Q3 2021 Adaptimmune Therapeutics PLC Earnings Call
[music] Good day, and thank you for standing by and welcome to the Q3 2021 adapting mean earnings conference call.
This time, all participants are in a listen only mode. After the speaker presentation, there will be a question and answer session.
Operator: Participants are in a listen-only mode. After the speaker's presentation, there will be a question and answer session. To ask a question during the session, you will need to press star 1 on your telephone. Please be advised that today's conference is being recorded. If you require any further assistance, please press star zero. I would now like to hand the conference over to your speaker today, Julie Miller. Please go ahead. Good morning, and welcome to Adapt Immune's conference call to discuss our third quarter.
You ask a question during the session you will need to press star one on your telephone.
Please be advised that today's conference is being recorded if you require any further assistance. Please press star zero.
I'd now like to hand, the conference over to your Speaker today Juli Miller. Please go ahead.
Good morning, and welcome to adapt and me on this conference call to discuss our third quarter 2021 financial results and business update.
Unknown Speaker: Please review our forward-looking statements from this morning's press release as we anticipate making projections during this call, and actual results could differ materially due to several factors, including those discussed in our latest filings with the SEC. Adrian Rockliff, our Chief Executive Officer,
Please review our forward looking statements from this mornings press release, as we anticipate making projections during this call and actual results could differ materially due to several factors, including those outlined in our latest filings with the SEC Adrian Roberts, Our Chief Executive Officer is with me for the prepared portion.
Unknown Speaker: Other members of our management team will be available for Q&A. With that, I'll turn the call over to Adrian Rockliff,
<unk> of this call.
Other members of our management team will be available for Q&A with that I'll turn the call over to Adrian Rockland AD.
Unknown Speaker: to Adrian Rockliff. Thanks, Deere.
Thanks Sterling.
Adrian G. Rawcliffe: And thank you everyone for joining us. About this time last year, we laid out our 2252 strategies. We are now one year into that five-year strategy, and we've made substantial progress against each of the four pillars we set out. The first pillar was that we wanted to have two marketed products targeting May J4. And the second pillar was to identify further indications for two additional BLAs for our SPIR T cell. The first product we're targeting for approval is our first generation TCR T cell therapy targeting Maj A4, a FAMESAR.
And thank you everyone for joining us.
This time last year, we laid out our <unk> T cells.
We are now one year into the <unk> strategy and we've made substantial progress against each of the four pillars, we set out.
The first pillar was we wanted to have two marketed products targeting MAGE, a pool and the <unk>.
Second was to identify further indications with two additional <unk> spear T cell products.
The first with Oxy for approval as a first generation TCR T cell therapy targeting MAGE April myself.
Adrian G. Rawcliffe: In June, we presented initial data from the Spearhead 1 trial at ASCO, demonstrating that Famistale is a life-changing therapy for people with Sonobial Starcoma and MRCLS. We remain on track to file our first BLA next year for FAMISAR, which we anticipate will be the first engineered T-Cell therapy on the market for a solid tuber indication. Based on the data presented recently at ESMO from the surpass trial, we have shown that our next-gen, May J-4 targeted therapy, ADPA2M4 CDA, is effective with responses in five different solid tumors, an overall response rate of 36%, and an 86% disease control rate. These data confirm the potential of a broader Mejavehaport therapy franchise.
In June we presented initial data from the spearhead one trial.
Demonstrating that the domicile is a life changing therapies to people with synovial sarcoma and MLC.
We remain on track to file our first BLA next year for a peso, which we anticipate will be the first engineered T cell therapy on the market for solid tumor indications.
Based on the data presented recently at <unk> from the <unk> trial, we have shown the non nextgen major <unk> targeted therapy <unk> in both CDI.
As expected with responses in five different solid tumors.
On overall response rate of 36%.
86% disease control rate.
These data confirm the potential of a broader maintain full therapy franchise.
In Q3, we announced that we initiated the phase two <unk> two trial for people with the GL and DJ Kansas.
Adrian G. Rawcliffe: In Q3, we announced that we initiated the phase two surpass two trial for people with esophageal and eGJCAT. Today, we announced that we'll start a second phase two trial next year called surpass three for patients with ovarian cancer. We continue to enroll patients in the original Phase 1 for Past trial with a focus on rapidly identifying additional additional indications for late stage development. Now on to our third pillar, five new Autologous products in the clinic from our extensive preclinical pipeline by 2025. We've reported substantial progress with additional HLAs, new targets, and next-gen programs.
