Q4 2019 Earnings Call
Ladies and gentlemen, thank you for standing by and welcome to the Foursquare and full year 2019, Adaptimmune earnings Conference call.
Operator: Ladies and gentlemen, thank you for standing by, and welcome to the fourth quarter and full year 2019 Adaptive Mean Earnings Conference Call. At this time, all participants are in a listen-only mode. After the speaker presentation, there will be a question and answer session. To ask a question during the session, you will need to press Star 1 on your telephone. If you require any further assistance, please press Star 0.
This time, all participants are no listen only mode. After speaker presentation, there won't be a question answer session.
A question. During this session you want me to press Star one on your telephone if you're quite any further assistance. Please press star Zero I would now like to turn the conference over to your speaker today truly Miller. Please go ahead ma'am.
Juli P. Miller: I would now like to turn the conference over to your speaker today, Juli Miller. Please go ahead, madam. Good morning, and welcome to Adaptimmune's conference call to discuss our fourth quarter and full year 2019 financial results and other business updates. We issued a press release earlier this morning, and I would ask you to please review the full text of our forward-looking statements there. As a brief reminder, we anticipate making projections during this call, and actual results could differ materially due to a number of factors, including those outlined in our latest filings with the SEC. Adrian Rawcliffe, our CEO, is with me for the prepared portion of this call, and other members of our management team will be available for Q&A after the prepared portion. With that, I'll turn the call over to Adrian Rawcliffe.
Good morning, and welcome to adapt it means conference call to discuss our fourth quarter and full year 2019 financial results and other business update.
We issued a press release earlier this morning, and I would ask you to please review the full text of our forward looking statements. There as a brief reminder, we anticipate making projections during this call and actual results could differ materially due to a number of factors, including those outlined in our latest filings with the FCC Adrian.
Rawcliffe, our CEO is with me for the prepared portion of this call and other members of our management team will be available for acuity. After the prepared portion with that I'll turn the call over to Adrian rocket Huh.
Thank you Judy and thank you everyone for joining us.
Adrian G. Rawcliffe: Thank you, Juli, and thank you everyone for joining us. 2019 was a transformative year for Adaptive Care. We issued a press release this morning summarizing our accomplishments last year. These accomplishments are the result of hard work by our dedicated colleagues here at Adaptimmune, the investigators with their teams at clinical sites, and other collaborators. I refer you to the press release for details because I think our time would be better spent providing context about what we are doing at Adaptimmune and our strategy going forward. So I want to focus on the following key areas. 1.
29 team was a transformative year for adapt to me.
We issued a press release this morning, summarizing our accomplishments last year.
These accomplishments are the result of hard work by our dedicated colleagues here at adapt to me the investigators with a teams that clinical sites and all the collaborative.
I refer you to the press release with details because I think all time would be back to spend providing context about what we're doing it adaptimmune that'll strategy going forward.
So I want to focus on the following key areas.
Juan organizational changes, including our new R&D team. So we announced at the beginning of this year to improve the flows and decision making process in our pipeline.
Adrian G. Rawcliffe: Organizational changes, including our new R&D team that we announced at the beginning of this year to improve the flow and decision-making process in our pipeline, to faster execution in our clinical trials, including driving ADPA2M4 to market in 2022 for sarcoma and demonstrating meaningful efficacy in other solid tumor indications. Three, our partnerships and collaborations, including our recent co-development and co-commercialization deal with Astellas, which Finally, I want to touch on some of our manufacturing accomplishments and why we believe integration is a key component of our future success. There were several changes to our leadership during 2019, some planned and some unexpected, including at the executive team level. We saw some notable departures last year, including our former CEO and co-founder James Noble, who retired. But it is a testament to those leaders who left that they built excellent teams.
Two false execution in our clinical trials, including driving 80 P. Eight two m. pool to market seem twentytwenty too for sarcoma and demonstrating meaningful efficacy in all the solid tumor indications.
Three oh partnerships and collaborations including our recent co development co commercialization deal with Astellas, which highlights the opportunity beyond our autologous spear T cell pipeline.
Finally, I want to talk to some of our manufacturing accomplishments and why we believe integration is a key component of all future success.
There were several changes to our leadership during 29 team some planned in some unexpected including the executive team level.
We saw some notable departures last year, including a former CEO and co founded James Noble who retired but is a testament to those leaders who left they built excellent team.
Adrian G. Rawcliffe: Those teams choose to work at Adaptimmune because we believe we can make a difference for people with cancer. And I want to thank everyone who has contributed to the work that we do. Firstly, I want to thank Mike Garone, who has served as our interim CFO after I became CEO. He has done a fantastic job, including through the recent financial crisis. Mike will be moving on, and as announced last week, Gavin Wood will assume the CFO role in April.
Those teams choose to work at adapt to me because we believe we can make a difference for people would cancel.
And I want to thank everyone, who has contributed to the work that we do.
Firstly I want to thank Mike <unk>, who has served as interim CFO after I became CEO.
He has done a fantastic job, including through the recent financing Mike will be moving gone and doesn't announced last week Gabi would want to see the CFO role in April.
Last August John longer was appointed Chief patient supply office so.
Adrian G. Rawcliffe: Last August, John Lunger was appointed Chief Patient Supply Officer. I will talk about the great strides we have made in manufacturing under John's leadership later in the course. We announced in August that Rafael Amado, our former president of R&D, was leaving and that Elliot Norry would be our acting CMO. In January, I was very pleased to announce that Elliot had been named permanent CMO.
I will talk about the great strides we have made in manufacturing under John's leadership later in the cool.
We announced in August that Rafael Amado, a former president of R&D was leaving and Eleonore would be are acting CMO.
In January I was very pleased to announce Elliott said being named permanent CMO and.
Yes, it's being ahead of safety and Pharmacovigilance and is that <unk> P programs is 2050.
Adrian G. Rawcliffe: Elliot has been our Head of Safety and Pharmacovigilance and has led our AFP program since 2015. He has a deep commitment to and expertise in self-therapy, and his passion for patients is clear. As we announced at the beginning of this year, we made other changes to our R&D leadership. Notably, we formed early and late stage development... Marc Dudley is leading our early stage group to develop and evaluate therapies for clinical safety and to quickly determine their efficacy. Marc has a 20-year history in cell therapy and is a true pioneer in the field, having worked on and published the initial cell therapy trials at the NIH and worked with Novartis on the development of Kimria. Dennis Williams was named chief executive officer. SVP Late Stage Development, taking products with clear efficacy signals through to registration as rapidly as possible.
He has a deep commitment and expertise in cell therapy and his passion for patients is clear.
As we announced at the beginning of this year, we made all the changes to our R&D leadership, notably we formed early and late stage development groups.
<unk> Dudley is leading our early stage group to develop an a body weight therapies, the clinical safety and quickly determine the efficacy.
Bulk has a 20 year history in cell therapy and is a true pioneer in the field having worked in published on the initial cell therapy trials out the NIH and work with Novartis on the development of Kim Ryan.
