Q2 2020 Adaptimmune Therapeutics PLC Earnings Call
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Ladies and gentlemen, please standby your conference call will begin momentarily once again, ladies and gentlemen, thank you for your patience and please standby.
Operator: Ladies and gentlemen, please stand by. Your conference call will begin momentarily. Once again, ladies and gentlemen, thank you for your patience, and please stand by.
[music].
Unnamed Speaker: www.cdc.gov.au [inaudible] © BF-WATCH TV 2021 ???
[noise], Hello, and welcome to adapt <unk> Q2 financial and business update.
Unnamed Speaker: Hello, and welcome to AdaptMQ2's financial and business update. With me on today's call is Juli Miller. Julie, you may begin.
With me on today's call is truly Miller.
Julie you may begin.
Good morning, and welcome to adapt the news conference call to discuss our second quarter 2020 financial result.
Juli P. Miller: Good morning, and welcome to Adaptimmune's conference call to discuss our second quarter 2020 financial results. I would ask you to please review the full text of our forward-looking statement in this morning's press release. We anticipate making projections during this call, and actual results could differ materially due to a number of factors, including those outlined in our latest filings with the FEC. Adrian Rawcliffe, our Chief Executive Officer, is with me for the prepared portion of this call, and other members of our management team will be available for Q&A. With that, I'll turn the call over to Adrian Rawcliffe.
I would ask you to please review the full text about forward looking statement from this mornings press release.
We anticipate making projections during this call and actual results could differ materially due to a number of factors, including those outlined in our latest filings with the FCC.
Adrian Rawcliffe, our Chief Executive Officer is with me for the prepared portion of this call and other members of our management team will be available acuity with that I'll turn the call over to Adrian Rawcliffe ad.
Thank you Judy and thank you everyone for joining us.
Adrian G. Rawcliffe: Thank you, Juli, and thank you, everyone, for joining us. After a strong start to the year, the second quarter of 2020 has continued to be very productive as we make progress to bring the promise of SPIR T-cell therapy to people with cancer. At ASCO, we reported new responses in gastroesophageal, lung, and head and neck cancer. We've now seen responses in a total of six different solid tumors, including a complete response in a patient with liver cancer. We initiated a Phase 2 trial combining ADPA2 and 4 with pembrolizumab in head and neck cancer and announced that we would shortly initiate a new Phase 2 trial in gastroesophageal cancer. We demonstrated continued efficacy and promising durability with ADPA2 and 4 in patients with synovial sarcoma and announced that we'd screened more than half the patients likely to be required to complete our Spearhead1 pivotal trial, working with 20 centers in Canada, France, Spain, the US, and now also in the UK, and we remain on track for the US launch of ADPA2M4 in 2022.
After the spin start to the through the second courtroom Twentytwenty has continued to be very productive because we make progress to bring the promise of spear T cell therapy people with council.
At ASCO, we reported new responses seen gastroesophageal long and head and neck councils. We've now seen responses in a total of six different solid tumor types, including a complete response in a patient with live accounts.
We initiated a phase two trial, combining a P. P eight to him pool with Pembrolizumab in had to Netcomm, So and announced that we would show the initiate a new phase two trial in gastroesophageal cancers.
We demonstrated continued efficacy and promising if your ability with a D. P. I too am pool in patients with synovial sarcoma and announced the lead screen more than half the patients likely to be required to complete they'll stay ahead, one pivotal trial working with 20 sentence in Canada, France, Spain.
The U.S. and now also in the UK.
And we remain on track for the U.S. launch a baby P I too am pool in Twentytwenty too.
In addition, further validating the potential of this product to meet the significant unmet medical need for patients with synovial sarcoma. The European Medicines Agency recently granted us access to prime regulatory support.
Adrian G. Rawcliffe: In addition, further validating the potential of this product to meet the significant unmet medical need for patients with synovial sarcoma, the European Medicines Agency recently granted us access to prime regulatory... Finally, we raised approximately $244 million and finished the quarter with a total liquidity of $419 million, funding us into 2022 and so enabling us to focus on developing the signals we've seen in our trials and bringing ADP A2M4 to market for patients with sarcoma.
Finally, we raised approximately $244 million I finished the quarter with a total liquidity or $419 million funding this into twentytwenty too and so enabling us to focus on developing the signals we've seen in all trials and bringing ATP eight two important market for patients.
Sorry.
For the remainder of Twentytwenty, we plan to provide clinical updates at major medical conferences, including an oral presentation by Dr. Bruno Steinberg from the Barbara University clinic in Spain.
Adrian G. Rawcliffe: For the remainder of 2020, we plan to provide clinical updates at major medical companies, including an oral presentation by Dr. Bruno Sangro from Navarra University Clinic in Spain, who will present data from the third dose cohort of our ADP-AA2-AFP trial at the International Liver Congress later this month. We also have to present updates from our SUPASS trial and additional durability and translational data from patients with synovial sarcoma, from our Phase 1 APA2M4 trial in Q4. We will update data from the radiation sub-study of this trial in 2021, as we have not yet recruited sufficient patients to be meaningful, partially due to the impact of COVID-19, the next topic I want to cover, like Moose Farmer and Biotech. And, as discussed last quarter, we have experienced recruitment delays in our clinical trials. But we, and the centers we work with, have done everything possible to carry on and be ready to hit the ground running as the situation allows. We already have active sites across our trials in Europe, the UK, the US, and Canada. And in each of those locations, the impact of COVID-19 is still evolving.
Present data from the third dose cohort about 80 P. Eight to <unk> P trial at the International live a Congress later this month.
We also tied to present updates from also post trial and additional durability and translational data from patients with synovial sarcoma.
Thank you to on a P. Eight two and four trials in Q4.
We will update data from the radiation sub study of this trial in 2021, as we have not yet recruiting sufficient patients to be meaningful possibly due to the impact of Covidien I'd say the next topic I want to cover.
Like most pharma and biotech companies and does discuss law school. So we have experienced recruitment delays enough clinical trials, but we and the sensors. We work with have done everything possible to carry on and be ready to hit the ground running as the situation allows.
We already have active sites across all trials in Europe, UK, the U.S. in Canada and each of those locations. The impact of Cobiz 19 is still evolving and say we've seen variations between regions and between clinical sites as they react to the challenges of a pandemic.