Today, we announced that we will start a second phase II trial next year could surpass three for patients with ovarian cancer.
We continue to enroll patients in the original phase <unk> trial with a focus on rapidly identifying additional indications for late stage development.
On to our third pillar.
Find new autologous products in the clinic from our extensive preclinical pipeline by 2025.
We reported substantial progress with additional hla's, new targets of Nextgen programs with our most advanced preclinical therapies being the next generation engineered IL seven til therapy.
In collaboration with CCI, Denmark.
And our next Gen MAGE, a full targeted therapy, incorporating <unk> developed in collaboration with Nuomi.
Additionally, the translational data we'll present the CCAR 60 next week showed a stellar quality of our translational science days and how the learnings from this research will help us develop better products to take into the clinic.
Last but not least is our fourth pillar to allogeneic products in the clinic by 2025.
In this morning's press release, we do so we plan to file our first IND in 2023 crore wholly owned allogeneic product targeting MAGE <unk>.
Adrian G. Rawcliffe: With our most advanced pre-clinical therapies being the next-generation engineered IL-7 TIL therapy in collaboration with CCIT Denmark and our next-gen, Mej4 targeted therapy, incorporating IL7 and CCL-19, developed in collaboration with Neulimim. Additionally, the translational data we will present at CETOS and SITSE next week will show the stellar quality of our translational science teams and how learnings from this research will help us develop Last but not least, our fourth pillar.
In Q3, we signed a fantastic strategic collaboration with Genentech that has now become effective for which we will receive the upfront payment of $150 million in Q4.
Okay.
We also announced that we would open a dedicated allogeneic manufacturing facility next year.
I believe that our allied platform represents a significant piece of the future of cell therapy for us and our partners and this progress confirms we are amongst the leaders in the allogeneic T cell space.
Looking forward, we will continue to deliver updates from our trials from our clinical and translational perspective.
Following the initial data presented at <unk> call pivotal spearhead one trial next week, we will present, a fuller data set of <unk> oral presentation Lithophyte, Brian Van Tine from Washington University.
We have also presented a poster highlighting translational scientific insights from this trial.
Adrian G. Rawcliffe: Two allergenetic products in the clinic by 2025. In this morning's press release, we confirmed that we plan to file our first I&D in 2023 for a wholly owned allergenetic product targeting Major A4. In Q3, we signed a fantastic strategic collaboration with Genentec that has now become effective and for which we will receive the upfront payment of 150 million in Q4. We also announced that we would open a dedicated allergenic manufacturing facility next year.
At <unk> next week.
Presented data demonstrating the positive impact of adding an 8-K T inhibitor to the expansion phase of our manufacturing process.
It is a feature of developing cell therapies. The epigenetic modifications during manufacturing have the potential to be as important as the genetic modifications, we made to the cells themselves.
And the same poster we will present clinical translational lettings for patients in the <unk> trial.
We reported clinical data at ESMO.
Indicating that these manufacturing improvements along with the nexgen and hubs months make an improved and more potent spear T cell product for people with cancer.
These types of translation of learning is critical as we aim to bring forward further nexgen products in house was debenture address solid achievements with our cell therapy.
We're looking across the pipeline of ongoing clinical trials with our <unk> two goals in mind, we need to pursue our ambitious rapidly and efficiently and critically evaluate what is and is not appropriate.
Today, we announced that we have ceased enrollment in our spearhead two trial with <unk> in combination with <unk>.
Given the compelling activity seen with our next Gen <unk> four CBA products across a range of solid tumors next year, we'll evaluate the combination of a checkpoint inhibitor with this therapy.
Adrian G. Rawcliffe: I believe that our Allo platform represents a significant piece of the future of cell therapy for us and our partners, and this progress confirms that we are amongst the leaders in the Allergenetic T-Self space. Looking forward, we will continue to deliver updates from our trials from a clinical and translational perspective. Following the initial dates presented at ASCO for our pivotal Spearhead 1 trial, next week we will present a full data set at CETOS in an oral presentation limited by Dr. Brian Van Tide from Washington University.