Dennis Williams was named.
SBP late stage development, taking products with clear efficacy signals through to registration as rapidly as possible.
Adrian G. Rawcliffe: The first of these products is ADPA2M4 for sarcoma, which has been evaluated in our Phase 2 Spearhead 1 trial. Dennis has substantial regulatory and drug development expertise in cell therapy, and he will continue to lead our regulatory affairs. Last year, under Dennis' leadership, ADPA2M4 received Orphan Drug Designation for Soft Tissue Sarcomas and Armat for Synovial Sarcomas. Outside of our early and late stage development groups, we have our pipeline research, preclinical testing, and translational sciences. Karen Miller has led these teams since joining us last year.
The first of these products is HBP I too am full for sarcoma, which is being evaluated you know they used to spearhead one trial.
Dennis has substantial regulatory and drug development expertise in cell therapy, and he will continue to lead our regulatory affairs team.
Last year on the Dennis his leadership I D. P. I too am for received orphan drug designation for soft tissue sarcoma, and Oh not for synovial sarcoma.
Outside of <unk> early and late stage development groups, we have a pipeline research preclinical testing and translational science is teams.
Carmella has led to these teams since joining us last year.
Currently the immunologist by training with more than 25 years of drug discovery experience with small molecules biologics and southern gene therapy, including at GSK, you CB and vertex across a broad range of therapy area.
Adrian G. Rawcliffe: Karen is an immunologist by training, with more than 25 years of drug discovery experience with small molecules, biologics, and cell and gene therapy, including at GSK, UCB, and Vertex across a broad range of therapy areas. Finally, and for many years, Joe Brewer has led the team that has delivered our stem cell-derived allogeneic program. Joe has two decades of direct cell therapy experience, and her team has produced one of the most advanced stem cell-derived allogeneic T cell platforms in the field. This platform has the capacity to generate T cells from stem cells without the use of stromal or feeder cells, and Without the Need for Human Therapy, both huge feats and critical parameters for ensuring we can ultimately scale up allogeneic cell production for the clinic and beyond. So that's the team we have in place to drive the pipeline.
Finally, and for many years Joe grew a has led the team has delivered a stem cell derived allogeneic program.
Joe has two decades of direct cell therapy experience and a team has produced one of the most advanced stem cell derived allogeneic T cell platforms in the field.
This platform has the capacity to generate T cells from stem cells without the use of stromal feed itself and without the need for human Sarah.
It was a huge fees and critical parameters for ensuring we kinda ultimately skyla allogeneic cell production for the clinic and beyond.
So that's the team we have in place to drive the pipeline now I want to touch on what we're doing to deliver data more rapidly in our clinical trials.
Adrian G. Rawcliffe: Now I want to touch on what we're doing to deliver data more rapidly in our clinical trials. This time last year, having transitioned NYESA to GSK in 2018, we were dose escalating our Phase 1 trials with our wholly owned assets. These Phase 1 trials have been ongoing for two years, and we have had no rhesus responses.
This time last year, having transition than what he said to GSK 2018, we would dose escalating a phase one trials with a wholly owned assets.
These phase one trials have been ongoing for two years and we had no resist responses.
Since then we have reported compelling initial response data with <unk>, two and four in synovial sarcoma, leading us to start off I used to spearhead one trial and announce our aim to commercialize this first product in 2022.
Adrian G. Rawcliffe: Since then, we have reported compelling initial response data with ADPA2M4 in synovial sarcoma, leading us to start our Phase 2 Spearhead 1 trial and announce our aim to commercialize this first product in 2022. In other indications, we narrowed our focus to our products targeting MAGE-A4 and AFP and to improving the potency of our SPIR T cells to convert the anti-tumor activity, which we were clearly seeing in a range of tumor types, into receptive responses that could be the basis for drug development. As reported in January of this year, we have observed rhesus responses in four new tumor indications. Two of these were from the first patient's dose in the Next Generation Surpass Trial and the Radiation Substudy. These trials began approximately six months earlier.
In other indications, we narrowed our focus to our products targeting major before and I F pace.
And through improving the potency of a spear T cells to come but anti tumor activity, which we would clearly seeing in a range of tumor types into resist responses that could be the basis for drug development.
As reported in January this year, we has a zoloft resist responses for new Chiba indications.
Two of these well from the first patients dosed in the next generation supports trial and the radiation sub study.
These trolls began approximately six months previously.
Another response was from the first patient dose to the target those in the 80 P. Eight to <unk> P trial remarkably the patients in this trial had a 100% reduction in that target lesions.
Adrian G. Rawcliffe: Another response was from the first patient dosed at the target dose in the ADPA2-AFP trial. Remarkably, the patient in this trial had a 100% reduction in their target lesion. These are early responses, and we need more patients and durability data to determine which indications we will develop. However, these data are a validation of the value of our SPIR T cell therapies for people with cancer, the importance of our proprietary affinity engineering, and the speed with which we are now able to execute them. We also announced that we will start a combination study in 2020, which we have now confirmed will be in head and neck cancer, with an innovative trial design, the details of which we will disclose in due course. We are incredibly grateful to the people who have chosen to take part in our trials.
These are early responses and we need more patients and durability data to determine which indications. We will develop however, these data are a validation of the value of our spear T cell therapies for people with cancer the importance of our proprietary affinity engineering and speed with which we are now able to execute.
We also announced that we will start a combination study in Twentytwenty, which we have now confirmed will be in head and neck cancer with innovative trial design the details of which we will disclose in due course.
We are incredibly grateful to the people who have chosen to take part in our trials. It is the strength of these people the clinical sites and the commitment to my colleagues.
Adrian G. Rawcliffe: It is the strength of these people, the clinical sites, and the commitment of my colleagues that have enabled us to get to where I believe we are today, on the cusp of revolutionizing cell therapies for solid tumors. The clinical benefit we demonstrate will translate into value for the company and for investors as long as we keep patients at the heart of everything we do. Now, about our partnership.
Have enabled us to get where I believe we ought to die on the cost, but revolutionizing cell therapies for solid tumors.
The clinical benefit we demonstrate will translate into value for the company and for investors as long as we keep patients at the heart of everything we do.
Onto our partnerships.
Adrian G. Rawcliffe: Although access to the US capital markets is critical to build a successful biotech... To be a world leader in cell therapy, it's also necessary to strike mutually beneficial partnerships both as an alternative source of capital and as a way of accessing partner capability. At the beginning of this year, we announced our first major pharma alliance in five years with Estella, a stem cell-derived allogeneic T-cell therapy. This agreement was based on the advances in our allogeneic program, building on our successful collaboration with Universal Cells, which was acquired by Estella. And it is important to note that we can use SPIR T-cells, CAR T-cells, or our recently disclosed HLA-independent T-cells, or HIT platform, to target tumors as part of this agreement. Key elements of the deal are, one, it takes us beyond our autologous spare T-cell platform. 2. It's a 50-50 global co-development and co-commercialization deal that sets the tone for our future pharma partnership.