Adrian G. Rawcliffe: And so we've seen variations between regions and between clinical sites as they react to the challenges of the pandemic. We believe that we have seen more of an impact in our early phase trials, for instance, with the radiation sub-study conducted at MD Anderson Cancer Center in Houston, as Texas is a region particularly affected by radiation. However, enrolment in our Spearhead 1 Pivotal trial has continued to progress well, in part due to the clear opportunity for benefit for patients based on the results seen in Sinovial Sarcoma to date. Additionally, our Spare T-Cell Manufacturing Facility at the Navy Yard has been very busy throughout this period.
We believe we have see more of an impact you know early phase trials for instance, with the radiation sub study conduct the MD Anderson cancer Center in Houston.
Texas is a region, particularly affected.
However, enrollments enough spearhead one pivotal trial has continued to progress well impart due to the clear opportunity, but benefit for patients based on results seen in synovial sarcoma, but to date.
Oh spear T cell manufacturing facility at the Navy out has been very busy throughout this period, we have been able to treat some patients and we believe the others, who moved manufactured sells well be able to continue enough trials when it's safe to say.
Adrian G. Rawcliffe: We have been able to treat some patients, and we believe that others for whom we've manufactured cells will be able to continue in our trials when it's safe to do so. But clearly, this has had an impact on patients in our trials. And whilst that impact was clearest across the board in April and May, it continues to impact on a site-by-site and country-by-country basis as the pandemic evolves, particularly in the United States.
But clearly this has had an impact on patients in our trials I'm off that impact is clearest across the board in April or May It continues to impact of a site by site and country by country basis, as the pandemic evolves, particularly in the United States.
Later this year, we plan to share a patient data updates from us the Pos trial and ATP a to I.P. trial, whom we reported topline data earlier this year as well as for any new patients who we've treated in the intervening period.
Adrian G. Rawcliffe: Later this year, we plan to share patient data updates from our SURPASS trial and ADP-A2-AFP trial, for which we reported top-line data earlier this year, as well as for any new patients whom we have treated in the intervening period. Looking beyond 2020, we will continue to progress indications with PROMIS into later phase trials, starting with a new phase 2 trial in gastroesophageal cancer, and using Test Combination Therapies and Next Generation Enhancements as the data guide. We will also continue to pursue partnership opportunities, such as the deal we completed earlier this year with Astellas, and we will continue to develop our off-the-shelf allogeneic program as part of our future vision for cell therapies for people with cancer. We are also preparing for the future by increasing our manufacturing capacity to meet the needs of ongoing and planned clinical trials.
Looking beyond Twentytwenty, we will continue to progress indications with promise into later stage trials, starting with the new phase two trial in gastroesophageal cancer and test combination therapies and next generation homes from the day to guide.
We will also continue to pursue partnership opportunities such as the deal. We completed earlier this year with this Dallas I will continue to develop our off the shelf allogeneic program as possible future vision cell therapies for people with council.
Yeah. We're also preparing for the future by increasing our manufacturing capacity to meet the needs of the ongoing and planned clinical trials. In addition, our commercial preparation is ramping up including development of all manufacturing capabilities towards commercial Scott.
Well external partners are important we remain convinced that for adaptimmune to be a leader in cell therapy, we need I mean, the manufacturing process, which enables us to innovate and be more efficient.
This includes back to production, where we intend to start using our GMP backed up manufactured in our dedicated facility and also POS trial later this year.
Throughout this period I've continues to be humbled by the dedication to my colleagues, who have worked tirelessly in the midst of a global pandemic with its associated personal challenges to maintain the ability of patients to receive all therapies and to carry on crucial research on our pipeline.
I'm pleased that we've recently named one of the best places to work in Philadelphia, or the Philadelphia business Journal.
Adrian G. Rawcliffe: In addition, our commercial preparation is ramping up, including the development of our manufacturing capabilities towards commercial... While external partners are important, we remain convinced that for Adaptimmune to be a leader in cell therapy, we need to own the manufacturing process, which enables us to innovate and be more efficient. This includes vector production, where we intend to start using our GMP vector manufactured in our dedicated facility in our SURPASS trial later this year. Throughout this period, I've continued to be humbled by the dedication of my colleagues who have worked tirelessly in the midst of a global pandemic with its associated personal challenges to maintain the ability of patients to receive our therapies and to carry on crucial research on our pipeline. I am pleased that we were recently named one of the best places to work in Philadelphia by the Philadelphia Business Journal.
Our said mission transforming the lives of people with cancer by designing and delivering cell therapies makes it up to me in a place where passionate people who want to cure cancer like to work.
However, the ongoing discussion about racial in equity, particularly as it relates to black lives shouldn't make everyone trying to in some sells about whether we are equally welcoming and nurturing to all.
Let's see here I'm committed to do everything we can in the schools I know my colleagues share. This commitment to ensure the adaptimmune is a great place to be placed with colleagues feel supported I could see a bright future.
Now I'll open the call up to questions operator.
Thank you ladies and gentlemen, if you have a question at this time. Please press Star then one and you touched on telephone. If your question has been answered I wish I love yourself from the Q. Please press the pound key Weeklys assets you. Please mute your phone once your question has been stated.
First question comes from the line of Marc Frahm with Cowen and company. Your line is open. Please go ahead.
Hi, Thanks for taking my questions.
You are in your prepared remarks you.
You mentioned present topline data and in new patients agree for Burke surpass and ask the program.
Is that if he presentations going to happen alongside the Eagle.
They should have new patients, where that's going to be leader in the year that we'll see additional ASCII difference.
So I'm going to Alaska Eleonore to outline what is coming got Oh, the I'll see at the end of August and ER and further on in the year with I think there.
Adrian G. Rawcliffe: Our shared mission, transforming the lives of people with cancer by designing and delivering self-therapies, makes Adaptive Immune a place where passionate people who want to cure cancer like to work. However, the ongoing discussion about racial inequities, particularly as it relates to black lives, should make everyone challenge themselves about whether we are equally welcoming and nurturing to all. As CEO, I'm committed to doing everything we can in this course, and I know my colleagues share this commitment to ensure that Adaptive Immune is a great place, a place where all colleagues feel supported and can see a bright future. Now I'll open the call to questions. Operator?