We will not go into details today, but we will update in due course about the best design and the path forward.
We also announced that we've enrolled a sufficient number of patients in our phase one trial with ADP <unk> paid for people with liver cancer, leading us to claim screening.
We presented data demonstrating the AEP to AFP as an active product with several patients receiving clinical benefit, including a durable complete response and other patients with prolonged stable disease associated with the significant decrease in serum AFP.
So the response rate to date is not what we had hoped.
We have analyzed data from the full patient population in this trial.
Seven next steps, including evaluation of alternatives at Tcl.
Manufacturing improvements and potential nextgen in houses.
Yes.
So far in 2021, we've delivered clear progress against our <unk> strategy and we will continue to deliver over the next four years.
We're on track followed first BLA sharing compelling data from the Pos confirming the potential of the major Botox franchise and we're working quickly to pursue further late stage trials, starting with the recently initiated <unk> trial, and our self the G&A EJ tenses, a Basel III and ovarian cancer, which was initiated in 2022.
Adrian G. Rawcliffe: We will also present a poster highlighting translational scientific insights from this trial at SITSE next week. We'll present data demonstrating the positive impact of adding an AKT inhibitor to the expansion phase of our manufacturing process. It's a feature of developing cell therapies that epigenetic modifications during manufacturing have the potential to be as important as the genetic modifications we make to the cells themselves. In this same poster, we will present clinical translational learnings from patients in the surpass trial for whom we reported clinical data at ESMO, indicating that these manufacturing improvements, along with the next-gen enhancements, make an improved and more potent spear T-cell product for people with cancer.
We are also planning to explore the use of checkpoint inhibitors alongside our nexgen products with the aim of identifying further treatment regimens for our cell therapies for people with cancer.
Beyond our current clinical trials, we have continued to make progress with our autologous and allogeneic preclinical pipeline, including in collaboration with GSK Astellas and most recently genentech.
Our progress this year brings us closer to achieving our vision of being a fully integrated cell therapy company and you can really see this when you consider that we are filing a BLA and preparing for our first commercial product while simultaneously building at allogeneic manufacturing facility for future generations of cell therapies to people with cancer.
As we put it out the year I'm pleased with our progress and we'll provide further guidance for 2022 at the beginning of next year with that I'll turn it over for questions operator.
As a reminder, if you would like to ask a question. Please press Star then the number one on your telephone keypad again. It is star then the number one Andrew.
And your first question comes from Marc Frahm with Cowen and company.
Yes, thanks for taking my questions.
Maybe on the.
On the filing is what other than obviously the presentation.
A week or two times, what's gating for the filing going in.
Is it just a little bit more follow up on a few last.
Last few patients.
Or are there still kind of real discussions we had on things like potency assays and exactly what needs to be included on that front.
Yeah.
And it's too expensive.
Yes sure.
Hi, Mark and thank you.
Adrian G. Rawcliffe: These types of translational learnings are critical as we aim to bring forward further next-gim products and enhancements to better address solid tumors with our cell therapy. We're looking across the pipeline of ongoing clinical trials with our 22552 goals in mind. We need to pursue our ambitions rapidly and officially and critically evaluate what is and is not a product.
Just.
With respect to the BLA filing.
Nearly various the data still needs to be.
Not in its final format.
It needs to be presented in the appropriate way.
The.
That.
Cohort that will support.
The filing cohort one from the spearhead one trial has completed so all the patients are enrolled and data collected and will be finalizing that dataset in the fairly near future.
So.
While that there is still work to be done I don't think that thats necessarily gating per se. There is also still work to be done with respect to demonstrating that in our manufacturing and release testing are acceptable to the agencies.
Adrian G. Rawcliffe: Today we announced that we've ceased enrollment in our Spearhead 2 trial with a famer cell in combination with Pembralisma. Given compelling activities with our next gen, ADPA2 and 4 CD8 product across a range of solid tumors, next year we'll evaluate the combination of a checkpoint inhibitor with this therapy. We will not go into details today, but we'll update in due course about the best design for the past forward.
And.
That go side by side with meeting the primary endpoint for efficacy and showing an acceptable safety profile.
And while I don't.
<unk>.
While I don't think that there are issues.
Issues.
That are insurmountable in either of those there is still and any of those there is still work to be done.
And that that work will take us out into <unk>.