Although access to the U.S. capital markets is critical to build a successful biotech company to be a world leader in cell therapy also necessary to strike mutual beneficial partnerships, both as an alternative source of capital and as a way of accessing partner capabilities.
At the beginning of this year, we announced our first major farmer alliance in five years, where the Stella stem cell derived allogeneic T cell therapies.
This agreement was based on the advances in our Allogeneic program building on our successful collaboration with Universal cells, which was acquired by Stella.
And this is important to note that we can use spear T cells car T cells or our recently disclosed h. delay independent T cells, all hit platform to target tumors as part of this Erie Greenland.
Key elements of the deal of one it takes us beyond our autologous spear T cell platform.
Too, it's a 50 50 global co development and co commercialization deal the sets the tone for all future pharma partnerships.
Three it's a clear statement of our intent to derive non dilutive capital from the capabilities and assets that we have built.
Adrian G. Rawcliffe: It's a clear statement of our intent to derive non-dilutive capital from the capabilities and assets that we have built, in addition to investing in people and partnerships. We have been building our manufacturing and supply capabilities for more than five years. This investment validates what is becoming widely recognized more broadly that control of process development, manufacturing, and supply is key to success for any cell therapy company. From the point of setting up our Navy Yard facility and initiating manufacturing at the beginning of 2017,
In addition to investing in people and partnerships, we've been building on manufacturing and supply capabilities for more than five years.
This investment validates what is becoming recognized more broadly.
Controller process development manufacturing and supply is key to success, so any cell therapy company.
From the point of standing up our Navy off facility and initiating manufacturing at the beginning of 2017.
We now the capability to deliver cells or existing and planned clinical trials as well.
Adrian G. Rawcliffe: We now have the capability to deliver cells for all existing and planned clinical trials, as well as, with additional investment, to be launch ready. Furthermore, at our dedicated space within the Cell and Gene Therapy Catapult Manufacturing Centre in the UK, where we have our internal vector manufacturing, we are in the process of building vector inventory to support all our trials. These accomplishments are due, in large part, to John Lunger and the team and facilities he has built. John has championed the importance of full integration to enable development flexibility. This is enhanced greatly by being able to rapidly design, test, and implement new processes in-house.
As with additional investment to be launch ready.
Further at our dedicated space within the cell and gene therapy catapult manufacturing center in the UK well, we have an internal vector manufacturing we are in the process a building back to inventory to support all our trials.
These accomplishments that due in large part to John longer and the team of facilities. He has built.
John has champion the importance of full integration to enable development flexibility.
This is enhanced greatly by being able to rapidly design test and implement new processes in house.
Adrian G. Rawcliffe: John has also been working with the clinical, manufacturing, and commercial teams to map out how we can optimize the way we supply our therapies to patients. We have made sizable investments in people, partnerships, and capabilities. We have a shared vision of Adaptimmune as an integrated cell therapy company. We believe that cell therapy will revolutionize cancer treatment and that the challenges of delivering cell therapy will be solved by such integrated companies. As a leader in this cancer revolution, Adaptamine is designed from the ground up to bring cell therapies to people with cancer. We're not here to simply conduct proof-of-concept studies on a technology.
John has also been working with the clinical manufacturing and commercial teams to map out how we can optimize the way we supply all therapies to patients.
We have made sizable investments in people partnerships and capabilities.
We have a shared vision of Adaptimmune as an integrated cell therapy company.
We believe that cell therapy will revolutionize cancer treatment and the challenges of delivering cell therapy will be sold by such integrated companies.
As a leader in this cancer Revolution adapt to mean this design from the ground up to bring cell therapies to people with cancer.
We're not hit the simply conduct proof of concept studies on the technology, we are here to bring cell therapies to patients.
Adrian G. Rawcliffe: We're here to bring cell therapies to patients. We're not here simply to be a one-product company; we're here to deliver our pipeline of products through innovation and expertise to treat a broad range of cancers. We stand here in early 2020 with responses in five different solid tumors. We have demonstrated we have the tools and expertise to tackle the challenges of difficult-to-treat cancer. We have the leadership and an organization entirely focused on our mission to transform the lives of people with cancer by designing and delivering self-therapy. I am privileged to lead Adaptamine into this new phase, and we look forward to providing data updates throughout the year at major medical conferences. And with that, I will open the call for questions. Operator?
We're not has simply to be a one product company. We're here to deliver a pipeline of products through innovation and expertise to treat a broad range of Kansas.
We stand here in early Twentytwenty with responses in five different solid tumors.
We have demonstrated we have the tools and expertise taco the challenges are difficult to treat cancers.
We have the leadership and an organization entirely focused on our mission to transform the lives of people with cancer, but designing and delivering cell therapies.
I am privileged lead adaptimmune into this new phase and we look forward to providing data updates throughout the year major medical conferences.
And with that I would open the call for questions operator.
Thank you as a reminder to ask the question you only to press star one on the telephone which are your question press the pound key.
Operator: Thank you. As a reminder, to ask a question, you will need to press Star 1 on your telephone. To withdraw your question, press the pound key. Our first question comes from Tony Butler of Roth Capital. Your line is now open.
Our first question comes from Tony Butler of Roth Capital. Your line is that open.
Oh, yes, Adrian and maybe to some degree Elliott first of all thanks very much for allowing me to ask these questions. So they're actually three and I'll be brief with reciting them.
Tony Butler: Yes, Adrian, and maybe to some degree Elliot, first of all, thanks very much for allowing me to ask these questions. So, as I recall, in the January update, there were two unconfirmed responses. You allude to all four being recessed today. I just want to confirm that. That's number one.
So as I recall in the January update there were two on confirmed responses you allude to all four being received today I just wanted to confirm that that's number one number two is again. Despite what you were alluding to in your press release I wanted just ask you specifically because I think it's important.
Tony Butler: Number two is, again, Despite what you're alluding to in your press release, I want to just ask you specifically, because I think it's important, what sorts of information you would like to present at appropriate medical meetings. And then the third question is, if we step back a minute, it seems that there have been, and this is very important because we don't really know the translational effects. There seems to have been some... positive outcomes confirming outcomes based on, I'm not really sure. For example, is it because cells are now able to traffic appropriately into the tumors? Or is it a durability concern? Or are the cells unable to grow?
What sorts of information you would like to present that appropriate medical meetings and in the third question is.
If we step back a minute.
It seems that there has been and this is very important we don't really know the translational effect. This there seems to have been some.
Positive reese's confirming outcomes based on.
Not really short for example.
Is it because sales are now able to traffic appropriately into the tumors or.
Is it a durability concerned or are these cells able to grow.
[music].
Tony Butler: to larger levels, because it seems that SURPASS and the radiation sub-study are telling us two different things, while AFP is telling us a third thing. And then, with all due respect, you're moving forward with the PD-1 combo, all of which I understand. I just wanna get a better grasp on. As we end this year, what do you think we will have or have learned from investigating these particular studies that are ongoing today?