Thanks, Ed So I'm just to be clear about expectations for but will be presented an easy. So first of all that we will not be presenting the non HCC not parasite elect cancer cohort at diesel and where you can mostly expect is.
An update on safety for the entire trial.
As well as presentation of the patients in group three.
At which will include at least an update on.
The patients that we gave topline results for in at end of May around ASKO.
And and beyond that it hasn't been much time, and I would not expect you know considerably more clinical information beyond those patients.
And we don't have any specific plans to update at at P. further beyond diesel conference for the rest of the year.
But can can I can speak to where you are today you know that.
Operator: Thank you. Ladies and gentlemen, if you have a question at this time, please press star then 1 on your touchtone telephone. If your question has been answered or you wish to remove yourself from the queue, please press the pound key. We please ask that you please mute your phone once your question has been stated. Our first question comes from the line of Marc Frahm with Cowan & Company. Your line is open. Please go ahead.
Maybe in some areas Coke impact has.
Lessened or just people that added to it.
Today are you more or less active screening and say you were a year ago, how much more.
Okay.
So compared to a year ago.
I'm not I'd have to go back and look at our screening data to really answer that from a year ago I can tell you what's.
Really been the trajectory <unk>.
You know March April when this really started.
If that's helpful.
You know, we really saw a market cut back in screening across programs in March and April.
Marc Alan Frahm: Thanks for taking my questions. Adrian, in your prepared remarks, you mentioned presenting top-line data on new patients, I believe for both the SURPASS and AFP programs. Is that AFP presentation going to happen alongside the easel presentation of new patients, or is that going to be later in the year when we'll see additional AFP patients?
And I think that centres were largely concerned that they just didn't have the capacity to manage the patient.
I'm concerned about ICU beds.
And just minimizing traffic and their centers and exposure to staff and and and whatnot. So.
I do think that things have improved since then.
And.
It really does depend region by region. Some regions have recently gotten worse again, so I don't think that the story is over.
Until we really have a handle on where the viruses is heading in regions could change.
Day to day really.
Adrian G. Rawcliffe: So, I'm going to ask Elliot Norry to outline what's coming at the ILC at the end of August and further on in the year with AFP.
I will say that we are seeing screening across our programs.
I think it would have been better if not for Cove at 19, perhaps with the exception of spearhead one where the screening really has.
Met our projections by and large.
Elliot Norry: How do you?
Elliot Norry: Thanks, Ed. So, just to be clear about expectations for what will be presented at ESOL, first of all, we will not be presenting the non-HCC, non-hepatiocellular cancer cohort at ESOL, and what you can mostly expect is an update on safety for the entire trial, as well as presentation of the patients in Group 3, and we don't have any specific plans to update AFP further beyond the ESOL conference for the rest of the year.
And.
We have worked with centers.
To the best of our ability to both sort of respect there needs to protect their employees and manage their patient flow.
And also to treat patients when we can in advance patients and our trials from screening to manufacturing to treatment when safe and possible.
It's hard to be more specific than that you know without walking around the globe and what was true a month ago will be different you know a month from now.
Okay, great. Thank you.
Thank you Thanks program.
Our next question comes from the line of Tony Butler with Ross Capital. You line is open. Please go ahead.
[noise] [noise] good morning, two questions if I may.
Marc Alan Frahm: Okay, great. And then
One is on the trial and heading that cancer, where you're sequencing from Bro lives amount.
Elliot Norry: Maybe Elliot, if you can also kind of speak generally, Adrian kind of highlighted the pushes and pulls on enrollment and, you know, patient access to your trials from both the added enthusiasm of seeing responses but then, obviously, the impact of COVID. Can you kind of just speak to where you are today, you know, now that maybe in some areas COVID's impact has lessened or just people have adapted to it? You know, today are you more or less active in screening than you were a year ago? You know, how much more?
I'd like to understand how did you think about dosier timbral relative to sell therapy.
It would it be before.
You actually add so therapy or after importantly.
Given the pin Bro does have an indication and heading cancerous if possible.
Patient population, it's just a second question for which you actually ended up screen.
Will be those that may be in fact refractory.
<unk>.
You see them, which will be.
A very interesting experiment in in of itself I'm trying to understand what would be the pieces that you see when you were able to scream and then again, how do you think about sequencing Pembroke relatively soldier. Thank you very much.
Elliot Norry: So, compared to a year ago... I'd have to go back and look at our screening data to really answer that question from a year ago. I can tell you what's really been the trajectory since March-April when this really started, if that's helpful. We really saw a marked cutback in screening across programs in March and April. I think that centers were largely concerned that they just didn't have the capacity to manage the patients, concerns about ICU beds and just minimizing traffic in their centers and exposure to staff and whatnot. So I do think that things have improved since then. It really does depend region by region.
Thanks, Bye, thanks for telling me I I I think.
Australia to walk through the the approach trial, because I think the approach Coke without trial to people think about what answer answer several of those questions are there might be able to look back if it if there's something else as well it can be we can help with Ah Elliot.
Yeah, Hi, Thanks again.
Ah.
So.
That trial.
As you May know we have.
A trial in progress poster to be presented.
<unk>.
And that will there won't be data presented it'll just be trial design and there'll be details provided.
<unk>.
In in greater length at that time.
In general though.
To.
To answer your question about the sequence.
Elliot Norry: Some regions have, you know, recently gotten worse again. So, I don't think that the story is over until we really have a handle on where the virus is heading, and regions could change, you know, day-to-day really. I will say that we are seeing screening across our programs. I think it would have been better if not for COVID-19, perhaps with the exception of Spearhead One, where the screening really has met our projections by and large, and, um... We have worked with centers to the best of our ability to both, you know, sort of respect their needs to protect their employees and manage their patient flow and also to treat patients when we can and advance patients in our trials It's hard to be more specific than that, you know, without walking around the globe, and what was true a month ago will be different a month from now.
We're generally screen patients who are <unk>.
Remember iliza mab naive or have recently started on <unk> and with the idea that Ah when patient.
When patients either don't respond or progress on <unk> that they're sells would be ready for treatment at that time in combination with pemble isn't that.
So ah and patients who respond to pemble isn't that initially would stay on <unk> as it is indicated.