Adrian G. Rawcliffe: We also announced that we have enrolled a sufficient number of patients in our phase one trial with ADPA2A2 for people with liver cancer, leading us to close screening. We presented Data Elka demonstrating that ADPA2AFP is an active product, with several patients receiving clinical benefits, including a durable, complete response, and other patients with prolonged stable disease associated with a significant decrease in serum AFP. But the response rate to date is not what we had hoped for.
Into 2022, and we're on track to meet the timeline to file a BLA next year.
Great. Thanks, that's very helpful.
And then.
Maybe.
Got you.
Just opening surpassed two and surpass III hasnt fully open yet, but just given the.
Increased demand for your trials, you've seen over the last year.
Six months.
Or two a year.
You gave some broad outlines you can give on how quickly those trials might enroll and when we might be able to start seeing data from some of those expansions into tumor specific cohorts.
We have not given guidance on timing so that we will give guidance on the.
2022 milestones and probably beyond at the beginning of next year.
Adrian G. Rawcliffe: We'll analyze data from the full patient population in this trial and determine next steps, including evaluation of alternative TCRs, manufacturing improvements, and potential next-gen enhancement. So far in 2021, we've delivered clear progress against our 2252 strategy, and we will continue to deliver over the next four years. We're on track to file our first BLA, we're showing compelling data from surpass, confirming the potential of the Majay4 targeted franchise, and we're working quickly to pursue further late-stage trials, starting with the recently initiated Spass 2 trial in esophageal cancer, LNG J cancers, and surpass 3 in ovarian cancer, which will start in 2022.
But.
Whoa deeply specific guidance on rates of accrual in those trials.
So.
Okay, Alright fair enough.
Thanks for taking my questions.
Sure.
Your next question comes from Michael Schmidt with Guggenheim.
Hey, guys. Good morning, Thanks for taking my questions.
I think you mentioned that you're in.
Initiating a new.
Pam Burleson map combination study with the Nexgen <unk> four asset, which obviously makes sense, but I was just wondering if there are any learnings from the initial trial.
It can be applied here.
The combination moving forward.
Yes so.
Hi, Michael Thank you.
But there are certainly learnings I mean, we're.
Adrian G. Rawcliffe: We are also planning to explore the use of checkpoint inhibitors alongside our next-gen product, with the aim of identifying further treatment of prejuice for our cell therapies for people with cancer. Beyond our current clinical trials, we've continued to make progress with our autologous and allergenic preclinical pipeline, including in collaboration with GSK, Estella, and most recently Genente. All of our progress this year brings us closer to achieving our vision of being a fully integrated cell therapy company.
<unk>.
We should be learning from everything that we do as it informs our next steps.
The real reason for us choosing to.
Really changed the focus of the combination to the Nexgen product is based on really at this point, having experience with the next generation products seeing it's improved.
Improved.
Potency efficacy and wanting to put sort of the best combination forward.
I think thats really the key point here.
Okay.
Okay got it and then.
The other question I had.
Perhaps related to <unk>.
Prior question just on CMC.
For a family.
Adrian G. Rawcliffe: And you can really see this when you consider that we are filing a BLA and preparing for our first commercial product, while simultaneously building an allergenetic manufacturing facility for future generations of cell therapies for people with cancer. As we close out the year, I'm pleased with our progress, and we'll provide further guidance for 2022 at the beginning of next year.
We have seen a number of.
Of FDA BLA delays around manufacturing in CMC.
Cheetah products and if you could.
Maybe provide some additional color in terms of what has to be done to really check the box on CMC.
For the BLA.
Yes.
Yes, Hi, this is John John longer.
I lead the CMC organization. So a couple of things. There. One is we are obviously going through all the activities we need to do to prepare this section three of the BLA the supply of our commercial product will come from the same supply chain that we've used for the phase III trial. So there's no changes in there, which I think is a big plus for us.
Operator: As a reminder, if you would like to ask a question, please press star, then the number one on your telephone keypad. Again, that is star, then the number one. And your first question comes from Mark Fram with Cowan Company.
We've had interactions related to potency assays and all the release assays frankly in and those are progressing well and we feel confident that we've got the right assays in place and we will have them in place by the time, we file the BLA next year.
Okay. Thanks, and then last one just around the Genentech collaboration obviously very interesting given there.