Two to two larger levels because it seems that surpass irradiation sub study are telling us two different things ASP is telling us a third thing.
And then with all due respect your moving forward with PD, one combo, all of which I understand I just wanted to.
Good.
Better grasp on.
As we in this year, what do you think we will have lower adaptimmune will have learned from investigating.
These particular studies that are ongoing today, thanks very much.
Tony Butler: Thanks very much.
Thanks, Tony.
Adrian G. Rawcliffe: Thanks Tony, I appreciate the questions. So on your first question about responses, I think everybody understands the history of our communication of data over the last couple of years, and I don't think it's done anybody any good to give patient-by-patient updates, and so we are absolutely categorically going to refuse to do that. And that brings me on to the second question about what we are going to disclose. However, I can confirm, perhaps not surprisingly given the responses that we reported for the patient for the two unconfirmed responses in January, one in a patient who was surpassed with GE junction cancer and the other one in a head and neck patient with the first generation ADPA2M4 phase one trial, both of those did confirm at their next scan, as anticipated and not particularly surprisingly. But we aren't going to comment further on individual patients as we go forward. Instead, and on to your second question, our plan is to
Appreciate the questions. So on your first one.
With about the responses I think.
Everybody understands the history of our communication of data over the last couple of years and I don't think you've done anybody any good to give patient by patient updates and so we are absolutely categorically going to refused to do that.
Brings me onto the second question about what we all going to disclose however, I can confirm not mean, perhaps not surprisingly given the responses that we reported for the patients for the two unconfirmed responses in January one in the past with GE junction cancer and the other one in head and neck patient with the first generation ADP.
I too am for.
Phase one trial.
Both of those states couldn't.
Our next Scott as anticipated and not particularly surprisingly.
So, we but we aren't going to comment but.
On individual patients as we go forward rather I don't to your second question our plan is to.
Adrian G. Rawcliffe: announced at major medical conferences. We have, as you pointed out, put in some slight more granularity about the first half versus the second half and what we plan on announcing. However, the deadlines for many of the conferences haven't passed, much less the acceptance notifications, although we have submitted to a number of the ones that you would anticipate we would be submitting to, and so we can't say exactly what we're going to present at the conference. But to talk more generally, I think the key for this year is to go from what we demonstrated in January, which is an unequivocal demonstration of the breadth of the potential of the platform, and turn that this year into a demonstration that we have a product in a particular area.
Announced that major medical conferences, we have as you pointed out.
Some slight more granularity about the first half versus the second half.
[music].
And what we plan on on announcing however, the deadlines for many of the conferences Haven passed a much less the acceptance notifications.
We have submitted to a number of the ones that you would anticipate we will be submitting today.
So we can't say exactly what we got to present at the conference but to talk more generally I think the key for this year is to go from what we have demonstrated in January we did unequivocal.
Demonstration of the breadth of the potential of the platform.
And convert that this year into a demonstration that we have a product in a particular area and we've talked in the past about what that would take.
Adrian G. Rawcliffe: And we've talked in the past about what that would take. You know, going back several years now, we've talked about the fact that we believe that three out of ten patients with good responses would be a good basis upon which to start a late stage development registration directed development program, be that a phase two trial or multiple. And so that's really what we want to get to this year with these trials, and we will be updating you on both the SURPASS trial, on AFP, and on the radiation sub-study, and actually on the first-generation MAGE-A4 pilot study, ADPA2M4 pilot study, throughout the year. But the clear objective for us is not just to report the data but to be able to define a route forward for one or more of these assets.
Going back several years now we've talked about the fact that we believe the three out of 10 patients with good responses would be a good.
Basis upon which to start.
Late stage development registration directed development program be that a phase two trial multiple.
So and so that's really what we want to get to this year on these trials and we will be updating on both on the support trial on Asap.
And on the radiation sub study and actually on the on the first generation May Jay for pilot study I'd pick two and four pilot study throughout the year, but the clear objective for US is not just to report the data but to be able to define for one or more of these assets a root board.
Adrian G. Rawcliffe: And so that's what we hope to be able to conclude from the data that we'll report at Major Medical. With respect to what we've learned, I'm just going to outline the framework, and then I'm going to just ask Elliot to comment on where we are with the translational data and the learning. But I think, I think you
And so that's what we hope to be.
Be able to conclude from the basis of the data that will report at major medical conferences.
With respect to what we've learned I'm just going to tee up the framework and then I'm going to just ask Elliott to comment on on on some of the.
On on where we all with the translational data and the learnings.
But I think I think you you outlined quite nicely.
Adrian G. Rawcliffe: outlined quite nicely the approaches that we're taking. From last May, we were of the firm belief that we were seeing activity from our TCRs.
The approaches that we're taking from last May we were of the firm belief that we were seeing activity from our TCR US we saw it in abundance and leaving two clinical benefits in sarcoma, and we saw it still high level activity at low levels, but across a range of difference.
Adrian G. Rawcliffe: We saw it in abundance and leading to clinical benefit in sarcoma, and we saw it still have high-level activity at low levels, but across a range of different solid tumors elsewhere. And so we set out, as I think, as you know, to be able to convert that low level of activity into responses. We looked at trafficking to tumors and the radiation sub-study.
Solid tumors elsewhere, and so we sets out.
As I think as as you know to be able to convert that low levels of activity into responses, we looked at trafficking to tumors and the radiation sub study we looked at a more potent T cell with the second generation and as announced in the tail end of last year and we'll initiate this year, we look to the combination study, which will now said will.
Adrian G. Rawcliffe: We looked at a more potent T cell with the second generation. And as announced at the tail end of last year, and we'll initiate this year, we looked at a combination study, which we've now said will be in the head and neck. Those are the three approaches that we have to shift from activity into clinical benefit for patients. And so it is true that the efficacy that we have seen, the response that we have seen in each of those settings in the first patient, I think, is a signal that those approaches are working and that we really were only one or two insights away from converting ourselves into effective therapies. But I'll ask Elliot to comment on other areas of learning.
In head and neck cancer. Those are the three approaches that we have to shift from.
Activity into clinical benefit to patients.
And so.
It is true that the efficacy that we have seen the response that we have seen in each of those settings. In the first patient I think is a signal that those those approaches are working.
And that we really were only one or two insights away from converting all sells into.
Into effective therapies, but I'll ask Elliott to comment on other areas of learnings.
Thanks, so much so.
Elliot Norry: Thanks so much. That was a pretty comprehensive answer, but I'll touch a little bit on the issue of using, for example, the PD-1 inhibitor combination trial. We have specific translational data that demonstrates that PD-1 can be upregulated in the presence of solid tumors, and we've looked at responders versus non-responders in the sarcoma population. And we published that data at CITSE in 2019.
That was a pretty comprehensive answer, but I'll touch a little bit on and the issue of.