For first lying treatment. So we really see this is the first line.
As a sequence following first line <unk> to continue embolism, AB and receive sells as soon as possible.
After documenting that patients have not had clinical benefit from pan-broil alone.
Oh, that's perfect thanks for Bob, but but so basically we just cells.
And virtually all cases after they've had timbral.
But they will continue on kimbro as they get itself that's fair to say.
Yes.
[noise] like fill it.
Thank you Andrea.
Thanksgiving.
Thank you.
Thank you and our next question comes down the line of Manhattan.
Citigroup Caroline is open. Please go ahead.
Great. Thanks for taking my question and very good money.
So.
From the so just wanted to follow up on Tony's question.
Can you just help us understand.
At what what is the.
Time difference between like the patient either progressing in non disappointing to not responding to pangle versus initiation of Teletherapy I'm asking them to contact so Ah understanding bed did you Ah.
Marc Alan Frahm: Okay, great. Thank you.
Operator: Thank you, and for our next question...
Tony Butler: Our next question comes from the line of Tony Butler with Roth Capital. Your line is open, please go ahead. Thank you.
Administering sell pet it be violet patients are progressing but it says they have progress I mean as in like is there a is it a diet.
Tony Butler: Good morning. I have two questions, if I may. One is in the trial in head and neck cancer where you're sequencing pembrolizumab, and I'd like to understand how you think about dosing pembrolizumab relative to cell therapy. Would it be before you actually add the cell therapy, or after? Given that Pimbro does have an indication for head and neck cancer, is it possible that the patient population, this is the second question, for which you actually end up screening will be those that may be, in fact, refractory to PEMBRO when you see them, which will be a very interesting experiment in and of itself? I'm trying to understand what the patients that you see when you're able to screen them, and then, again, how Thank you very much.
Just to make like Mr. That'd be after that.
It is.
I'm Gonna I'm going to defer sort of greater detail explanation of the study until the asthma poster, but it to generally answer your question. If if a patient has progressed beyond the point of having potential benefit.
From continued therapy, then it would be the discretion of an investigator to not to not proceed.
But patients who have had pamper Elizabeth and do not respond.
You know have significant unmet medical need and it's really that position, where we're trying to sequence as rapidly as possible. So as to not have that patient wait for cell therapy at that point and be ready to go in combination with continued pamper Elizabeth.
Got it and then what other question on live Okay, a little kind of so so.
So so far we have seen one complete response and I think two other patients did not but as far as if I understanding correctly.
Did you see any other biomarker some needs to patients.
Which you could which would be like loading and then the follow up is do you have some internal bad.
Adrian G. Rawcliffe: Thanks Tony. I think I'll ask Elliot to walk through the approach to that trial because I think the protocol for that trial will answer several of those questions and then maybe we'll look back if there's something else as well that we can help with. Elliot?
That these many responses if you see you would actually.
Move ahead with the face to kind of fries, just like you had done with the Spanish had bun tribes.
Ah Yeah sofa with respect to Ah Ah additional biomarkers and further details on those patients I'm going to defer to the presentation. That's only a couple of weeks away at the international liver Congress.
There is there are embargoes and whatnot and we should really just allow Dr. Sangre to make his presentation.
With respect to the bar for proceeding to a phase to study I think it's more complex than any just single parameter, but we would look for some combination of a response rate and duration of response.
Elliot Norry: Yeah, hi, thanks again. So that trial, as you may know, we have a trial-in-progress poster to be presented at ASMO, and there won't be data presented, it'll just be trial design, and there'll be details provided in... in greater length at that time. In general, though, to answer your question about the sequence.
Got it.
Previously Margaret we've still abuse the rule of thumb of both of <unk>, but whether we're seeing a civic know of three out of 10 patients.
<unk>.
A good starting bench mall, because I won't be asleep. The two out of two responses, but we saw the lowest docents a path.
Elliot Norry: We're generally screening patients who are Pembrolizumab-naive or have recently started on Pembrolizumab with the idea that when patients... when patients either don't respond to or progress on Pembrolizumab, their cells would be ready for treatment at that time in combination with Pembrolizumab. And patients who respond to Pembrolizumab initially would stay on Pembrolizumab as it is indicated for So we really see this as a sequence following first-line pembrolizumab to continue pembrolizumab and receive cells as soon as possible after documenting that patients have not had clinical benefit from pembrolizumab.
Sufficient to persuade us the rest of a truck to bowl late stage develop a program the industrialists off a G O, Kansas, but more generally speaking a signal and sell therapy.
Thank you have three out of 10 seems reasonable and and hence the ongoing Ah recruitment of.
Patients turncoat what in the.
Study too understands her brother characterized the response right in nature of the responses.
This is that he has so thank you again, thank you and it.
[noise]. Thank you and our next question comes from the line of my Gosh meant was Guggenheim's Securities. Your line is open. Please go ahead.
Hey, this is Kelsey I'm from Michael things you could take care of question and I guess now that we're seeing responses to TCR therapy.
Solid tumors.
I guess are you noticing any pattern, then who or what type of humor I'm more likely to is fine and then specifically for the S. P cohort.
H T T to me I guess, what kind of two married iced tea and that Colorado, Oh, it's too risky expectancy. Thank you.
Elliot Norry: That's perfect. Thanks, sir. So basically, we get cells in virtually all cases after they've had Pembro, but they will continue on Pembro as they get cells.
So.
I think that all all separate it into two Angelus first of all with respect to.
A major of course surpass program.
I think that you know the tumors that we might expect to see responses in going forward are the ones, where Ah we've seen a degree of antitumor activity to date and we <unk>.
Elliot Norry: Is that fair to say? Yes. Thanks, Elliot. Thank you, Adrian. Thank you, Tony. Thank you.
Previously stated that will be focusing.
Mohit Bansal: Thank you, and our next question comes from the line of Mohit Bansal with Citigroup. Your line is open, please go ahead.
[noise] surpassed study you know going forward on on those tumor types.
So ah.
That's specifically.
Mohit Bansal: Great. Thanks for taking my question and good morning. So, I just wanted to follow up on Tony's question.
Had a neck.
Bladder.
In long and and gastroesophageal.