Elliot Norry: Thanks for checking my question. Maybe on the filing, other than, obviously, the presentation in about a week at C-Tos, what's the kind of gate to the filing going in? Is it just a little bit more follow-up on a few, the last few patients? Or are there still real discussions that we have had on things like potency assays and exactly what needs to be included from that front? Elliot, do you want to pay them?
Given their engagement with adaptive as well, but just wondering how we should think about potential news flow coming out of that collaboration over the next one to two years or so.
Hi, Michael.
It will take longer.
Here again.
And we haven't disclosed specifics.
Great.
Perhaps specific updates.
We can.
We can see that.
The condition of Nippon steel.
Leslie.
Alright.
Handmade Chad.
Thank you.
We are ready to give guidance, but we will be updating Chris.
Detailed disclosures.
Okay.
When we can provide.
Nathan.
Great. Thank you.
Thanks Mark.
Your next question is from Nick Abbott with Wells Fargo.
Elliot Norry: Yeah, sure. Hi Mark, and thank you. Just with respect to the BLA filing, clearly, the data still needs to, is not in its final format, and, you know, needs to be presented in the appropriate way. Cohort one from the Spearhead 1 trial has completed, so all the patients are enrolled, and data collected, and we will be, you know, finalizing that data set in the fairly near future.
Hey, good morning, Thanks, taking my questions.
Yes, congratulations on a very very good update very solid.
You mentioned earlier, we have totaled <unk> two but there is also a cohort two.
So can you provide any details on how that is enrolling.
Yes.
Without.
Without providing specific numbers it continues to enroll well.
There's clearly interest in treating patients with.
<unk>, who have synovial sarcoma.
And.
So.
Elliot Norry: So while there's still work to be done, I don't think that that's necessarily, you know, gating, per se. There is also still work to be done with respect to demonstrating that, you know, our manufacturing and release testing are acceptable to the agencies. And, you know, that goes side by side with, you know, meeting the primary endpoint for efficacy and showing an acceptable safety profile. And while I don't... Well, I don't think that there are issues that are insurmountable in either of those, there is still, in any of those, there's still work to be done.
The answer to the recruitment question.
It's not intended to be part of the hypothesis testing for the filing but will be supported from the standpoint of additional safe.
Safety and efficacy.
Considerations as well as looking at specific subgroups.
Okay. Thanks Elliot.
In your prepared comments that you mentioned to Paul three in ovarian cancer.
Is the intent.
Have you discussed the size of this trial with FDA is the intention to seek registration if that's positive.
I think it's early to push push the boat out too far on exactly what the trial looks like and.
And.
To.
Disclose conversations with FDA.
<unk>.
Yes.
I think that's the answer yes. Thanks.
Okay.
And then.
Just going going back to.
Operator: And that work will take us out into 2022, and we're on track to meet the timeline to file the BLA next year. Okay, thanks, that's very helpful. And then maybe I realize, you know, you're just opening Surpast 2 and Surpass 3 hasn't fully opened yet, but just given the increased demand for your trials you've seen over the last, you know, six months or so, you have some broad outlines you can give on how quickly those trials might enroll and when we might be able to start seeing data from some of those expansions into tumor-specific cohorts.
The next set of trials over the next trial with <unk>.
Next Gen. If I'm a cell in a checkpoint inhibitor.
In the prepared comments that.
Statement is tied to spearhead two so I know you're not going to go into details, but is the plan here to test. This in a broad range of tumors or is it more as a replacement to spearhead two.
Yes.
Correct, Nick without going into great details.
It will it will likely be broader than just head and neck cancer, specifically what tumor types are in our in the study we havent discussed but is intended to be across tumor types not just a single tumor type.
Perfect Great. Thank you very much.
Thanks, Nick.
Your next question comes from Sean <unk> with Jones Research.
Hi, This is Daniel honestly.
Operator: We've not given guidance on timings for that, and we will give guidance on the 2022 milestones and probably beyond the beginning of next year, but it won't include specific guidance on rates of accrual in those trials.
First all of it.
Sure.
Chris.
Question would be can you provide some color on.
Spearhead two.
Two.
Please proceed trial, how many patients have been enrolled and when do you expect.
So expect data update.
Okay.
Okay.
Yes.
I think we have disclosed we have not moved any patients in that trial.