Using for example, the PD one inhibitor combination trial, we have specific we have specific translational data that demonstrates the PD one can be up regulated and in the presence of solid tumors and we've looked at responders versus non responders in the sarcoma populate.
And.
And we publish that data at city.
In 2019.
Elliot Norry: So it's with that type of translational data that we're moving forward with a combination study with a PD-1 inhibitor. There are preclinical and clinical data that demonstrate that low-dose radiation can improve the trafficking of T cells to tumors. That's largely leveraged by our relationship with MD Anderson Cancer Center. For that reason, we chose to open the radiation sub-study and explore whether or not low-dose radiation, so not enough radiation to actually treat the tumor on its own but to just change the microenvironment, change the architecture of the tumor to make it more amenable for T cells to traffic. And that's the translational and scientific information behind that. And with respect to CD8-alpha, again, it's really a multimodality approach whereby we not only translate the CD4 cells into having better killing potential, but we also improve the ability for the T cells to activate the rest of the immune system and to bring other parts of it into the tumor to help with activity.
So with that type of translational data that we're moving forward with a combination study with a PD one inhibitor.
Theres preclinical and clinical data that demonstrate that low dose radiation can improve trafficking and T cells to tumors.
And that's largely leveraged by our relationship with MD Anderson Cancer Center.
And and for that reason.
We chose to open the radiation sub study.
And.
Open the radiation sub study and explore whether or not low dose radiation, so not enough radiation to actually treat the tumor on its own but to just change the micro environment changed the architecture. The tumor syndicate more amenable for T cells to traffic and and that's the translational and scientists.
And behind that and with respect to C.D.A. Alpha and.
Again, it's really a multi modality approach whereby we not only translate the cdfour cells into having better killing potential, but we also improved the ability for.
For the T cells to activate the rest of the immune system.
And to bring other parts of it into the tumor to help with activity and that the preclinical work associated with that we published last year at a CR. So it's really the we're really taking scientific information and feeding it back into the clinical trial system. So that we can task which of these.
Elliot Norry: And that, the preclinical work associated with that, we published last year at AACR. So we're really taking scientific information and feeding it back into the clinical trial system so that we can test which of these things work once you really get into humans with tumors as compared to, you know, the laboratory and scientific findings. Which ones really can work. And I will also say that they're not exclusive. There's nothing to say that one can't use a second-generation product with low-dose radiation or with a PD-1 combination. But in order to see which of them is working and which is not working, you have to study them individually. And that's what we're doing. Thank you very much.
Things once you really get into humans with tumors as compared to.
The laboratory and scientific findings, which ones really can work and and I'll also say that they're not exclusive and there's nothing to say that one can't use.
Second generation product with low dose radiation.
Or with a PD, one combination, but in order to see which of them is working in which is not working you have to study them individually and that's what we're doing.
Thanks very much.
Thank you and then next question comes from Marc Frahm of Cowen and company. Your line is to open.
Marc Alan Frahm: Thank you, and our next question comes from Marc Frahm of Cowan & Company, your line is now open. Thanks for taking my questions. I guess one is, you know, with these reports or these responses, you know, have you noticed, I recognize it has been terribly long, but have you noticed kind of a change in enthusiasm in the space and, you know, how many patients are being, the pace of patients being referred in for screening for the trials? And, you know, maybe alongside that, if you can kind of give us an update on kind of where you are in the enrollment of, say, cohort 3 for AFP and, you know, and within the other, the, you know, M4 trials. So.
Yes, Thanks for taking my questions. Just one is in with these reports of these responses.
Have you noticed really recognize it has been terribly on but have you noticed it kind of a change in enthusiasm in the space in your how many patients are being the pace of patients being referred in for screening.
The trials and maybe alongside that if you can can give us a update on where you are in the enrollment CECO or three for U.S.P. and even within the other the.
And for trials.
So a lot.
I think first of all I don't think we're going to provide data specifically around enrollment in specific trials and but I will say that we've long believed in I think it's sort of well recognize that there's no better.
Adrian G. Rawcliffe: I think, first of all, I don't think we're going to provide data specifically around enrollment in specific trials. But I will say that we've long believed, and I think it's sort of well recognized, that there's no better tool for recruiting patients to trials than having responses. So I think that we are seeing interest. We're seeing more patients and advocacy groups contacting us, asking for information about our trials. So I do believe that what we're seeing will have a positive effect on recruitment and enrollment in the study. Okay, great. And then just to clarify a little bit from the press release, it breaks out separately a safety update for cohorts 1 and 2 of the AFP trial versus the update for cohort 3. So should we be assuming that those are independent conferences that those are likely to be presented at, or is that just the way you decided to write it instead?
Tool for recruiting patients to trials and having responses.
So I think that we are seeing interest, we're seeing more patients and advocacy groups contacting us asking for information about our trials. So I do believe that what we're seeing will have a positive effect on on recruitment and enrollment in this study.
Okay, Great and then.
Just to clarify a little bit from the pressure press release, it breaks out separately safety update for cohorts when two of the ASP trial.
This is the update for quarter three so should we be assuming that those are independent conferences that those are likely to be presented at or is that just.
The way you decided to right into that.
It's just the way we decided to write it does I think we've talked about what we've seen in the.
Adrian G. Rawcliffe: It's just the way we decided to write it. I think we've talked about what we've seen in the past with respect to AFP, the first two doses of AFP, and I think the specific thing we want to call out is that Phase 1 and 2 are primarily a safety update. Whilst we did see what we believe are signs of activity there, that is a safety update, whereas it's obvious that, given that we've announced a response in the top dose cohort already, that will be a little more than a safety update.
In the past.
With respect to I the I pay the first two doses of I pay and nothing specific thing we want to call out is that they are the phase one and two is primarily a safety update whilst we did see what we believe all signs of activity that that is a safety update where it is obvious that the given that we've announced iris.
Response in the.
Top dose cohort already but that will be at more than a safety update.
Okay, great. Thank you very much.
Adrian G. Rawcliffe: Okay, great. Thank you very much. Thank you. And our next question comes from Michael Schmidt of Guggenheim Securities. Your line is now open. Hey, this is Kelsey on behalf of Michael.
Thanks, Yeah, and then next question comes from Michael Schmidt of Guggenheim Securities. Your line is now open.
Hey, this is kelcy on for Michael Thanks for taking my questions and building a bit off of your first answer I guess kind of.
Kelsey Beatrice Goodwin: Thanks for taking our questions. Building a bit off of your first answer, I guess kind of, as Spearhead progresses with the first generation of M4 and Surpass progresses with the next generation, how do you see both of these assets fitting within your platform longer term? And then, secondly, could you just remind us how your iPSC-derived platform differs from some of the others in the space? Thank you.
Spearhead progress is with the first generation of M and surpassed progress is what's the next generation I guess, how do you see both of these assets sitting within your platform longer term and then secondly could you just remind us how youre I'd PSC dress platform differs from some of the others in the space. Thank you.