Ah that's not to say that we've exhausted the ability to look in any other tumors and we may continue to to explore that but that study will focus on on those four tumors from the standpoint of how we approach study centers and investigators.
Mohit Bansal: Can you please help us understand what the time difference is between when the patient is either progressing and not responding to PAMRO versus initiation of cell therapy? I'm asking in the context of understanding whether you are administering cell therapy while patients are progressing or they have already progressed. I mean, is there a time point where it is just too late to administer cell therapy?
I think some of that has to do with the frequency of expression of May J four in in in different tumor types in in those tumors that degree of expression.
But it's also guided by are are clinical experience to date.
And then with respect to the non H C C cohort.
And and AFP study Ah, it's really a variety of tumors that we may see they're rare tumors and.
Elliot Norry: Elliot.
Elliot Norry: I'm going to defer a sort of greater detail explanation of the study until the ESMO poster, but to generally answer your question, if a patient has progressed beyond the point of having potential benefit from continued therapy, then it would be the discretion of an investigator to not proceed. But patients who have had pembrolizumab and do not respond, you know, have significant unmet medical need, and it's really that position where we're trying to sequence as rapidly as possible so as not to have that patient wait for cell therapy at that point but be ready to go in combination with continued pembrolizumab.
If you look at the frequency of AFP expression and other tumor types. There are some rare gastric cancer is that express AFP cholangiocarcinoma terms sell tumors.
A rare apatow blastoma.
So I think that there are some rare tumor types that we would never really find the numbers to study in individual cohorts on their own and we had received request from investigators to try and include these patients with limited treatment options.
In the study so we opened a cohort that essentially as a basket of them.
That are that are non HCC tuners.
God. Thank you so much.
Sure.
Thank you and our next question comes on the line a gym, Virginia off with Wells Fargo Security. Your line is open. Please go ahead.
Okay.
The gym. This morning first question.
Pause trial I believe in May.
You announce that do smells too and three would be <unk> and the three patients would be treated that.
Okay.
Elliot Norry: Got it. And then there was another question on liver cancer. So, so far, we have seen one complete response, and I think two other patients did not respond, if I understand correctly. Did you see any other biomarkers in these two patients which you could, which would be worth noting? And then the follow-up question is, do you have some internal bar that these many responses, if you see, you would actually move ahead with the phase two kind of trial just like you did with the SPARES Head 1 trial?
Can you provide an update on those three patients.
And the timing of.
Not expansion cohort.
And what expectations and it should date of presentation.
Thank you.
So we're not providing updates on the surpassed patient at this time, we do we do plan to provide an update later in the year about specific patients cohorts et cetera.
Okay, Alright, Thank you and then obviously that.
Product is designed C D cokes yourself become competence.
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You had the opportunity from patients samples to look at the the C. D Court T cells and.
And sure that they remain competence off you kidding [noise].
A patient.
[noise] so it's.
I I hate to be disappointing, but it's just sort of the same answer.
Elliot Norry: Yeah, so with respect to additional biomarkers and further details on those patients, I'm gonna defer to the presentation that's only a couple of weeks away at the International Liver Congress. There are embargoes and whatnot, and we should really just allow Dr. Sangro to make his presentation. With respect to the bar for proceeding to a Phase 2 study, I think it's more complex than any single parameter. But we would look for, you know, some combination of response rate and duration of response.
That we're gonna provide information about about that at an update later in the year.
Okay, [laughter] I'll try one more which I suspect cool [laughter].
And that is Oh very <unk>.
And they also with Astellas, where there was full bill collaboration on.
Do you sell programs and I believe you said there no candidate and selected can provide any updates so.
Program.
Yeah, Hi, this is <unk> I'll check them out can you help you today to take that I think.
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Moving that thing so there's plenty of.
[laughter], so that's something that we.
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A dog.
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What can I can feedback on some of the C. M. P. P I suppose etcetera.
Mohit Bansal: Oh, that's great. Very great.
I can set you up with it.
Okay, great well, thanks for the updates.
Adrian G. Rawcliffe: Previously, Murray, we've sort of used the rule of thumb of whether we're seeing a signal of three out of ten patients being a good starting benchmark. Now, obviously, the two out of two responses that we saw at the lowest dose in surpass were sufficient to persuade us that there is a tractable late-stage development program there in gastroesophageal cancers. But more generally speaking, a signal in cell therapy, we think three out of 10 seems reasonable, and hence the ongoing recruitment of patients who are in cohort in the AFP study to understand and further characterize the response rate and nature of the response.
Okay.
Thank you and our next question comes from the lineup Jonathan Chang with S. T. D. Leery Caroline is open. Please go ahead.
Good morning, Thanks for taking my questions and congrats on the progress.
First question Ah Pepsi unconfirmed responses with the second <unk> for a program report that as a ton of basketball been confirmed at this point.
So we haven't issued any new informational not and we will too so the clinic.
Yeah.
Got it.
And the second question I guess related to that for for both of them H a four first genin second Jen programs.
Sarcoma, how should we be thinking about durability of responses what are the reasons for concert and sent durability of responses and how are you thinking about benchmarks for durability.
HM.
Good question I think Ah the reasons for confidence a really difficult because to me confidence requires data.
Mohit Bansal: This is very helpful. Thank you, Adrian. Thank you, Elliot.
Michael Schmidt: Thank you. And our next question comes from the line of Michael Schmidt with Guggenheim Securities. Your line is open. Please go ahead.
A diet fine and patience and we're in the process of gathering lottery. So we all understand a lot more about the longevity of the responses and the nature and ready to them as we as we go through these jobs reach out.
Kelsey Beatrice Goodwin: Hey, this is Kelsey. I'm from Michael. Thanks for taking our questions. I guess now that we're seeing responses to TCR therapy across
Yeah Yeah.
<unk> study for example is.
In dos escalation.
We still responses of the first doses.
Kelsey Beatrice Goodwin: Numerous Solid Tumors. I guess, are you noticing any patterns in who or what types of tumors are more likely to respond? And then specifically for the AFP cohort and the non-HCC tumors, I guess, what kind of tumors are you seeing in that cohort or what kind of tumors do you expect to see? Thank you.
Fantastic, but yeah, there's an early stage study and we need to get more patients almost stomach. So I think.
Will understand lots of <unk> in terms of such as we were pretty those patients in terms of the.
