiting, but the T-cell PPQ essentially is the last step in the chain where you need to complete those prerequisites first. So, chronologically, it is the last activity to occur prior to finalizing module three of the BLM. Okay, that's helpful. And then maybe just with experience, you know, of the team having filed some other works towards commercialization and filing of some other self-therapies.
Your commercial vector in hand so.
I wouldn't necessarily categorize one versus another as being great limiting but.
The T cell PDQ essentially is the last step in the chain, where you need to complete those prerequisite is first so chronologically. It has the last activity to occur prior to finalizing module three of the BLA.
Dennis Williams: It compares contrast to the assays that you need to handfulily validate here to what's been done with some other self-therapies that have been successfully developed and then maybe, you know, also with what we've seen go on in the till. [inaudible] Sure. This is Dennis Williams again.
Okay. That's helpful and then maybe just with the experience.
The team having filed some other work towards commercialization filing or some other cell therapies. A compare contrast is the assay.
You need to fully validate year to what's been done with <unk>.
Some others out there besides successfully developed and then maybe also with what we've seen go on in the tool space.
Dennis Williams: So, you know, many of these assays were validated prior to their use in Phase 2 trials, including Spearhead 1. Now, as we look towards commercialization, we would like to tighten these assays and further optimize them. So these are the method validations that I'm speaking about; we're, you know, these are an ongoing process now for this BALC-EI. Um, I think maybe you're alluding to posh anti-assays, you know, and I think, you know, for what we do, that we use an antigen specific to toxicity assay, right? So I think our circumstance... for potency is quite different from what one may see in it, and it tilts out.
Sure. This is Dennis Williams again.
So.
Many of these assays were validated prior to us even in <unk>.
Phase II trials, including spearhead one now as we look towards commercialization, we like to tighten these assays and further optimize so these are the method validation that I'm speaking about.
These are an ongoing process now.
Now for this for this dossier.
I think maybe youre alluding to potency assays.
For what we do that we use.
<unk> specific toxicity assay.
Our circumstance.
For potency is quite different from what one may see in the til therapy.
Dennis Williams: [inaudible] We have been using the same set of toxicity assays prior to the start of spearheading. So hopefully, I don't know if I addressed your question or not. Yes, that's all, thank you. Thanks, Mark. Your next question is from Michael. And Han, Juline. Hi, everyone. This is Paul.
We've been using the same set of toxicity assay prior.
Prior to the start of spearhead one.
So hopefully that.
Don't know if I addressed your question or not.
Yes, that's helpful. Thank.
Thank you.
Thanks Ross.
Your next question is from Michael Schmidt from Guggenheim. Your line is open.
Operator: I'm from Michael. Thanks for taking the time to ask your question. First one is just quickly; could you provide some guidance on how many additional patients will be getting from the SIRPATH trial at Esmo this year? And then secondly, you know, there was some data last year from Immunoforce by specific targeting MAJ-4 with somewhat different enrollment criteria in terms of expression. I was wondering if you could just talk about differentiation from your approach, maybe how you view coming updates from that program relative to your MAJ-4 franchise? Thanks, Sue. I'll truncate it.
Hi, everyone. This is Paul on for Michael Thanks for taking my question first one is just how quickly could you provide some guidance on how many additional patients get from the surpass trial at ESMO This year.
And then secondly.
There was some data last year from the meat of course by specific targeting MAGE <unk> four with somewhat different enrollment criteria interest expression wondering if you could just talk about differentiation from your approach maybe how you view coming updates from that program.
Relative to your major four franchise.
Some of them.
Adrian Rawcliffe: We've not been specific about the number of patients, but we anticipate that it will be a significant update, and that's all we've said about patients. With respect to the differentiation of our cell therapy from immunocles in specific and other matters, I'll ask Elliot to comment on that. Yeah, I'll just add that with respect to the update that's anticipated at ESMO, we do anticipate that it will be across tumor types. With respect to the Immunocore data, I think there was a publication earlier this year where they made initial data public, and their approach to antigen expression was really quite different from ours, and in addition to that, the data that they presented was really very early.
Thanks Sue.
I will truncate, we've not been specific about the number of patients, but we anticipate that it will be a significant update and that's what we've said about patients with respect to the differentiation of our cell therapy from <unk> by specific and other message I'll ask Elliot to.
To comment on that.
Just to add that.
With respect.
The update that's anticipated ESMO, we do anticipate that it will be across tumor types.
With respect to the.
Immuno core data I mean, I think there was a publication earlier this year, where they they made initial data public.
And.
Their approach to <unk>.