So thanks Kelsey.
Adrian G. Rawcliffe: So thanks, Kelsey. So with respect to spearhead and surpass, I think what you've seen us do with spearhead is what every patient-focused drug development company does and should be doing, which is I've seen a signal. It's clearly enough with generation one, a 50% response rate in this setting and a 90-plus percent disease control rate are clearly sufficient to enable that product to be of huge benefit to patients who sorely need it and need options in this space. So I think driving forward with spearhead is absolutely the right thing to do, particularly as, you know, it is actually unknown, generally speaking, but also in sarcoma, what the incremental benefit of the CD8 That's the purpose of the Surpass Phase 1 trial, and that's what we seek to understand.
So with respect to stay ahead and support US I think I think what you've seen us do with spare head is is Walt every patient focused drug development and company should be dolls, and should be doing which is I've seen a signal it's clearly enough in the fight with the.
Generation won a 50% response right in this setting and a 90 plus percent disease control rate is clearly sufficient to enable that product to be a huge benefit to patients who solely needed a need options in this space. So I think driving forward with spearheaded ups.
We do the right thing today.
Typically as you know it is actually are known generally speaking, but also in sarcoma, what the incremental benefit of the CB eight will be about the purpose of the surpassed phase one trial and that's what we seek to understand.
I would just caution that where we have looked at the back of and this is a general statement not a specific statement as it relates to CB eight in sarcoma, because we don't have that but generally speaking where we have looked at the effects of second generation approaches.
Adrian G. Rawcliffe: I would just caution that where we have looked at the effects of, and this is a general statement not a specific statement as it relates to CD8 in sarcoma because we don't have that, but generally speaking where we have looked at the effects of second generation approaches, they are most effective where the first generation doesn't work very well in the in vitro in the labs and so where I have with sarcoma something that works really well you know we don't know what the impact of adding the CD8 will be in sarcoma specifically and we'll have to understand that so I think we've got a phase one product we've got a generation one product it's clearly a product we have said that we are closing the enrollment on the MAGE A4 first generation pilot trial outside of the radiation sub-study and I think we will report out on that in due course as well and so I think it is clear from our previous statements that the first generation programs probably outside sarcoma either require something else, require something else to be effective, be that a second generation or a combination or radiation, because when we've tested the first generation and we've now gone back, we've got NY-ISO, we've got MAY-J10, and we've got MAY-J4. Outside of sarcoma, we see a consistent level of low of activity, but we see very few responses, with the head and neck patient being the exception to that. So that's the overview of Gen 1 versus Gen 2, and I think they both fit in depending on where they work in patients. For the allogeneic, I'll ask Helen Tayton-Martin, who is the architect of the deal with Estelas, to comment on the differentiation that our platform provides versus others.
They are most effective where the first generation doesn't work very well in the in vitro in the labs.
And so well I have with sarcoma something to works really well.
Yeah, we don't know what the impact of adding the CD eight will be in sarcoma, specifically and we'll have to understand that so I think we've got a phase one part we've got a generation one product. It's clearly a product we have said that we are closing the.
Enrollment on the May each a for first generation pilot trial outside of the radiation sub study.
And I think we will Oh, we will report out on that in due course as well I'm. So I think I think it is clear from our previous statements the first generation.
Programs, probably outside sarcoma, either require something else.
We acquire something else to be effective be that second generation or combination of radiation because when we tested the first generation and we've now come back with go and why you. So we've got major tandem we've got May Jay for outside of sarcoma, we see a consistent level of low of activity, but we see very few responses with the head and neck patient being.
The exception to that.
So that that's the that's the overview of Gen. One versus Gen. Two and I think they both between depending on where where they work in patients.
For the Allogeneic, Alaska, Helen tighten Martin who is the architect of the deal with a with a Stella.
To comment on the differentiation the our platform provides versus others.
Yes, thanks to the question.
Adrian G. Rawcliffe: Yeah. Thanks for the question.
So there are two elements to it to the platform.
Helen Katrina Tayton: So there are two elements to the platform that we've been developing in collaboration originally with Universal Cells and, subsequently, Estelles for the last four years. There's the editing component, from which we work with the Universal Cells technology, which is AAV-based gene editing steps and sequential deletion and addition of specific genes. And that's a very, it's an accurate but laborious process, but it enables us to select out specific edits very successfully each time.
We've been developing and collaboration with any with Universal styles subsequently astellas for the last four years.
Does the editing component, which from which we we work with the universe the cells technology, which is a the base.
In editing that.
Sequential deletion, an additional of specific genes and that's a very it's it's an accurate and voice process, but it is enabling us to select out specific edit and very successfully each time and the component that does that mean has developed an wholly owns this proprietary process for differentiation of.
Helen Katrina Tayton: And the component that Adaptimmune has developed and wholly owns is a proprietary process for differentiation of stem cells into T cells, which we've been able to reproduce with those edited stem cells in addition. And the differences there relate to the ability to use a serum-free process and also a feeder cell-free process. And those are the two very different and clear distinctions that we have that we've been focused on to have an effective process, but also one which is scalable down the line to get to large batches of products for patients. So those are distinctions that also give us a very unique IP position as well. So those are the key differences.
Stem cells to T cells, which we've been able to we produce but those edited stem cells. In addition, and the difference is that relate to the ability to use assume free process and also as fee to sell free process and those are the two very different Sinclair distinctions that we have that we said.
Focused on to have an effective process that will say, one which is scalable.
It is down the line to get to large batches.
Products for the patients.
So there is a distinctions that also obviously gives us a very unique IP position as well. So those are the key differences.
Noah Penzell: And our next question comes from Noah Penzell of Citi. Your line is now open. Hey guys, this is James Shannon from OHIT. Um, just wanted to ask a question. How much do we know about the safety of the SPIR-T platform at this point, and what are you monitoring in your ongoing trials? And then I have a couple of follow-ons after that.
Great. Thank you.
Thank you know at our next question comes from L., It and all of Citi. Your line is now open.
Hey, guys as Jim Sheehan on from ahead.
Just wanted to ask a question how much do we know about the safety of spear T platform at this point and what are you monitoring your ongoing trials.
And then I had a couple of follow on after that.
Earlier do you want to take the safety question.
Elliot Norry: Elliot, do you want to take the safety question?
Yes, so we.
We the safety profile of the of the of the platform I think is generally demonstrating favorable benefit risk to support ongoing development, we see similar adverse event to other T cell therapies.
Elliot Norry: Yeah, so the safety profile of the platform, I think, is generally demonstrating favorable benefit risk to support ongoing development. We see similar adverse events to other T cell therapies, including cytokine release syndrome and neurotoxicity, although the frequency and severity may be lower than has been typically. From the chemotherapy regimen, we also see a decrease in blood counts that follow on, which is the intended effect of the chemotherapy.
Including cytokine release syndrome and neurotoxicity.
So the frequency in severity may be lower than has been typically seen with car T therapy.