What I think benchmark sorry.
Largely depends on the indication on the setting.
Where we're going off topic will have a bit more data a bit more information to share when we talk about the nature of the gastroesophageal trial, but with setting up later on this year and then we got into next year, where where I think we've got an understanding web.
Elliot Norry: So, um... I think that I'll separate it into two answers. First of all, with respect to the MAJ-4 Surpass program, I think that the tumors that we might expect to see responses in going forward are the ones where we've seen a degree of anti-tumor activity to date. And we've previously stated that we'll be focusing the SURPASS study going forward on those tumor types. So that's specifically head and neck, bladder, and lung and gastroesophageal. That's not to say that we've exhausted the ability to look at any other tumors, and we may continue to explore that, but that study will focus on those four tumors from the standpoint of how we approach study centers and investigators. I think some of that has to do with the frequency of expression of MAYJ4 in different tumor types and, in those tumors, the degree of expression. But it's also guided by our clinical experience to date.
<unk> and the second of blood line settings, but elsewhere, it's gonna depend on who's gonna depend on what those settings are and what else is what else is out there at the time, but we we see that signal.
Got it and just last question.
Zooming with with a promising early date as in the next Gen. Late J for a program. How are you thinking about potential pipeline prioritization with regards to first generation program. Thank you.
That's a really good good question I mean, I think they strategically for us the the commitment, but we might as well.
Where we will see a signal.
We have done very robust signal and sarcoma and was a clear on medical need and it's definitely that with the first general.
Oh, it's with that first generation program.
As fast as we can to market and I think there's there's.
Elliot Norry: And then with respect to the non-HCC cohort, in the AFP study, it's really a variety of tumors that we may see. They're rare tumors. If you look at the frequency of AFP expression in other tumor types, there are some rare gastric cancers that express AFP, cholangiocarcinoma, germ cell tumors, and a rare hepatoblastoma. So I think that there are some rare tumor types that we would never really find the numbers to study.
It's important to do that because.
Evolution of these products one can be quite Rockford, because we're getting real tongue translational data that we can put it back into researching back into the manufacturing and and so there will always be the potential for something Bachelor coming down the pipe I don't think the benefit Oh, I don't think that benefit.
It's anybody to constantly be waiting for the perfect sell therapy product.
Rather our objective is where we were we see significant benefit patients to move those things quickly as possible.
Elliot Norry: Individual cohorts on their own, and we had received requests from investigators to try and include these patients with limited treatment options in the study. So we opened a cohort that essentially is a basket of them that are non-HCC tumors.
Having said that the I D. P. I T O M for trial has a pilot child has now finished rolling with the exception of the radiation sub study and so I'll focus full Magi pool. For example is very much on the <unk> study the second generation program on the combination of the.
Kelsey Beatrice Goodwin: God, thank you so much.
Jim Birchinoff: Thank you, and our next question comes from the line of Jim Birchinoff with Wells Fargo Security. Your line is open, please go ahead.
Jen one with the head and headed <unk> with Pepper Iliza mob and on the radiation sub study so <unk> magnitude approaches beyond adjourn one outside of salt kind of aware, obviously, we have a product.
Nick Holm: Hi, good morning. This is Nick Holm for Jim this morning.
And was progressing towards towards registration. So that's sort of how we think about that conceptually, but we <unk> Ah Russo I'd want to raise the point.
Nick Holm: The first question is on Mr. Parr's trial. I believe in May, you announced that dose levels 2 and 3 would be merged and that three patients would be treated at 5 million cells prior to opening an expansion cohort. Can you provide an update on those three patients and the timing of opening that expansion cohort and what expectations advancers should have for the data presentation and then a follow-up? Thank you.
Yeah for general generally, but I think cell therapy companies have got to get comfortable with the fact that if we all successful then Iowa emerging research will cannibalize already existing products and as they are on the.
Okay. So that's just a feature of the space of the early stage of a space and integrated capabilities enable us to understand that.
To prioritize of execute quickly across all popcorn.
Elliot Norry: So, we're not providing updates on the surpassed patients at this time. We do plan to provide an update later in the year about specific patients, cohorts, etc.
Got it. Thank you thanks for taking the questions.
Extra.
Thank you and again, ladies and gentlemen, if you'll have a question at this time. Please press Star then one our next question does come from the line I gave him that song.
Uh-huh Securities. Your line is open. Please go ahead.
Nick Holm: Okay, thank you. And then, obviously, that product is designed such that CD4 T-cells become competent. Have you had the opportunity from patient samples to look at the CD4 T-cells and ensure that they remain competent after you've given them to the patient?
Hello, everyone isn't gave it on behalf of <unk>.
Just a question here on the data hi, four surpassed could you just like that to be that's all you're getting on which.
Target provinces and also on the.
On the manufacturing are there any expected differences in yoga class using the Navy Navy yard facility Tomatoes manufacture solids for your head stand for taking the question.
Sure. So I'll I'll take I'll take the first one on so pass and if you look very carefully in the headlines press release, you'll say that word regarding too cute for for that and as long as in September.
Elliot Norry: So it's, I hate to be disappointing you, but it's sort of the same answer that we're gonna provide information about that at an update later in the year.
Nick Holm: Okay. I'll try one more, and I suspect I'll show it off as well.
Studies, no that's not gonna be an asthma and then secondly, Ah the I'll hand over to Joan to talk about the Ah Navy yard manufacturing and add costs about.
Helen Katrina Tayton: And that is, very early in the year, you had an announcement with Astellas where there was a formal collaboration on endosteropod and T-cell programs. I believe you said there's a candidate that's selected, and provide any updates on the program. Yeah, hi, this is Helen Tayton-Rodden. Happy to take that.
Yeah. So in terms of this is John in terms of the the manufacturing costs.
The things that we mentioned earlier is that we have our own in the house vector, which we plan to use later on in the year. So I will certainly in sourcing.
Vector well that'd be positive impact Cogs.
Helen Katrina Tayton: I think we also mentioned in our update at the end of May that the first program is moving forward successfully to date, and we, jointly with Acellus, have nominated our first target, which will be an HLA-independent TCR, a HIT program, so a TCR that can see a cell surface protein, a bit like an antibody, but we're not disclosing the targets of that joint program. But it is continuing to move forward on time and on track at this point, so we're really pleased with how the collaboration is progressing. Thanks Helen.