Antigen expression was really quite different from ours and in addition to that the data. They presented was really very early so I think it's really premature to make broad comparisons.
We're.
Adrian Rawcliffe: So I think it's really premature to make broad comparisons, but we are pretty rigorous about ensuring that patients who come into the trial have a known level of antigen expression, and that helps us with respect to interpreting the results. I think that at least our takeaway from the information that was published by Immunocore was that for some of their tumor types, they did not require antigen expression measurement prior to entry into the trial and then did that retrospectively.
Pretty rigorous about ensuring that patients who come into the trial have.
Unknown level of antigen expression.
And and that helps us with respect.
<unk> the results.
Thank that.
At least our takeaway from the information that was published by.
And Unicorn.
Was that for some of their tumor types they did not.
Require.
Antigen expression measurement prior to entering the trial and then did that retrospectively.
Adrian Rawcliffe: And they also saw some responses with what they described as very low levels of expression, although the durability of those responses was not very good. I just don't think they've had enough time to be able to fully describe it in their early publication.
And they also saw some responses with what they described as very low levels of expression.
Although the durability of those responses was not.
Very well I, just don't think they've had enough time to be able to fully describe it in the early publication. So the bottom line is that I think there's a long way to go as it as it relate.
Elliot Norry: So the bottom line is that I think there's a long way to go as it relates to making comparisons. But I think we'll stand behind our data with clear definition of antigen expression and a resistance response rate of 36% in very advanced patients with multiple tumor types. Great, thanks a lot. Thanks for all. Thanks a lot. This is from Nick Abbott from Wells Fargo, Your Line.
It relates to making comparisons.
We will stand behind our data.
With a clear.
Definition of antigen expression.
And and.
Ah resist response rate of 36%.
In very advanced pace.
Patients with multiple tumor types.
Great. Thanks, a lot.
Thanks, Paul.
Next is from Nick Abbott from Wells Fargo. Your line is open.
Operator: Oh, good morning. Thanks for taking our questions. First, Ed, in terms of the expansion at the Navy Yard, can you talk about what percentage increase in capacity over current capacity you're targeting there? And presumably, this is going to come online following the BLA approval. Yeah, so I lost John Lunger at the Chief Patient Supply Office. That's a comment on that. John?
Oh good morning, Thanks for taking our questions.
Thanks, Ed.
The expand.
Expansion in the Navy yard so could you talk about sort of what percentage, you're increasing capacity as a current capacity.
Tom take that.
Presumably this is going to come online.
Following the BLA.
Approval.
John Lunger: Yeah, thanks for the question. So, yeah, the current capacity that we have at the facility is around about 300 patients a year. And when I talk about capacity, I'm talking about room and equipment. And it might say current capacity. I mean, we have the staffing available to do that.
Yes, so I'll ask John Lunger, our chief patient supply officer to comment on that John Yes. Thanks for the question. So yes. The current capacity we have the facility is around about 300, or so patients per year and when I talk about capacity I'm talking about room and equipment and then when I say current capacity.
I mean, we have the staffing available to do that the.
The expansion in the yard will bring us up to a theoretical capacity of six to 700 patients per year out of that facility, which is a combination of clinical supplies for future autologous products as well as commercial for a fan Michelle.
Obviously, we'll need to staff that we're looking to have the.
Rooms, complete and ready to move manufacturing in later on this year.
Dennis Williams: So can you talk about, you know, a companion diagnostic for HLA and MAJ4 or whether these just get kind of rolled into currents of NGS style diagnostics. I'll ask Dennis to come in, Dennis. Yes, sure. So, I'll take the MAI-J4 first. So, we are developing with a compendium diagnostic manufacturer, Agilent, that they are developing a commercial MAI-J4 IHC test, And we... that pre-market application or PMA is planned to be scheduled.
Great I appreciate the detail.
And then I actually joined late so apologies if you addressed this.
So can you talk about.
A companion diagnostic for HLA in May Jay.
The teachers.
Kind of rolled into current NDS type style.
Sure.
Diagnostics.
I'll ask Dennis to comment on that Dennis.
Yes sure so.
I'll take <unk> first so we are developing.
With the companion diagnostic manufacturer.
Agila.
We're developing a commercial.
Major for IAC test.
And we.
That that pre market application or PMA is.
Plan to the schedule is planned to be submitted contemporaneously with the BLA, so that will be the <unk>.
Dennis Williams: Plan to be submitted contemporaneously with the VLA, so that will be the diagnostic companion that will patience for a femme cell be selected in the commercial set. For HLA, we use a 510K cleared test presently, called anger sequencing, and that is likely to be the test that people will use in the commercial setting.