From the chemotherapy regimen, and we also see a decrease in blood counts that follow on which is the intended effect of the chemotherapy and we were very clear about making changes to our chemotherapy regimen last year in response to.
Elliot Norry: And we were very clear about making changes to our chemotherapy regimen last year in response to two deaths associated with aplastic anemia. And since doing that, and based on data that we have from prior to..., increasing the chemotherapy regimen, we're very confident with the safety of the regimen at this juncture. So I think that...
Two deaths associated with a plastic in EMEA.
And since doing that.
And based on data that we have from prior to.
To increasing the chemotherapy regimen, we're very confident with the safety of the regimen.
At this juncture so I.
I think that.
In general and those are the three adverse events sort of particular interest to us and we obviously follow all patients as it relates to all adverse events consistent with typical drug development standards and and pay special attention to those and and are very comfortable.
Adrian G. Rawcliffe: In general, those are the three adverse events sort of of particular interest to us. We obviously follow all patients as it relates to all adverse events consistent with, you know, typical drug development standards and pay special attention to those, and we are very comfortable at this juncture with respect to the safety profile. I will also add that there was a specific safety level of attention to liver toxicity associated with the alpha-fetoprotein study, but to date, we have not seen any evidence of T cell activity against the non-cancerous liver. And then, at the beginning of the call, you guys mentioned there were a lot of changes to the team, and given that... Moving towards commercialization, should we expect some more additions to the team, or is what the team currently is, what you envision for 2022, for the 2022 launch?
At this juncture.
With respect to the safety profile I will also add that there wasn't specific safety.
A level of attention to liver toxicity associated with the Alpha Fetoprotein study.
But to date, we have not seen any evidence of a T cell.
Activity against the Noncancerous liver, so we're very and were very positive about.
That particular.
The resolution of that safety concern.
Got it and then the beginning of the call you guys mentioned there was a lot of changes to the team and given that.
Moving towards commercialization should we expect some more additions to the team orders.
What the team currently is what do you envision for 22 for the 2022 launch.
Adrian G. Rawcliffe: Yeah I think we have a, I think I feel very comfortable with the strength of the team that we have now. I think clearly as we move forward into commercialization we'll need to build that capability and and I don't I don't think it's appropriate to comment on intended future changes to that but clearly we'll need to build a commercial capability on a European and US basis as a minimum and we look forward to doing that and in fact I would argue we've already started we've had a head of commercial for some years now working with groups thinking about pricing interactions with payers and what the patient journey looks like and we look forward to building on that as we go forward. Fantastic. Thank you.
Yes, I think we have I think I feel very comfortable with the strength of the team.
But we have now I think clearly as we move forward into commercialization will need to build that capability and.
I don't I don't think it's appropriate to comment on.
Intended future changes.
To that but clearly we'll need to build a commercial capability auto European and U.S. basis as a minimum.
We look forward to doing that and in fact I would argue we've already started.
We've had to head of commercial for some years now working with group's thinking about pricing.
Interactions with payers my what the patient journey looks like and we look forward to building on that as we go forward.
That's aspect thanks for taking my question.
Adrian G. Rawcliffe: Fantastic. Thank you for taking my questions. Thank you. And our next question comes from Jonathan Chang of SCB Learning. Your line is now open.
Thanks.
Thank you and your next question comes from Jonathan Chang of Sep Leerink Your line open.
Wei Ji Chang: Good morning and thanks for taking my questions and congratulations on a great start to the year. Thanks. Thanks. First question, how should we be thinking about benchmarks for durability for snowmobile sarcoma? So, um... With the data that we've published to date with synovial sarcoma, we've seen durability out to nine months.
Hi, good morning, and thanks for taking my questions and perhaps in the great start there.
Thanks. Thanks.
And how should we be thinking about benchmarks for durability farmers sarcoma.
So.
With the data that we published today with synovial sarcoma, we've seen durability out to nine month, and and we do plan to provide an update to that again at a future medical conference.
Elliot Norry: And we do plan to provide an update on that, again, at a future medical conference. I'm not sure. I hope that addresses the question. Got it. And just one more question from me. So, it looks like GSK entered into a partnership last week with another company for TCR self-therapy. How should we be thinking about the impact of this, if any, on your existing partnership with GIST?
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Yes.
I'm not sure I I hope that addresses the question.
Got it.
Just one more question for me.
So it looks like GE Oh.
Partnership last week with another comfortable on Keith.
So these.
How should we be thinking about the impact on sales.
System.
So I think I'd like.
Wei Ji Chang: So, I think I'd like to ask Helen to answer that, but I would just point out, the only thing I would point out before that is, I'm not sure that anybody, least of all GSK or us, expected our relationship to be monogamous. And if there were any doubts from the GSK side on that front, that would have been dispelled by our deal with Astellas. So I think there's a broad range of companies out there looking at this, and I fully anticipate that a company like GSK would make multiple bets in this space. And we believe, furthermore, that we're at the stage of development of a technology where a rising tide lifts all boats. And we and Ematics and GSK and all the other companies that are trying to put products on the market for patients in the solid tumor setting, with cell therapies in the solid tumor setting, I think will benefit from increased activity in the space. But I'll just hand over to Helen to talk a bit more about that.
Asked kellen too.
To answer that but I would.
I would just pointed out is there anything I would point out before that is.
I'm not sure that anybody leasable GSK Ross expected our relation to be monogamous.
If the were already doubts from the GSK side on that front that would have been to dispel bile deal with Astellas.
So I think there's a there's a broad range of companies out there looking at this or not fully anticipate that a company like GSK with Mike would make multiple that in this space.
And we believe Furthermore that were at the stage of development of a technology, where a rising tide lifts all boats, and we and Im ethics and GSK and all the other companies with our in trying to put products on the market for patients with.
Installed in the solid tumor setting with cell therapies and saw the tumor setting I think job benefit from increased increased activity in the space, but I'll just highlight Helen to talk a bit more together rather.
Yes. Thanks, Thanks to the question thinking is obviously very good question I think one or two observations. One you may recall at the time is the anyway. So ex exercised an option exercise with adopt mean by GSK.
Adrian G. Rawcliffe: Yes, thanks for the question. I think it's obviously a very good question.
Helen Katrina Tayton: I think one or two observations. One, you may recall at the time of the NYISO exercise, the option exercise with Adaptimmune by GSK, there was the scope to take two more targets, and that has happened. And that work is progressing and going well, and both parties are comfortable with how that is progressing. Beyond that, GSK only has access to one further target from Adaptimmune under the arrangements for our original collaboration, and that will come at some point in the future in relation to Gen 2 programs. And so really, I think what that deal probably shows is an ongoing commitment to T cell therapy, which is obviously in our interest in our partnership with GSK as well as more broadly, and potentially looking outside for other targets.
Is that the scope to take.
Timo targets and then that thought that has happened.
That work is in its progressing and going well and based both parties are comfortable with you know with how that is progressing.