And if we haven't we just don't have.
Some of the reasons why we're closing that now so that we can get onto the.
Operator: So. Okay, fair enough. Thanks for taking my question. Thank you, thank you, Mark. Your next question comes from Michael Schmidt with Guggenheim. Hey guys, good morning, thanks for taking my questions.
<unk> more potent product in combinations with a multi product.
Got it thank you.
Can you provide.
Any.
Color on this depressed or I know you said that you provide further details but.
Thank you.
Moving on to ovarian cancer are you going to focus on Pascal resistance.
We can provide any.
Unknown Speaker: So I think you mentioned that you're, you know, initiating a new Pemberlism Map combination study with the next-gen major major asset, which obviously makes sense. But I was just wondering if there are any learnings from the initial trial that can be applied here in terms of the combination moving forward. Yeah, so, hi, Michael, thank you. There are certainly learnings. I mean, you know, we should be learning from everything that we do as it informs our next steps.
Details on that.
Yes. It is.
I wanted to touch on them.
So.
The.
We haven't really given details with respect to exactly what the patient population.
Look like there.
The current trial is enrolling patients who are platinum ineligible.
So not patients who are eligible to receive another.
Another cycle of platinum will typically get that from there from their physician before being entered into a clinical trial.
Thank you very much.
Your next question is from Mara Goldstein with Mizuho.
Great. Thanks, so much for taking the questions.
Can you maybe drill down a little bit into the allo program.
And I know you mentioned that you'll have manufacturing up.
Unknown Speaker: The real reason for us choosing to really change the focus of the combination to the next-gen product is based on really having experience with the next generation products, seeing their improved potency and efficacy, and wanting to put, you know, sort of the best combination forward. I think that's really the key point here. Got it. And then, you know, the other question I had, perhaps related to the prior question, just on CMC for a family sale.
Later in 2022, but maybe you could talk a little bit about if possible.
Particular focus I know the agreement calls for you to.
Look at five different.
So maybe if you could speak to us a little bit about that that would be helpful. And then I'm just curious.
Just on the Allogeneic program, given what we've seen obviously with allergies program and how you think about that.
Approaching FDA with your IMD.
Okay.
Thank you Mara this is independent.
Martin.
It is difficult to easily online program.
Well, we think we've made reference to building out our manufacturing facilities.
Hi, Mark.
Sure.
Our internal risk Jay for I'll add private brand that will be cancelled.
<unk> can be recycled.
Great 2023.
Unknown Speaker: I mean, we have seen a number of FDA, you know, BLA delays around manufacturing and CMC of TISA products. And yeah, if you could maybe just provide some additional color in terms of what has to be done to really check the box on CMC.
<unk>.
I appreciate these important assets.
Hello, Facebook collaboration programs.
That was the question I think in terms of okay.
There is nothing changed.
Have a proprietary differentiation pricing.
Tesco.
T cells.
Okay.
Rail and gaming and BNP.
Having already.
Great quarter.
Thank you.
In terms of the characterization, what we can to already I think.
So rather than to reality.
In July.
Sure.
At the time.
So differentiated product.
We see a great team at Athene, we presented a few ways.
And simulation and the interactions with the agency will be.
Deepwater against.
Other than the Sidoti and countries.
John Lunger: Yeah, this is John Lunger, the lead for the CMC organization. So a couple things there.
I think were quite good.
Okay.
Yes.
<unk> cell characterization of every step of the asking price cycle rates being important.
John Lunger: One is we are obviously going through all the activities we need to do to prepare Section 3 of the BLA. The supply of our commercial product will come from the same supply chain that we used for the Phase 2 trial. So there's no changes in there, which I think is a big plus for us. We had interactions related to potency assays and all the release assays, and those are progressing well, and we feel confident that we've got the right assays in place and we'll have them in place by the time we file the BLA next year.
Thanks.
Thank you.
Yes.
Karen advantage in some ways intensive exactly well.
The characterization in terms of edit and generated impressive data.
Clients and differentiation price tag.
Thank you.
The pension it will be important in our engagements with the FDA between now and <unk>.
Okay, and if I could just ask a different question, which is that as youre approaching.
The.
Filing.
For snowmobile sarcoma.
How are you planning to layer in our commercial organization as you approach that that filing period.