Diagnostic companion that will patients.
For FEMSA will be selected in the commercial setting.
For HLA, we use a five 10-K cleared.
Presently.
Sanger sequencing and.
That is likely to be the tests that people will use in the commercial setting.
Dennis Williams: Your comment is well taken about NGS; I'm quite aware that the field is moving on with new technologies for HLA testing. But at the moment, we use in trials a finger sequencing test for you. Thank you, and welcome from me. [inaudible] And it goes to... Obviously, when you selected the two sarcoma subtypes, it was because they had very high expression of MAJ4, but there is a sprinkling of MAJ4, presumably, in other subtypes. Sarcoma subtypes
Your comment is well taken about Ngls.
Im quite aware that the field is moving on with new technologies for HLA testing.
But at the moment, we use in trials of.
<unk> sequencing test for HLA.
Alright, Thank you and then.
Awesome for me and.
It goes to.
Obviously when you when you selected.
Sarcoma subtypes is because they had very high expression, hey, Jay pool, but there is a sprinkling of May J code presumably.
That sounds.
Dennis Williams: So do you think there would be any interest, or when you speak of physicians, is there interest in evaluating this in other sarcoma subtypes that may have lower levels of MAJ-4 than you see in..., the two that you've selected so far? Yeah, thank you. This is Dennis Williams again.
So I'll kind of subtypes. So do you think there would be any.
Interest so when you speak with physicians as well.
Interest who are evaluating this in all of those.
Sarcoma subtypes.
The levels of my James Corden.
C.
In.
The two that you've collected so far.
Dennis Williams: This, that's a good question. And we are evaluating, and will continue to evaluate, to see expression levels of MAYJ4 and other sarcoma subtypes, as you mentioned. Sarcoma as a disease is very heterogeneous, and there are many different subsites. Of note, like for example, we certainly are looking to evaluate whether or not any of the sarcomas that occur in children, with Express May J4 as we... consider pediatric. But, you know, some of that will, at the end of the day, will be dictated by how much expression there is and how, you know, some sarcoma subtypes are even rarer than the mixoid round cell liposarcoma for synovial sarcoma. So that's something we're continuing to evaluate at this point in time. Thank you very much. Thanks, thanks. Next we have Jonathan Chang from SVB-Link. You're live. Hi guys, this is special graffiti on Prajianathan Chang.
Yes. Thank you. This is Dennis again this that's a good question.
We are.
Are you winning new to evaluate to see expression levels of <unk> four and other sarcoma subtypes as you mentioned.
Sarcoma is a disease is better very heterogeneous and there are many different subtypes.
Of note like for example, we certainly are looking to evaluate whether or not any of the sarcomas that occur in children.
With express <unk> four as we.
Consider pediatric plan.
But some of that will have at the end of the day will will be dictated on how much expression level, there is and how some sarcoma subtypes or even rare.
Then then myxoid round saw Lego sarcoma.
Or synovial sarcoma, so that's something.
We're continuing to evaluate.
At this point in time.
Alright, Thank you very much.
Thanks, Dave.
Next we have Jonathan Chang from SBB Leerink. Your line is open.
Operator: I'm just having a question on surpass three if you have any updated docs or guidance on what the ideal patient population is within varying cancers for the spiritual approach. So maybe I'll just take that one very quickly. The patients treated in surpass one are platinum and eligible patients, and we'll probably anticipate that the surpass three trial will recruit into a similar population. Thank you. And then for surpass two, does prior PD-1 have an effect on those GVF spirity cells, and does this inform the trial design anyway?
Hi, guys. Just proceed on for Jonathan Chang just had a question on surpass three if you had any updated thoughts or guidance on what the ideal patient population is within ovarian cancer for the spear T cell approach.
So maybe I'll just take that one very quickly.
The patients treated in the past one platinum ineligible patients.
We probably anticipate that the <unk> III trial will recruit into a similar population.
Got it. Thank you and then for surpassed two does prior PD. One has an effect on that give via spear T cells and does this inform the trial design in the U S.
Okay.
Elliot Norry: Yeah, so I think that the impact of prior checkpoint inhibition with respect to T-cell therapy is one that we're continuing to evaluate. In that patient population, the vast majority of patients going forward are likely going to have received checkpoint inhibitors as part of their first line therapy. So we're specifically aiming to study that population and actually allow us an opportunity to potentially treat patients, some patients in second line as compared to after the sequence of chemotherapy followed by checkpoint inhibitors; those patients often get them in combination.
Yes.
I think that the.
The impact of prior.
Checkpoint inhibition.
With respect to T cell therapy is is one that's that we're continuing to evaluate.