Beyond that GSK and he has access to one side the target from from from Adaptimmune onto the.
Arrangement, so for our original collaboration and that will come at some point in the future in relation to Gen. Two programs and so really I think that deal to would be shows is a is an ongoing commitment to to T cell therapy, which is obviously in our interests in our partnership with GSK as well as more broadly.
And potentially looking outside for other targets, we are not applies to share targets with that GSK that we've already working on so I think that will say probably speaks to the types of deals we would want to doing teacher is a bit more like the one we have just done with the sellers, where we're looking for co development commercialization as we build an integrated south.
Helen Katrina Tayton: We are not obliged to share targets with GSK that we were already working on, so I think that also probably speaks to the type of deal we would want to do in the future, a bit more like the one we have just done with Astellas, where we're looking for co-development and co-commercialization as we build an integrated cell therapy company.
Therapy company.
Got it thank you.
Helen Katrina Tayton: Got it. Thank you. Thanks, gentlemen. Thank you. And our next question comes from Jim Bertranessa, Wells Fargo Securities. Your line is now open. Hi, thanks for taking the questions. This is Yanan in for Jim.
Thanks Trevor.
Thank you and then next question comes from CIMB Freshness of Wells Fargo Securities. Your line is open.
Hi, Thanks for taking the questions. This is the yen in Fourg in just two questions on the technology platforms.
Yanan Zhu: Just two questions on the technology platform. First, can you talk a little bit about the HLA-independent T-cell technology in terms of how HLA-independence is achieved? And secondly, regarding the stem cell-derived allogeneic T-cell platform, can you talk about whether you have reached the capability to differentiate the stem cells into CD4 T-cells as well as the ability to differentiate them into CD8 T-cells?
First can you talk a little bit about the H.L.A. independent T cell technology.
In terms of how is surely independence is.
Achieved.
Secondly.
Regarding the stem cell derived allogeneic T cell platform.
You talk about whether you have a reached the capability to differentiate ourselves into the stem cells into cdfour T cells as well as the ability to differentiate into CD eight deals. Thank you.
Helen Katrina Tayton: Yes, this is Helen. Thanks very much for the two questions. So, the HLA-independent TCR platform is exactly what it says on the tin. These are TCRs that we have been able to isolate from our platform capabilities that are able to recognize cell surface proteins, traditional CAR targets, if you will, but function on the surface of the T cell in much the same physiological way as a TCR. So, there are other companies out there that you will probably be familiar with that utilize CAR or antibody targeting, linking it to TCR signaling. This is actually a T cell with TCR signaling but able to recognize a cell surface protein. Now, that may seem slightly unusual and unexpected immunologically, but these have been reported historically in the past.
Oh, yes, a this is helen thanks very much the for the two questions. So the H. play independent Tcl platform is exactly what it says on the 10 cities all TCR that we have been able to isolate.
Mmm platform capabilities that are able to recognize cell surface proteins traditional car targets, if you will but to function on the surface at the T cell in much the same physiological whereas the TCR. So there are other companies out there that you will probably be familiar with that utilize causal.
Antibody targeting linking it to Tcl signaling. This is actually a TCR with TCR signaling, but able to recognize a cell surface protein now that may seem slightly unusual an unexpected immunologically, but these have been reported historically in the past and as we have deepak.
Helen Katrina Tayton: And as we have deep expertise in isolating TCRs, we have a lot of capabilities around our phage libraries and the types of TCRs that we can source and the diversity of those libraries. We have been able to find these TCRs on more than one occasion now for CAR targets. And in addition to that, we're also leveraging the deep expertise and the specificity testing, and the safety testing of these types of TCRs, which is something we've utilized in our ongoing pipeline programs. So, it's really the marriage of those two capabilities that has enabled us to generate TCRs for CAR targets and to look to take those forward, and they become potential programs for ourselves, but also under the Astellas collaboration. So, and so I hope that answers that question, and you'll be hearing more about that as, you know, as we have more to talk about publicly. With regard to the second question, I think the simple answer is yes. We've been able to make CD4 and CD8 T-cells, and we'll be able to, again, talk more about those at forthcoming scientific conferences in terms of the functionality of those cells.
He in isolating TCR, we have a lot of capabilities around Osage libraries.
And the types of Tcl. So we can source in the diversity of tape libraries, we have been able to find the DTC hours on more than one occasion now two car targets and in addition to that were also leveraging the deep expertise in the specificity testing the safety testing of these types of TCOS, which is something we've lead you to.
Lies.
In our ongoing pipeline programs. So it's really the marriage if they to capabilities that it has enabled us to generate tcl to call targets and to add up to take those forward and they become potential programs onto the for us for ourselves, but also under these Dallas collaboration.
So and so I hope that answers that question on you'll be hearing more about that as you know as we have more to talk about publicly.
With relation in relation to the second question.
I can see plants with yes, we've been able to make cdfour and Cdeight T cells and will be I would say again footwear about days at forthcoming scientific conferences in terms of the functionality of those south.
Yanan Zhu: Great. Thanks for the color. Very helpful. Thank you. Thank you. And, ladies and gentlemen, this does conclude our question and answer session. I would now like to turn the call back over to Adrian Rawcliffe for any closing remarks.
Great. Thanks for the color very helpful.
Thank you.
Thank you and ladies and gentlemen, this does conclude our question answer session I would now like to trying to call back over to Asia Rawcliffe for any closing remarks.
Thanks.
Adrian G. Rawcliffe: Thanks. This year, we've confirmed the potential of the platform with responses in five different solid tumors, and we look forward to sharing data updates at future conferences throughout 2020. We're recruiting, very effectively, patients in synovial sarcoma and in MRCLS with the Spearhead 1 trial, and we're gearing up our commercial readiness to go to market in 2022. And as reflected by the last question, we're working on a pipeline of cell therapies and treatments, including next-gen, allogeneic, and the HIP platform to go beyond our current pipeline in transforming the lives of people And we'll update those as we go through 2020 as well.
This year.
We've confirmed the potential of the platform.
Responses in five different solid tumors.
We look forward to sharing data updates that future conferences throughout twentytwenty.
We're recruiting very effectively patients in synovial sarcoma and did MRC LSW with the spearhead one trial and we're gearing up our commercial readiness to go to market in 22 inch do.
And as reflected by the last question, we're working on a pipeline of.
Cell therapies treatments, including Nexgen allogeneic and the hit platform.
To.
Go beyond our current pipeline in transforming the lives of people were cancer and we'll update those as we go through Twentytwenty as well with that I'd like to thank you will feel time and close the cool. Thanks Bye.
Adrian G. Rawcliffe: With that, I'd like to thank you all for your time and close the call. Thanks. Bye. Ladies and gentlemen, this concludes today's conference call. Thank you for your...
Ladies and gentlemen, this concludes today's conference call. Thank you for your part for participating you may now disconnect.
Operator: Ladies and gentlemen, this concludes today's conference call. Thank you for participating. You may now disconnect.
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