One other thing we're also continuing to do is just optimize how we got to run the Navy yard facility. So we're investing a fair bit of time and resources and electronic systems for example, which allow us to the optimize the process of reduce the the overhead that goes into each one of those so so I'll tell you that it's continuous process of improving our call.
So we're making some fairly big step changes in terms of efficiency optimization as we go alone.
Okay. Thanks, and actually just one really quick follow up here I was just wondering has the company ever well actually I have this company thing about exploring your asset you can't you know candidates.
[noise] outpatient setting.
Whether or not this could be a potential use in the future.
HM.
How long do you want to talk to them.
Yeah.
Yeah.
Okay. Great question, I think maybe I'm, sorry give me all it's doing that we're thinking about that but it seems to say exactly.
Asked me go forward plenty, you'll get a T T M T.
Nick Holm: And what is, what is the roughly the timeline for moving that into the clinic? So, that's something that we are not disclosing at this point in time, but I would also say that the first program into the clinic will be our May Day 4 program, using the same technology, but that happens to be further advanced. So, these things are tracking forward. To some extent, it depends on regulatory feedback on some of the CMT processes, etc., but we're not disclosing exactly when, but it's not imminent. Okay, great. Well, thanks for the update.
Semi-independent carpet on thank you much of anything so I think I'm gonna put cheese with how about anything tracking with authentic sorry yesterday I was doing it.
At this point getting how 'bout decided to gotcha, how that will.
Thanks, everybody.
Right.
Thank you and we do have another question from the line of Tony Butler with.
You're lying is open. Please go ahead [noise].
Yes, thanks very much for for for letting me ask another I'll be brief.
Oh, you made a.
And then lightning common about research cannibalizing existing products.
And then.
With respect to her last comment on.
The community Saturday.
As you think about outpatient the question really outpatient therapy question really is around.
Multiple dosing options right now where we most of therapy companies have a single both <unk>. It's just.
This.
Interesting and there was some a lot of exploration, but I'm just curious in the Grand scheme of things when we Wanna fess forward.
Nick Holm: Okay.
Wei Ji Chang: Thank you, and our next question comes from the line of Jonathan Chang with SBB Lyric. Your line is open; please go ahead.
Do you all sure.
Those are definitely ensure the view that really truly cures, we're going to come when you have.
Wei Ji Chang: Good morning, thanks for taking my questions and congratulations on the progress. First question, have the unconfirmed responses with the 2nd Gen MEJ-4 program reported at the time of ASCO been confirmed at this point?
Multi dose option functionality such the single bills.
Is most unlikely.
Two two <unk> at least as we think across a variety of salt tumors. Thank you.
Yeah.
Maybe I'll take.
I I think the short answer is yeah, we we don't know.
Elliot Norry: So we haven't issued any new information on that, and we will do so at the clinics later this year.
Tony what the dynamic is between.
Between dosing.
Wei Ji Chang: Got it. And second question, I guess related to that, for both the MAGE A4 first-gen and second-gen programs, beyond sarcoma, how should we be thinking about durability of responses? What are the reasons for confidence in the durability of responses, and how are you thinking about benchmarks for durability? Hmm.
And a a single versus multi antigen approaches.
In order to get to curative therapies or any other faster, but we and others are looking at in order to get too broadly curative therapies. We do we have the experience of reducing patience.
Adrian G. Rawcliffe: That's a good question. I think the reasons for confidence are a little difficult because, to me, confidence requires data, and daytime, and patience, and we're in the process of gathering those, so we all understand a lot more about the longevity of the responses and the nature and rate of them as we go through these trials, which are, you know, I want to be clear, the SURPASS study, for example, is in dose escalation. The fact that we saw So I think we'll understand that, and in terms of, as we recruit those patients, in terms of the question of what I think benchmarks are, I think that largely depends on the indication and the setting that we're going after.
In in our trials and we have I would suggest.
T have that is somewhat mix that would definitely some patients who have responded.
To the second infusion of cells and there are some patients where the reason <unk> from a response bearing in mind way Roni, we dosing impatiens, where there was continued expression of the of the topic antigen.
So so I think the jury's out on on whether second second multiple dosing will be required I think in the context of the current paradigm of nymphet depletion.
That'll be asleep put some extra huddle on second or third those things so to the extent evolution around it believed depletion regimen that would be.
Interesting to.
Help get to a place where have more routine dosing as possible.
And then lastly, it's obvious that different products formats in particular, we think about allogeneic platform.
Adrian G. Rawcliffe: I think we'll have a bit more data or a bit more information to share when we talk about the nature of the gastroesophageal trial that we're setting up later on this year and as we go into next year, where I think we've got an understanding of where the benchmarks are in the second and third line settings, but elsewhere it's going to depend on what those settings are and what else is out there at the time that we see that signal.
Make a multiple dosing.
Potentially easier as well as potentially being able to address some of the other drivers that's mice leads to the mightily too.
Yeah, more prolonged durable responses and potentially even cure tip therapy in due course as well sorry.
Alright, and we will continue to explore all of <unk> elements as we think about how best to.
Wei Ji Chang: Got it. And just last question. Zooming out, with the promising early data from the next-gen MAYJ4 program, how are you thinking about potential pipeline prioritization with regard to the first-generation program? Thank you.
Treat the patients with also therapies.
[noise] hi teenagers.
[noise] [noise], thank you and I'm showing no further questions at this time and I would like to turn the conference back over to Adrian request for any further remarked.
Thank you very much and thanks, everybody for your time and your questions. Today, we've made great progress in the first off the 2020.
Adrian G. Rawcliffe: That's a really good question. I mean, strategically for us, the commitment that we've made is that when we see a signal, such as we have done a very robust signal in sarcoma, and there's a clear unmet medical need, and it's definitely there with the first generation, with that first-generation program as fast as we can get to market, and I think there's a there's a
Bush bored with the products and sarcoma aggressively and we are generating responses across a broad range of solid tumors and I look forward to updating you all as we continue to make progress to bring all spayed T cells to <unk> cancel and with that replace the cool. Thank you.
Ladies and gentlemen, thank you for participating in today's conference. This does conclude the program and you may all disconnect everyone have a great day.