And that patient population the.
The vast majority of patients going forward.
Likely going to have received.
Checkpoint inhibitor as part of their first line therapy.
So where specifically aiming to study that population that actually allows us an opportunity to potentially treat patients. Some patients in second line as compared to after the sequence of chemotherapy followed by <unk>.
Checkpoint inhibitors, those patients often get them in combination so.
I think that the data will have to bear itself out but in the in the realm of treating a range of solid tumors.
And late stage, where certainly gain.
<unk> plenty of experience of of dosing patients who have already received checkpoint inhibitor.
That doesn't preclude that they couldnt benefit from further use of checkpoint inhibitor with <unk>.
In combination with with T cell therapy, and we're going to be exploring that as well.
Adrian mentioned earlier that we're opening.
<unk> arm of the surpass trial the phase one surpass trial to look at T cells in combination our spear T cells in combination with checkpoint inhibition.
Got it thank you for the explanation.
Thanks.
Next question is from Peter Lawson with Barclays. Your line is open.
Operator: The next question is from Peter Lawson with Barclays. Your line is open. Hi, everyone. This is Alex on behalf of Peter.
Operator: Thank you for taking our question. Just on the genotype collaboration, I was just curious what we should expect to learn from this over the next year, so maybe in terms of targets, two and a time to disclose that. Thank you. I'll ask Helen to answer that for you. Yeah, hi there.
Hi, everyone. This is Alex on for Peter Thank you for taking our question.
Just on the Genentech collaboration I was just curious.
What we should expect to learn from this over the next year. So maybe in terms of targets to any plans to disclose that thank you.
I'll ask I'll ask Helen to answer that for you.
Helen Tayton: So we haven't disclosed the target selected by Genitech, and there isn't actually an intention to do that. What we have talked about is, you know, there are research milestones which we will continue to track, which comes as part of that deal. So I think really that's probably where we will be updating on the market. It will be through progress that comes through those committed payments. So that's all I can say is it's kicked off well, and it started well. So we're really pleased with the progress. Let's say so.
Yes.
So we haven't disclosed the targets selected by by Genentech and there isn't actually an intention to do that what we have talked about it.
Research milestone.
We will continue to track three.
Which come as part of that deal. So I think really that's probably where we will be updating on the market it will be cheaper.
Three days.
Can I see payments.
But all I can say it kicked off well and it started well say we are very pleased with Piper CFO .
Helen Tayton: Great. Thank you. Thank you. We have a question from Summatory, from Joint Streating, Your Lane is Open. Hi, this is Dania Benhail. She'll show me how to write.
Great. Thank you.
Thank you.
We have a question from Thomas Ferrari from Jones trading your line is open.
Operator: Thank you for taking my question. It's for your first question about cohort two that you expect to... Update data in ASCO. If upon a positive, do you expect to submit the data also to support the VLA? I'll ask Dennis to highlight data that we'll be presenting at ASCO and CETOS and how Cohort 1 and Cohort 2 will be used in the BLA. Dennis?
Hi, Thanks. This is Daniel <unk> from Macquarie. Thank you for taking my question.
It's four.
Paresh.
Go ahead.
About the cohort two.
Do you expect to.
Update.
In the ESCO.
Yes.
Positive do you expect to submit the data also support the BLA.
Yeah.
I'll ask Dennis to highlight data that we'll be presenting gasco and sito somehow cohort one cohort two will be used in the BLA Dennis yes sure.
Dennis Williams: Yeah, sure. So, yeah, for ASCO, actually, Cohort 2 data is not planned to be presented. For ASCO, there are plans to present data that's actually pooled from our Phase 1 experience and sarcoma as well as the data from cohort one, spearhead one in the final data set, data that's more mature than what was presented at CTAS. And that'll really focus in on areas about where Kuberis that may be interesting from, that may impact efficacy.
So yes.
<unk> actually cohort two data is not planned to be presented for <unk>.
There are plans to present.
David Thats actually pool from our phase one experience.
Sarcoma as well as the data from cohort one spearhead one and the final data set. So this is data that is more mature than what was presented at <unk>.
And that'll really focus in on.
Dennis Williams: So stay tuned for that; that'll be something we've submitted for ASCO. At C-toss, we're targeting to have data from both Cohort 1 and Cohort 2 presented. To answer your question about the VLA, Cohort 1 is the primary data set to be in the BLA, and that is what the clinical documents are being written around. Ultimately, for the BLA, we will have to update, as required, something that's known as the Safety Update, and cohort two data would be utilized, um..., for that data. But cohort 2 data is not planned to be included from an F- Got it.