Operator: Okay, thanks. And then last one, just around the Genentech collaboration, obviously very interesting, given their engagement with adaptive as well. But just wondering how we should think about potential news flow coming out of that collaboration over the next, you know, one to two years or so.
Thank you.
Hello again.
So in terms of preparation as you would imagine given the time that it has been.
We're proud of the progress we have.
Have been laying the groundwork.
Actually dimension.
Commercial readiness, obviously looking a long ways out.
King.
The what.
<unk> prepared Scott in terms of authorization that initially you can touch on that team.
And looking very closely at.
<unk>, we need where we need them when we need them and we think they'll be recruiting NAND everything move to come on that I think as we get closer to.
The BLA filing.
Alright, well, thank you very much.
Sure.
Yes.
And there are no further questions at this time I will now turn the call back over to Adrian <unk> for closing remarks.
Helen Katrina Tayton: Yeah, hi Michael, it's Helen here and Tate Martin nice to speak with you again and we haven't disclosed specific when we'll have specific updates on the on the programme but clearly we anticipate that we will need to do that given our position and the importance of this deal to us and its progress and the fact that it's on a very long-term nature we've only just passed HFR clearance so I think it's a little early to give guidance on when we'll be updating but we hope that sort of during the course of the next year, we'll be able to sort of map out when we can provide more more data and more information. Great, thank you. Your next question is from Nick Abbott with Wells Fargo. Hey, good morning, thanks taking our questions and yeah, congratulations on a very, very good update, very solid.
So thank you everybody for your questions on what has been a very busy quarter and Lucas.
When we look to them to be a very busy next 12 months. It is notable that the questions that you asked kind of what the broad spectrum of the activities that define it that to be in from a BLA file all the way through our mid stage trials.
To the earlier parts of our allogeneic platform.
And also interesting that there is an increased focus which I think is representative of the industry focus at this point in time.
CMC aspects and actually making the products, which I think speaks to the investments that we've made I.
Consistently over the last five years as we seek to build on.
Integrated cell therapy company to deliver these.
These potentially transformative therapies to patients with us. Thank you for your time today.
Look forward to future discussions.
[music].
Operator: You mentioned earlier we have cohort one, it's fair, too, but there's also cohort two. So can you provide any details on how that is enrolling? Without providing specific numbers, it continues to enroll well. You know, there's clearly interest in treating patients with a family history who have synobial sarcoma. And, and...
Elliot Norry: So that's the answer to the recruitment question. It's not intended to be, you know, part of the hypothesis testing for the filing but will be supportive from the standpoint of additional safety and efficacy considerations as well as looking at specific subgroups. Terrific, thanks, Elliot. In your prepared comments, you mentioned PASS 3, the ovarian cancer trial, is the intent. Have you discussed the size of this trial with FDA as the intention to seek registration if it's positive?
Elliot Norry: I think it's early to push the boat out too far on exactly what the trial looks like and to disclose conversations with FDA. I think that that's the answer. Yeah, thanks. Okay, and then, just going back to the next set of trials or the next trial with next genifamacel and a checkpoint inhibitor. I mean, in the prepared comments, that statement is tied to spearhead, too. So I know you're not going to go into details, but is the plan here to test this in a broad range of tumors, or is it more as a replacement for spearheads?
Elliot Norry: Yeah, correct, Nick, without going into great detail, it will likely be broader than just head and neck cancer, specifically what tumor types are in the study we haven't discussed, but it is intended to be across tumor types, not just a single tumor type.
Unknown Speaker: Okay, perfect, great, thank you very much. Thanks, Dave. Your next question comes from Show Mitt Roy with Jones Research. Hi, this is Daniel Anfon.
Operator: I'm from Strzarin. The first question would be, can you provide them for us?
Unknown Speaker: First question would be, can you provide a piece on the spearhead too? As to since you ceased the trial, how many patients have been enrolled in it, and when we expect data updates? So, I think we have disclosed that we have not enrolled any patients in that trial. And if we have it, we just don't have it.
Unknown Speaker: And that's one of the reasons why we're closing that now so that we can get onto the more potent product in combination with the more potent product. Got it, thank you. And can you provide any color on the supratory inneris said that you provided for the details, but as you're moving on to ovarian cancer, are you going to focus on platinum resistance or can you provide details on that? Yeah, do you want to touch on that?