[music].
Adrian G. Rawcliffe: It's important to do that because the evolution of these products can be quite rapid because we're getting real-time translational data that we can feed back into research and back into manufacturing. And so there will always be the potential for something better coming down the pipe.
Adrian G. Rawcliffe: And I don't think that benefits anybody to constantly be waiting for the perfect cell therapy product; rather, our objective is where we see significant benefits to patients to move those things as quickly as possible. Having said that, the ADPA2M4 pilot trial has now finished, enrolling with the exception of the radiation sub-study. And so our focus for MAGE A4, for example, is very much on the SURPASS study, the second generation program, the combination of the Gen 1 with head and neck cancer with Pembrolizumab and on the radiation sub-study, so augmented approaches beyond the Gen 1 outside of sarcoma, where obviously we have a product that's progressing towards registration. So that's sort of how we think about it conceptually.
[music].
Wei Ji Chang: I think cell therapy companies have got to get comfortable with the fact that if we are successful, then our emerging research will cannibalize our existing products as they are on the market. And that's just a feature of this space, at the early stage of this space. And our integrated capabilities enable us to understand that and to prioritize and execute.
Wei Ji Chang: Got it. Thank you. Thanks for taking the question. Thanks, everyone.
Gabriel Song: Thank you. And again, ladies and gentlemen, if you have a question at this time, please press star then 1. Our next question comes from the line of Gabriel Song with Mazzuho Securities. Your line is open. Please go ahead.
Gabriel Song: Hi there everyone, this is Gabriel on behalf of Mara Goldstein. Um, there's a question here on the data, hi, hi, um, for Surpass. Could we expect that to be a SMART guide for which, um, uh, target provinces? And also on the manufacturing, are there any expected differences in yield and cost using the Navy Yard facility to manufacture cells for spearhead?
Adrian G. Rawcliffe: Thanks for taking the question.
John Lunger: Sure. So I'll take the first one on Surpass. And if you look very carefully in the headlines of our press release, you'll see that we're guiding to Q4 for that, and ESMO's in September. So the answer to that is no, it's not going to be at ESMO. And then, secondly, I'll hand over to John to talk about the Navy Yard manufacturing and costs of that.
Adrian G. Rawcliffe: Yeah, so in terms of, this is John, in terms of manufacturing costs, one of the things that we mentioned earlier is that we have our own in-house vector, which we plan to use later on in the year, so certainly, insourcing vector will have a positive impact on COGS. One other thing we're also continuing to do is just optimize how we actually run the Navy Yard facilities. So we're investing a fair bit of time and resources in electronic systems, for example, which allow us to optimize the process and reduce the overhead that goes into each one of those. So, I'd say that it's a continuous process of improving our costs, and we're making some fairly big step changes in terms of efficiency and optimization as we go along. Great, thanks. And actually, just one really quick follow-up here. I was just wondering, has the company ever – or actually, how does the company think about exploring your assets, your candidates in the outpatient setting, and whether or not this could be a potential use in the future?
Helen Katrina Tayton: Helen, do you want to talk to him about that?
Helen Katrina Tayton: Yes, yeah, this is Helen. It's a great question, and I think that the answer is, yes, we are exploring that, we're thinking about that, but it's too soon to say exactly what that will look like as we move forward. Clearly, the ability to treat in a community setting depends quite a bit on safety as much as anything, so I think, and we're quite pleased with how that has been tracking with our therapies, so yes, we are exploring it, but at this point, we don't have a definitive answer as to how that will look.
Gabriel Song: Thanks, everybody.
Tony Butler: Thank you, and we do have another question from the line of Tony Butler with Your line is open, please go ahead.
Tony Butler: Yes, thanks very much for letting me ask another question. I'll be brief. Elliot, you made an enlightening comment about research cannibalizing existing products. And then, with respect to Helen's last comment on the community setting and effect, as you think about outpatient therapy, the question really is around multiple dosing options. Right now, clearly, most cell therapy companies have a single dose. You know, re-dosing is just, interesting, and there's a lot of exploration, but I'm just curious, in the grand scheme of things, when we want to fast forward, do you all share or... Does adaptome share the view that really, truly cures are going to come when you have, you know, a multi-dose option, optionality such that a single dose is most unlikely to generate cures, at least as we think across a variety of cell tumors? Thank you.
Adrian G. Rawcliffe: Yeah, so may I speak? I think the short answer is...
Adrian G. Rawcliffe: We don't know, Tony, what the dynamic is between dosing and single versus multi-antigen approaches in order to get to curative therapies or any other facet that
Adrian G. Rawcliffe: We and others are looking at, in order to get to broadly curative therapies; we do, we have experience of re-dosing patients in our trials, and we have, I would suggest, the reality of that is somewhat mixed. There are definitely some patients who have responded to the second infusion of cells, and there are some patients where there isn't a response, and bearing in mind we're only re-dosing in patients where there is continued expression of the target antigen. So I think the jury is out on whether second multiple dosing will be required. I think in the context of the current paradigm of lymph depletion, that obviously puts an extra hurdle on second or third dosing. So to the extent of the evolution around the lymph depletion regimen, it would be interesting to help get to a place where more routine dosing is possible.
[music].
Adrian G. Rawcliffe: Lastly, it's obvious that different product formats, and in particular, we think about our allogeneic platform, make multiple dosing potentially easier as well as potentially being able to address some of the other drivers that might lead to more prolonged, durable responses and potentially even curative therapy in due course as well. And we will continue to explore all of those elements as we think about how best to treat patients with our cell therapy. Thank you, Adrian.
Adrian G. Rawcliffe: Thank you, and I'm showing no further questions at this time, and I would like to turn the conference back over to Adrian Rawcliffe for any further remarks.
Adrian G. Rawcliffe: Thank you very much and thank everybody for your time and your questions today. We've made great progress in the first half of 2020. We've pushed forward with the products in sarcoma aggressively, and we are generating responses across a broad range of solid tumors, and I look forward to updating you all as we continue to make progress to bring our T-cells to people with cancer. And with that, we'll close the call. Thank you.
[music].
Operator: Ladies and gentlemen, thank you for participating in today's conference. This does conclude the program, and you may all disconnect. Everyone have a great day.
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