Areas about where covariates that may be interesting from.
That may impact efficacy.
So stay tuned for that that'll be something we submitted for <unk> at <unk> tostes or we're targeting to have.
Data from both cohort one and cohort two presented.
To answer your question about the BLA co.
Cohort one is the primary dataset.
Tended to be in the BLA.
That is the clinical.
Documents are being written around ultimately for the BLA, we will have to update as required as something thats known as the safety update in cohort two data would be utilized for that for that data by cohort. Two data is not planned to be included from an efficacy perspective.
Got it thank you.
Thank you.
Ganesh with Doctor ask question Press Star then the number one on returning phone keypad.
Operator: Again, if you'd like to ask a question, press star, then the number 1 on your telephone. We have a question from Mara Goldstein from Missoula, Yolanda. Hi everyone, this is Jerry Gong Gong from Mera. Thanks for taking our questions. The first one is about the single center study of the PIL program.
We have a question from Mara Goldstein from Mizuho. Your line is open.
Hi, everyone. This is Jerry doggone premiere, thanks for taking our questions.
The first one is for the single Center study. The Til program can you give us some more details on which indication the company may be focusing on.
Okay.
Suddenly.
I'll ask Karen to of box tenants, leaving the til efforts today.
So of course this is going to be a single center study.
Working in partnership with an array of Savannah the CCI.
Mark and we are targeting melanoma wins.
Til product.
And how much by the secretion of interleukin Stephane.
Got you. Thank you and for the finances I believe the current guidance is for 2024.
Which should include the milestones how much of the current runway guidance.
These milestones.
Yes.
Karen: Thank you. And for the finances, I believe the current guidance is for 2024, which should include some milestones. How much of the current runway guidance includes these milestones? Hi there, it's Gavin Wood, CFO. We haven't broken that out in detail, but we're reiterating guidance to early 20...
Hi, there.
<unk> CFO , we haven't broken that out in detail.
With pricing guidance 2024.
Gavin Wood: Thank you. Thank you. There are no further questions at this time. I would now like to turn the conference back to Mr. Adrian Rawcliffe. Thanks and thanks to everyone for your time and your questions today. I look forward to updating you throughout 2022 as we track towards the BLA for the first ever engineered TCR therapy for synovial sarcoma. Thanks, and have a great day. This concludes today's conference call. Thank you for joining me. Give me now. [music]
Got you. Thank you.
Thank you.
Yes.
There are no further question at this time I would now like to turn the conference back to Mr. Adrian Ralph.
Thanks, and thanks, everyone for your time and your questions today.
Look forward to updating you throughout 2022, as we track towards the BLA for the first ever engineered TCR therapy.
I find myself.
Synovial sarcoma, thanks, and have a great day.
This concludes today's conference call. Thanks for joining you may now disconnect.
Yeah.
[music].
Okay.
Sure.
[music].
Yes.
[music].
Operator: Can you give us some more details on which communication the company may be focusing on? Certainly, I asked Karen to answer that; Karen's been leaving the till efforts today. Yes, of course, this is going to be a single center study working in partnership with Maria Svana at the CCIT in Denmark, and we are targeting Malanoma with a till product that is enhanced by the secretion of interleukin, Gotcha.
Adrian Rawcliffe: We previously worked on delivering market-ready self-therapies products at both Novartis and BMS. In conclusion, we have seen the power of T cells to treat cancer, as shown in our own engineered TCRT cells and also Carties, Tills, and Checkpoint. We have taken an ambitious path to develop cell therapies for difficult-to-treat solid tumors, and it is extremely gratifying and motivating to hear about the impact our cell therapies have in conversations with our investigators and the people they treat.
John Lunger: The expansion in the AV yard will bring us up to a theoretical capacity of six to 700 patients per year out of that facility, which is a combination of clinical supplies for future autologous products as well as commercial for a Famous Cell. So, we obviously will need to staff that. We are looking to have the rooms complete and ready to move manufacturing in later this year. Great, I appreciate the detail. And then I had to join later; later apologies if you address this, Edward.
Elliot Norry: So I think that the data will have to bear itself out, but in the realm of treating a range of solid tumors in late stage, we're certainly gaining plenty of experience of dosing patients who have already received checkpoint inhibitor. That doesn't preclude that they couldn't benefit from further use of checkpoint inhibitors in combination with T-cell therapy, and we're going to be exploring that as well.
Elliot Norry: Adrian mentioned earlier that we're opening an arm of the surpass trial, the phase one surpass trial, to look at T-cells in combination, our spirit T-cells in combination with checkpoint inhibition. You got it. Thank you for the explanation.