Unknown Speaker: Yeah, so we haven't really given details with respect to exactly what the patient population will look like. The current trial is enrolling patients who are platinum ineligible. So patients who are eligible to receive another cycle of platinum will typically get that from their physicians before being entered into a clinical trial. Thank you very much. Your next question is from Mara Goldstein with Missouho. Thank you.
Operator: Great, thanks so much for taking the questions. So I just wanted to maybe drill down a little bit into the Allo program, and I know you mentioned that you'll have manufacturing up later in 2022, but maybe you could talk a little bit about, if possible, the particular focus. I know the agreement calls for you to look at five different targets. So maybe if you could speak to us a little bit about that, that would be helpful. And then I'm just curious about the allergenic program, given what we've seen, obviously, with Allergeen's program and how you think about that vis-a-vis approaching FDA with your I-ND.
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Helen Katrina Tayton: Thanks Mara, this is Helen Tate and Martin again here, just to talk about the Allo program. Obviously, we've made reference to building out our aloe manufacturing facility, primarily in the first instance, that will be to support our internal May J4 allo program. That will be the first into the clinic, and the IAD will re-signaled in late 2023. You know, the Allo facility will initially be supporting that. Obviously, the capabilities and space will also support collaboration programs. So I think that was the first question.
Helen Katrina Tayton: And I think in terms of focus, obviously, we have a proprietary differentiation process from our edited stem cells to T cells that's going through the process of scale, scaling, and anti-MP transfer. So there is work to be done, hence having our own facility will be important as well components of that. And I think in terms of the characterization work, which is really, I think, you know, where it's relevant to the allergen position, obviously, that's a donor-derived product as opposed to a stem cell differentiated product.
Helen Katrina Tayton: Obviously, you know, it's a great team of allergy, and we, you know, we know that there will be evaluation and interactions with the agency. It will be important, not just for us but, you know, others in the field to make close change. I think we're quite, we have differences though, around the stem cell characterization at every step of the editing process. That's always been important for our approach. And I think that that also gives us, you know, perhaps an advantage in some ways in terms of knowing
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Helen Katrina Tayton: exactly what the characterisation in terms of edits has generated
Helen Katrina Tayton: has been generated at each step of the clone and differentiation process. So, you know, obviously, we'll pay a lot of attention to it, and it will be quite important in our engagements with the FTA between now and our IND filing.
Helen Katrina Tayton: Okay, and if I could just ask a different question, which is that as you're approaching the filing for the snow veal sarcoma, how are you planning to layer in a commercial organization as you approach that filing period?
Helen Katrina Tayton: So, thanks, Mara, and Helen again here. So, in terms of the preparation, as you would imagine, given the plans for steerhead, stairhead one trial, and the progress through it, we have been laying the groundwork for every dimension of commercial readiness, obviously looking a long ways out. That obviously includes the work to prepare and scale up John's organization, and I'm sure you can touch on that too. But we have also.
Helen Katrina Tayton: We've also been looking very closely at what type of team we need, where we need them, when we need them, and have been building accordingly. And there'll be more to come on that, I think, as we get closer to the BLA filing. All right. Well, thank you.
Adrian G. Rawcliffe: All right, well, thank you very much. Cheers, Rob. And there are no further questions at this time. I will now turn the call back over to Adrian Rockcliffe for closing remarks.
Adrian G. Rawcliffe: So thank you everybody for your questions on what has been a very busy quarter and looks forward to being a very busy next 12 months. So it's notable that the questions that you asked cover the broad spectrum of the activities that define Adapt to Me from our BLA file all the way through our mid-stage trials and into the earliest parts of our allergeniac platform. And also interesting that there's an increased focus, which we think is representative of the industry focus at this point in time on the CMC aspects and actually making the product, which I think speaks to the investment that we've made consistently over the last five years as we seek to build an integrated cell therapy company to deliver.
Operator: Patients, and with that, thank you for your time today, and we look forward to future discussions. This concludes today's conference call. Thank you for participating. You may now disconnect.
Operator: and Thank you. Thank you. Thank you. Thee and and and Thank you. Thank you, Thank you, Thank you.
Operator: Thank you Thee. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you, and thank you. Thank you. Thank you. Thank you, and I'm going to be I'm going to be.